Hyrimoz 40 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Hyrimoz 40 mg solution for injection in pre-filled syringe

adalimumab

40 mg/0.4 ml

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• Your doctor will give you a patient information card containing important safety information you need to know before and during treatment with Hyrimoz.
• Keep this patient information card during your treatment and for 4 months after your last injection (or your child's last injection) of Hyrimoz.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Hyrimoz is and what it is used for

Hyrimoz contains the active substance adalimumab, a medicine that acts on the immune (defence) system of your body.

Hyrimoz is indicated for the treatment of the following inflammatory diseases:

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

The active substance in Hyrimoz, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that target a specific substance in the body.

Adalimumab targets another protein called tumour necrosis factor (TNFα), which is present at high levels in the inflammatory diseases described above. By binding to TNFα, Hyrimoz blocks its action and reduces inflammation in these diseases.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease affecting the joints.

Hyrimoz is used to treat rheumatoid arthritis in adults. If you have moderate to severe active rheumatoid arthritis, you may have been given other disease-modifying medicines such as methotrexate first. If these medicines do not work well enough, you will be given Hyrimoz to treat your rheumatoid arthritis.

Hyrimoz may also be used to treat severe, active and progressive rheumatoid arthritis without prior treatment with methotrexate.

Hyrimoz can reduce joint damage to cartilage and bone caused by the disease and improve physical function.

Hyrimoz is usually used in combination with methotrexate. If your doctor considers methotrexate to be inappropriate, Hyrimoz may be given alone.

Polyarticular juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis is an inflammatory joint disease.

Hyrimoz is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged between 2 and 17 years. Patients may have first received other disease-modifying drugs such as methotrexate. If these medicines do not work well enough, patients will be given Hyrimoz.

Enthesitis-related arthritis

Enthesitis-related arthritis is an inflammatory disease affecting the joints and the sites where tendons attach to bone. Hyrimoz is used to treat enthesitis-related arthritis in patients from 6 years of age.

Patients may have first received other disease-modifying drugs such as methotrexate. If they do not respond well enough to these medicines, they will be given Hyrimoz.

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory diseases affecting the spine.

Hyrimoz is used in adults to treat these diseases. If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be treated with other medicines, and if these do not work well enough, you will receive Hyrimoz to reduce the signs and symptoms of your disease.

Plaque psoriasis in adults and children

Plaque psoriasis is an inflammatory skin disease that causes red, scaly, crusted areas covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to deteriorate, thicken, and lift from the nail bed, which can be painful. Psoriasis is believed to be caused by a defect in the body's immune system that leads to increased production of skin cells.

Hyrimoz is used to treat moderate to severe plaque psoriasis in adults. Hyrimoz is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years who have not responded or are not suitable candidates for topical (skin-applied) medicines or UV light treatment.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory joint disease associated with psoriasis.

Hyrimoz is used to treat psoriatic arthritis in adults. Hyrimoz can reduce joint damage caused by the disease in cartilage and bone and improve physical function.

Hidradenitis suppurativa in adults and adolescents

Hidradenitis suppurativa (sometimes called inverse acne) is a long-term, often painful inflammatory skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may discharge pus.

It usually affects specific areas of the skin such as under the breasts, armpits, inner thighs, groin, and buttocks. Scarring may also occur in affected areas.

Hyrimoz is used to treat

• moderate to severe hidradenitis suppurativa in adults and
• moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years.

Hyrimoz can reduce the number of nodules and abscesses and the pain usually associated with this disease. You may have received other medicines previously. If these medicines do not work well enough, you will be given Hyrimoz.

Crohn's disease in adults and children

Crohn's disease is an inflammatory disease of the gastrointestinal tract.

Hyrimoz is used to treat

• moderate to severe Crohn's disease in adults and
• moderate to severe Crohn's disease in children and adolescents aged 6 to 17 years.

If you have Crohn's disease, you will first be treated with other medicines. If you do not respond sufficiently to these medicines, you will be given Hyrimoz to reduce the signs and symptoms of Crohn's disease.

Ulcerative colitis in adults and children

Ulcerative colitis is an inflammatory disease of the large intestine.

Hyrimoz is used to treat

• moderate to severe ulcerative colitis in adults and
• moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years.

If you have ulcerative colitis, you may first be prescribed other medicines. If these medicines do not work well enough, you will be prescribed Hyrimoz to reduce the signs and symptoms of ulcerative colitis.

Non-infectious uveitis in adults and children

Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye. The inflammation causes reduced vision and/or the presence of floaters (black spots or thin lines moving across the visual field). Hyrimoz works by reducing this inflammation.

Hyrimoz is used to treat

• 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.

You may have received other medicines previously. If you do not respond well enough to these medicines, you will be given Hyrimoz.

2. What you need to know before your child starts using Hyrimoz

Do not use Hyrimoz

• If your child is allergic to adalimumab or to any of the other components of this medicine (listed in section 6).

• If your child has a serious infection, including tuberculosis, sepsis (blood poisoning), or other opportunistic infections (unusual infections associated with a weakened immune system). If your child has symptoms of any infection, such as fever, wounds, fatigue, or dental problems, it is important to inform your doctor (see “Warnings and precautions”).

• If your child has moderate or severe heart failure. It is important to tell your doctor if your child has had or currently has serious heart problems (see “Warnings and precautions”).

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with Hyrimoz.

Allergic reaction

• If your child experiences an allergic reaction with symptoms such as chest tightness, difficulty breathing, dizziness, swelling, or rash, stop administering Hyrimoz and contact your doctor immediately, as in rare cases these reactions may be life-threatening.

Infections

• If your child has any infection, including chronic or localized infections (e.g., a leg ulcer), consult your doctor before starting treatment with Hyrimoz. If you are unsure, contact your doctor.

• While being treated with Hyrimoz, your child may be more likely to get infections. This risk may be higher if your child has reduced lung function. These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites, bacteria, or other unusual infectious organisms, and sepsis (blood poisoning).

• In rare cases, these infections may be life-threatening. It is important to inform your doctor if your child develops symptoms such as fever, wounds, fatigue, or dental problems. Your doctor may recommend temporarily stopping treatment with Hyrimoz.

Tuberculosis (TB)

• Cases of tuberculosis have been reported in patients treated with adalimumab. Therefore, your doctor will examine your child for signs or symptoms of tuberculosis before starting treatment with Hyrimoz. This includes a thorough medical evaluation, including medical history and diagnostic tests (e.g., chest X-ray and tuberculin skin test). The performance and results of these tests must be recorded on your patient information card. It is very important to inform your doctor if your child has ever had tuberculosis or has been in contact with someone who has tuberculosis. Tuberculosis may develop during treatment even if your child has received preventive treatment for tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, lack of energy, low-grade fever) or any other infection appear during or after treatment, contact your doctor immediately.

Travel/recurrent infection

• Inform your doctor if your child has lived in or traveled to regions where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common.

• Inform your doctor if your child has a history of recurrent infections or other conditions or risk factors that increase the risk of infections.

Hepatitis B virus

• Inform your doctor if your child is a carrier of hepatitis B virus (HBV), has active HBV infection, or thinks they may be at risk of contracting HBV. Your doctor should perform a test for HBV. Adalimumab can reactivate HBV in carriers of this virus. In rare cases, especially if your child is taking other medicines that suppress the immune system, reactivation of HBV infection may be life-threatening.

Age over 65 years

• If your child is over 65 years of age, they may be more susceptible to infections while being treated with Hyrimoz. Both you and your doctor should pay special attention to the appearance of signs of infection during treatment. It is important to inform your doctor if your child develops symptoms of infection, such as fever, wounds, fatigue, or dental problems.

Dental procedures or surgery

• If your child is scheduled for surgery or dental procedures, inform the doctor or dentist that your child is taking Hyrimoz. Your doctor may recommend temporarily stopping treatment with Hyrimoz.

Demyelinating disease

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

Vaccines

• Certain vaccines contain live but weakened forms of bacteria or viruses that can cause disease and should not be given during treatment with Hyrimoz, as they may cause infections. Consult your doctor before administering any type of vaccine. It is recommended, if possible, that children receive all age-appropriate scheduled vaccines before starting treatment with Hyrimoz. If your child receives Hyrimoz while pregnant, your baby may have an increased risk of infections for approximately 5 months after the last dose of Hyrimoz received during pregnancy. It is important to inform your child’s doctor and other healthcare professionals about your use of Hyrimoz during pregnancy, so they can decide whether your child should receive any vaccines.

Heart failure

• It is important to inform your doctor if your child has had or currently has serious heart problems. If your child has mild heart failure and is being treated with Hyrimoz, your doctor should monitor their heart failure closely. If new symptoms of heart failure appear or existing symptoms worsen (e.g., difficulty breathing or swelling of the feet), contact your doctor immediately.

Fever, bruising, bleeding, or pale appearance

• In some patients, the body may be unable to produce enough of the type of blood cells that fight infections (white blood cells) or those that help stop bleeding (platelets). If your child has persistent fever, bruising, easy bleeding, or appears very pale, contact your doctor immediately. Your doctor may decide to stop treatment.

Cancer

• Very rarely, certain types of cancer have been reported in children and adults treated with adalimumab or other agents that block TNFα. People with more severe rheumatoid arthritis or who have had the disease for a long time may have a higher than average risk of developing lymphoma and leukemia (cancer affecting blood cells and bone marrow). If your child is being treated with Hyrimoz, the risk of developing lymphoma, leukemia, and other types of cancer may increase. A specific and serious type of lymphoma has been observed rarely in patients treated with adalimumab.

• Some of these patients were also receiving azathioprine or mercaptopurine. Inform your doctor if your child is taking azathioprine or mercaptopurine with Hyrimoz.

• Cases of skin cancer (non-melanoma type) have been observed in patients using adalimumab. Inform your doctor if new skin lesions appear during or after treatment, or if existing marks or damaged areas of skin change in appearance.

• Cases of cancers other than lymphoma have occurred in patients with a specific lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNF blocker. If your child has COPD or is a heavy smoker, consult your doctor to determine whether treatment with a TNF blocker is appropriate.

Autoimmune diseases

• Rarely, treatment with Hyrimoz may lead to a lupus-like syndrome. Contact your doctor if your child develops symptoms such as unexplained persistent rash, fever, joint pain, or fatigue.

Children and adolescents

• Vaccines: If possible, your child should be up to date with all recommended vaccines before starting Hyrimoz.

Other medicines and Hyrimoz

Inform your doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines.

Hyrimoz can be used together with methotrexate or certain disease-modifying antirheumatic drugs (DMARDs) (sulfasalazine, hydroxychloroquine, leflunomide, and injectable gold salts), corticosteroids, or pain medicines, including non-steroidal anti-inflammatory drugs (NSAIDs).

Hyrimoz must not be used together with medicines containing anakinra or abatacept due to an increased risk of serious infection. Combining adalimumab and other TNF antagonists with anakinra or abatacept is not recommended because of the possible increased risk of infections, including serious infections, and other potential drug interactions. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• You should consider using appropriate contraceptive methods to avoid becoming pregnant and continue using them for at least 5 months after the last dose of Hyrimoz.
• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor about using this medicine.
• Hyrimoz should be used during pregnancy only if clearly necessary.
• According to a pregnancy study, there was no increased risk of congenital malformations when mothers received adalimumab during pregnancy compared to mothers with the same disease who did not receive adalimumab.
• Hyrimoz may be used during breastfeeding.
• If you use Hyrimoz while pregnant, your baby may have an increased risk of infection.
• It is important to inform your child’s doctor and other healthcare professionals about your use of Hyrimoz during pregnancy before the baby receives any vaccine (for more information on vaccines, see section “Warnings and precautions”).

Driving and using machines

The effect of Hyrimoz on the ability to drive, ride a bicycle, or operate machinery is minimal. Dizziness (a sensation that the room is spinning) and vision disturbances may occur after using Hyrimoz.

Hyrimoz contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 0.4 ml dose; therefore, it is essentially “sodium-free”.

3. How to use Hyrimoz

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor again.

The following table shows the recommended doses of Hyrimoz for each of its approved uses. Your doctor may prescribe a different dose of Hyrimoz if needed.

Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis
Age or body weight	What dose and how often should it be taken?	Notes
Adults	40 mg every other week as a single dose	In the case of rheumatoid arthritis, treatment with methotrexate should be maintained during Hyrimoz use. If your doctor determines methotrex游戏副本 Polyarticular juvenile idiopathic arthritis Age or body weight What dose and how often should be taken? Notes Children, adolescents and adults from 2 years of age weighing 30 kg or more 40 mg every other week Not applicable Children and adolescents from 2 years of age weighing between 10 kg and less than 30 kg 20 mg every other week Not applicable Enthesitis-related arthritis Age or body weight What dose and how often should be taken? Notes Children, adolescents and adults from 6 years of age weighing 30 kg or more 40 mg every other week Not applicable Children and adolescents from 6 years of age weighing between 15 kg and less than 30 kg 20 mg every other week Not applicable Plaque psoriasis Age or body weight What amount and how often should it be taken? Notes Adults An initial dose of 80 mg (as two 40 mg injections on the same day), followed by 40 mg every other week starting one week after the first dose. You must continue injecting Hyrimoz for as long as your doctor has instructed you. If this dose is not working well enough, your doctor may increase the dose to 40 mg weekly or 80 mg every other week. Pediatric Plaque Psoriasis Age or Body Weight What Dose and How Often Should Be Taken? Notes Children and adolescents aged 4 to 17 years weighing 30 kg or more An initial dose of 40 mg, followed by 40 mg one week later. Thereafter, the usual dose is 40 mg every other week. Not applicable Children and adolescents aged 4 to 17 years weighing between 15 kg and less than 30 kg An initial dose of 20 mg, followed by 20 mg one week later. Thereafter, the usual dose is 20 mg every other week. Not applicable Hidradenitis Suppurativa Age or Body Weight What dose and how often should it be taken? Notes Adults An initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by a dose of 80 mg (as two 40 mg injections on the same day) two weeks later. After another two weeks, continue with a 40 mg dose weekly or 80 mg every other week, as prescribed by your doctor. It is recommended to use an antiseptic wash daily on affected areas. Adolescents aged 12 to 17 years weighing 30 kg or more An initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting one week later. If this dose is not effective sufficiently, your doctor may increase the dose to 40 mg weekly or 80 mg every other week. It is recommended to use an antiseptic wash daily on affected areas. Crohn's Disease Age or body weight What amount and how often should be taken? Notes Adults An initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting two weeks later. If a more rapid response is required, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (as two 40 mg injections in one day) two weeks later. After that, 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. Pediatric Crohn's Disease Age or body weight What amount and how often should be taken? Notes Children and adolescents from 6 to 17 years of age weighing 40 kg or more An initial dose of 80 mg (as two 40 mg injections on the same day), followed by 40 mg every other week starting two weeks later. If a faster response is needed, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (as two 40 mg injections on one day) two weeks later. After that, the usual dose is 40 mg every other week. If this dose is not effective enough, your child's doctor may increase the dose to 40 mg weekly or 80 mg every other week. Children and adolescents from 6 to 17 years of age weighing less than 40 kg An initial dose of 40 mg, followed by 20 mg every other week starting two weeks later. If a faster response is needed, your doctor may prescribe an initial dose of 80 mg (as two 40 mg injections on the same day), followed by 40 mg two weeks later. After that, the usual dose is 20 mg every other week. If this dose is not effective enough, your child's doctor may increase the dosing frequency to 20 mg weekly. Ulcerative colitis Age or body weight What amount and how frequently should be taken? Notes Adults An initial dose of 160 mg (as four injections of 40 mg in one day or two injections of 40 mg per day for two consecutive days), followed by 80 mg (as two injections of 40 mg in one 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. Pediatric Ulcerative Colitis Age or body weight What amount and how often should be taken? Notes Children and adolescents from 6 years of age weighing 40 kg or more An initial dose of 160 mg (as four injections of 40 mg in one day or two injections of 40 mg per day on two consecutive days), followed by 80 mg (as two injections of 40 mg in one day) two weeks later. Thereafter, the usual dose is 80 mg every other week. Patients who turn 18 years old while being treated with 80 mg every other week should continue on the prescribed dose. Children and adolescents from 6 years of age weighing less than 40 kg An initial dose of 80 mg (as two injections of 40 mg in one day), followed by 40 mg (as 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 being treated with 40 mg every other week should continue on the prescribed dose. Non-infectious uveitis Age or body weight What dose and how often should it be taken? Notes Adults An initial dose of 80 mg (as two injections of 40 mg), followed by 40 mg every other week, starting one week after the first dose. In non-infectious uveitis, treatment with corticosteroids or other immunosuppressive medications may be continued during Hyrimoz use. Hyrimoz may also be administered alone. Hyrimoz injections should be continued for the duration prescribed by your doctor. Children and adolescents aged 2 years and older with body weight of 30 kg or more 40 mg every other week Your doctor may also prescribe an initial dose of 80 mg, which may be administered one week before starting the routine dose of 40 mg every other week. Use of Hyrimoz in combination with methotrexate is recommended. Children and adolescents aged 2 years and older with body weight less than 30 kg 20 mg every other week Your doctor may also prescribe an initial dose of 40 mg, which may be administered one week before starting the routine dose of 20 mg every other week. Use of Hyrimoz in combination with methotrexate is recommended. Form and route of administration Hyrimoz is injected under the skin (subcutaneous route). Detailed instructions on how to inject Hyrimoz are provided in section 7, “Instructions for use”. If you use more Hyrimoz than you should If you accidentally inject Hyrimoz more frequently than you should, call your doctor or pharmacist and inform them that you have taken more than required. Always carry the medicine carton with you, even if it is empty. If you forget to use Hyrimoz If you forget to administer an injection, you should inject the next dose of Hyrimoz as soon as you remember. Then, administer the following dose as usual, as if no dose had been missed. If you stop using Hyrimoz The decision to discontinue treatment with Hyrimoz should be discussed with your doctor. Your symptoms may return after stopping treatment. If you have any further questions about the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everyone gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur up to 4 months or more after the last injection of Hyrimoz. Seek urgent medical attention if you notice any of the following signs of an allergic reaction or heart failure: severe rash, hives; swelling of the face, hands, feet; difficulty breathing, swallowing; shortness of breath with physical activity or when lying down, or swelling of the feet. Contact your doctor as soon as possible if you notice any of the following effects: signs and symptoms of infection such as fever, feeling unwell, wounds, dental problems, burning sensation when urinating, feeling weak, tired, or cough; symptoms of nervous system problems, such as tingling, numbness, double vision, weakness in arms or legs; signs of skin cancer, such as a bump or an open sore that does not heal; signs and symptoms of blood disorders such as persistent fever, bruising, bleeding, and paleness. The following side effects have been observed with adalimumab: Very common (may affect more than 1 in 10 people) injection site reactions (including pain, swelling, redness, or itching); lower respiratory tract infections (including cold, runny nose, sinusitis, pneumonia); headache; abdominal pain; nausea and vomiting; rash; muscle pain. Common (may affect up to 1 in 10 people) serious infections (including blood poisoning and flu); intestinal infections (including gastroenteritis); skin infections (including cellulitis and herpes); ear infection; mouth infections (including dental infection and cold sores); infections of the reproductive system; urinary tract infection; fungal infections; joint infections; benign tumors; skin cancer; allergic reactions (including seasonal allergies); dehydration; mood changes (including depression); anxiety; difficulty sleeping; sensory disturbances such as tingling, burning, or numbness; migraine; symptoms of nerve root compression (including low back and leg pain); visual disturbances; eye inflammation; eyelid inflammation and eye swelling; dizziness (feeling that the room is spinning); sensation of rapid heartbeat; high blood pressure; flushing; bruising (solid swelling with clotted blood); cough; asthma; difficulty breathing; gastrointestinal bleeding; dyspepsia (indigestion, bloating, and heartburn); acid reflux; dry eye syndrome (including dry eyes and mouth); itching; itchy rash; bruises; skin inflammation (such as eczema); cracking or breaking of fingernails and toenails; increased sweating; hair loss; new-onset psoriasis or worsening of existing psoriasis; muscle spasms; blood in urine; kidney problems; chest pain; edema (fluid accumulation in the body that may cause swelling of affected tissues); fever; decreased platelet count in blood, increasing the risk of bleeding or bruising; problems with wound healing. Uncommon (may affect up to 1 in 100 people) unusual infections (including tuberculosis and other infections that occur when disease resistance is reduced); neurological infections (including viral meningitis); eye infections; bacterial infections; diverticulitis (inflammation and infection of the large intestine); cancer, including cancer affecting the lymphatic system (lymphoma) and melanoma (a type of skin cancer); immune system disorders that may affect the lungs, skin, and lymph nodes (most commonly presenting as a disease called sarcoidosis); vasculitis (inflammation of blood vessels); tremor (feeling shaky); neuropathy (nerve damage); stroke; hearing loss, ringing in the ears; sensation of irregular heartbeat such as palpitations; heart problems that may cause difficulty breathing or ankle swelling; heart attack; aneurysm (bulge in the wall of a large artery), inflammation and clotting in a vein, blockage of a blood vessel; lung diseases that may cause difficulty breathing (including inflammation); pulmonary embolism (blockage of an artery in the lung); pleural effusion (abnormal fluid buildup in the pleural space); inflammation of the pancreas causing severe abdominal and back pain; difficulty swallowing; facial edema (swelling); gallbladder inflammation; gallstones; fatty liver (accumulation of fat in liver cells); night sweats; scarring; abnormal muscle spasms; systemic lupus erythematosus (an immune disorder involving inflammation of the skin, heart, lungs, joints, and other organs); sleep disturbances; impotence; inflammations. Rare (may affect up to 1 in 1,000 people) leukemia (cancer affecting blood and bone marrow); severe allergic reaction with shock; multiple sclerosis; nervous system disorders (such as inflammation of the optic nerve 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 in the lungs); intestinal perforation (a hole in the intestinal wall); hepatitis (inflammation of the liver); reactivation of hepatitis B virus infection; autoimmune hepatitis (liver inflammation caused by the body's own immune system); cutaneous vasculitis (inflammation of blood vessels in the skin); Stevens-Johnson syndrome (a potentially life-threatening illness with flu-like symptoms and blistering rash); facial edema (swelling) associated with allergic reactions; erythema multiforme (inflammatory skin rash); lupus-like syndrome; angioedema (localized swelling of the skin); lichenoid skin reaction (reddish-purple itchy rash). Frequency not known (cannot be estimated from available data) hepatosplenic T-cell lymphoma (a rare, often fatal blood cancer); Merkel cell carcinoma (a type of skin cancer); Kaposi's sarcoma, an uncommon cancer associated with human herpesvirus 8 infection. Kaposi's sarcoma usually presents more frequently as purplish skin lesions; liver failure; worsening of a condition called dermatomyositis (seen as skin rash accompanied by muscle weakness); weight gain (in most patients, weight gain was minimal). Some side effects observed in clinical studies with adalimumab have no symptoms and can only be detected by a blood test. These include: Very common (may affect more than 1 in 10 people) low blood count of white blood cells; low blood count of red blood cells; increased blood lipids; elevated liver enzymes. Common (may affect up to 1 in 10 people) high blood count of white blood cells; low blood count of platelets; increased blood uric acid; abnormal blood sodium levels; low blood calcium; low blood phosphate; high blood sugar; high blood lactate dehydrogenase levels; presence of autoantibodies in blood; low blood potassium. Uncommon (may affect up to 1 in 100 people) high bilirubin levels (a blood test of liver function). Rare (may affect up to 1 in 1,000 people) low blood counts for white blood cells, red blood cells, and platelets. Reporting of side effects If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine. 5. Storage of Hyrimoz 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/blister/box after “CAD” or “EXP”. The expiry date refers to the last day of the month indicated. Store in a refrigerator (between 2 °C and 8 °C). Do not freeze. Keep the pre-filled syringe in the outer packaging to protect it from light. Alternative storage: When necessary (e.g., when travelling), Hyrimoz may be stored at room temperature (up to 25 °C) for a maximum period of 42 days (ensure it is protected from light). Once removed from the refrigerator for storage at room temperature, the pre-filled syringe must be used within the following 42 days or discarded, even if it is later returned to the refrigerator. You should record the date on which the pre-filled syringe was removed from the refrigerator, and the date after which it must be discarded. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment. 6. Contents of the pack and other information Composition of Hyrimoz The active substance is adalimumab. Each pre-filled syringe contains 40 mg of adalimumab in 0.4 ml of solution. The other components are: adipic acid, mannitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524), and water for injections (see section 2 “Hyrimoz contains sodium”). Appearance of the product and contents of the pack Hyrimoz 40 mg solution for injection (injection) in a pre-filled syringe is supplied as 0.4 ml of a solution that is transparent to slightly opalescent, colourless or slightly yellowish. Hyrimoz is supplied in a single-use, transparent type I glass syringe with a 29-gauge stainless steel needle, needle shield with gripping wings, rubber needle cap (thermoplastic elastomer), and plastic plunger, containing 0.4 ml of solution. Packs containing 1 and 2 pre-filled syringes of Hyrimoz. Multiple pack cartons containing 6 (3 packs of 2) pre-filled syringes of Hyrimoz. Only certain pack sizes may be marketed. Hyrimoz is available in pre-filled syringe and pre-filled pen. Marketing Authorisation Holder Sandoz GmbH Biochemiestr. 10 6250 Kundl Austria Manufacturer Sandoz GmbH Schaftenau Biochemiestr. 10 6336 Langkampfen Austria Novartis Pharmaceutical Manufacturing GmbH Biochemiestrasse 10 6336 Langkampfen Austria More information about this medicinal product is available upon request to the local representative of the Marketing Authorisation Holder: Belgium/Belgique/Belgien Sandoz nv/sa Tél/Tel: +32 2 722 97 97 Lithuania Sandoz Pharmaceuticals d.d. branch Tel: +370 5 2636 037 Luxembourg/Luxemburg Sandoz nv/sa (Belgium/Belgien) Tél/Tel.: +32 2 722 97 97 Czech Republic Sandoz s.r.o. Tel: +420 225 775 111 Hungary Sandoz Hungária Kft. Tel.: +36 1 430 2890 Denmark/Norway/Iceland/Sweden Sandoz A/S Tlf./Sími/Tel: +45 63 95 10 00 Malta Sandoz Pharmaceuticals d.d. Tel: +356 21222872 Germany Hexal AG Tel: +49 8024 908 0 Netherlands Sandoz B.V. Tel: +31 36 52 41 600 Estonia Sandoz d.d. Estonia branch Tel: +372 665 2400 Austria Sandoz GmbH Tel: +43 5338 2000 Greece Novartis (Hellas) A.E.B.E. Tel: +30 210 281 17 12 Poland Sandoz Polska Sp. z o.o. Tel.: +48 22 209 70 00 Spain Sandoz Farmacéutica, S.A. Tel: +34 900 456 856 Portugal Sandoz Farmacêutica Lda. Tel: +351 21 196 40 00 France Sandoz SAS Tél: +33 1 49 64 48 00 Romania Sandoz SRL Tel: +40 21 407 51 60 Croatia Sandoz d.o.o. Tel: +385 1 23 53 111 Slovenia Lek farmacevtska družba d.d. Tel: +386 1 580 21 11 Ireland Rowex Ltd. Tel: +353 27 50077 Slovakia Sandoz d.d. - organisational unit Tel: +421 2 48 200 600 Italy Sandoz S.p.A. Tel: +39 02 96541 Finland Sandoz A/S Puh/Tel: +358 10 6133 400 Cyprus SANDOZ HELLAS MONOPROSOPIKI EPE (Greece) Tel: +30 216 600 5000 United Kingdom (Northern Ireland) Sandoz GmbH Tel: +43 5338 2000 Latvia Sandoz d.d. Latvia branch Tel: +371 67 892 006 Date of latest review of this leaflet Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. Instructions for use To help prevent possible infections and ensure proper use of the medicine, it is important to follow these instructions. Make sure you read, understand, and follow these instructions for use before injecting Hyrimoz. Your healthcare professional should train you on how to correctly prepare and inject Hyrimoz using the single-use pre-filled syringe before your first use. If you have any questions, consult your healthcare professional. Your single-use pre-filled syringe of Hyrimoz, with needle shield and additional grip wings Figure A: Hyrimoz pre-filled syringe with needle shield and grip wings It is important that: Do not use the prefilled syringe if the blister seals are broken, as it may not be safe to use. Do not open the outer carton until you are ready to use the prefilled syringe. Never leave the prefilled syringe unattended where others could handle it. If the syringe is dropped, do not use it if it is damaged or if it was dropped without the needle cap in place. Do not remove the needle cap until immediately before administering the injection. Be careful not to touch the wings of the needle guard before using the syringe. Touching them may cause the guard to activate too early. Do not remove the gripping wings before the injection. To make the injection more comfortable, inject Hyrimoz 15–30 minutes after removing it from the refrigerator. Dispose of the used syringe immediately after use. Do not reuse prefilled syringes. See “4. Disposal of used prefilled syringes” at the end of these instructions for use. Storage of the Hyrimoz prefilled syringe Store the prefilled syringe carton in a refrigerator, between 2 °C and 8 °C. When necessary (e.g., when traveling), Hyrimoz may be stored at room temperature (up to 25 °C) for a maximum period of 42 days (ensure it is protected from light). Once removed from the refrigerator for storage at room temperature, the prefilled syringe must be used within the next 42 days or discarded, even if it is later returned to the refrigerator. You should record the date the prefilled syringe was removed from the refrigerator and the date after which it must be discarded. Keep the prefilled syringes in their original packaging until ready to use to protect them from light. Do not expose the prefilled syringes to extreme heat or cold. Do not freeze the prefilled syringes. Keep Hyrimoz and all medicines out of the reach of children. What is needed for the injection? Place the following items on a clean, flat surface. The prefilled syringe carton includes: Hyrimoz prefilled syringe(s) (see Figure A). Each prefilled syringe contains 40 mg/0.4 ml of adalimumab. The Hyrimoz prefilled syringe carton does not include (see Figure B): Alcohol wipe Cotton ball or gauze Sharps disposal container. See section “4. Disposal of Used Syringes” at the end of these instructions for use. Adhesive bandage Figure B:items not included in the carton Before injection Figure C: needle shield is not activated; syringe is ready to use In this configuration, the needle shield is NOT ACTIVATED. The syringe is ready to use (see Figure C). Figure D: needle shield is activated; do not use In this configuration, the needle shield IS ACTIVATED. DO NOT USE the syringe (see Figure D). Preparation of the syringe To make the injection more comfortable, remove the box containing the pre-filled syringe from the refrigerator and leave it unopened on the work surface for approximately 15–30 minutes so that it reaches room temperature. Remove the pre-filled syringe from the blister pack. Look through the viewing window. The solution should be colourless or slightly yellowish, and clear to slightly opalescent. Do not use if you see particles or changes in colour. If you are concerned about the appearance of the solution, consult your pharmacist. Do not use the pre-filled syringe if it is damaged or if the needle safety guard has been activated. Return the pre-filled syringe and its packaging to the pharmacy. Check the expiry date (EXP) on the pre-filled syringe. Do not use the pre-filled syringe after the expiry date. If the syringe fails any of the above checks, contact your pharmacist. Selection of the injection site: The recommended injection site is the front of the thighs. It may also be administered in the lower abdomen, except for an area of 5 cm around the navel (see Figure E ). Choose a different site each time you self-administer an injection. Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or extensive markings. If you have psoriasis, do not inject directly into areas with psoriasis plaques. Figure E: select the injection site Cleaning the injection site: Wash your hands thoroughly with soap and water. Clean the injection site with an alcohol wipe using circular motions. Wait for it to dry before administering the injection (see Figure F). Do not touch the cleaned area before the injection. Figure F: clean the injection site Injection administration: Carefully pull the needle cap straight off to remove it from the pre-filled syringe (see Figure G). Discard the cap. You may see a drop of liquid at the tip of the needle. This is normal. Figure G: remove the needle cap Gently pinch the skin at the injection site (see Figure H). Insert the needle into the skin as shown. Push the needle fully in to ensure that the entire dose of medication can be delivered. Use the syringe within 5 minutes after removing the cap. Figure H: insert the needle Hold the pre-filled syringe as shown (see Figure I). Slowly push the plunger until it reaches the stop, ensuring that the plunger's push disk is completely between the wings of the needle guard. Keep the plunger fully depressed while holding the syringe steady for 5 seconds. Figure I: hold the syringe Keep the plunger fully depressed while carefully removing the needle straight out from the injection site, allowing it to leave the skin (see Figure J). Figure J: remove the needle straight out Slowly release the plunger and allow the syringe's safety needle guard to automatically cover the exposed needle (see Figure K). There may be a small amount of blood at the injection site. You may press a cotton ball or gauze pad against the area for 10 seconds. Do not rub the injection site. If needed, you may cover it with a small adhesive bandage. Figure K: release the plunger slowly Disposal of used syringes: Dispose of the used syringe in a sharps container (puncture-resistant and sealable, see Figure L). For your health and safety and that of others, needles and used syringes must never be reused. Medicines must not be disposed of via wastewater drains or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment. Disposal of unused medicine and all materials that have come into contact with it must be carried out in accordance with local regulations. Figure L: disposal of used pre-filled syringe If you have any questions, consult a doctor, pharmacist, or nurse who is familiar with Hyrimoz.