Hyrimoz 40 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

adalimumab

40 mg/0.4 ml

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

• Keep this leaflet, as you may need to read it again.
• Your doctor will provide you with a patient information card containing important safety information you need to know before and during treatment with Hyrimoz.

Keep this patient information card throughout your treatment and for 4 months after your last (or your child's) 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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 in the treatment of 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 that typically first appears in childhood.

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 receive 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 adequately 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, or 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 to, or are not suitable candidates for, topical 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 skin areas 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 from 12 to 17 years of age.

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 receive Hyrimoz.

Crohn's disease in adults and children

Crohn's disease is an inflammatory disease of the digestive 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 from 6 to 17 years of age.

If you have Crohn's disease, you will first be treated with other medicines. If you do not respond adequately to these medicines, you will receive 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 from 6 to 17 years of age.

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 in the eye (black spots or thin lines moving across the field of vision). 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 adequately to these medicines, you will receive 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 (uncommon 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 develop infections. This risk may be higher if your child has reduced lung function. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites, or bacteria, other uncommon 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 receiving adalimumab. Therefore, your doctor will examine your child for signs or symptoms of tuberculosis before starting treatment with Hyrimoz. This will include 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 in your child’s patient information card. It is very important to inform your doctor if your child has 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 occur 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 likelihood 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 may reactivate HBV in carriers of this virus. In rare cases, especially if your child is taking other medicines that suppress the immune system, HBV reactivation 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 or surgical procedures

• If your child is scheduled for surgery or a dental procedure, inform the doctor or dentist that your child is using 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 insulating layer around nerves, such as multiple sclerosis), your doctor will decide whether treatment with Hyrimoz should be initiated 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 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 you receive Hyrimoz during pregnancy, your child may have an increased risk of infections for approximately 5 months after your last dose of Hyrimoz. 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 closely monitor their heart condition. If new symptoms of heart failure develop or existing symptoms worsen (e.g., difficulty breathing or swelling of the feet), contact your doctor immediately.

Fever, bruising, bleeding, or paleness

• 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, bleeds easily, or appears very pale, consult 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, albeit rarely, in patients treated with adalimumab.

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

• In addition, 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 change in appearance.

• Cases of cancers other than lymphoma have occurred in patients with a specific lung disease called chronic obstructive pulmonary disease (COPD) who were 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 may be taken together with methotrexate or certain disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide, and injectable gold salts), corticosteroids, or pain medications, including non-steroidal anti-inflammatory drugs (NSAIDs).

Hyrimoz must not be used together with medicines containing the active substances 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 pharmacological 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 have a baby, consult your doctor about using this medicine.
• Hyrimoz should only be used during pregnancy if clearly needed.
• 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 condition who did not receive adalimumab.
• Hyrimoz may be used during breastfeeding.
• If you use Hyrimoz while pregnant, your child may have a higher risk of developing an infection.
• It is important to inform your child’s pediatrician and other healthcare professionals about your use of Hyrimoz during pregnancy before your child receives any vaccines (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; this is essentially “sodium-free”.

3. How to use Hyrimoz

Follow exactly the administration instructions for this medicine 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 you require an alternative dose.

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, contact your doctor or pharmacist and inform them that you have taken more than required. Always keep the medicine carton with you, even if it is empty.

If you forget to use Hyrimoz

If you miss an injection, you should inject the next dose of Hyrimoz as soon as you remember. Then, administer the following dose as usual, as if you had not missed a dose.

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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Most of the adverse effects are mild to moderate. However, some may be serious and require treatment. Adverse 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 sick, wounds, dental problems, burning sensation when urinating, feeling weak, tired or having a cough;
• symptoms of nervous system problems, such as tingling, numbness, double vision, weakness in arms or legs;
• signs of skin cancer, such as a lump or an open sore that does not heal;
• signs and symptoms of blood disorders such as persistent fever, bruising, bleeding, and paleness.

The following adverse 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 infection;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergy);
• dehydration;
• mood changes (including depression);
• anxiety;
• drowsiness and difficulty sleeping;
• sensory disturbances such as tingling, stinging, or numbness;
• migraine;
• symptoms of nerve root compression (including low back and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (sensation 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 burning);
• acid reflux;
• dry eye syndrome (including dry eyes and mouth);
• itching;
• itchy rash;
• bruises;
• skin inflammation (such as eczema);
• breakage 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 tissue);
• fever;
• decreased platelets 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);
• immunological disorders that may affect the lungs, skin, and lymph nodes (the most common presentation is 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 swelling of ankles;
• 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 accumulation 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 condition that may cause muscle weakness, abnormal sensations, tingling in arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring in the lung);
• intestinal perforation (hole in the intestinal wall);
• hepatitis (liver inflammation);
• 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 (itchy red-purple 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 adverse effects observed in clinical studies with adalimumab have no symptoms and can only be detected through 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 levels;
• low blood phosphate levels;
• high blood sugar;
• high blood lactate dehydrogenase levels;
• presence of autoantibodies in blood;
• low blood potassium levels.

Uncommon (may affect up to 1 in 100 people)

• high bilirubin levels (liver function blood test).

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

• low blood counts of white blood cells, red blood cells, and platelets.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet.

You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 pen in the outer packaging to protect it from light.

Alternative storage:

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 protection from light). Once removed from the refrigerator for storage at room temperature, the pre-filled pen must be used within the following 42 days or discarded, even if it is returned to the refrigerator later. You should record the date on which the pre-filled pen 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 once they are no longer needed. 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 pen 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 pen is supplied as 0.4 ml of a solution that is clear to slightly opalescent, colourless or slightly yellowish.

Hyrimoz is supplied in a single-use pre-filled syringe attached to a triangular-shaped pen with a transparent viewing window and label. The syringe inside the pen is made of Type I glass with a 29-gauge stainless steel needle and an inner needle cap made of rubber (thermoplastic elastomer), containing 0.4 ml of solution.

Cartons containing 1, 2 and 4 pre-filled pens of Hyrimoz.

Multiple pack cartons containing 6 (3 packs of 2) pre-filled pens of Hyrimoz.

Only some pack sizes may be marketed.

Hyrimoz is available in a pre-filled syringe and in a 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

You can request further information about this medicinal product by contacting the local representative of the Marketing Authorisation Holder:

Date of last 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.

1. Instructions for use

To help prevent possible infections and ensure correct use of Hyrimoz, it is important that you 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 properly prepare and inject Hyrimoz using the Hyrimoz single-dose pre-filled pen before you use it for the first time. If you have any questions, consult your healthcare professional.

Your single-use pre-filled pen of Hyrimoz

Figure A: Parts of the Hyrimoz pen

Figure A shows the pen after removal of the cap. Do not remove the cap until you are ready to administer the injection.

If you have any questions, consult a doctor, pharmacist, or nurse who is familiar with Hyrimoz.