Imraldi

Package leaflet: Information for the patient

Imraldi 40 mg solution for injection in pre-filled syringe

adalimumab
Please read all of this leaflet carefully before using this medicine because it contains important information for you

• Keep this leaflet. You may need to read it again.
• Your doctor will also provide you with a Patient Reminder Card containing important safety information that you need to know before receiving Imraldi and during treatment with Imraldi. Keep this Patient Reminder Card throughout your treatment and for 4 months after the last injection of Imraldi (yours or your child's).
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Imraldi is and what it is used for
2. What you need to know before using Imraldi
3. How to use Imraldi
4. Possible side effects
5. How to store Imraldi
6. Contents of the pack and other information
7. Instructions for use

1. What Imraldi is and what it is used for

Imraldi contains the active substance adalimumab, a medicine that acts on the immune system (the body's defence system).
Imraldi is indicated for the treatment of:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• enthesitis-related arthritis,
• ankylosing spondylitis,
• non-radiographic axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• psoriatic arthritis,
• psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis, and
• non-infectious uveitis.

The active ingredient in Imraldi, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that bind to a specific target.
The target of adalimumab is a protein called tumour necrosis factor (TNF α ), which is present at high levels in the inflammatory diseases described above. By binding to TNF α , Imraldi reduces the inflammatory process in these diseases.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease affecting the joints.
Imraldi is used to treat rheumatoid arthritis in adults.
If you have moderate to severe rheumatoid arthritis, other disease-modifying drugs such as methotrexate may initially be prescribed. If these drugs do not work satisfactorily, you will be given Imraldi to treat rheumatoid arthritis.
Imraldi may also be used to treat severe, active and progressive rheumatoid arthritis without prior treatment with methotrexate.
Imraldi can slow down the progression of cartilage and bone damage in the joints caused by the disease and improve physical function.
Imraldi is generally used in combination with methotrexate. If your doctor considers methotrexate treatment inappropriate, Imraldi may be given alone.

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory joint diseases that typically first appear in childhood.
Imraldi is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years. At diagnosis, other disease-modifying drugs such as methotrexate may be administered. If these drugs do not work satisfactorily, patients will be given Imraldi to treat polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Ankylosing spondylitis and non-radiographic axial spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory conditions affecting the spine.
Imraldi is used to treat ankylosing spondylitis and non-radiographic axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be given other medicines. If these medicines do not work satisfactorily, you will be given Imraldi to reduce the signs and symptoms of the disease.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease associated with psoriasis.
Imraldi is used to treat psoriatic arthritis in adults. Imraldi can slow down joint cartilage and bone damage caused by the disease and improve physical function.

Plaque psoriasis in adults and children
Plaque psoriasis is an inflammatory skin condition causing red, scaly and thickened patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thicker, or lift from the nail bed, which can be painful. Psoriasis is believed to be caused by a problem with the body’s immune system leading to increased production of skin cells.
Imraldi is used to treat moderate to severe plaque psoriasis in adults. Imraldi is also used to treat severe plaque psoriasis in children and adolescents weighing 30 kg or more when topical therapy and phototherapies have not worked optimally or are not suitable.

Hidradenitis suppurativa in adults and adolescents
Hidradenitis suppurativa (sometimes called acne inversa) is a chronic inflammatory skin disease, often painful. Symptoms may include painful nodules and abscesses (cysts) that may drain pus. It most commonly affects specific skin areas such as under the breasts, armpits, inner thighs, groin, and buttocks. Scarring may also develop in affected areas.
Imraldi is used to treat hidradenitis suppurativa in adults and adolescents aged 12 years and older. Imraldi can reduce the number of nodules and abscesses you have and the pain often associated with this disease. You may initially receive other medicines. If you do not respond adequately to these medicines, you will be given Imraldi.

Crohn’s disease in adults and children
Crohn’s disease is an inflammation of the intestine.
Imraldi is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If you have Crohn’s disease, you will first be given other medicines. If these medicines do not work satisfactorily, you will be given Imraldi to reduce the typical symptoms of Crohn’s disease.

Ulcerative colitis in adults and children
Ulcerative colitis is an inflammation of the large intestine.
Imraldi is used to treat moderate to severe ulcerative colitis in adults and children aged 6 to 17 years. If you have ulcerative colitis, you may first take other medicines. If these medicines do not work satisfactorily, you will take Imraldi to reduce the signs and symptoms of the disease.

Non-infectious uveitis in adults and children
Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
Imraldi is used for the treatment of:

• Adults with non-infectious uveitis with inflammation affecting the back of the eye
• Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye

This inflammation may lead to reduced vision and/or the presence of floating bodies in the eye (black spots or fine lines moving across the visual field). Imraldi works by reducing this inflammation.

2. What you should know before using Imraldi

Do not use Imraldi

• If you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have a serious infection, including tuberculosis (see "Warnings and precautions"). It is important to inform your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, or dental problems.
• If you have moderate or severe heart failure. It is important to inform your doctor if you have had or currently have a serious heart condition (see "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before using Imraldi.

Allergic reaction

• In case of allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or skin rash, do not administer Imraldi again and contact your doctor immediately, as these reactions may, in rare cases, be life-threatening.

Infection

• If you have an infection, including long-term or localized infections (e.g., leg ulcers), consult your doctor before starting treatment with Imraldi. If you are in doubt, contact your doctor.
• You may be more likely to get infections while being treated with Imraldi. This risk may increase if your lung function is reduced. These infections can be serious and may include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, other opportunistic infections (unusual infections associated with a weakened immune system), and sepsis (blood poisoning). In rare cases, these infections may be life-threatening. It is important to inform your doctor if you experience symptoms such as fever, wounds, feeling tired, or dental problems. Your doctor may advise temporarily stopping Imraldi.

Tuberculosis

• Cases of tuberculosis have occurred in patients treated with Imraldi. Therefore, your doctor will check for signs and symptoms of tuberculosis before starting therapy with Imraldi. This will involve a detailed medical evaluation, including your medical history and clinical examinations (e.g., chest X-ray and tuberculin skin test). The performance and results of these tests must be recorded in the Patient Reminder Card. It is very important to inform your doctor if you have ever had tuberculosis or have had close contact with people who have tuberculosis. Tuberculosis may develop during treatment even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, lack of energy, low-grade fever) or other infections occur during or after treatment.

Travel/recurrent infection

• Inform your doctor if you have lived in or traveled to regions where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic.
• Inform your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

• Inform your doctor if you are a carrier of hepatitis B virus (HBV), if you have an active hepatitis B infection, or if you think you may be at risk of contracting hepatitis B virus. Your doctor must test you for hepatitis B infection. Taking Imraldi may reactivate hepatitis B virus infection in carriers of this virus. In rare cases, especially if you are also taking other medicines that suppress the immune system, reactivation of hepatitis B virus infection may be life-threatening.

Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Imraldi. You and your doctor should pay particular attention to signs of infection during treatment with Imraldi. It is important to inform your doctor if symptoms of infection such as fever, wounds, feeling tired, or dental problems occur.

Surgery or dental procedures

• Before undergoing surgery or dental procedures, inform your doctor that you are taking Imraldi. Your doctor may advise temporarily stopping Imraldi.

Demyelinating disease

• If you have or develop a demyelinating disease (diseases affecting the protective covering of nerves, such as multiple sclerosis), your doctor will decide whether to start or continue treatment with Imraldi. Inform your doctor immediately if you experience symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling in any part of the body.

Vaccines

• Certain vaccines contain weakened but live bacteria or viruses and must not be given during treatment with Imraldi. Consult your doctor before receiving any vaccination. In children, it is recommended, if possible, to complete the age-appropriate vaccination schedule before starting treatment with Imraldi. If you receive Imraldi during pregnancy, the baby may have an increased risk of infection for up to approximately 5 months after your last dose during pregnancy. It is important that you inform the paediatrician or other healthcare provider about your use of Imraldi during pregnancy so they can decide when the baby should receive any type of vaccination.

Heart failure

• If you have mild heart failure and are being treated with Imraldi, your doctor must carefully monitor your heart condition. It is important to inform your doctor about any past or present heart problems. If new symptoms of heart failure appear or if existing symptoms worsen (e.g., shortness of breath or swelling of the feet), contact your doctor immediately. Your doctor will decide whether you can continue taking Imraldi.

Fever, bruising, bleeding or paleness

• In some patients, the body may not be able to produce enough blood cells to help fight infections or stop bleeding. If you experience persistent fever, bruising, easy bleeding, or paleness, contact your doctor immediately. Your doctor may decide to stop the treatment.

Cancer

• Very rarely, certain types of cancer have occurred in children and adults treated with Imraldi or other anti-TNFα medicines. Patients with long-standing, severe rheumatoid arthritis may have a higher than average risk of developing lymphoma (a cancer affecting the lymphatic system) and leukaemia (a cancer affecting blood and bone marrow). If you take Imraldi, your risk of developing lymphoma, leukaemia, or other tumours may increase. In rare cases, a specific and serious type of lymphoma has been observed in patients treated with Imraldi. Some of these patients were also taking azathioprine or mercaptopurine. Inform your doctor if you are taking azathioprine or mercaptopurine with Imraldi.

• In addition, cases of non-melanoma skin cancer have been observed in patients taking Imraldi. If new areas of damaged skin appear during or after treatment, or if the appearance of existing lesions or damaged areas changes, inform your doctor.

• Cases of neoplasms, other than lymphoma, have been reported in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα medicine. If you have COPD or are a heavy smoker, you should discuss with your doctor whether treatment with an anti-TNFα medicine is appropriate.

Lupus-like syndrome

• Rarely, treatment with Imraldi may lead to a lupus-like syndrome. Inform your doctor if you develop symptoms such as unexplained persistent skin rash, fever, joint pain, or fatigue.

Children and adolescents

• Do not give Imraldi to children under 2 years of age with polyarticular juvenile idiopathic arthritis.
• Do not use the 40 mg pre-filled syringe if the recommended dose is different from 40 mg.

Other medicines and Imraldi
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Imraldi may be taken together with methotrexate and other disease-modifying antirheumatic drugs (DMARDs) (such as sulfasalazine, hydroxychloroquine, leflunomide, and parenteral gold salts), corticosteroids, or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Imraldi must not be taken together with medicines containing the active substances anakinra or abatacept due to an increased risk of serious infections. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• You should use an effective method of contraception to prevent pregnancy and continue using it for at least 5 months after your last injection of Imraldi.
• If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
• Imraldi should only be used during pregnancy if necessary.
• According to a pregnancy study, no increased risk of birth defects was observed in babies whose mothers received adalimumab during pregnancy compared to mothers with the same condition who did not receive adalimumab.
• Imraldi may be used during breastfeeding.
• If you receive Imraldi during pregnancy, the baby may have an increased risk of infection.
• It is important that you inform the paediatrician or other healthcare provider about your use of Imraldi during pregnancy before the baby receives any type of vaccination (for more information on vaccinations, see section "Warnings and precautions").

Driving and using machines
Imraldi may affect your ability to drive, ride a bicycle, or use machines, although only to a minor extent. After taking Imraldi, you may experience vision disturbances or a sensation that your surroundings are spinning (dizziness).

Imraldi contains sodium and sorbitol
Sorbitol
This medicine contains 20 mg of sorbitol per pre-filled syringe. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 0.8 ml dose, i.e., essentially 'sodium-free'.

3. How to use Imraldi

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or axial spondyloarthritis without
radiographic evidence of ankylosing spondylitis.
The pre-filled syringe and the pre-filled pen of Imraldi are available only in a 40 mg dose. Therefore, the pre-filled syringe and the pre-filled pen of Imraldi cannot be used in paediatric patients requiring less than the full 40 mg dose. If an alternative dose is required, other products offering this option must be used.
Imraldi is injected under the skin (subcutaneous use). The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, and for patients with psoriatic arthritis is 40 mg of adalimumab every other week, administered as a single dose.
In rheumatoid arthritis, methotrexate is continued during treatment with Imraldi. If your doctor determines that methotrexate is not appropriate, Imraldi may be administered alone.
If you have rheumatoid arthritis and are not receiving methotrexate in combination with Imraldi, your doctor may decide to prescribe 40 mg of adalimumab weekly or 80 mg every other week.

Children, adolescents, and adults with polyarticular juvenile idiopathic arthritis
Children and adolescents aged 2 years and older, weighing between 10 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.
Children, adolescents, and adults aged 2 years and older, weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.

Children, adolescents, and adults with enthesitis-related arthritis
Children and adolescents aged 6 years and older, weighing between 15 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.
Children, adolescents, and adults aged 6 years and older, weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.

Adults with psoriasis
The usual dose of Imraldi for adults with psoriasis is an initial dose of 80 mg (via two injections of 40 mg on the same day), followed by 40 mg every other week, starting the week after the initial dose. You must continue treatment with Imraldi for the duration prescribed by your doctor. If this dose does not work satisfactorily, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.

Children and adolescents with plaque psoriasis
Children and adolescents aged between 4 and 17 years, weighing between 15 kg and less than 30 kg
The recommended dose of Imraldi is an initial dose of 20 mg, followed by a 20 mg dose the following week. Subsequently, the usual dose is 20 mg every other week.
Children and adolescents aged between 4 and 17 years, weighing 30 kg or more
The recommended dose of Imraldi is an initial dose of 40 mg, followed by a 40 mg dose the following week. Subsequently, the usual dose is 40 mg every other week.

Adults with hidradenitis suppurativa
The usual dose for hidradenitis suppurativa is an initial dose of 160 mg (via four injections of 40 mg on the same day or two injections of 40 mg per day for two consecutive days), followed by 80 mg (via two injections of 40 mg on the same day) two weeks later. After another two weeks, continue with 40 mg weekly or 80 mg every other week, as prescribed by your doctor. It is recommended to use an antiseptic wash solution daily on affected areas.

Adolescents with hidradenitis suppurativa, aged between 12 and 17 years, weighing 30 kg or more
The recommended dose of Imraldi is an initial dose of 80 mg (via two injections of 40 mg on the same day), followed by 40 mg every two weeks starting one week later. If this dose of 40 mg of Imraldi every other week does not work satisfactorily, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.
It is recommended to use an antiseptic wash solution daily on affected areas.

Adults with Crohn’s disease
The usual dose for Crohn’s disease is initially 80 mg (via two injections of 40 mg on the same day), followed by 40 mg every other week after two weeks. If a more rapid response is needed, your doctor may prescribe an initial dose of 160 mg (via four injections of 40 mg on the same day or two injections of 40 mg per day for two consecutive days), followed by 80 mg (via two injections of 40 mg on the same day) after two weeks, and subsequently 40 mg every other week. If this dose does not work satisfactorily, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.

Children and adolescents with Crohn’s disease
Children and adolescents aged between 6 and 17 years, weighing less than 40 kg
The usual dose is initially 40 mg, followed by 20 mg after two weeks. If a more rapid response is required, your doctor may prescribe an initial dose of 80 mg (via two injections of 40 mg on the same day), followed by 40 mg after two weeks.
Subsequently, the usual dose is 20 mg every other week. If this dose does not work satisfactorily, your doctor may increase the frequency to 20 mg weekly.
Children and adolescents aged between 6 and 17 years, weighing 40 kg or more
The usual dose is initially 80 mg (via two injections of 40 mg on the same day), followed by 40 mg after two weeks. If a more rapid response is required, your doctor may prescribe an initial dose of 160 mg (via four injections of 40 mg on the same day or two injections of 40 mg per day for two consecutive days), followed by 80 mg (via two injections of 40 mg on the same day) after two weeks.
Subsequently, the usual dose is 40 mg every other week. If this dose does not work satisfactorily, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.

Adults with ulcerative colitis
The usual dose of Imraldi for adults with ulcerative colitis is 160 mg (via four injections of 40 mg on the same day or two injections of 40 mg per day for two consecutive days) at week 0, and 80 mg (via two injections of 40 mg on the same day) at week 2, followed by 40 mg every other week. If this dose does not work satisfactorily, your doctor may increase the dosage to 40 mg weekly or 80 mg every other week.

Children and adolescents with ulcerative colitis
Children and adolescents aged 6 years and older, weighing less than 40 kg
The usual dose of Imraldi is 80 mg (via two injections of 40 mg on the same day), followed by 40 mg (via a single 40 mg injection) two weeks later. Subsequently, the usual dose is 40 mg every other week.
Patients who turn 18 years old while receiving 40 mg every other week should continue the prescribed dose.
Children and adolescents aged 6 years and older, weighing 40 kg or more
The usual dose of Imraldi is 160 mg (via four injections of 40 mg on the same day or two injections of 40 mg per day for two consecutive days), followed by 80 mg (via two injections of 40 mg on the same day) after two weeks. Subsequently, the usual dose is 80 mg every other week.
Patients who turn 18 years old while receiving 80 mg every other week should continue the prescribed dose.

Adults with non-infectious uveitis
The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (via two injections on the same day), followed by 40 mg every two weeks starting one week after the initial dose. Continue injecting Imraldi for the entire duration prescribed by your doctor.
In non-infectious uveitis, corticosteroids or other immunosuppressive medications may be continued during treatment with Imraldi. Imraldi may also be administered as monotherapy.

Children and adolescents with chronic non-infectious uveitis, aged 2 years and older
Children and adolescents aged 2 years and older, weighing less than 30 kg
The usual dose of Imraldi is 20 mg administered every other week in combination with methotrexate.
Your child’s doctor may also prescribe an initial dose of 40 mg, which may be administered one week before starting the usual dosing regimen.
Children and adolescents aged 2 years and older, weighing 30 kg or more
The usual dose of Imraldi is 40 mg administered every other week in combination with methotrexate.
Your doctor may also prescribe an initial dose of 80 mg, which may be administered one week before starting the usual dosing regimen.

Method and route of administration
Imraldi is administered by subcutaneous injection. For instructions on use, refer to section 7.

If you use more Imraldi than you should
If you accidentally inject Imraldi more frequently than prescribed, contact your doctor or pharmacist and inform them that you have taken more medicine than intended. Always keep the medicine carton, even if empty.

If you forget to use Imraldi
If you forget to administer an injection, inject the next dose of Imraldi as soon as you remember. Then resume your regular dosing schedule.

If you stop using Imraldi
The decision to discontinue treatment with Imraldi should be discussed with your doctor. Symptoms may return after stopping treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the side effects are mild to moderate in severity. However, some may be serious and require treatment. Side effects may occur up to 4 months or more after the last injection of Imraldi.

Contact your doctor immediately if you notice any of the following reactions:

• severe rash, hives, or other signs of allergic reaction;
• swelling of the face, hands, or feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath during exertion or when lying down, or swollen feet.

Inform your doctor as soon as possible if you notice any of the following reactions:

• signs of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating;
• fatigue or weakness;
• cough;
• tingling;
• numbness;
• double vision;
• weakness in arms or legs;
• swelling or sores that do not heal;
• signs and symptoms suggesting disorders of the haematopoietic system, such as persistent fever, bruising, bleeding, or pallor.

The symptoms described above may be signs of the following side effects, which have been observed with adalimumab:

Very common (may affect more than 1 in 10 people):

• injection site reactions (including pain, swelling, redness, or itching);
• respiratory tract infections (including colds, runny nose, sinusitis, and pneumonia);
• headache;
• abdominal pain (stomach pain);
• nausea and vomiting;
• rash;
• muscle pain.

Common (may affect up to 1 in 10 people):

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including dental infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• joint infections;
• benign tumours;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, stabbing sensations, or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (sensation of spinning);
• sensation of rapid heartbeat;
• high blood pressure;
• hot flushes;
• haematoma (a solid swelling with clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux disorder;
• dry syndrome (including dry eyes and dry mouth);
• itching;
• itchy rash;
• bruising;
• skin inflammation (such as eczema);
• cracking of fingernails and toenails;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in urine;
• kidney problems;
• chest pain;
• oedema (fluid accumulation in the body causing swelling of affected tissues);
• fever;
• reduced platelet count in blood, increasing the risk of bleeding or bruising;
• delayed wound healing.

Uncommon (may affect up to 1 in 100 people):

• opportunistic infections (including tuberculosis and other infections that occur when immune defences are reduced);
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumours, including lymphatic system tumours (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders affecting lungs, skin, and lymph nodes (most commonly in the form of a disease called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• sensation of irregular heartbeat such as palpitations;
• heart problems that may cause shortness of breath or swelling of the ankles;
• myocardial infarction;
• formation of a sac in the wall of a major artery, vein inflammation and clot, or blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• pancreatitis causing severe abdominal and back pain;
• difficulty swallowing;
• facial oedema;
• gallbladder inflammation, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scar formation;
• abnormal muscle breakdown;
• systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints, and other organs);
• disrupted sleep;
• impotence;
• inflammations.

Rare (may affect up to 1 in 1,000 people):

• leukaemia (a blood cancer affecting bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as optic neuritis and Guillain-Barré syndrome, a disease that may cause muscle weakness, abnormal sensations, and tingling in arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (lung scarring);
• intestinal perforation;
• hepatitis;
• reactivation of hepatitis B;
• autoimmune hepatitis (liver inflammation caused by the body’s own immune system);
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• Stevens-Johnson syndrome (early symptoms include malaise, fever, headache, and rash);
• facial oedema associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy red-purple rash).

Not known (frequency cannot be estimated from the available data):

• hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi's sarcoma, a rare cancer associated with human herpesvirus 8 infection. Kaposi's sarcoma usually presents with purple skin lesions;
• liver failure;
• worsening of a condition called dermatomyositis (characterized by rash accompanied by muscle weakness);
• weight gain (in most patients, weight gain has been low).

Some of the side effects observed with adalimumab may be asymptomatic and detectable only through blood tests.
These include:

Very common (may affect more than 1 in 10 people):

• low white blood cell count;
• low red blood cell count;
• increased blood lipids;
• increased liver enzymes.

Common (may affect up to 1 in 10 people):

• increased white blood cell count;
• reduced platelet count;
• increased uric acid in blood;
• altered sodium levels in blood;
• reduced calcium in blood;
• reduced phosphorus in blood;
• increased blood sugar;
• increased lactate dehydrogenase in blood;
• presence of autoantibodies in blood;
• reduced potassium in blood.

Uncommon (may affect up to 1 in 100 people):

• elevated bilirubin levels in blood (liver blood test).

Rare (may affect up to 1 in 1,000 people):

• low white blood cell, red blood cell, and platelet counts.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Imraldi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the carton after
EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled syringe in its outer packaging to protect the medicine from light.

Alternative storage conditions:
When necessary (e.g. when travelling), a single pre-filled syringe may be
stored at room temperature (up to 25°C) for a maximum period of 28 days – ensure the medicine is protected from light. Once removed from the refrigerator for storage at room temperature, the syringe must be used within 28 days or must be discarded, even if it is returned to the refrigerator.
You must record the date on which the syringe was first removed from the refrigerator and the date after which the syringe must be discarded.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Imraldi contains

• The active substance is adalimumab.
• The other components are sodium citrate, monohydrate citric acid, histidine, monohydrate histidine hydrochloride, sorbitol, polysorbate 20 and water for injections.

Description of the appearance of Imraldi and contents of the pack
Imraldi 40 mg solution for injection in pre-filled syringes is supplied as 0.8 ml of solution from
clear to opalescent and from colourless to light brown.
Imraldi is available in packs containing 1, 2, 4 or 6 pre-filled syringe(s) (Type I glass)
with a stainless steel needle, a rigid cap, a rubber plunger, a rod, a protective coating and a finger flange for patient use, and respectively 2, 2, 4 or 6 alcohol-impregnated swabs included in the pack.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands

Manufacturer
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Biogen Belgium NV/S.A Biogen Lithuania UAB
Tél/Tel: + 32 2 2191218 Tel: +370 5 259 6176

България Luxembourg/Luxemburg
Ewopharma AG Representative Office Biogen Belgium NV/SA
Teл.: + 35929621200 Tél/Tel: +32 2 2191218

Česká republika Magyarország
Biogen (Czech Republic) s.r.o. Biogen Hungary Kft.
Tel: + 420 255 706 200 Tel.: + 36 1 899 9880

Danmark Malta
Biogen (Denmark) A/S Pharma.MT Ltd
Tlf.: + 45 77 41 57 57 Tel: + 35621337008

Deutschland Nederland
Biogen GmbH Biogen Netherlands B.V.
Tel: + 49 (0) 89 99 6170 Tel: + 31 20 542 2000

Eesti Norge
Biogen Estonia OÜ Biogen Norway AS
Tel: + 372 618 9551 Tlf: + 47 23 40 01 00

Ελλάδα Österreich
Genesis Pharma S.A. Biogen Austria GmbH
Τηλ: + 302108771500 Tel: + 43 1 484 46 13

España Polska
Biogen Spain, S.L. Biogen Poland Sp. z o.o.
Tel: +34 91 310 7110 Tel.: + 48 22 351 51 00

France Portugal
Biogen France SAS Biogen Portugal Sociedade Farmacêutica,
Tél: + 33 (0)1 776 968 14 Unipessoal, Lda
Tel: + 351 21 318 8450

Hrvatska România
Ewopharma d.o.o Ewopharma Romania SRL
Tel: + 385 (0)1 6646 563 Tel: + 40212601344

Ireland Slovenija
Biogen Idec (Ireland) Ltd. Biogen Pharma d.o.o.
Tel: +353 (0)1 463 7799 Tel: + 386 1 511 02 90

Ísland Slovenská republika
Icepharma hf. Biogen Slovakia s.r.o.
Sími: + 354 540 8000 Tel: + 421 2 323 340 08

Italia Suomi/Finland
Biogen Italia s.r.l. Biogen Finland Oy
Tel: + 39 02 584 99 010 Puh/Tel: + 358 207 401 200

Κύπρος Sverige
Genesis Pharma (Cyprus) Ltd Biogen Sweden AB
Τηλ: + 357 22 76 57 15 Tel: +46 8 594 113 60

Latvija
Biogen Latvia SIA
Tel: + 371 68 688 158

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .

7. Instructions for use

Follow these instructions carefully: you will soon become familiar with the procedure and will be able to administer injections confidently.

• Before administering injections, ask your doctor or nurse to show you how to use the pre-filled syringe. Your doctor or nurse must verify that you are able to use the syringe correctly.

Appearance of the single-dose pre-filled syringe

After pushing the plunger fully down, the needle retracts automatically, thereby preventing needlestick injuries.
Use of the pre-filled syringe
Storage of the syringe

• Store the syringe in the refrigerator, but do not freeze.
• Keep the syringe in its original box, protected from light.
• Keep the syringe out of sight and reach of children.

Disposal of the syringe

• Use each syringe only once. Never reuse a syringe.
• Dispose of used syringes in a special container, as instructed by your doctor, nurse, or pharmacist.

Caution

• If the syringe falls with the cap ON, it may still be used. If the syringe falls without the cap in place, do not use it. The needle may be dirty or damaged.
• Do not use a damaged syringe.

Preparing the injection site

• For the injection, choose an area with a fatty layer: the most suitable injection sites are generally areas rich in fat, such as the abdomen. Fatty areas are easier to pinch between the fingers and are appropriate for correct needle insertion.
• Always choose a different injection site each time: when selecting an injection site, choose an area that has not been recently used, in order to avoid irritation and bruising.
• Push the plunger slowly: rapid injections may sometimes be painful. Pushing the plunger slowly will make the injection less uncomfortable.

How to administer the injection using the pre-filled syringe

1. Gather the necessary supplies

Place the pre-filled syringe and alcohol swabs on a clean, dry surface.

• Remember to wash your hands!
• Do not remove the cap yet!

2. Wait 15-30 minutes

Wait 15-30 minutes to bring the pre-filled syringe to room temperature, in order to reduce
pain during injection.

• Do not remove the cap yet!

3. Check the medicine and the expiration date

Always check that the medicine is from clear to opalescent, colorless to light brown, free of particles, and not expired. Do not use the medicine if it is not clear to opalescent, colorless to light brown, and free of particles, or if it has expired.
One or more air bubbles may be present, which is not a problem. There is no need to remove them.

• Do not remove the cap yet!

4. Choose an injection site and clean the skin

Choose an injection site on the body. The most suitable areas are the abdomen (except the area around the navel) or the thighs.
Clean the injection site with an alcohol swab. Do not touch it again before the injection.

• Avoid areas with lesions, bruises, scars, peeling skin, or red spots.

5. Remove the needle cap

Carefully remove the needle cap.
It is normal for a few drops of liquid to come out of the needle.
If you remove the needle cap before you are ready to administer the injection, do not reattach it.
Otherwise, you may bend or damage the needle, and you risk accidentally pricking yourself or spilling some of the medicine.

6. Pinch the skin between your fingers and insert the needle

Carefully pinch a fold of skin between your fingers and insert the needle all the way in, at an angle
of approximately 45 degrees.

7. Push the plunger all the way in

Hold the syringe steady and push the plunger all the way in.
Then lift the thumb so that the needle retracts into the body of the syringe.

8. Remove and dispose of the syringe

Remove the syringe from the skin.
After injecting Imraldi, check that the needle has retracted and immediately dispose of the used syringe in a special container, as explained to you by your doctor, nurse, or pharmacist.

• If you are not sure whether you received the full dose, consult your doctor, nurse, or pharmacist.

Patient information leaflet

Imraldi 40 mg solution for injection in a pre-filled pen

adalimumab
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• Your doctor will also provide you with a Patient Reminder Card containing important safety information that you need to know before administering Imraldi and during treatment with Imraldi. Keep this Patient Reminder Card throughout the treatment period and for 4 months after the last injection of Imraldi (yours or your child's).
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Imraldi is and what it is used for
2. What you need to know before using Imraldi
3. How to use Imraldi
4. Possible side effects
5. How to store Imraldi
6. Contents of the pack and other information
7. Instructions for use

1. What Imraldi is and what it is used for

Imraldi contains the active substance adalimumab, a medicine that acts on the immune system (the body's defence system).
Imraldi is indicated for the treatment of:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• enthesitis-related arthritis,
• ankylosing spondylitis,
• non-radiographic axial spondyloarthritis (axial spondyloarthritis without radiographic evidence of ankylosing spondylitis),
• psoriatic arthritis,
• psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis, and
• non-infectious uveitis.

The active ingredient in Imraldi, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that bind to a specific target.
The target of adalimumab is a protein called tumour necrosis factor (TNF α ), which is present at high levels in the inflammatory diseases described above. By binding to TNF α , Imraldi reduces the inflammatory process in these diseases.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease affecting the joints.
Imraldi is used to treat rheumatoid arthritis in adults.
If you have moderate to severe rheumatoid arthritis, other disease-modifying drugs such as methotrexate may be used first. If these drugs do not work satisfactorily, you will be given Imraldi to treat rheumatoid arthritis.
Imraldi may also be used to treat severe, active and progressive rheumatoid arthritis without prior treatment with methotrexate.
Imraldi can slow down the progression of cartilage and bone damage in the joints caused by the disease and improve physical function.
Imraldi is generally used in combination with methotrexate. If your doctor considers methotrexate treatment inappropriate, Imraldi may be administered alone.

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory joint diseases that typically first appear in childhood.
Imraldi is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years. At diagnosis, other disease-modifying drugs such as methotrexate may be administered. If these drugs do not work satisfactorily, patients will be given Imraldi to treat polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis
Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory conditions affecting the spine.
Imraldi is used to treat ankylosing spondylitis and non-radiographic axial spondyloarthritis in adults. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be treated with other medicines. If these medicines do not work satisfactorily, you will be given Imraldi to reduce the signs and symptoms of the disease.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease associated with psoriasis.
Imraldi is used to treat psoriatic arthritis in adults. Imraldi can slow down joint cartilage and bone damage caused by the disease and improve physical function.

Plaque psoriasis in adults and children
Plaque psoriasis is an inflammatory skin condition causing red, scaly, thickened patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crumble, thicken, or lift away from the nail bed, which may be painful. Psoriasis is believed to be caused by a problem with the body’s immune system leading to an increased production of skin cells.
Imraldi is used to treat moderate to severe plaque psoriasis in adults. Imraldi is also used to treat severe plaque psoriasis in children and adolescents weighing at least 30 kg when topical therapy and phototherapies have not worked adequately or are not suitable.

Hidradenitis suppurativa in adults and adolescents
Hidradenitis suppurativa (sometimes called acne inversa) is a chronic inflammatory skin disease that is often painful. Symptoms may include painful nodules and abscesses (cysts) that may drain pus. It most commonly affects specific skin areas such as under the breasts, armpits, inner thighs, groin, and buttocks. Scarring may also develop in affected areas.
Imraldi is used to treat hidradenitis suppurativa in adults and adolescents aged 12 years and older. Imraldi can reduce the number of nodules and abscesses you have, as well as the pain often associated with this disease. You may initially receive other medicines. If you do not respond adequately to these medicines, you will be given Imraldi.

Crohn’s disease in adults and children
Crohn’s disease is an inflammation of the intestine.
Imraldi is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If you have Crohn’s disease, you will first be given other medicines. If these medicines do not work satisfactorily, you will be given Imraldi to reduce the typical symptoms of Crohn’s disease.

Ulcerative colitis in adults and children
Ulcerative colitis is an inflammation of the large intestine (colon).
Imraldi is used to treat moderate to severe ulcerative colitis in adults and children aged 6 to 17 years. If you have ulcerative colitis, you may first take other medicines. If these medicines do not work satisfactorily, you will take Imraldi to reduce the signs and symptoms of the disease.

Non-infectious uveitis in adults and children
Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
Imraldi is used for the treatment of:

• Adults with non-infectious uveitis with inflammation affecting the back of the eye
• Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front part of the eye

This inflammation may lead to decreased vision and/or the presence of floaters (small specks or lines moving across the visual field). Imraldi works by reducing this inflammation.

2. What you need to know before using Imraldi

Do not use Imraldi

• If you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have a severe infection, including tuberculosis (see "Warnings and precautions"). It is important to inform your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, or dental problems.
• If you have moderate or severe heart failure. It is important to inform your doctor if you have had or currently have a serious heart condition (see "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before using Imraldi.

Allergic reaction

• If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or skin rash, do not administer Imraldi again and contact your doctor immediately, as these reactions may rarely be life-threatening.

Infection

• If you have an infection, including long-term or localized infections (e.g., leg ulcers), consult your doctor before starting treatment with Imraldi. If you are in any doubt, contact your doctor.
• You may be more likely to get infections while being treated with Imraldi. This risk may increase if your lung function is reduced. These infections can be serious and may include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, other opportunistic infections (unusual infections associated with a weakened immune system), and sepsis (blood poisoning). In rare cases, these infections may be life-threatening. It is important to inform your doctor if you have symptoms such as fever, wounds, feeling tired, or dental problems. Your doctor may advise temporarily stopping Imraldi.

Tuberculosis

• Cases of tuberculosis have occurred in patients treated with Imraldi. Your doctor must check for signs or symptoms of tuberculosis before starting therapy with Imraldi. This will involve a detailed medical evaluation including your medical history and clinical tests (e.g., a chest X-ray and tuberculin skin test). The performance and results of these tests must be recorded in the Patient Reminder Card. It is very important to inform your doctor if you have ever had tuberculosis or if you have had close contact with people who have tuberculosis. Tuberculosis may develop during treatment even if you have received preventive treatment. Contact your doctor immediately if you develop symptoms of tuberculosis (persistent cough, weight loss, lack of energy, low-grade fever) or other infections during or after treatment.

Travel/recurrent infection

• Inform your doctor if you have lived in or traveled to regions where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic.
• Inform your doctor if you have had recurring infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

• Inform your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active hepatitis B infection, or if you think you may be at risk of contracting hepatitis B. Your doctor must test you for hepatitis B infection. Taking Imraldi may reactivate hepatitis B infection in carriers of this virus. In rare cases, especially if you are also taking other medicines that suppress the immune system, reactivation of hepatitis B infection may be life-threatening.

Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Imraldi. You and your doctor should pay particular attention to signs of infection while you are being treated with Imraldi. It is important to inform your doctor if you develop symptoms of infection such as fever, wounds, feeling tired, or dental problems.

Surgery or dental procedure

• Before any surgery or dental procedures, inform your doctor that you are taking Imraldi. Your doctor may advise temporarily stopping Imraldi.

Demyelinating disease

• If you have or develop a demyelinating disease (diseases affecting the protective covering of nerves, such as multiple sclerosis), your doctor will decide whether or not to start or continue treatment with Imraldi. Inform your doctor immediately if you experience symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling in any part of the body.

Vaccines

• Certain vaccines contain weakened but live bacteria or viruses and must not be given during treatment with Imraldi. Consult your doctor before receiving any vaccinations. In children, it is recommended, if possible, to complete the age-appropriate vaccination schedule before starting treatment with Imraldi. If you receive Imraldi during pregnancy, your baby may have an increased risk of infection for up to about 5 months after your last dose during pregnancy. It is important that you inform your paediatrician or other healthcare provider that you used Imraldi during pregnancy, so they can determine when your baby should receive any vaccinations.

Heart failure

• If you have mild heart failure and are being treated with Imraldi, your doctor must carefully monitor your heart condition. It is important to inform your doctor about any past or present heart problems. If new symptoms of heart failure appear or if existing symptoms worsen (e.g., shortness of breath or swelling of the feet), contact your doctor immediately. Your doctor will decide whether you can continue taking Imraldi.

Fever, bruising, bleeding or paleness

• In some patients, the body may not produce enough blood cells to help fight infections or stop bleeding. If you have persistent fever, bruising, easy bleeding, or paleness, contact your doctor immediately. Your doctor may decide to stop treatment.

Cancer

• Very rarely, certain types of cancer have been observed in children and adults treated with Imraldi or other anti-TNFα medicines. Patients with long-standing, severe rheumatoid arthritis may have a higher than average risk of developing lymphoma (a cancer affecting the lymphatic system) and leukaemia (a cancer affecting blood and bone marrow). If you are taking Imraldi, your risk of developing lymphoma, leukaemia, or other tumours may increase. In rare cases, a specific and serious type of lymphoma has been observed in patients treated with Imraldi. Some of these patients were also taking azathioprine or mercaptopurine. Inform your doctor if you are taking azathioprine or mercaptopurine with Imraldi.
• In addition, cases of non-melanoma skin cancer have been observed in patients taking Imraldi. If new areas of damaged skin appear during or after treatment, or if the appearance of existing lesions or damaged areas changes, inform your doctor.
• Cases of neoplasms other than lymphoma have been reported in patients with a specific lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα medicine. If you have COPD or are a heavy smoker, you should discuss with your doctor whether treatment with an anti-TNFα medicine is appropriate.

Lupus-like syndrome

• Rarely, treatment with Imraldi may cause a lupus-like syndrome. Inform your doctor if you develop symptoms such as unexplained persistent skin rash, fever, joint pain, or fatigue.

Children and adolescents

• Do not give Imraldi to children under 2 years of age with polyarticular juvenile idiopathic arthritis.
• Do not use the 40 mg pre-filled pen if the recommended dose is different from 40 mg.

Other medicines and Imraldi
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Imraldi may be taken together with methotrexate and other disease-modifying antirheumatic drugs (DMARDs) (such as sulfasalazine, hydroxychloroquine, leflunomide, and parenteral gold salts), corticosteroids, or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Imraldi must not be taken together with medicines containing the active substances anakinra or abatacept due to an increased risk of serious infections. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• You should use an appropriate contraceptive method to prevent pregnancy and continue using it for at least 5 months after your last injection of Imraldi.
• If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
• Imraldi should be used during pregnancy only if necessary.
• According to a pregnancy study, no increased risk of birth defects was observed in babies whose mothers received adalimumab during pregnancy, compared to mothers with the same condition who did not receive adalimumab.
• Imraldi may be used during breastfeeding.
• If you receive Imraldi during pregnancy, your baby may have an increased risk of infection.
• It is important that you inform your paediatrician or other healthcare provider about your use of Imraldi during pregnancy before your baby receives any vaccinations (for more information on vaccinations, see the section "Warnings and precautions").

Driving and using machines
Imraldi may affect your ability to drive, ride a bicycle, or use machines, although only to a minor extent. After taking Imraldi, you may experience visual disturbances or a sensation that your surroundings are spinning (dizziness).

Imraldi contains sodium and sorbitol
Sorbitol
This medicine contains 20 mg of sorbitol per pre-filled pen. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 0.8 ml dose, i.e., essentially 'sodium-free'.

3. How to use Imraldi

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis
The pre-filled syringe and pre-filled pen of Imraldi are available only in a 40 mg dose. Therefore, the pre-filled syringe and pre-filled pen of Imraldi cannot be used in pediatric patients requiring less than the full 40 mg dose. If an alternative dose is needed, other products offering this option must be used.
Imraldi is injected under the skin (subcutaneous use). The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and for patients with psoriatic arthritis is 40 mg of adalimumab every other week, administered as a single dose.
In rheumatoid arthritis, methotrexate should be continued during treatment with Imraldi. If your doctor determines that methotrexate is not appropriate, Imraldi may be given alone.
If you have rheumatoid arthritis and are not receiving methotrexate in combination with Imraldi, your doctor may decide to prescribe you 40 mg of adalimumab weekly or 80 mg every other week.

Children, adolescents, and adults with polyarticular juvenile idiopathic arthritis
Children and adolescents aged 2 years and older, weighing between 10 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.
Children, adolescents, and adults aged 2 years and older, weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.

Children, adolescents, and adults with enthesitis-related arthritis
Children and adolescents aged 6 years and older, weighing between 15 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.
Children, adolescents, and adults aged 6 years and older, weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.

Adults with psoriasis
The usual dose of Imraldi for adults with psoriasis is an initial dose of 80 mg (via two injections on the same day), followed by 40 mg every other week, starting the week after the initial dose. You must continue treatment with Imraldi for as long as your doctor has instructed. If this dose does not work satisfactorily, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.

Children and adolescents with plaque psoriasis
Children and adolescents aged 4 to 17 years, weighing between 15 kg and less than 30 kg
The recommended dose of Imraldi is an initial dose of 20 mg, followed by a second dose of 20 mg the following week. After that, the usual dose is 20 mg every other week.
Children and adolescents aged 4 to 17 years, weighing 30 kg or more
The recommended dose of Imraldi is an initial dose of 40 mg, followed by a second dose of 40 mg the following week. After that, the usual dose is 40 mg every other week.

Adults with hidradenitis suppurativa
The usual dose for hidradenitis suppurativa is an initial dose of 160 mg (via four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days), followed by 80 mg (via two 40 mg injections on the same day) two weeks later. After another two weeks, continue with a dose of 40 mg weekly or 80 mg every other week, as prescribed by your doctor. It is recommended to use an antiseptic wash solution daily on the affected areas.

Adolescents with hidradenitis suppurativa aged 12 to 17 years, weighing 30 kg or more
The recommended dose of Imraldi is an initial dose of 80 mg (via two 40 mg injections on the same day), followed by 40 mg every two weeks, starting one week later. If this dose of 40 mg of Imraldi every other week does not work satisfactorily, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.
It is recommended to use an antiseptic wash solution daily on the affected areas.

Adults with Crohn's disease
The usual dose for Crohn's disease is initially 80 mg (via two 40 mg injections on the same day), followed by 40 mg every other week, two weeks later. If a more rapid response is needed, your doctor may prescribe an initial dose of 160 mg (via four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days), followed by 80 mg (via two 40 mg injections on the same day) two weeks later, and then 40 mg every other week. If this dose does not work satisfactorily, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.

Children and adolescents with Crohn's disease
Children and adolescents aged 6 to 17 years, weighing less than 40 kg
The usual dose is initially 40 mg, followed by 20 mg after two weeks. If a more rapid response is needed, your doctor may prescribe an initial dose of 80 mg (via two 40 mg injections on the same day), followed by 40 mg after two weeks.
After that, the usual dose is 20 mg every other week. If this dose does not work satisfactorily, your doctor may increase the frequency to 20 mg weekly.
Children and adolescents aged 6 to 17 years, weighing 40 kg or more
The usual dose is initially 80 mg (via two 40 mg injections on the same day), followed by 40 mg after two weeks. If a more rapid response is needed, your doctor may prescribe an initial dose of 160 mg (via four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days), followed by 80 mg (via two 40 mg injections on the same day) after two weeks.
After that, the usual dose is 40 mg every other week. If this dose does not work satisfactorily, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.

Adults with ulcerative colitis
The usual dose of Imraldi for adults with ulcerative colitis is 160 mg (via four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days) at week 0, and 80 mg (via two 40 mg injections on the same day) at week 2, followed by 40 mg every other week. If this dose does not work satisfactorily, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.

Children and adolescents with ulcerative colitis
Children and adolescents aged 6 years and older, weighing less than 40 kg
The usual dose of Imraldi is 80 mg (via two 40 mg injections on the same day), followed by 40 mg (via one 40 mg injection) two weeks later. After that, the usual dose is 40 mg every other week.
Patients who turn 18 years old while taking 40 mg every other week should continue the prescribed dose.
Children and adolescents aged 6 years and older, weighing 40 kg or more
The usual dose of Imraldi is 160 mg (via four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days), followed by 80 mg (via two 40 mg injections on the same day) two weeks later. After that, the usual dose is 80 mg every other week.
Patients who turn 18 years old while taking 80 mg every other week should continue the prescribed dose.

Adults with non-infectious uveitis
The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (via two injections on the same day), followed by 40 mg every two weeks, starting one week after the initial dose. Continue injecting Imraldi for as long as your doctor has instructed.
In non-infectious uveitis, corticosteroids or other immunosuppressive medications may be continued during treatment with Imraldi. Imraldi may also be administered as monotherapy.

Children and adolescents with chronic non-infectious uveitis aged 2 years and older
Children and adolescents aged 2 years and older, weighing less than 30 kg
The usual dose of Imraldi is 20 mg administered every other week with methotrexate.
Your child’s doctor may also prescribe an initial dose of 40 mg, which can be administered one week before starting the usual dosing schedule.
Children and adolescents aged 2 years and older, weighing 30 kg or more
The usual dose of Imraldi is 40 mg administered every other week with methotrexate.
Your doctor may also prescribe an initial dose of 80 mg, which can be administered one week before starting the usual dosing schedule.

Method and route of administration
Imraldi is administered by subcutaneous injection. For instructions on use, refer to section 7.

If you use more Imraldi than you should
If you accidentally inject Imraldi more frequently than prescribed, contact your doctor or pharmacist and inform them that you have taken more medicine than you should. Always keep the medicine packaging, even if empty.

If you forget to use Imraldi
If you forget to administer an injection, inject the next dose of Imraldi as soon as you remember. Then resume your regular dosing schedule.

If you stop using Imraldi
The decision to discontinue Imraldi should be discussed with your doctor. Symptoms may return after stopping treatment.

If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them. Most side effects are mild to moderate in severity. However, some may be serious and require treatment. Side effects may occur up to 4 months or more after the last injection of Imraldi.

Contact your doctor urgently if you notice any of the following reactions:

• severe skin rash, hives, or other signs of allergic reaction;
• swelling of the face, hands, or feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath during exertion or when lying down, or swollen feet.

Inform your doctor as soon as possible if you notice any of the following reactions:

• signs of infection such as fever, feeling unwell, wounds, dental problems, burning sensation when urinating;
• fatigue or weakness;
• cough;
• tingling;
• numbness;
• double vision;
• weakness in arms or legs;
• swelling or a sore that does not heal;
• signs and symptoms suggesting disorders of the haematopoietic system, such as persistent fever, bruising, bleeding, or paleness.

The symptoms described above may be signs of the following side effects, which have been observed with adalimumab:

Very common (may affect more than 1 in 10 people):

• injection site reactions (including pain, swelling, redness, or itching);
• respiratory tract infections (including colds, runny nose, sinusitis, and pneumonia);
• headache;
• abdominal pain;
• nausea and vomiting;
• skin rash;
• muscle pain.

Common (may affect up to 1 in 10 people):

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including dental infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• joint infections;
• benign tumours;
• skin tumours;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, stabbing sensations, or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (sensation of spinning);
• sensation of rapid heartbeat;
• high blood pressure;
• hot flushes;
• haematoma (a solid swelling containing clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux disorder;
• dry syndrome (including dry eyes and dry mouth);
• itching;
• itchy skin rash;
• bruising;
• skin inflammation (such as eczema);
• cracking or breaking of fingernails and toenails;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in the urine;
• kidney problems;
• chest pain;
• oedema (fluid accumulation in the body causing swelling of affected tissues);
• fever;
• reduced platelet count in the blood, increasing the risk of bleeding or bruising;
• impaired wound healing.

Uncommon (may affect up to 1 in 100 people):

• opportunistic infections (including tuberculosis and other infections that occur when immune defences are reduced);
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumours, including lymphatic system tumours (lymphoma) and melanoma (a skin tumour);
• immune system disorders that may affect lungs, skin, and lymph nodes (most commonly in the form of a disease called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• sensation of irregular heartbeat such as palpitations;
• heart problems that may cause shortness of breath or swelling of the ankles;
• myocardial infarction;
• formation of a sac in the wall of a major artery, inflammation and clot in a vein, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• pancreatitis (inflammation of the pancreas causing severe abdominal and back pain);
• difficulty swallowing;
• facial oedema;
• gallbladder inflammation, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle breakdown;
• systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints, and other organs);
• disrupted sleep;
• impotence;
• inflammations.

Rare (may affect up to 1 in 1,000 people):

• leukaemia (a cancer affecting blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as optic neuritis and Guillain-Barré syndrome, a disease that may cause muscle weakness, abnormal sensations, and tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lung);
• intestinal perforation;
• hepatitis;
• reactivation of hepatitis B;
• autoimmune hepatitis (liver inflammation caused by the body's own immune system);
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• Stevens-Johnson syndrome (early symptoms include malaise, fever, headache, and skin rash);
• facial oedema associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy, red-purple skin rash).

Not known (frequency cannot be estimated from available data):

• hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi’s sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi’s sarcoma most commonly presents with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (characterized by skin rash accompanied by muscle weakness);
• weight gain (in most patients, weight gain has been low).

Some of the side effects observed with adalimumab may be asymptomatic and may only be detected through blood tests.
These include:
Very common (may affect more than 1 in 10 people):

• low white blood cell count;
• low red blood cell count;
• increased blood lipids;
• increased liver enzymes.

Common (may affect up to 1 in 10 people):

• increased white blood cell count;
• reduced platelet count;
• increased uric acid in the blood;
• altered sodium levels in the blood;
• reduced calcium in the blood;
• reduced phosphorus in the blood;
• increased blood sugar;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• reduced potassium in the blood.

Uncommon (may affect up to 1 in 100 people):

• elevated bilirubin levels in the blood (liver blood test).

Rare (may affect up to 1 in 1,000 people):

• low white blood cell, red blood cell, and platelet counts.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Imraldi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled pen in the outer packaging to protect the medicine from light.

Alternative storage conditions:
When necessary (e.g. when travelling), a single pre-filled pen may be stored at room temperature (up to 25 °C) for a maximum of 28 days – ensure the medicine is protected from light. Once removed from the refrigerator for storage at room temperature, the pen must be used within 28 days or must be discarded, even if it is placed back into the refrigerator.
You must record the date when the pen is first removed from the refrigerator and the date after which the pen must be discarded.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Imraldi contains

• The active substance is adalimumab.
• The other components are sodium citrate, monohydrate citric acid, histidine, monohydrate histidine hydrochloride, sorbitol, polysorbate 20 and water for injections.

Description of the appearance of Imraldi and contents of the pack
Imraldi 40 mg solution for injection in pre-filled pen is supplied as 0.8 ml of solution, from clear to opalescent and from colourless to light brown.
Imraldi is available in packs containing 1, 2, 4 or 6 pre-filled pen(s) containing a pre-filled syringe (Type I glass) with a stainless steel needle, a hard cap, a rubber plunger for patient use, and respectively 2, 2, 4 or 6 alcohol swabs included in the pack.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands

Manufacturer
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Biogen Belgium NV/S.A Biogen Lithuania UAB
Tél/Tel: + 32 2 2191218 Tel: +370 5 259 6176

България Luxembourg/Luxemburg
Ewopharma AG Representative Office Biogen Belgium NV/SA
Teл.: + 35929621200 Tél/Tel: +32 2 2191218

Česká republika Magyarország
Biogen (Czech Republic) s.r.o. Biogen Hungary Kft.
Tel: + 420 255 706 200 Tel.: + 36 1 899 9880

Danmark Malta
Biogen (Denmark) A/S Pharma.MT Ltd
Tlf.: + 45 77 41 57 57 Tel: + 35621337008

Deutschland Nederland
Biogen GmbH Biogen Netherlands B.V.
Tel: + 49 (0) 89 99 6170 Tel: + 31 20 542 2000

Eesti Norge
Biogen Estonia OÜ Biogen Norway AS
Tel: + 372 618 9551 Tlf: + 47 23 40 01 00

Ελλάδα Österreich
Genesis Pharma S.A. Biogen Austria GmbH
Τηλ: + 302108771500 Tel: + 43 1 484 46 13

España Polska
Biogen Spain, S.L. Biogen Poland Sp. z o.o.
Tel: +34 91 310 7110 Tel.: + 48 22 351 51 00

France Portugal
Biogen France SAS Biogen Portugal Sociedade Farmacêutica,
Tél: + 33 (0)1 776 968 14 Unipessoal, Lda
Tel: + 351 21 318 8450

Hrvatska România
Ewopharma d.o.o Ewopharma Romania SRL
Tel: + 385 (0)1 6646 563 Tel: + 40212601344

Ireland Slovenija
Biogen Idec (Ireland) Ltd. Biogen Pharma d.o.o.
Tel: +353 (0)1 463 7799 Tel: + 386 1 511 02 90

Ísland Slovenská republika
Icepharma hf. Biogen Slovakia s.r.o.
Sími: + 354 540 8000 Tel: + 421 2 323 340 08

Italia Suomi/Finland
Biogen Italia s.r.l. Biogen Finland Oy
Tel: + 39 02 584 99 010 Puh/Tel: + 358 207 401 200

Κύπρος Sverige
Genesis Pharma (Cyprus) Ltd Biogen Sweden AB
Τηλ: + 357 22 76 57 15 Tel: +46 8 594 113 60

Latvija
Biogen Latvia SIA
Tel: + 371 68 688 158

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu .

7. Instructions for Use

Follow these instructions carefully: you will soon become familiar with the procedure and will be able to administer injections confidently.

• Before administering injections, ask your doctor or nurse to show you how to use the pre-filled pen. Your doctor or nurse must verify that you are able to use the pen correctly.

Appearance of the single-dose pre-filled pen

The pre-filled pen does not have a button.
The needle is hidden beneath the green base. When you press the pre-filled pen firmly against the skin, the injection starts automatically.
Use of the pre-filled pen
Storage of the pen

• Store the pen in the refrigerator, but do not freeze it.
• Keep the pen in its original box, protected from light.
• Keep the pen out of the sight and reach of children.

Disposal of the pen

• Use each pen only once. Never reuse the same pen.
• Dispose of the used pen in a special container, as instructed by your doctor, nurse, or pharmacist.

Caution

• If the pen falls with the cap ON, it may still be used. If the pen falls without the cap in place, do not use it. The needle may be dirty or damaged.
• Do not use a damaged pen.

Preparing the injection site

• For the injection, choose an area with a good amount of fatty tissue: The most suitable injection sites are generally areas rich in fat, such as the abdomen. Fatty areas are appropriate for correct needle insertion.
• Always choose a different injection site: When selecting an injection site, look for an area that has not been recently used, in order to avoid irritation, bruising, or tissue damage.

How to administer the injection using the pre-filled pen

1. Gather the necessary items

Place the pre-filled pen and alcohol wipes on a clean, dry surface.

• Remember to wash your hands!
• Do not remove the cap yet!

2. Wait 15–30 minutes

Wait 15–30 minutes to bring the pen to room temperature, in order to reduce pain during injection.

• Do not remove the cap yet!

3. Check the medicine and the expiration date

Check that the medicine is from clear to opalescent, from colourless to light brown, free of
particles, and not expired. Do not use the medicine if it is not from clear to opalescent, from colourless to
light brown, and free of particles, or if it has expired.
One or more air bubbles may be present, which are not a problem. There is no need to
remove them.

• Do not remove the cap yet!

4. Choose an injection site and clean the skin

Choose an injection site on the body. The most suitable areas are the abdomen (except the area around the navel) or the thighs.
Clean the injection site with an alcohol swab. Do not touch it again before the injection.

• Avoid areas with lesions, bruises, scars, peeling, or red spots.

5. Remove the transparent needle cap

Carefully remove the transparent needle cap with metal center from the pen.
It is normal for a few drops of liquid to come out of the needle.
If you remove the needle cap before you are ready to perform the injection, do not reattach it.
Otherwise, you risk bending or damaging the needle. You also risk accidentally pricking yourself or spilling some of the medicine.

6. Place the green base, press and hold

Place the green base straight (90 degrees) against the skin and firmly press down the pre-filled pen to start the injection.

• When pressing down, the injection starts. You may hear one click.

7. Continue to press and hold

Keep pressing the pen against the skin until the yellow indicator has filled the inspection window and stopped moving.

• After a few seconds, you may hear a second click.

8. Confirm completion of the injection and dispose of the pen

After injecting Imraldi, check that the entire inspection window is yellow.
Dispose of the used pen in a special container, as instructed by your doctor, nurse, or pharmacist.

• Not sure whether you received the full dose? Contact your doctor, nurse, or pharmacist.

Package leaflet: information for the patient

Imraldi 40 mg/0.8 ml solution for injection

adalimumab
Please read this leaflet carefully before your child uses this medicine because it contains
important information.

• Keep this leaflet. You may need to read it again.
• Your doctor will also give you a Patient Reminder Card containing important safety information that you need to know before Imraldi is administered to your child and during treatment with Imraldi. Keep this Patient Reminder Card throughout your child’s treatment and for 4 months after your child’s last injection of Imraldi.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to other people, even if their symptoms are the same as your child’s, because it could be harmful.
• If your child experiences any adverse reaction, including those not listed in this leaflet, consult your child’s doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Imraldi is and what it is used for
2. What you need to know before your child uses Imraldi
3. How to use Imraldi
4. Possible side effects
5. How to store Imraldi
6. Contents of the pack and other information
7. Instructions for use

1. What Imraldi is and what it is used for

Imraldi contains the active substance adalimumab, a medicine that acts on the immune system (the body's defence system).
Imraldi is indicated for the treatment of:

• polyarticular juvenile idiopathic arthritis,
• enthesitis-related arthritis,
• paediatric plaque psoriasis,
• hidradenitis suppurativa in adolescents,
• paediatric Crohn’s disease,
• ulcerative colitis in paediatric patients,
• paediatric uveitis.

The active ingredient in Imraldi, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that bind to a specific target.
The target of adalimumab is a protein called tumour necrosis factor (TNF α), which is present at high levels in the inflammatory diseases described above. By binding to TNF α, Imraldi reduces the inflammatory process in these diseases.

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory joint diseases that typically first appear in childhood.
Imraldi is used to treat polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis.
At diagnosis, other disease-modifying drugs such as methotrexate may be given.
If these medicines do not work satisfactorily, patients will be given Imraldi for the treatment of polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.

Paediatric plaque psoriasis
Plaque psoriasis is an inflammatory skin condition that causes red, scaly, and thickened patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thicker, and lift from the nail bed, which can be painful. Psoriasis is thought to be caused by a problem with the body’s immune system leading to increased production of skin cells.
Imraldi is used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years in whom topical therapy and phototherapies have not worked optimally or are not suitable.

Hidradenitis suppurativa in adolescents
Hidradenitis suppurativa (sometimes called inverse acne) is a long-term inflammatory skin disease, often painful. Symptoms may include painful nodules and abscesses (cysts) that may drain pus. It most commonly affects specific areas of the skin, such as the area under the breasts, armpits, inner thighs, groin, and buttocks. Scarring may also develop in affected areas.
Imraldi is used to treat hidradenitis suppurativa in adolescents aged 12 years and older. Imraldi can reduce the number of nodules and abscesses you have and the pain often associated with this disease. Initially, you may receive other medicines. If you do not respond adequately to these medicines, you will be given Imraldi.

Paediatric Crohn’s disease
Crohn’s disease is inflammation of the intestine.
Imraldi is indicated for the treatment of Crohn’s disease in children aged 6 to 17 years. Other medicines may be given to patients first. If these medicines do not work satisfactorily, patients will be given Imraldi to reduce the typical symptoms of the disease.

Ulcerative colitis in paediatric patients
Ulcerative colitis is an inflammatory bowel disease affecting the large intestine. Imraldi is used to treat moderate to severe ulcerative colitis in children aged 6 to 17 years. Other medicines may be given initially. If these medicines do not work well enough, Imraldi will be given to reduce the signs and symptoms of the disease.

Paediatric uveitis
Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
Imraldi is used to treat children from 2 years of age with chronic non-infectious uveitis involving inflammation of the front part of the eye. This inflammation can lead to decreased vision and/or the presence of floaters in the eye (black spots or thin lines moving across the visual field). Imraldi works by reducing this inflammation.

2. What you should know before your child uses Imraldi

Do not use Imraldi

• If your child is allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If your child has a serious infection, including tuberculosis (see "Warnings and precautions"). It is important to inform the doctor if your child has signs or symptoms of infection, such as fever, wounds, feeling tired, or dental problems.
• If your child has moderate or severe heart failure. It is important to inform the doctor if your child has had or currently has a serious heart condition (see "Warnings and precautions").

Warnings and precautions
Talk to your child’s doctor or pharmacist before using Imraldi.

Allergic reaction

• If your child has allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash, do not administer Imraldi again and contact the doctor immediately, as in rare cases these reactions may be life-threatening.

Infection

• If your child has an infection, including long-term or localized infections (e.g., leg ulcers), consult the doctor before starting treatment with Imraldi. If you have any doubts, contact the doctor.
• Your child may be more likely to get infections while being treated with Imraldi. This risk may increase if lung function is reduced. These infections can be serious and may include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, other opportunistic infections (unusual infections associated with a weakened immune system), and sepsis (blood poisoning). In rare cases, these infections may be life-threatening. It is important to inform the doctor if your child has symptoms such as fever, wounds, feeling tired, or dental problems. The doctor may recommend temporarily stopping Imraldi.

Tuberculosis

• Since cases of tuberculosis have occurred in patients treated with Imraldi, the doctor will check whether your child shows signs or symptoms typical of tuberculosis before starting therapy with Imraldi. This will involve a detailed medical assessment including your child’s medical history and clinical examinations (e.g., a chest X-ray and tuberculin skin test). The performance and results of these tests must be recorded in your child’s Patient Reminder Card. It is very important to inform the doctor if your child has ever had tuberculosis or has been in close contact with people who have tuberculosis. Tuberculosis can develop during treatment even if your child has received preventive treatment for tuberculosis. Contact the doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, lack of energy, low-grade fever) or other infections appear during or after treatment.

Travel/recurrent infection

• Inform the doctor if your child has lived in or traveled to regions where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic.
• Inform the doctor if your child has had recurrent infections or has conditions that increase the risk of infection.

Hepatitis B virus

• Inform the doctor if your child is a carrier of the hepatitis B virus (HBV), has an active hepatitis B virus infection, or if you think your child may be at risk of contracting hepatitis B virus. Your child’s doctor must test your child for hepatitis B virus infection. Taking Imraldi may reactivate hepatitis B virus infection in people who are carriers of this virus. In some rare cases, especially if your child is also being treated with other medicines that suppress the immune system, reactivation of hepatitis B virus infection may be life-threatening.

Surgery or dental procedure

• Before any surgery or dental procedures, inform the doctor that your child is taking Imraldi. The doctor may advise temporarily stopping Imraldi.

Demyelinating disease

• If your child has or develops a demyelinating disease (diseases affecting the protective covering of nerves, such as multiple sclerosis), the doctor will decide whether your child should start or continue treatment with Imraldi. Inform the doctor immediately if your child experiences symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling in any part of the body.

Vaccines

• Certain vaccines contain weakened but live bacteria or viruses and must not be given during treatment with Imraldi. Consult the doctor before your child receives any vaccinations. In children, it is recommended, if possible, to complete the age-appropriate vaccination schedule before starting treatment with Imraldi. If you receive Imraldi during pregnancy, your baby may have an increased risk of infection for up to about 5 months after your last dose during pregnancy. It is important that you inform the pediatrician or other healthcare provider about your use of Imraldi during pregnancy so they can determine when your baby should receive any vaccinations.

Heart failure

• If your child has mild heart failure and is being treated with Imraldi, the doctor will need to carefully monitor your child’s heart condition. It is important to inform the doctor about any past or current heart problems your child may have. If new symptoms of heart failure appear or if existing symptoms worsen (e.g., shortness of breath or swelling of the feet), contact the doctor immediately. The doctor will decide whether your child can continue taking Imraldi.

Fever, bruising, bleeding, or paleness

• In some patients, the body may not produce enough blood cells to help fight infections or stop bleeding. If your child has persistent fever, bruising, easy bleeding, or paleness, contact the doctor immediately. The doctor may decide to stop the treatment.

Cancer

• Very rarely, certain types of cancer have occurred in children and adults treated with Imraldi or other anti-TNFα medicines. Patients with long-standing, severe rheumatoid arthritis may have a higher than average risk of developing lymphoma (a cancer affecting the lymphatic system) and leukemia (a cancer affecting blood and bone marrow). If your child takes Imraldi, the risk of developing lymphomas, leukemia, or other tumors may increase. In rare cases, a specific and serious type of lymphoma has been observed in patients treated with Imraldi. Some of these patients were also being treated with azathioprine or mercaptopurine. Inform the doctor if your child is taking azathioprine or mercaptopurine with Imraldi.

• In addition, cases of non-melanoma skin cancer have been observed in patients taking Imraldi. If new areas of damaged skin appear during or after treatment, or if the appearance of existing lesions or damaged areas changes, inform the doctor.

• There have been cases of tumors other than lymphoma in patients with a specific lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα medicine. If your child has COPD or smokes heavily, discuss with the doctor whether anti-TNFα treatment is appropriate for your child.

Lupus-like syndrome

• Rarely, treatment with Imraldi may cause a lupus-like syndrome. Inform the doctor if symptoms such as unexplained persistent skin rash, fever, joint pain, or fatigue occur.

Other medicines and Imraldi
Inform your child’s doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
Imraldi may be taken together with methotrexate and other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide, and parenteral gold salts), corticosteroids, or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Imraldi must not be taken by your child together with medicines containing the active substances anakinra or abatacept due to an increased risk of serious infections. If you have any doubts, consult the doctor.

Pregnancy and breastfeeding

• You should use an effective contraceptive method to prevent pregnancy and continue using it for at least 5 months after the last injection of Imraldi.
• If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
• Imraldi should be used during pregnancy only if necessary.
• According to a pregnancy study, no increased risk of birth defects was observed when mothers received adalimumab during pregnancy compared to mothers with the same condition who did not receive adalimumab.
• Imraldi may be used during breastfeeding.
• If you receive Imraldi during pregnancy, your baby may have an increased risk of infection. It is important that you inform the pediatrician or other healthcare provider about your use of Imraldi during pregnancy before your baby receives any vaccinations (for more information on vaccinations, see the section "Warnings and precautions").

Driving and using machines
Imraldi may affect, although only to a minor extent, the ability to drive, ride a bicycle, or use machines. After taking Imraldi, vision disturbances or dizziness (a sensation that the surroundings are spinning) may occur.

Imraldi contains sodium and sorbitol
Sorbitol
This medicine contains 20 mg of sorbitol per vial. If your doctor has diagnosed your child with an intolerance to certain sugars, contact the doctor before taking this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 0.8 ml dose, i.e., it is essentially 'sodium-free'.

3. How to use Imraldi

Use this medicine exactly as instructed by your child’s doctor or pharmacist. If you have any doubts about the instructions or any questions, consult your child’s doctor or pharmacist. The doctor may prescribe a different dose of Imraldi if your child requires a different amount.

Children and adolescents with polyarticular juvenile idiopathic arthritis

Children and adolescents aged 2 years and older, weighing between 10 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.

Children and adolescents aged 2 years and older, weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.

Children, adolescents, and adults with enthesitis-related arthritis

Children and adolescents aged 6 years and older, weighing between 15 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.

Children, adolescents, and adults aged 6 years and older, weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.

Children and adolescents with plaque psoriasis

Children and adolescents aged between 4 and 17 years, weighing between 15 kg and less than 30 kg
The recommended dose of Imraldi is an initial dose of 20 mg, followed by a second dose of 20 mg the following week. After that, the usual dose is 20 mg every other week.

Children and adolescents aged between 4 and 17 years, weighing 30 kg or more
The recommended dose of Imraldi is an initial dose of 40 mg, followed by a second dose of 40 mg the following week. After that, the usual dose is 40 mg every other week.

Adolescents with hidradenitis suppurativa aged between 12 and 17 years, weighing 30 kg or more
The recommended dose of Imraldi is an initial dose of 80 mg (administered as two 40 mg injections on the same day), followed by 40 mg every two weeks, starting one week later. If this dose does not work satisfactorily with 40 mg of Imraldi every other week, the doctor may increase the dose to 40 mg weekly or 80 mg every other week.
It is recommended to use an antiseptic wash solution daily on the affected areas.

Children and adolescents with Crohn’s disease

Children and adolescents aged between 6 and 17 years, weighing less than 40 kg
The usual dose is initially 40 mg, followed by 20 mg after two weeks. If a more rapid response is needed, your child’s doctor may prescribe an initial dose of 80 mg (administered as two 40 mg injections in one day), followed by 40 mg after two weeks.
Subsequently, the usual dose is 20 mg every other week. If this dose does not work satisfactorily, your child’s doctor may increase the dosing frequency to 20 mg weekly.

Children and adolescents aged between 6 and 17 years, weighing 40 kg or more
The usual dose is initially 80 mg (administered as two 40 mg injections in one day), followed by 40 mg after two weeks. If a more rapid response is needed, your child’s doctor may prescribe an initial dose of 160 mg (administered as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (administered as two 40 mg injections in one day) after two weeks.
Subsequently, the usual dose is 40 mg every other week. If this dose does not work satisfactorily, your child’s doctor may increase the dose to 40 mg weekly or 80 mg every other week.

Children and adolescents with ulcerative colitis

Children and adolescents aged 6 years and older, weighing less than 40 kg
The usual dose of Imraldi is 80 mg (administered as two 40 mg injections in one day), followed by 40 mg (administered as a single 40 mg injection) after two weeks. Subsequently, the usual dose is 40 mg every other week.
Patients who turn 18 years old while taking 40 mg every other week should continue the prescribed dose.

Children and adolescents aged 6 years and older, weighing 40 kg or more
The usual dose of Imraldi is 160 mg (administered as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (administered as two 40 mg injections in one day) after two weeks. Subsequently, the usual dose is 80 mg every other week.
Patients who turn 18 years old while taking 80 mg every other week should continue the prescribed dose.

Children and adolescents with chronic non-infectious uveitis, aged 2 years and older

Children and adolescents aged 2 years and older, weighing less than 30 kg
The usual dose of Imraldi is 20 mg administered every other week in combination with methotrexate.
Your child’s doctor may also prescribe an initial dose of 40 mg, which may be administered one week before starting the usual dosing regimen.

Children and adolescents aged 2 years and older, weighing 30 kg or more
The usual dose of Imraldi is 40 mg administered every other week in combination with methotrexate.
Your child’s doctor may also prescribe an initial dose of 80 mg, which may be administered one week before starting the usual dosing regimen.

Method and route of administration
Imraldi is administered by subcutaneous injection (injected under the skin). For instructions on use, refer to section 7.

If you use more Imraldi than you should
If you accidentally inject more Imraldi solution than prescribed or administer Imraldi more frequently than instructed, contact your child’s doctor or pharmacist and inform them that your child has received an overdose. Always keep the medicine carton or vial, even if empty.

If you use less Imraldi than you should
If you accidentally inject less Imraldi solution than prescribed or administer Imraldi less frequently than instructed, contact your child’s doctor or pharmacist and inform them that your child has received a lower dose than required. Always keep the medicine carton or vial, even if empty.

If you forget to use Imraldi
If you forget to give your child an injection, administer the missed dose of Imraldi as soon as you remember. Then resume your child’s regular dosing schedule.

If you stop using Imraldi
The decision to stop using Imraldi should be discussed with your child’s doctor. Your child’s symptoms may return after stopping treatment.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them. Most side effects are mild to moderate in severity. However, some may be serious and require treatment. Side effects may occur up to 4 months or more after the last injection of Imraldi.

Contact your doctor urgently if you notice any of the following reactions:

• severe rash, hives or other signs of allergic reaction;
• swelling of the face, hands or feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath during exertion or when lying down, or swollen feet.

Inform your doctor as soon as possible if you notice any of the following reactions:

• signs of infection such as fever, feeling unwell, wounds, dental problems, burning during urination;
• fatigue or weakness;
• cough;
• tingling;
• numbness;
• double vision;
• weakness in arms or legs;
• swelling or a sore that does not heal;
• signs and symptoms suggesting disorders of the haematopoietic system, such as persistent fever, bruising, bleeding, paleness.

The symptoms described above may be signs of the following side effects, which have been observed with adalimumab:

Very common (may affect more than 1 in 10 people):

• reactions at the injection site (including pain, swelling, redness or itching);
• respiratory tract infections (including colds, runny nose, sinusitis and pneumonia);
• headache;
• abdominal pain (in the stomach);
• nausea and vomiting;
• skin rash;
• muscle pain.

Common (may affect up to 1 in 10 people):

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including dental infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• joint infections;
• benign tumours;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, stabbing sensations or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (sensation of the environment spinning);
• awareness of heartbeat;
• high blood pressure;
• hot flushes;
• haematoma (a solid swelling containing clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux disorder;
• dry syndrome (including dry eyes and dry mouth);
• itching;
• itchy skin rash;
• bruising;
• skin inflammation (such as eczema);
• breaking of fingernails and toenails;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in the urine;
• kidney problems;
• chest pain;
• oedema (fluid accumulation in the body causing swelling of affected tissues);
• fever;
• reduced platelet count in the blood, increasing the risk of bleeding or bruising;
• poor wound healing.

Uncommon (may affect up to 1 in 100 people):

• opportunistic infections (including tuberculosis and other infections that occur when immune defences are reduced);
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumours, including tumours of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that may affect lungs, skin and lymph nodes (most commonly in the form of a disease called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• sensation of irregular heartbeat such as palpitations;
• heart problems that may cause shortness of breath or swelling of the ankles;
• myocardial infarction;
• formation of a sac in the wall of a major artery, inflammation and clot in a vein, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• inflammation of the pancreas causing severe abdominal and back pain;
• difficulty swallowing;
• facial oedema;
• inflammation of the gallbladder, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle breakdown;
• systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints and other organs);
• interrupted sleep;
• impotence;
• inflammations.

Rare (may affect up to 1 in 1,000 people):

• leukaemia (a cancer affecting blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as optic neuritis of the eye and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lung);
• intestinal perforation;
• hepatitis;
• reactivation of hepatitis B;
• autoimmune hepatitis (liver inflammation caused by the body’s own immune system);
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and skin rash);
• facial oedema associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy red-purple skin rash).

Not known (frequency cannot be estimated from the available data):

• hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi’s sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi’s sarcoma most commonly presents with purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (which presents as a skin rash accompanied by muscle weakness);
• Weight gain (in most patients, weight gain has been low).

Some of the side effects observed with adalimumab may be asymptomatic and may only be detected through blood tests.

These include:

Very common (may affect more than 1 in 10 people):

• low white blood cell count;
• low red blood cell count;
• increased blood lipids;
• increased liver enzymes.

Common (may affect up to 1 in 10 people):

• increased white blood cell count;
• reduced platelet count;
• increased blood uric acid;
• changes in blood sodium;
• reduced blood calcium;
• reduced blood phosphorus;
• increased blood sugar;
• increased blood lactate dehydrogenase;
• presence of autoantibodies in the blood;
• reduced blood potassium.

Uncommon (may affect up to 1 in 100 people):

• elevated bilirubin levels in the blood (liver blood test).

Rare (may affect up to 1 in 1,000 people):

• low white blood cell, red blood cell and platelet counts.

Reporting of side effects

If your child experiences any side effect, including those not listed in this leaflet, talk to your child’s doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Imraldi

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Imraldi contains

• The active substance is adalimumab.
• The other components are sodium citrate, monohydrate citric acid, histidine, monohydrate histidine hydrochloride, sorbitol, polysorbate 20, and water for injections.

Description of the appearance of Imraldi and contents of the pack
Imraldi 40 mg solution for injection in vial is supplied as 0.8 ml of solution, from clear to opalescent and from colourless to light brown.
The Imraldi vial is a glass vial containing a solution of adalimumab. One pack contains 2 boxes, each containing 1 vial, 1 empty sterile syringe, 1 needle, 1 vial adapter, and 2 alcohol swabs.
Imraldi may be available in the form of a vial, pre-filled syringe, and/or pre-filled pen.

Marketing Authorization Holder
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands

Manufacturer
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgien
Biogen Belgium NV/SA
Tel: +32 2 2191218

Bulgaria
Ewopharma AG Representative Office
Tel: +359 2 9621200

Czech Republic
Biogen (Czech Republic) s.r.o.
Tel: +420 255 706 200

Denmark
Biogen (Denmark) A/S
Tlf: +45 77 41 57 57

Germany
Biogen GmbH
Tel: +49 (0) 89 99 6170

Estonia
Biogen Estonia OÜ
Tel: +372 618 9551

Greece
Genesis Pharma S.A.
Tel: +30 210 8771500

Spain
Biogen Spain, S.L.
Tel: +34 91 310 7110

France
Biogen France SAS
Tel: +33 (0)1 776 968 14

Croatia
Ewopharma d.o.o
Tel: +385 (0)1 6646 563

Ireland
Biogen Idec (Ireland) Ltd.
Tel: +353 (0)1 463 7799

Iceland
Icepharma hf.
Sími: +354 540 8000

Italy
Biogen Italia s.r.l.
Tel: +39 02 584 99 010

Cyprus
Genesis Pharma (Cyprus) Ltd
Tel: +357 22 76 57 15

Latvia
Biogen Latvia SIA
Tel: +371 68 688 158

Lithuania
Biogen Lithuania UAB
Tel: +370 5 259 6176

Luxembourg/Luxemburg
Biogen Belgium NV/SA
Tel: +32 2 2191218

Hungary
Biogen Hungary Kft.
Tel: +36 1 899 9880

Malta
Pharma.MT Ltd
Tel: +356 21337008

Netherlands
Biogen Netherlands B.V.
Tel: +31 20 542 2000

Norway
Biogen Norway AS
Tlf: +47 23 40 01 00

Austria
Biogen Austria GmbH
Tel: +43 1 484 46 13

Poland
Biogen Poland Sp. z o.o.
Tel: +48 22 351 51 00

Portugal
Biogen Portugal Sociedade Farmacêutica, Unipessoal, Lda
Tel: +351 21 318 8450

Romania
Ewopharma Romania SRL
Tel: +40 21 2601344

Slovenia
Biogen Pharma d.o.o.
Tel: +386 1 511 02 90

Slovakia
Biogen Slovakia s.r.o.
Tel: +421 2 323 340 08

Finland
Biogen Finland Oy
Puh/Tel: +358 207 401 200

Sweden
Biogen Sweden AB
Tel: +46 8 594 113 60

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

7. Instructions for Use

The following instructions explain how to inject Imraldi. Read the instructions carefully and follow them step by step. Your doctor or their assistant will provide you with guidance on the administration technique and the correct dose to administer to the child. Do not proceed with the injection until you are confident that you understand how to prepare and administer the dose correctly. After proper training, the injection may be administered by you or another person, such as a family member or friend.
Failure to follow these instructions as described may result in contamination, which could in turn cause infections in the child.
The contents of the syringe must not be mixed with other medicines in the same syringe or vial.

Use of the Vial

• Store the vial in the refrigerator, but do not freeze it.
• Keep the vial in its original carton, protected from light.
• Keep the vial out of the sight and reach of children.

Disposal of the Vial

• Use each vial only once. Never reuse a vial or any of its components.
• Dispose of the used vial in a special container, as instructed by your doctor, nurse, or pharmacist.

Preparation of the Injection Site

• Choose a fatty area for the injection: Suitable injection sites are generally areas rich in fat, such as the abdomen. Fatty areas are easier to pinch and suitable for correct needle insertion.
• Always select a different injection site: When choosing an injection site, select an area that has not been recently used to avoid irritation and bruising.
• Press slowly on the plunger: Rapid injections may sometimes be painful. Pressing slowly on the plunger will make the injection less uncomfortable.

How to Administer the Injection Using the Vial

1) Preparation

• Make sure you know the correct amount (volume) required for the dose. If you do not know the amount, STOP and contact your doctor for further instructions.
• You will need a special waste container, such as a sharps container, or as directed by your nurse, doctor, or pharmacist. Place the container on your work surface.
• Wash your hands thoroughly.
• Remove from the kit one box containing a syringe, a vial adapter, a vial, two alcohol swabs, and a needle. If there is a second box in the kit for the next administration, immediately return it to the refrigerator.
• Check the expiration date on the box. DO NOT use any items in the box after the expiration date.
• Place the following items on a clean surface, WITHOUT removing them from their packaging yet:

o 1) A 1 ml syringe
o 2) A vial adapter
o 3) A pediatric vial of Imraldi injectable solution
o 4) Two alcohol-impregnated swabs
o 5) A needle

• Imraldi is a liquid that ranges from clear to opalescent and from colorless to light brown. DO NOT use if the liquid is not clear to opalescent, colorless to light brown, or if it contains particles.

2) Preparing the Dose of Imraldi for Injection
General instructions: DO NOT discard any items until the injection is completed.

• Prepare the needle by partially opening the packaging from the end closest to the yellow connector of the syringe. Open the packaging just enough to expose the yellow connector of the syringe. Place the packaging with the clear side facing up.

• Remove the plastic cap from the vial until the top of the vial stopper is visible.

• Use one of the alcohol swabs to clean the vial stopper. DO NOT touch the vial stopper after cleaning it with the swab.
• Remove the cover of the vial adapter packaging without removing the adapter from its packaging.

• Hold the vial with the stopper facing upwards.
• While keeping the vial adapter inside its transparent packaging, attach it to the vial stopper by pushing it down until it clicks into place.
• Once you are sure the adapter is securely attached to the vial, remove the packaging from the adapter.
• Gently place the vial and adapter on a clean work surface, taking care not to let them fall. DO NOT touch the adapter.

• Prepare the syringe by partially opening the packaging from the end closest to the white plunger.
• Open the transparent packaging just enough to expose the white plunger, without removing the syringe from its packaging.
• While holding the syringe packaging, slowly pull out the white plunger by 0.1 ml above the prescribed dose (for example, if the prescribed dose is 0.5 ml, push the plunger to 0.6 ml). Never exceed the 0.9 ml mark regardless of the prescribed dose.
• The volume will be adjusted to the prescribed dose in a later step.
• DO NOT push the white plunger completely out of the syringe.

NOTE:
If the white plunger is pushed completely out of the sy游戏副本

Patient information leaflet

Imraldi 40 mg solution for injection in pre-filled syringe

adalimumab
Please read this leaflet carefully before using this medicine because it contains important information for you

• Keep this leaflet. You may need to read it again.
• Your doctor will also provide you with a Patient Reminder Card containing important safety information that you need to know before starting treatment with Imraldi and during treatment. Keep this Patient Reminder Card throughout your treatment and for 4 months after the last injection of Imraldi (yours or your child's).
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Imraldi is and what it is used for
2. What you need to know before using Imraldi
3. How to use Imraldi
4. Possible side effects
5. How to store Imraldi
6. Contents of the pack and other information
7. Instructions for use

1. What Imraldi is and what it is used for

Imraldi contains the active substance adalimumab, a medicine that acts on the immune system (the body's defence system).
Imraldi is indicated for the treatment of:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• enthesitis-related arthritis,
• ankylosing spondylitis,
• non-radiographic axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• psoriatic arthritis,
• psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis, and
• non-infectious uveitis.

The active ingredient in Imraldi, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that bind to a specific target.
The target of adalimumab is a protein called tumour necrosis factor (TNF α ), which is present at high levels in the inflammatory diseases described above. By binding to TNF α , Imraldi reduces the inflammatory process in these diseases.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease affecting the joints.
Imraldi is used to treat rheumatoid arthritis in adults.
If you have moderate to severe rheumatoid arthritis, you may initially be given other disease-modifying drugs, such as methotrexate. If these medicines do not work satisfactorily, you will be given Imraldi to treat rheumatoid arthritis.
Imraldi may also be used for the treatment of severe, active and progressive rheumatoid arthritis without prior treatment with methotrexate.
Imraldi can slow down the progression of joint cartilage and bone damage caused by the disease and can improve physical function.
Imraldi is generally used in combination with methotrexate. If your doctor considers methotrexate treatment inappropriate, Imraldi may be given alone.

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory joint diseases that usually first appear in childhood.
Imraldi is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years. At diagnosis, other disease-modifying drugs such as methotrexate may be given. If these medicines do not work satisfactorily, patients will be given Imraldi to treat polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Ankylosing spondylitis and non-radiographic axial spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory conditions of the spine.
Imraldi is used to treat ankylosing spondylitis and non-radiographic axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will initially be given other medicines. If these medicines do not work satisfactorily, you will be given Imraldi to reduce the signs and symptoms of the disease.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease associated with psoriasis.
Imraldi is used to treat psoriatic arthritis in adults. Imraldi can slow down the damage to joint cartilage and bones caused by the disease and improve physical function.

Plaque psoriasis in adults and children
Plaque psoriasis is an inflammatory skin condition causing red, scaly, hardened patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, making them crumble, thicken, or lift from the nail bed, which can be painful. Psoriasis is believed to be caused by a problem with the body’s immune system leading to increased production of skin cells.
Imraldi is used to treat moderate to severe plaque psoriasis in adults. Imraldi is also used to treat severe plaque psoriasis in children and adolescents weighing at least 30 kg when topical therapy and phototherapy have not worked satisfactorily or are not suitable.

Hidradenitis suppurativa in adults and adolescents
Hidradenitis suppurativa (sometimes called acne inversa) is a chronic, often painful inflammatory skin disease. Symptoms may include painful nodules and abscesses (cysts) that may drain pus. It most commonly affects specific skin areas such as under the breasts, armpits, inner thighs, groin, and buttocks. Scarring may also develop in affected areas.
Imraldi is used to treat hidradenitis suppurativa in adults and adolescents aged 12 years and older. Imraldi can reduce the number of nodules and abscesses you have and the pain often associated with this disease. You may initially be given other medicines. If you do not respond adequately to these medicines, you will be given Imraldi.

Crohn’s disease in adults and children
Crohn’s disease is an inflammation of the intestine.
Imraldi is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If you have Crohn’s disease, you will initially be given other medicines. If these medicines do not work satisfactorily, you will be given Imraldi to reduce the typical symptoms of Crohn’s disease.

Ulcerative colitis in adults and children
Ulcerative colitis is an inflammation of the large intestine.
Imraldi is used to treat moderate to severe ulcerative colitis in adults and children aged 6 to 17 years. If you have ulcerative colitis, you may initially take other medicines. If these medicines do not work satisfactorily, you will take Imraldi to reduce the signs and symptoms of the disease.

Non-infectious uveitis in adults and children
Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
Imraldi is used for the treatment of:

• adults with non-infectious uveitis with inflammation affecting the back of the eye,
• children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.

This inflammation may lead to decreased vision and/or the presence of floaters in the eye (black spots or thin lines moving across the visual field). Imraldi works by reducing this inflammation.

2. What you should know before using Imraldi

Do not use Imraldi

• If you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have a serious infection, including tuberculosis (see "Warnings and precautions"). It is important to inform your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, or dental problems.
• If you have moderate or severe heart failure. It is important to inform your doctor if you have had or currently have a serious heart condition (see "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before using Imraldi.

Allergic reaction

• In case of allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or skin rash, do not administer Imraldi again and contact your doctor immediately, as these reactions may, in rare cases, be life-threatening.

Infection

• If you have an infection, including long-term or localized infections (e.g., leg ulcers), consult your doctor before starting treatment with Imraldi. If you are unsure, contact your doctor.
• You may be more likely to get infections while being treated with Imraldi. This risk may increase if your lung function is reduced. These infections can be serious and may include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, other opportunistic infections (unusual infections associated with a weakened immune system), and sepsis (blood poisoning). In rare cases, these infections may be life-threatening. It is important to inform your doctor if you experience symptoms such as fever, wounds, feeling tired, or dental problems. Your doctor may advise temporarily stopping Imraldi.

Tuberculosis

• Since cases of tuberculosis have occurred in patients treated with Imraldi, your doctor will need to check for signs or symptoms of tuberculosis before starting therapy with Imraldi. This will include a detailed medical evaluation including your medical history and clinical tests (e.g., a chest X-ray and tuberculin skin test). The performance and results of these tests must be recorded in the Patient Reminder Card. It is very important to inform your doctor if you have ever had tuberculosis or if you have had close contact with people who have tuberculosis. Tuberculosis may occur during therapy even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, lack of energy, low-grade fever) or other infections develop during or after treatment.

Travel/recurrent infection

• Inform your doctor if you have lived in or traveled to areas where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic.
• Inform your doctor if you have had recurring infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

• Inform your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active hepatitis B infection, or if you think you may be at risk of contracting hepatitis B virus. Your doctor must test you for hepatitis B virus infection. Taking Imraldi may reactivate hepatitis B virus infection in patients who are carriers of this virus. In some rare cases, especially if the patient is also being treated with other medicines that suppress the immune system, reactivation of hepatitis B virus infection may be life-threatening.

Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Imraldi. You and your doctor should pay particular attention to signs of infection during treatment with Imraldi. It is important to inform your doctor if symptoms of infection such as fever, wounds, feeling tired, or dental problems occur.

Surgery or dental procedure

• Before undergoing surgery or dental procedures, inform your doctor that you are taking Imraldi. Your doctor may advise temporarily stopping Imraldi.

Demyelinating disease

• If you have or develop a demyelinating disease (diseases affecting the protective covering of nerves, such as multiple sclerosis), your doctor will decide whether to start or continue treatment with Imraldi. Inform your doctor immediately if you experience symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling in any part of your body.

Vaccines

• Certain vaccines contain weakened but live bacteria or viruses and should not be given during treatment with Imraldi. Consult your doctor before receiving any vaccinations. In children, it is recommended, if possible, to complete the age-appropriate vaccination schedule before starting treatment with Imraldi. If you receive Imraldi during pregnancy, your baby may have an increased risk of infection for up to about 5 months after your last dose during pregnancy. It is important that you inform your pediatrician or other healthcare provider about your use of Imraldi during pregnancy so they can decide when your baby should receive any vaccinations.

Heart failure

• If you have mild heart failure and are being treated with Imraldi, your doctor will need to carefully monitor your heart condition. It is important to inform your doctor about any past or current heart problems. If new symptoms of heart failure appear or if existing symptoms worsen (e.g., shortness of breath or swelling of the feet), contact your doctor immediately. Your doctor will decide whether you can continue taking Imraldi.

Fever, bruising, bleeding, or paleness

• In some patients, the body may not be able to produce enough blood cells to help fight infections or stop bleeding. If you have persistent fever, bruising, easy bleeding, or paleness, contact your doctor immediately. Your doctor may decide to stop the treatment.

Cancer

• Very rarely, certain types of cancer have been reported in children and adults treated with Imraldi or other anti-TNFα medicines. Patients with long-standing, severe rheumatoid arthritis may have a higher than average risk of developing lymphoma (a cancer affecting the lymphatic system) and leukemia (a cancer affecting blood and bone marrow). If you take Imraldi, your risk of developing lymphomas, leukemia, or other tumors may increase. In rare cases, a specific and serious type of lymphoma has been observed in patients treated with Imraldi. Some of these patients were also taking azathioprine or mercaptopurine. Inform your doctor if you are taking azathioprine or mercaptopurine with Imraldi.

• In addition, cases of non-melanoma skin cancer have been observed in patients treated with Imraldi. If new skin lesions appear during or after treatment, or if the appearance of existing lesions changes, inform your doctor.

• There have been cases of neoplasms other than lymphoma in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα medicine. If you have COPD or are a heavy smoker, you should discuss with your doctor whether treatment with an anti-TNFα medicine is appropriate.

Lupus-like syndrome

• Rarely, treatment with Imraldi may lead to a lupus-like syndrome. Inform your doctor if you develop unexplained persistent skin rash, fever, joint pain, or fatigue.

Children and adolescents

• Do not give Imraldi to children under 2 years of age with polyarticular juvenile idiopathic arthritis.
• Do not use the 40 mg pre-filled syringe if the recommended dose is different from 40 mg.

Other medicines and Imraldi
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Imraldi can be taken together with methotrexate and other disease-modifying antirheumatic drugs (DMARDs) such as sulfasalazine, hydroxychloroquine, leflunomide, and parenteral gold salts, as well as corticosteroids or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Imraldi must not be used together with medicines containing the active substances anakinra or abatacept due to an increased risk of serious infections. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• You should use an effective method of contraception to prevent pregnancy and continue using it for at least 5 months after your last injection of Imraldi.
• If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
• Imraldi should only be used during pregnancy if necessary.
• According to a pregnancy study, no increased risk of birth defects was observed when mothers received adalimumab during pregnancy compared to mothers with the same condition who did not receive adalimumab.
• Imraldi may be used during breastfeeding.
• If you receive Imraldi during pregnancy, your baby may have an increased risk of infection.
• It is important that you inform your pediatrician or other healthcare provider about your use of Imraldi during pregnancy before your baby receives any vaccinations (for more information on vaccinations, see the section "Warnings and precautions").

Driving and using machines
Imraldi may have a minor influence on your ability to drive, ride a bicycle, or use machines. After taking Imraldi, you may experience vision disturbances or a sensation that your surroundings are spinning (dizziness).

Imraldi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 0.4 ml dose, i.e., it is essentially 'sodium-free'.

3. How to use Imraldi

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or axial spondyloarthritis without
radiographic evidence of ankylosing spondylitis.
The pre-filled syringe and the pre-filled pen of Imraldi are available only in a 40 mg dose. Therefore, the pre-filled syringe and pre-filled pen of Imraldi cannot be used in paediatric patients requiring less than the full 40 mg dose. If an alternative dose is required, other products offering this option must be used.
Imraldi is injected under the skin (subcutaneous use). The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, and for patients with psoriatic arthritis is 40 mg of adalimumab every other week, administered as a single dose.
In rheumatoid arthritis, methotrexate is continued during treatment with Imraldi. If your doctor determines that methotrexate is not appropriate, Imraldi may be given alone.
If you have rheumatoid arthritis and are not receiving methotrexate in combination with Imraldi, your doctor may decide to prescribe 40 mg of adalimumab weekly or 80 mg every other week.

Children, adolescents, and adults with polyarticular juvenile idiopathic arthritis
Children and adolescents aged 2 years and older, weighing between 10 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.
Children, adolescents, and adults aged 2 years and older, weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.

Children, adolescents, and adults with enthesitis-related arthritis
Children and adolescents aged 6 years and older, weighing between 15 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.
Children, adolescents, and adults aged 6 years and older, weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.

Adults with psoriasis
The usual dose of Imraldi for adults with psoriasis is an initial dose of 80 mg (via two injections of 40 mg on the same day), followed by 40 mg every other week, starting the week after the initial dose. You must continue treatment with Imraldi for the duration prescribed by your doctor. If this dose is not effective enough, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.

Children and adolescents with plaque psoriasis
Children and adolescents aged between 4 and 17 years, weighing between 15 kg and less than 30 kg
The recommended dose of Imraldi is an initial dose of 20 mg, followed by a dose of 20 mg the following week. Thereafter, the usual dose is 20 mg every other week.
Children and adolescents aged between 4 and 17 years, weighing 30 kg or more
The recommended dose of Imraldi is an initial dose of 40 mg, followed by a dose of 40 mg the following week. Thereafter, the usual dose is 40 mg every other week.

Adults with hidradenitis suppurativa
The usual dose for hidradenitis suppurativa is an initial dose of 160 mg (via four injections of 40 mg on the same day or two injections of 40 mg per day for two consecutive days), followed by 80 mg (via two injections of 40 mg on the same day) two weeks later. After another two weeks, continue with 40 mg weekly or 80 mg every other week, as prescribed by your doctor. It is recommended to use an antiseptic wash solution daily on the affected areas.

Adolescents with hidradenitis suppurativa aged between 12 and 17 years, weighing 30 kg or more
The recommended dose of Imraldi is an initial dose of 80 mg (via two injections of 40 mg on the same day), followed by 40 mg every two weeks, starting one week later. If this dose of 40 mg of Imraldi every other week is not effective enough, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.
It is recommended to use an antiseptic wash solution daily on the affected areas.

Adults with Crohn’s disease
The usual dose for Crohn’s disease is initially 80 mg (via two injections of 40 mg on the same day), followed by 40 mg every other week, two weeks later. If a more rapid response is needed, your doctor may prescribe an initial dose of 160 mg (via four injections of 40 mg on the same day or two injections of 40 mg per day for two consecutive days), followed by 80 mg (via two injections of 40 mg on the same day) two weeks later, and subsequently 40 mg every other week. If this dose is not effective enough, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.

Children and adolescents with Crohn’s disease
Children and adolescents aged between 6 and 17 years, weighing less than 40 kg
The usual dose is initially 40 mg, followed by 20 mg after two weeks. If a more rapid response is needed, your doctor may prescribe an initial dose of 80 mg (via two injections of 40 mg on the same day), followed by 40 mg after two weeks.
Thereafter, the usual dose is 20 mg every other week. If this dose is not effective enough, your doctor may increase the frequency to 20 mg weekly.
Children and adolescents aged between 6 and 17 years, weighing 40 kg or more
The usual dose is initially 80 mg (via two injections of 40 mg on the same day), followed by 40 mg after two weeks. If a more rapid response is needed, your doctor may prescribe an initial dose of 160 mg (via four injections of 40 mg on the same day or two injections of 40 mg per day for two consecutive days), followed by 80 mg (via two injections of 40 mg on the same day) two weeks later.
Thereafter, the usual dose is 40 mg every other week. If this dose is not effective enough, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.

Adults with ulcerative colitis
The usual dose of Imraldi for adults with ulcerative colitis is 160 mg (via four injections of 40 mg on the same day or two injections of 40 mg per day for two consecutive days) at week 0, followed by 80 mg (via two injections of 40 mg on the same day) at week 2, and subsequently 40 mg every other week. If this dose is not effective enough, your doctor may increase the dosage to 40 mg weekly or 80 mg every other week.

Children and adolescents with ulcerative colitis
Children and adolescents aged 6 years and older, weighing less than 40 kg
The usual dose of Imraldi is 80 mg (via two injections of 40 mg on the same day), followed by 40 mg (via one injection of 40 mg) two weeks later. Thereafter, the usual dose is 40 mg every other week.
Patients who turn 18 years old while receiving 40 mg every other week should continue the prescribed dose.
Children and adolescents aged 6 years and older, weighing 40 kg or more
The usual dose of Imraldi is 160 mg (via four injections of 40 mg on the same day or two injections of 40 mg per day for two consecutive days), followed by 80 mg (via two injections of 40 mg on the same day) two weeks later. Thereafter, the usual dose is 80 mg every other week.
Patients who turn 18 years old while receiving 80 mg every other week should continue the prescribed dose.

Adults with non-infectious uveitis
The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (via two injections on the same day), followed by 40 mg every two weeks, starting one week after the initial dose. Continue injecting Imraldi for the entire duration prescribed by your doctor.
In non-infectious uveitis, corticosteroids or other immunosuppressive medications may be continued during treatment with Imraldi. Imraldi may also be administered as monotherapy.

Children and adolescents with chronic non-infectious uveitis aged 2 years and older
Children and adolescents aged 2 years and older, weighing less than 30 kg
The usual dose of Imraldi is 20 mg administered every other week with methotrexate.
Your child’s doctor may also prescribe an initial dose of 40 mg, which can be administered one week before starting the usual dosing regimen.
Children and adolescents aged 2 years and older, weighing 30 kg or more
The usual dose of Imraldi is 40 mg administered every other week with methotrexate.
Your doctor may also prescribe an initial dose of 80 mg, which can be administered one week before starting the usual dosing regimen.

Method and route of administration
Imraldi is administered by subcutaneous injection. For instructions on use, refer to section 7.

If you use more Imraldi than you should
If you accidentally inject Imraldi more frequently than prescribed, contact your doctor or pharmacist and inform them that you have taken more medicine than intended. Always keep the medicine carton, even if empty.

If you forget to use Imraldi
If you forget to administer an injection, inject the next dose of Imraldi as soon as you remember. Then resume your regular dosing schedule.

If you stop using Imraldi
The decision to discontinue treatment with Imraldi should be discussed with your doctor. Symptoms may return after stopping treatment.

If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate in severity. However, some may be serious and require treatment. Side effects may occur up to 4 months or more after the last injection of Imraldi.

Contact your doctor urgently if you notice any of the following reactions:

• severe rash, hives, or other signs of allergic reaction;
• swelling of the face, hands, or feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath during exertion or when lying down, or swollen feet.

Inform your doctor as soon as possible if you notice any of the following reactions:

• signs of infection such as fever, feeling unwell, wounds, dental problems, burning during urination;
• fatigue or weakness;
• cough;
• tingling;
• numbness;
• double vision;
• weakness in arms or legs;
• swelling or a wound that does not heal;
• signs and symptoms suggesting disorders of the hematopoietic system, such as persistent fever, bruising, bleeding, or paleness.

The symptoms described above may be signs of the following side effects, which have been observed with adalimumab:

Very common (may affect more than 1 in 10 people):

• reactions at the injection site (including pain, swelling, redness, or itching);
• respiratory tract infections (including cold, runny nose, sinusitis, and pneumonia);
• headache;
• abdominal pain (stomach pain);
• nausea and vomiting;
• skin rash;
• muscle pain.

Common (may affect up to 1 in 10 people):

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including dental infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• joint infections;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, stabbing sensations, or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (sensation of spinning);
• sensation of rapid heartbeat;
• high blood pressure;
• hot flushes;
• hematoma (a solid swelling with clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux disorder;
• dry syndrome (including dry eyes and dry mouth);
• itching;
• itchy skin rash;
• bruising;
• skin inflammation (such as eczema);
• splitting of fingernails and toenails;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in the urine;
• kidney problems;
• chest pain;
• edema (fluid accumulation in the body causing swelling of affected tissues);
• fever;
• reduced platelet count in the blood, increasing the risk of bleeding or bruising;
• impaired wound healing.

Uncommon (may affect up to 1 in 100 people):

• opportunistic infections (including tuberculosis and other infections occurring when immune defenses are reduced);
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors, including tumors of the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• disorders of the immune system that may affect lungs, skin, and lymph nodes (most commonly in the form of a disease called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• sensation of irregular heartbeat such as palpitations;
• heart problems that may cause shortness of breath or swelling of the ankles;
• myocardial infarction;
• formation of a sac in the wall of a major artery, inflammation and clot in a vein, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• inflammation of the pancreas causing severe abdominal and back pain;
• difficulty swallowing;
• facial edema;
• gallbladder inflammation, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle breakdown;
• systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints, and other organs);
• disrupted sleep;
• impotence;
• inflammations.

Rare (may affect up to 1 in 1,000 people):

• leukemia (a cancer affecting blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as optic neuritis of the eye and Guillain-Barré syndrome, a disease that may cause muscle weakness, abnormal sensations, tingling in arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lungs);
• intestinal perforation;
• hepatitis;
• reactivation of hepatitis B;
• autoimmune hepatitis (liver inflammation caused by the body's own immune system);
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• Stevens-Johnson syndrome (early symptoms include malaise, fever, headache, and skin rash);
• facial edema associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (pruritic red-purple skin rash).

Not known (frequency cannot be estimated from the available data):

• hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi’s sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi’s sarcoma most commonly appears as purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (manifesting as skin rash accompanied by muscle weakness);
• weight gain (in most patients, weight gain has been low).

Some of the side effects observed with adalimumab may be asymptomatic and can only be detected through blood tests.

These include:

Very common (may affect more than 1 in 10 people):

• low white blood cell count;
• low red blood cell count;
• increased blood lipids;
• increased liver enzymes.

Common (may affect up to 1 in 10 people):

• increased white blood cell count;
• decreased platelet count;
• increased uric acid in the blood;
• altered sodium levels in the blood;
• decreased calcium in the blood;
• decreased phosphorus in the blood;
• increased blood glucose;
• increased lactate dehydrogenase in the blood;
• presence of autoantibodies in the blood;
• decreased potassium in the blood.

Uncommon (may affect up to 1 in 100 people):

• elevated bilirubin levels in the blood (liver blood test).

Rare (may affect up to 1 in 1,000 people):

• low white blood cell, red blood cell, and platelet counts.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Imraldi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the carton after
EXP. The expiry date refers to the last day of that month.
Store in the refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.

Alternative storage conditions:
When necessary (for example, when travelling), a single pre-filled syringe may be
stored at room temperature (up to 25 °C) for a maximum of 31 days – ensure the medicine is protected from light. Once removed from the refrigerator for storage at room temperature, the syringe must be used within 31 days or must be discarded, even if it is placed back into the refrigerator.
You must record the date when the syringe is first removed from the refrigerator and the date after which the syringe must be discarded.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Imraldi contains

• The active substance is adalimumab.
• The other components are monobasic monohydrate sodium phosphate, dibasic heptahydrate sodium phosphate, succinic acid, dibasic sodium succinate, histidine, monohydrate hydrochloride histidine, mannitol, polysorbate 20 and water for injections.

Description of the appearance of Imraldi and contents of the pack
Imraldi 40 mg solution for injection in pre-filled syringes is supplied as 0.4 ml of solution from
clear to opalescent and from colourless to light brown.
Imraldi is available in packs containing 1, 2, 4 or 6 pre-filled syringe(s) (Type I glass)
with a stainless steel needle, a rigid cap, a rubber plunger, a rod, a protective cover and a finger flange for patient use, and respectively 2, 2, 4 or 6 alcohol swabs included in the pack.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands

Manufacturer
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Biogen Belgium NV/S.A Biogen Lithuania UAB
Tél/Tel: + 32 2 2191218 Tel: +370 5 259 6176

България Luxembourg/Luxemburg
Ewopharma AG Representative Office Biogen Belgium NV/SA
Teл.: + 35929621200 Tél/Tel: +32 2 2191218

Česká republika Magyarország
Biogen (Czech Republic) s.r.o. Biogen Hungary Kft.
Tel: + 420 255 706 200 Tel.: + 36 1 899 9880

Danmark Malta
Biogen (Denmark) A/S Pharma.MT Ltd
Tlf.: + 45 77 41 57 57 Tel: + 35621337008

Deutschland Nederland
Biogen GmbH Biogen Netherlands B.V.
Tel: + 49 (0) 89 99 6170 Tel: + 31 20 542 2000

Eesti Norge
Biogen Estonia OÜ Biogen Norway AS
Tel: + 372 618 9551 Tlf: + 47 23 40 01 00

Ελλάδα Österreich
Genesis Pharma S.A. Biogen Austria GmbH
Τηλ: + 302108771500 Tel: + 43 1 484 46 13

España Polska
Biogen Spain, S.L. Biogen Poland Sp. z o.o.
Tel: +34 91 310 7110 Tel.: + 48 22 351 51 00

France Portugal
Biogen France SAS Biogen Portugal Sociedade Farmacêutica,
Tél: + 33 (0)1 776 968 14 Unipessoal, Lda
Tel: + 351 21 318 8450

Hrvatska România
Ewopharma d.o.o Ewopharma Romania SRL
Tel: + 385 (0)1 6646 563 Tel: + 40212601344

Ireland Slovenija
Biogen Idec (Ireland) Ltd. Biogen Pharma d.o.o.
Tel: +353 (0)1 463 7799 Tel: + 386 1 511 02 90

Ísland Slovenská republika
Icepharma hf. Biogen Slovakia s.r.o.
Sími: + 354 540 8000 Tel: + 421 2 323 340 08

Italia Suomi/Finland
Biogen Italia s.r.l. Biogen Finland Oy
Tel: + 39 02 584 99 010 Puh/Tel: + 358 207 401 200

Κύπρος Sverige
Genesis Pharma (Cyprus) Ltd Biogen Sweden AB
Τηλ: + 357 22 76 57 15 Tel: +46 8 594 113 60

Latvija
Biogen Latvia SIA
Tel: + 371 68 688 158

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu .

7. Instructions for use

Follow these instructions carefully: you will soon become familiar with the procedure and will be able to administer the injections confidently.

• Before administering the injections, ask your doctor or nurse to show you how to use the prefilled syringe. Your doctor or nurse must verify that you are able to use the syringe correctly.

Appearance of the single-dose prefilled syringe

After pushing the plunger fully down, the needle retracts automatically, thereby preventing needlestick injuries.
Use of the prefilled syringe
Storage of the syringe

• Store the syringe in the refrigerator, but do not freeze it.
• Keep the syringe in its original box, protected from light.
• Keep the syringe out of sight and reach of children.

Disposal of the syringe

• Use each syringe only once. Never reuse a syringe.
• Dispose of the used syringe in a special container, as instructed by your doctor, nurse, or pharmacist.

Caution

• If the syringe falls with the cap in place, it may still be used. If the syringe falls without the cap in place, do not use it. The needle may be contaminated or damaged.
• Do not use a damaged syringe.

Preparing the injection site

• Choose an area with a good amount of fatty tissue for the injection: the most suitable injection sites are generally areas rich in fat, such as the abdomen. Fatty areas are easier to grasp between the fingers and are appropriate for correct needle insertion.
• Always choose a different injection site each time: when selecting an injection site, choose an area that has not recently been used, in order to avoid irritation and bruising.
• Push the plunger slowly: sometimes rapid injections can be painful. Pushing the plunger slowly will make the injection less uncomfortable.

How to administer the injection using the prefilled syringe

1. Gather the necessary items

Place the pre-filled syringe and alcohol swabs on a clean, dry surface.

• Remember to wash your hands!
• Do not remove the cap yet!

2. Wait 15–30 minutes

Wait 15–30 minutes to bring the pre-filled syringe to room temperature, in order to reduce pain during injection.

• Do not remove the cap yet!

3. Check the medicine and the expiry date

Always check that the medicine is from clear to opalescent, from colourless to light brown, free of particles, and not expired. Do not use the medicine if it is not clear to opalescent, colourless to light brown, and free of particles, or if it has expired.
One or more air bubbles may be present, which is not a problem. There is no need to remove them.

• Do not remove the cap yet!

4. Choose an injection site and clean the skin

Choose an injection site on the body. The most suitable areas are the abdomen (except the area around the navel) or the thighs.
Clean the injection site with an alcohol swab. Do not touch it again before the injection.

• Avoid areas with lesions, bruises, scars, peeling skin, or red spots.

5. Remove the needle cap

Carefully remove the needle cap.
It is normal for a few drops of liquid to come out of the needle.
Do not reattach the needle cap once it has been removed, if you are not ready to perform the injection. Otherwise, you risk bending or damaging the needle. There is also a risk of accidentally pricking yourself or spilling some of the medicine.

6. Pinch the skin with your fingers and insert the needle

Carefully pinch a fold of skin with your fingers and insert the needle all the way in at an angle
of approximately 45 degrees.

7. Push the plunger fully

Hold the syringe steady and push the plunger fully.
Then lift the thumb so that the needle retracts into the body of the syringe.

8. Remove and dispose of the syringe

Remove the syringe from the skin.
After injecting Imraldi, check that the needle has retracted and immediately dispose of the used syringe in a special container, as explained to you by your doctor, nurse, or pharmacist.

• If you are not sure whether you received the full dose, consult your doctor, nurse, or pharmacist.

Patient information leaflet

Imraldi 40 mg solution for injection in pre-filled pen

adalimumab
Please read this leaflet carefully before using this medicine because it contains important information for you

• Keep this leaflet. You may need to read it again.
• Your doctor will also provide you with a Patient Reminder Card containing important safety information that you need to know before administering Imraldi and during treatment with Imraldi. Keep this Patient Reminder Card throughout your treatment and for 4 months after the last injection of Imraldi (yours or your child's).
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Imraldi is and what it is used for
2. What you need to know before using Imraldi
3. How to use Imraldi
4. Possible side effects
5. How to store Imraldi
6. Contents of the pack and other information
7. Instructions for use

1. What Imraldi is and what it is used for

Imraldi contains the active substance adalimumab, a medicine that acts on the immune system (the body's defence system).
Imraldi is indicated for the treatment of:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• enthesitis-related arthritis,
• ankylosing spondylitis,
• non-radiographic axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• psoriatic arthritis,
• psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis, and
• non-infectious uveitis.

The active ingredient in Imraldi, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that bind to a specific target.
The target of adalimumab is a protein called tumour necrosis factor (TNF α ), which is present at high levels in the inflammatory diseases described above. By binding to TNF α , Imraldi reduces the inflammatory process in these diseases.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease affecting the joints.
Imraldi is used to treat rheumatoid arthritis in adults.
If you have moderate to severe rheumatoid arthritis, you may initially be given other disease-modifying drugs, such as methotrexate. If these medicines do not work satisfactorily, you will be given Imraldi to treat rheumatoid arthritis.
Imraldi may also be used for the treatment of severe, active and progressive rheumatoid arthritis without prior treatment with methotrexate.
Imraldi can slow down the progression of joint cartilage and bone damage caused by the disease and improve physical function.
Imraldi is generally used in combination with methotrexate. If your doctor considers methotrexate treatment inappropriate, Imraldi may be given alone.

Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory joint diseases that usually first appear in childhood.
Imraldi is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years, and enthesitis-related arthritis in children and adolescents aged 6 to 17 years. At diagnosis, other disease-modifying drugs such as methotrexate may be given. If these drugs do not work satisfactorily, patients will be given Imraldi to treat polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Ankylosing spondylitis and non-radiographic axial spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory conditions affecting the spine.
Imraldi is used to treat ankylosing spondylitis and non-radiographic axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be given other medicines. If these medicines do not work satisfactorily, you will be given Imraldi to reduce the signs and symptoms of the disease.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease associated with psoriasis.
Imraldi is used to treat psoriatic arthritis in adults. Imraldi can slow down the damage to joint cartilage and bone caused by the disease and improve physical function.

Plaque psoriasis in adults and children
Plaque psoriasis is an inflammatory skin condition causing reddish, scaly, thickened patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thicker, or lift from the nail bed, which can be painful. Psoriasis is thought to be caused by a problem with the body's immune system leading to increased production of skin cells.
Imraldi is used to treat moderate to severe plaque psoriasis in adults. Imraldi is also used to treat severe plaque psoriasis in children and adolescents weighing at least 30 kg when topical therapy and phototherapy have not worked satisfactorily or are not suitable.

Hidradenitis suppurativa in adults and adolescents
Hidradenitis suppurativa (sometimes called acne inversa) is a chronic inflammatory skin disease, often painful. Symptoms may include painful nodules and abscesses (cysts) that may drain pus. It most commonly affects specific skin areas such as under the breasts, armpits, inner thighs, groin, and buttocks. Scarring may also develop in affected areas.
Imraldi is used to treat hidradenitis suppurativa in adults and adolescents aged 12 years and older. Imraldi can reduce the number of nodules and abscesses you have, as well as the pain often associated with this disease. You may initially receive other medicines. If you do not respond adequately to these medicines, you will be given Imraldi.

Crohn’s disease in adults and children
Crohn’s disease is an inflammation of the intestine.
Imraldi is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If you have Crohn’s disease, you will first be given other medicines. If these medicines do not work satisfactorily, you will be given Imraldi to reduce the typical symptoms of Crohn’s disease.

Ulcerative colitis in adults and children
Ulcerative colitis is an inflammation of the large intestine (colon).
Imraldi is used to treat moderate to severe ulcerative colitis in adults and children aged 6 to 17 years. If you have ulcerative colitis, you may first be given other medicines. If these medicines do not work satisfactorily, you will be given Imraldi to reduce the signs and symptoms of the disease.

Non-infectious uveitis in adults and children
Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
Imraldi is used for the treatment of:

• Adults with non-infectious uveitis with inflammation affecting the back of the eye
• Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front part of the eye

This inflammation can lead to decreased vision and/or the presence of floaters in the eye (black spots or fine lines moving across the visual field). Imraldi works by reducing this inflammation.

2. What you need to know before using Imraldi

Do not use Imraldi

• If you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have a serious infection, including tuberculosis (see "Warnings and precautions"). It is important to inform your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, or dental problems.
• If you have moderate or severe heart failure. It is important to inform your doctor if you have had or currently have a serious heart condition (see "Warnings and precautions").

Warnings and precautions
Talk to your doctor or pharmacist before using Imraldi.

Allergic reaction

• In case of allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or skin rash, do not administer Imraldi again and contact your doctor immediately, as these reactions may, in rare cases, be life-threatening.

Infection

• If you have an infection, including long-term or localized infections (e.g., leg ulcers), consult your doctor before starting treatment with Imraldi. If in doubt, contact your doctor.
• You may be more likely to get infections while being treated with Imraldi. This risk may increase if your lung function is reduced. These infections can be serious and may include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, other opportunistic infections (unusual infections associated with a weakened immune system), and sepsis (blood poisoning). In rare cases, these infections may be life-threatening. It is important to inform your doctor if you experience symptoms such as fever, wounds, feeling tired, or dental problems. Your doctor may advise temporarily stopping Imraldi.

Tuberculosis

• Cases of tuberculosis have occurred in patients treated with Imraldi. Therefore, your doctor will check for signs and symptoms of tuberculosis before starting therapy with Imraldi. This will include a detailed medical evaluation including your medical history and clinical examinations (e.g., chest X-ray and tuberculin skin test). The performance and results of these tests must be recorded in the Patient Reminder Card. It is very important to inform your doctor if you have ever had tuberculosis or if you have had close contact with people who have tuberculosis. Tuberculosis may develop during treatment, even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, lack of energy, low-grade fever) or other infections occur during or after treatment.

Travel/recurrent infection

• Inform your doctor if you have lived in or traveled to regions where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic.
• Inform your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

• Inform your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active hepatitis B virus infection, or if you think you may be at risk of contracting hepatitis B virus. Your doctor must test you for hepatitis B virus infection. Taking Imraldi may reactivate hepatitis B virus infection in people who are carriers of this virus. In rare cases, especially if the patient is also receiving treatment with other medicines that suppress the immune system, reactivation of hepatitis B virus infection may be life-threatening.

Age over 65 years

• If you are over 65 years old, you may be more susceptible to infections while taking Imraldi. You and your doctor should pay particular attention to signs of infection during treatment with Imraldi. It is important to inform your doctor if symptoms of infection such as fever, wounds, feeling tired, or dental problems occur.

Surgery or dental procedures

• Before undergoing surgery or dental procedures, inform your doctor that you are taking Imraldi. Your doctor may advise temporarily stopping Imraldi.

Demyelinating disease

• If you have or develop a demyelinating disease (diseases affecting the protective covering of nerves, such as multiple sclerosis), your doctor will decide whether to start or continue treatment with Imraldi. Inform your doctor immediately if you experience symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling in any part of the body.

Vaccines

• Certain vaccines contain weakened but live bacteria or viruses and must not be administered during treatment with Imraldi. Consult your doctor before receiving any vaccinations. In children, it is recommended, if possible, to complete the age-appropriate vaccination schedule before starting treatment with Imraldi. If you receive Imraldi during pregnancy, your baby may have an increased risk of infection for up to about 5 months after your last dose during pregnancy. It is important that you inform your child's paediatrician or other healthcare provider about your use of Imraldi during pregnancy so they can determine when your child should receive any vaccinations.

Heart failure

• If you have mild heart failure and are being treated with Imraldi, your doctor must carefully assess and monitor your heart condition. It is important to inform your doctor about any past or current heart problems. If new symptoms of heart failure appear or if existing symptoms worsen (e.g., shortness of breath or swelling of the feet), contact your doctor immediately. Your doctor will decide whether you can continue taking Imraldi.

Fever, bruising, bleeding or paleness

• In some patients, the body may not be able to produce enough blood cells to help fight infections or stop bleeding. If you have persistent fever, bruising, easy bleeding, or paleness, contact your doctor immediately. Your doctor may decide to stop treatment.

Cancer

• Very rare cases of certain types of cancer have been observed in children and adults treated with Imraldi or other anti-TNFα medicines. Patients with long-standing, severe rheumatoid arthritis may have a higher than average risk of developing lymphoma (a tumour affecting the lymphatic system) and leukaemia (a tumour affecting blood and bone marrow). If you are taking Imraldi, your risk of developing lymphomas, leukaemia, or other tumours may increase. In rare cases, a specific and serious type of lymphoma has been observed in patients treated with Imraldi. Some of these patients were also receiving azathioprine or mercaptopurine. Inform your doctor if you are taking azathioprine or mercaptopurine with Imraldi.
• In addition, cases of non-melanoma skin cancer have been observed in patients treated with Imraldi. If new areas of damaged skin appear during or after treatment, or if the appearance of existing lesions or damaged areas changes, inform your doctor.
• Cases of neoplasms other than lymphoma have been reported in patients with a specific lung disease called chronic obstructive pulmonary disease (COPD) treated with another anti-TNFα medicine. If you have COPD or are a heavy smoker, discuss with your doctor whether treatment with an anti-TNFα medicine is appropriate.

Lupus-like syndrome

• Rarely, treatment with Imraldi may lead to a lupus-like syndrome. Inform your doctor if you develop symptoms such as persistent unexplained skin rash, fever, joint pain, or fatigue.

Children and adolescents

• Do not give Imraldi to children under 2 years of age with polyarticular juvenile idiopathic arthritis.
• Do not use the 40 mg pre-filled pen if the recommended dose is different from 40 mg.

Other medicines and Imraldi
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Imraldi may be taken with methotrexate and other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide, and parenteral gold salts), corticosteroids, or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Imraldi must not be taken together with medicines containing the active substances anakinra or abatacept due to an increased risk of serious infections. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• You should consider using an effective method of contraception to prevent pregnancy and continue using it for at least 5 months after your last injection of Imraldi.
• If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
• Imraldi should be used during pregnancy only if necessary.
• According to a pregnancy study, no increased risk of birth defects was observed in babies whose mothers received adalimumab during pregnancy, compared to mothers with the same condition who did not receive adalimumab.
• Imraldi may be used during breastfeeding.
• If you receive Imraldi during pregnancy, your baby may have an increased risk of infection.
• It is important that you inform your child's paediatrician or other healthcare provider about your use of Imraldi during pregnancy before your baby receives any vaccinations (for more information on vaccinations, see section “Warnings and precautions”).

Driving and using machines
Imraldi may affect, although only to a minor extent, your ability to drive, ride a bicycle, or use machines. After taking Imraldi, you may experience vision disturbances and a sensation that your surroundings are spinning (dizziness).

Imraldi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 0.4 ml dose, i.e., it is essentially 'sodium-free'.

3. How to use Imraldi

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or axial spondyloarthritis without
radiographic evidence of ankylosing spondylitis.
The pre-filled syringe and the pre-filled pen of Imraldi are available only in a 40 mg dose. Therefore, the pre-filled syringe and the pre-filled pen of Imraldi cannot be used in pediatric patients who require less than the full 40 mg dose. If an alternative dose is required, other products offering this option must be used.
Imraldi is injected under the skin (subcutaneous use). The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, and for patients with psoriatic arthritis is 40 mg of adalimumab every other week, administered as a single dose.
In rheumatoid arthritis, methotrexate should be continued during treatment with Imraldi. If your doctor decides that methotrexate is not appropriate, Imraldi may be given alone.
If you have rheumatoid arthritis and are not receiving methotrexate in combination with Imraldi, your doctor may decide to prescribe you 40 mg of adalimumab weekly or 80 mg every other week.

Children, adolescents, and adults with polyarticular juvenile idiopathic arthritis
Children and adolescents aged 2 years and older, weighing between 10 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.
Children, adolescents, and adults aged 2 years and older, weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.

Children, adolescents, and adults with enthesitis-related arthritis
Children and adolescents aged 6 years and older, weighing between 15 kg and less than 30 kg
The recommended dose of Imraldi is 20 mg every other week.
Children, adolescents, and adults aged 6 years and older, weighing 30 kg or more
The recommended dose of Imraldi is 40 mg every other week.

Adults with psoriasis
The usual dose of Imraldi for adults with psoriasis is an initial dose of 80 mg (via two injections on the same day), followed by 40 mg every other week, starting from the week after the initial dose. You must continue treatment with Imraldi for the duration prescribed by your doctor. If this dose does not work satisfactorily, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.

Children and adolescents with plaque psoriasis
Children and adolescents aged 4 to 17 years, weighing between 15 kg and less than 30 kg
The recommended dose of Imraldi is an initial dose of 20 mg, followed by a dose of 20 mg the following week. Subsequently, the usual dose is 20 mg every other week.
Children and adolescents aged 4 to 17 years, weighing 30 kg or more
The recommended dose of Imraldi is an initial dose of 40 mg, followed by a dose of 40 mg the following week. Subsequently, the usual dose is 40 mg every other week.

Adults with hidradenitis suppurativa
The usual dose for hidradenitis suppurativa is an initial dose of 160 mg (via four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days), followed by 80 mg (via two 40 mg injections on the same day) two weeks later. After another two weeks, continue with 40 mg weekly or 80 mg every other week, as prescribed by your doctor. It is recommended to use an antiseptic wash solution daily on affected areas.

Adolescents with hidradenitis suppurativa, aged 12 to 17 years, weighing 30 kg or more
The recommended dose of Imraldi is an initial dose of 80 mg (via two 40 mg injections on the same day), followed by 40 mg every two weeks, starting one week later. If this dose does not work satisfactorily at 40 mg of Imraldi every other week, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.
It is recommended to use an antiseptic wash solution daily on affected areas.

Adults with Crohn’s disease
The usual dose for Crohn’s disease is initially 80 mg (via two 40 mg injections on the same day), followed by 40 mg every other week, two weeks later. If a more rapid response is needed, your doctor may prescribe an initial dose of 160 mg (via four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days), followed by 80 mg (via two 40 mg injections on the same day) two weeks later, and subsequently 40 mg every other week. If this dose does not work satisfactorily, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.

Children and adolescents with Crohn’s disease
Children and adolescents aged 6 to 17 years, weighing less than 40 kg
The usual dose is initially 40 mg, followed by 20 mg after two weeks. If a more rapid response is required, your doctor may prescribe an initial dose of 80 mg (via two 40 mg injections on the same day), followed by 40 mg after two weeks.
Subsequently, the usual dose is 20 mg every other week. If this dose does not work satisfactorily, your doctor may increase the dosing frequency to 20 mg weekly.
Children and adolescents aged 6 to 17 years, weighing 40 kg or more
The usual dose is initially 80 mg (via two 40 mg injections on the same day), followed by 40 mg after two weeks. If a more rapid response is required, your doctor may prescribe an initial dose of 160 mg (via four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days), followed by 80 mg (via two 40 mg injections on the same day) after two weeks.
Subsequently, the usual dose is 40 mg every other week. If this dose does not work satisfactorily, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.

Adults with ulcerative colitis
The usual dose of Imraldi for adults with ulcerative colitis is 160 mg (via four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days) at week 0, 80 mg (via two 40 mg injections on the same day) at week 2, and subsequently 40 mg every other week. If this dose does not work satisfactorily, your doctor may increase the dose to 40 mg weekly or 80 mg every other week.

Children and adolescents with ulcerative colitis
Children and adolescents aged 6 years and older, weighing less than 40 kg
The usual dose of Imraldi is 80 mg (via two 40 mg injections on the same day), followed by 40 mg (via a single 40 mg injection) two weeks later. Subsequently, the usual dose is 40 mg every other week.
Patients who turn 18 years old while receiving 40 mg every other week should continue the prescribed dose.
Children and adolescents aged 6 years and older, weighing 40 kg or more
The usual dose of Imraldi is 160 mg (via four 40 mg injections on the same day or two 40 mg injections per day for two consecutive days), followed by 80 mg (via two 40 mg injections on the same day) after two weeks. Subsequently, the usual dose is 80 mg every other week.
Patients who turn 18 years old while receiving 80 mg every other week should continue the prescribed dose.

Adults with non-infectious uveitis
The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (via two injections on the same day), followed by 40 mg administered every two weeks, starting one week after the initial dose. Continue injecting Imraldi for the duration prescribed by your doctor.
In non-infectious uveitis, corticosteroids or other immunosuppressive medications may be continued during treatment with Imraldi. Imraldi may also be administered as monotherapy.

Children and adolescents with chronic non-infectious uveitis, aged 2 years and older
Children and adolescents aged 2 years and older, weighing less than 30 kg
The usual dose of Imraldi is 20 mg administered every other week with methotrexate.
Your child’s doctor may also prescribe an initial dose of 40 mg, which can be administered one week before starting the usual dosing regimen.
Children and adolescents aged 2 years and older, weighing 30 kg or more
The usual dose of Imraldi is 40 mg administered every other week with methotrexate.
Your doctor may also prescribe an initial dose of 80 mg, which can be administered one week before starting the usual dosing regimen.

Method and route of administration
Imraldi is administered by subcutaneous injection. For instructions on use, refer to section 7.

If you use more Imraldi than you should
If you accidentally inject Imraldi more frequently than prescribed, contact your doctor or pharmacist and inform them that you have taken more medicine than intended. Always keep the medicine carton, even if empty.

If you forget to use Imraldi
If you forget to administer an injection, inject the next dose of Imraldi as soon as you remember. Then resume your regular dosing schedule.

If you stop using Imraldi
The decision to discontinue treatment with Imraldi should be discussed with your doctor. Symptoms may return after stopping treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate in severity. However, some may be serious and require treatment. Side effects may occur up to 4 months or more after the last injection of Imraldi.

Contact your doctor urgently if you notice any of the following reactions:

• severe rash, hives, or other signs of allergic reaction;
• swelling of the face, hands, or feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath during exertion or when lying down, or swollen feet.

Inform your doctor as soon as possible if you notice any of the following reactions:

• signs of infection such as fever, feeling unwell, wounds, dental problems, burning during urination;
• fatigue or weakness;
• cough;
• tingling;
• numbness;
• double vision;
• weakness in arms or legs;
• swelling or a sore that does not heal;
• signs and symptoms suggesting disorders of the haematopoietic system, such as persistent fever, bruising, bleeding, or paleness.

The symptoms described above may be signs of the following side effects, which have been observed with adalimumab:

Very common (may affect more than 1 in 10 people):

• reactions at the injection site (including pain, swelling, redness, or itching);
• respiratory tract infections (including colds, runny nose, sinusitis, and pneumonia);
• headache;
• abdominal pain (stomach pain);
• nausea and vomiting;
• skin rash;
• muscle pain.

Common (may affect up to 1 in 10 people):

• serious infections (including sepsis and influenza);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes zoster infection);
• ear infections;
• mouth infections (including dental infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• joint infections;
• benign tumours;
• skin tumours;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, stabbing sensations, or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (sensation of the environment spinning);
• sensation of rapid heartbeat;
• high blood pressure;
• hot flushes;
• haematoma (a solid swelling containing clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux disorder;
• dry syndrome (including dry eyes and dry mouth);
• itching;
• itchy skin rash;
• bruising;
• skin inflammation (such as eczema);
• breakage of fingernails and toenails;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in the urine;
• kidney problems;
• chest pain;
• oedema (fluid accumulation in the body causing swelling of affected tissues);
• fever;
• reduced platelet count in the blood, increasing the risk of bleeding or bruising;
• delayed wound healing.

Uncommon (may affect up to 1 in 100 people):

• opportunistic infections (including tuberculosis and other infections that occur when immune defences are reduced);
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumours, including lymphatic system tumours (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that may affect lungs, skin, and lymph nodes (most commonly in the form of a disease called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• sensation of irregular heartbeat such as palpitations;
• heart problems that may cause shortness of breath or swelling of the ankles;
• myocardial infarction;
• formation of a sac in the wall of a major artery, vein inflammation and clot, or blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• pancreatitis causing severe abdominal and back pain;
• difficulty swallowing;
• facial oedema;
• gallbladder inflammation, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle breakdown.

Rare (may affect up to 1 in 1,000 people):

• lupus erythematosus (including inflammation of the skin, heart, lungs, joints, and other organs);
• sleep disturbance;
• impotence;
• inflammation.
• leukaemia (a blood and bone marrow cancer);
• severe allergic reaction with shock;
• multiple sclerosis;
• neurological disorders (such as optic nerve inflammation of the eye and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, and tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (lung scarring);
• intestinal perforation;
• hepatitis;
• reactivation of hepatitis B;
• autoimmune hepatitis (liver inflammation caused by the body’s own immune system);
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• Stevens-Johnson syndrome (early symptoms include malaise, fever, headache, and skin rash);
• facial oedema associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy red-violet skin rash).

Not known (frequency cannot be estimated from the available data):

• hepatosplenic T-cell lymphoma (a rare and often fatal blood cancer);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi's sarcoma, a rare form of cancer associated with human herpesvirus 8 infection. Kaposi's sarcoma most commonly appears as purple lesions on the skin;
• liver failure;
• worsening of a condition called dermatomyositis (characterized by skin rash accompanied by muscle weakness);
• weight gain (in most patients, weight gain has been low).

Some of the side effects observed with adalimumab may be asymptomatic and may only be detected through blood tests.

These include:

Very common (may affect more than 1 in 10 people):

• low white blood cell count;
• low red blood cell count;
• increased blood lipids;
• increased liver enzymes.

Common (may affect up to 1 in 10 people):

• increased white blood cell count;
• reduced platelet count;
• increased blood uric acid;
• altered blood sodium;
• reduced blood calcium;
• reduced blood phosphorus;
• increased blood glucose;
• increased blood lactate dehydrogenase;
• presence of autoantibodies in the blood;
• reduced blood potassium.

Uncommon (may affect up to 1 in 100 people):

• elevated bilirubin levels in the blood (liver blood test).

Rare (may affect up to 1 in 1,000 people):

• low white blood cell, red blood cell, and platelet counts.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Imraldi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the carton after
EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled pen in the outer packaging to protect the medicine from light.

Alternative storage conditions:
When necessary (e.g. when travelling), a single pre-filled pen may be stored
at room temperature (up to 25 °C) for a maximum of 31 days – ensure the medicine is protected from light.
Once removed from the refrigerator for storage at room temperature, the pen must be used within 31 days or must be discarded, even if it is returned to the refrigerator.
You must record the date on which the pen is first removed from the refrigerator and the date after which the pen must be discarded.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Imraldi contains

• The active substance is adalimumab.
• The other ingredients are monosodium phosphate monohydrate, disodium phosphate heptahydrate, succinic acid, disodium succinate, histidine, histidine hydrochloride monohydrate, mannitol, polysorbate 20, and water for injections.

Description of the appearance of Imraldi and contents of the pack
Imraldi 40 mg solution for injection in pre-filled pen is supplied as 0.4 ml of solution, from clear to opalescent and from colourless to light brown.
Imraldi is available in packs containing 1, 2, 4 or 6 pre-filled pen(s) containing a pre-filled syringe (Type I glass) with a stainless steel needle, a rigid cap, a rubber plunger for patient use, and respectively 2, 2, 4 or 6 alcohol swabs included in the pack.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands

Manufacturer
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Biogen Belgium NV/S.A Biogen Lithuania UAB
Tél/Tel: + 32 2 2191218 Tel: +370 5 259 6176

България Luxembourg/Luxemburg
Ewopharma AG Representative Office Biogen Belgium NV/SA
Teл.: + 35929621200 Tél/Tel: +32 2 2191218

Česká republika Magyarország
Biogen (Czech Republic) s.r.o. Biogen Hungary Kft.
Tel: + 420 255 706 200 Tel.: + 36 1 899 9880

Danmark Malta
Biogen (Denmark) A/S Pharma.MT Ltd
Tlf.: + 45 77 41 57 57 Tel: + 35621337008

Deutschland Nederland
Biogen GmbH Biogen Netherlands B.V.
Tel: + 49 (0) 89 99 6170 Tel: + 31 20 542 2000

Eesti Norge
Biogen Estonia OÜ Biogen Norway AS
Tel: + 372 618 9551 Tlf: + 47 23 40 01 00

Ελλάδα Österreich
Genesis Pharma S.A. Biogen Austria GmbH
Τηλ: + 302108771500 Tel: + 43 1 484 46 13

España Polska
Biogen Spain, S.L. Biogen Poland Sp. z o.o.
Tel: +34 91 310 7110 Tel.: + 48 22 351 51 00

France Portugal
Biogen France SAS Biogen Portugal Sociedade Farmacêutica,
Tél: + 33 (0)1 776 968 14 Unipessoal, Lda
Tel: + 351 21 318 8450

Hrvatska România
Ewopharma d.o.o Ewopharma Romania SRL
Tel: + 385 (0)1 6646 563 Tel: + 40212601344

Ireland Slovenija
Biogen Idec (Ireland) Ltd. Biogen Pharma d.o.o.
Tel: +353 (0)1 463 7799 Tel: + 386 1 511 02 90

Ísland Slovenská republika
Icepharma hf. Biogen Slovakia s.r.o.
Sími: + 354 540 8000 Tel: + 421 2 323 340 08

Italia Suomi/Finland
Biogen Italia s.r.l. Biogen Finland Oy
Tel: + 39 02 584 99 010 Puh/Tel: + 358 207 401 200

Κύπρος Sverige
Genesis Pharma (Cyprus) Ltd Biogen Sweden AB
Τηλ: + 357 22 76 57 15 Tel: +46 8 594 113 60

Latvija
Biogen Latvia SIA
Tel: + 371 68 688 158

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

7. Instructions for use

Follow these instructions carefully: you will soon become familiar with the procedure and will be able to administer injections confidently.

• Before administering injections, ask your doctor or nurse to show you how to use the pre-filled pen. Your doctor or nurse must check that you are able to use the pen correctly.

Appearance of the single-dose pre-filled pen

The pre-filled pen does not have a button.
The needle is hidden beneath the green base. When the pre-filled pen is pressed firmly against the skin, the injection starts automatically.
Use of the pre-filled pen
Storage of the pen

• Store the pen in the refrigerator, but do not freeze.
• Keep the pen in its original box, protected from light.
• Keep the pen out of the sight and reach of children.

Disposal of the pen

• Use each pen only once. Never reuse a pen.
• Dispose of the used pen in a special container, as instructed by your doctor, nurse, or pharmacist.

Caution

• If the pen falls with the cap ON, it may still be used. If the pen falls without the cap in place, do not use it. The needle may be dirty or damaged.
• Do not use a damaged pen.

Preparing the injection site

• For the injection, choose an area with fatty tissue: The most suitable injection sites are generally areas rich in fat, such as the abdomen. Areas rich in fat are appropriate for correct needle insertion.
• Always choose a different injection site: When selecting an injection site, choose an area that has not recently been used, in order to avoid irritation, bruising, or tissue damage.

How to administer the injection using the pre-filled pen

1. Gather the necessary items

Place the pre-filled pen and alcohol swabs on a clean, dry surface.

• Remember to wash your hands!
• Do not remove the cap yet!

2. Wait 15-30 minutes

Wait 15-30 minutes to bring the pen to room temperature, in order to reduce pain during injection.

• Do not remove the cap yet!

3. Check the medicine and the expiration date

Check that the medicine is from clear to opalescent, from colorless to light brown, free of
particles, and not expired. Do not use the medicine if it is not from clear to opalescent, from colorless to
light brown, and free of particles, or if it has expired.
One or more air bubbles may be present, which are not a problem. There is no need to
remove them.

• Do not remove the cap yet!

4. Choose an injection site and clean the skin

Choose an injection site on the body. The most suitable areas are the abdomen (except the area around the navel) or the thighs.
Clean the injection site with an alcohol swab. Do not touch it again before the injection.

• Avoid areas with lesions, bruises, scars, peeling, or red spots.

5. Remove the transparent needle cap

Carefully remove the transparent needle cap with metal center from the pen.
It is normal for a few drops of liquid to come out of the needle.
If you remove the needle cap before you are ready to inject, do not reattach it.
Otherwise, you may bend or damage the needle. You also risk accidental needlestick injury or spilling some of the medicine.

6. Position the green base, press and hold

Place the green base straight down (at a 90-degree angle) onto the skin and firmly press the pre-filled pen downward to start the injection.

• As you press down, the injection begins. You may hear one click.

7. Continue to press

Keep pressing the pen against the skin until the yellow indicator has filled the inspection window and stopped moving.

• After several seconds, you may hear a second click.

8. Confirm completion of the injection and dispose of the pen

After injecting Imraldi, check that the entire viewing window is yellow.
Dispose of the used pen in a special container, as explained to you by your doctor, nurse, or pharmacist.

• Not sure whether you received the dose? Contact your doctor, nurse, or pharmacist.