HYRIMOZ 40 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the Patient

Hyrimoz 40 mg Solution for Injection in Pre-filled Syringe

adalimumab

40 mg/0.4 ml

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• Your doctor will give you a patient information card, which contains important safety information that you need to know before and during treatment with Hyrimoz.
• Keep this patient information cardduring your treatment and for 4 months after your last injection (or your child's) of Hyrimoz.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Hyrimoz and what is it used for

Hyrimoz contains the active substance adalimumab, a medicine that works on the immune system (the body's defense system).

Hyrimoz is used to treat inflammatory diseases, which are described below:

• rheumatoid arthritis,
• juvenile idiopathic polyarticular 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 target in the body.

The target of adalimumab is another protein called tumor necrosis factor (TNFα), which is found in high concentrations 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 of 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 medicines that modify the disease, such as methotrexate, beforehand. If these medicines have not worked well enough, you will be given Hyrimoz to treat your rheumatoid arthritis.

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

Hyrimoz can reduce the damage to the cartilage and bones of the joints caused by the disease and improve physical function.

Hyrimoz is usually used in combination with methotrexate. If your doctor considers that methotrexate is not suitable, Hyrimoz can be given alone.

Juvenile Idiopathic Polyarticular Arthritis

Juvenile idiopathic polyarticular arthritis is an inflammatory disease of the joints.

Hyrimoz is used to treat juvenile idiopathic polyarticular arthritis in children and adolescents from 2 to 17 years of age. Patients may have received other disease-modifying medicines, such as methotrexate, beforehand. If these medicines have not worked well enough, patients will receive Hyrimoz.

Enthesitis-related Arthritis

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

Patient may have received other disease-modifying medicines, such as methotrexate, beforehand. 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 that affect 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 be treated first with other medicines, and if these medicines 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 disease of the skin that causes red, scaly, crusty, and silvery-scaled patches. Plaque psoriasis can also affect the nails, causing them to deteriorate, thicken, and lift off the nail bed, which can be painful. It is believed that psoriasis is caused by a defect in the body's immune system that leads to an increase in the 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 from 4 to 17 years of age who have not responded or are not suitable for topical medicines or ultraviolet (UV) light treatment.

Psoriatic Arthritis

Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.

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

Hidradenitis Suppurativa in Adults and Adolescents

Hidradenitis suppurativa (also known as inverse acne) is a long-term and often painful inflammatory skin disease. Symptoms can include painful nodules (lumps) and abscesses (boils) that can ooze pus.

It usually affects specific areas of the skin, such as under the breast, armpits, inner thighs, groin, and buttocks. There may also be scarring in the 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 that is usually associated with this disease. You may have received other medicines beforehand. If these medicines have not worked 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 be treated first with other medicines. If you do not respond well enough 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 be treated first with other medicines. If these medicines do not work well enough, you will receive Hyrimoz to reduce the signs and symptoms of ulcerative colitis.

Non-infectious Uveitis in Adults and Children

Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye. The inflammation causes a decrease in vision and/or the presence of floaters in the eye (black dots or thin lines that move along the field of vision). Hyrimoz works by reducing this inflammation.

Hyrimoz is used to treat

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

You may have received other medicines beforehand. If you do not respond well enough 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 any of the other components of this medicine (listed in section 6).

• If your child has a severe 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 essential that you inform your doctor (see "Warnings and precautions").

• If your child has moderate or severe heart failure. It is crucial that you tell your doctor if your child has had or has any serious heart problems (see "Warnings and precautions").

Warnings and precautions

Consult your doctor or pharmacist before starting to use Hyrimoz.

Allergic reaction

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

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.

• With Hyrimoz treatment, your child may be more likely to get infections. This risk may be higher if your child's lung function is reduced. These infections can be severe and include tuberculosis, viral, fungal, parasitic, or bacterial infections, or other uncommon infectious organisms, and sepsis (blood poisoning).

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

Tuberculosis (TB)

• Since cases of tuberculosis have been reported in patients treated with adalimumab, 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 test). The performance and results of these tests should be recorded on your child's patient information card. It is crucial that you inform your doctor if your child has had tuberculosis or has been in contact with a tuberculosis patient. Tuberculosis can 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/infection recurrence

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

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

Hepatitis B virus

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

Age over 65 years

• If your child is over 65 years old, 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 infection signs while your child is being treated with Hyrimoz. It is essential that you inform your doctor if your child has symptoms of infections, such as fever, wounds, feeling tired, or dental problems.

Dental procedures or surgery

• If your child is going to have surgery or dental work, inform your doctor that they are taking Hyrimoz. Your doctor may recommend temporarily stopping treatment with Hyrimoz.

Demyelinating disease

• If your child has or develops a demyelinating disease (a disease that affects the protective covering of nerves, such as multiple sclerosis), your doctor will decide whether your child should be treated or continue treatment with Hyrimoz. Inform your doctor immediately if your child has 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 live, weakened forms of bacteria or viruses that can cause diseases and should not be given during treatment with Hyrimoz, as they may cause infections. Consult your doctor before administering any vaccine. It is recommended that children receive all scheduled vaccinations for their age before starting treatment with Hyrimoz. If your child receives Hyrimoz while you are pregnant, your child may have a higher risk of getting infections during the approximately 5 months following the last dose of Hyrimoz they received during your pregnancy. It is essential that you 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 vaccine.

Heart failure

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

Fever, bruising, bleeding, or pale appearance

• In some patients, the body may be unable to produce a sufficient number of the type of blood cells that fight infections (white blood cells) or help stop bleeding (platelets). If your child has persistent fever, bruising, or bleeding easily, or is very pale, consult their doctor immediately. Their doctor may decide to interrupt treatment.

Cancer

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

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

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

• Cases of cancer, other than lymphoma, have been reported in patients with a specific lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNFα blocker. If your child has COPD or is a heavy smoker, they should consult their doctor to determine if treatment with a TNFα blocker is suitable for them.

Autoimmune diseases

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

Children and adolescents

• Vaccines: if possible, your child should be up-to-date on all vaccinations before using Hyrimoz.

Other medicines and Hyrimoz

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

Hyrimoz can be taken 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).

Do not use Hyrimoz with medicines whose active substances are anakinra or abatacept due to an increased risk of severe infection. It is not recommended to combine adalimumab and other TNFα blockers with anakinra or abatacept, due to the possible increased risk of infections, including severe infections, and other potential pharmacological interactions. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

• Your child's mother should consider using adequate contraceptive methods to avoid becoming pregnant and continue using them for at least 5 months after the last treatment with Hyrimoz.
• If the mother is pregnant, thinks she may be pregnant, or plans to have a baby, she should ask her doctor for advice on using this medicine.
• Hyrimoz should be used during pregnancy only if necessary.
• According to a pregnancy study, there was no increased risk of congenital defects when the mother had received treatment with adalimumab during pregnancy compared to mothers with the same disease who did not receive treatment with adalimumab.
• Hyrimoz can be used during breastfeeding.
• If the mother uses Hyrimoz while pregnant, her child may have a higher risk of getting infections.
• It is essential that the mother informs her child's doctor and other healthcare professionals about her use of Hyrimoz during pregnancy before the baby receives any vaccine (for more information on vaccines, see the "Warnings and precautions" section).

Driving and using machines

Hyrimoz has a minor influence on the ability to drive, ride a bicycle, or use machines. Dizziness 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; it is essentially "sodium-free".

3. How to use Hyrimoz

Follow your doctor's administration instructions for this medication exactly. If in doubt, consult your doctor again.

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

Form and route of administration

Hyrimoz is injected under the skin (subcutaneously).

Detailed instructions on how to inject Hyrimoz are found 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 explain that you have taken more than necessary. Always carry the medicine box 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 next dose as usual, as if you had not forgotten a dose.

If you stop treatment with Hyrimoz

The decision to stop using Hyrimoz should be discussed with your doctor. Your symptoms may return after stopping treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Most adverse effects are mild to moderate. However, some can be serious and require treatment. Adverse effects may appear up to 4 months or more after the last injection of Hyrimoz.

Seek medical attention urgentlyif you notice any of the following signs of allergic reaction or heart failure:

• severe rash, hives;
• swelling of the face, hands, feet;
• difficulty breathing, swallowing;
• difficult breathing with physical activity or when lying down or swelling of feet.

Contact your doctor as soon as possibleif you notice any of the following effects:

• signs and symptoms of infection such as fever, nausea, wounds, dental problems, burning sensation when urinating, feeling of weakness, fatigue 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 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)

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

• rash;
• muscle pain.

Common(may affect up to 1 in 10 people)

• severe infections (including sepsis and flu);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes);
• ear infection;
• mouth infections (including dental infection and cold sore);
• infections of the reproductive system;
• urinary tract infection;
• fungal infections;
• joint infections;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergy);
• dehydration;
• mood changes (including depression);
• anxiety;
• difficulty sleeping;
• sensory disturbances such as tingling, itching or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• vertigo (feeling of spinning);
• feeling of rapid heartbeat;
• high blood pressure;
• flushing;
• bruises (solid swelling with clotted blood);
• cough;
• asthma;
• difficulty breathing;
• gastrointestinal bleeding;
• indigestion (indigestion, bloating and heartburn);
• acid reflux;
• dry eye syndrome (including dryness in eyes and mouth);
• itching;
• itchy rash;
• bruises;
• skin inflammation (such as eczema);
• breaking of fingernails and toenails;
• increased sweating;
• hair loss;
• new onset or worsening of psoriasis;
• muscle spasms;
• blood in urine;
• kidney problems;
• chest pain;
• edema (fluid accumulation in the body that can cause swelling of the affected tissue);
• fever;
• decrease in blood platelets, which increases the risk of bleeding or bruising;
• wound healing problems.

Uncommon(may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections that occur when disease resistance decreases);
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• cancer, including cancer that affects the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that can affect the lungs, skin and lymph nodes (the most common presentation is in the form of a disease called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremors (feeling shaky);
• neuropathy (nerve damage);
• stroke;
• hearing loss, ringing in the ears;
• feeling of irregular heartbeat like skips;
• heart problems that can cause difficulty breathing or swelling of ankles;
• heart attack;
• aneurysm in the wall of a major artery, inflammation and clotting in a vein, blockage of a blood vessel;
• lung diseases that can cause difficulty breathing (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal fluid accumulation in the pleural space);
• pancreatitis that causes severe abdominal and back pain;
• difficulty swallowing;
• facial edema;
• gallbladder inflammation; gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scars;
• abnormal muscle crisis;
• systemic lupus erythematosus (an immune disorder that includes 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 that affects the blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• nervous system disorders (such as optic neuritis of the eye and Guillain-Barré syndrome, a disease that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring in the lung);
• intestinal perforation (hole in the wall of the intestine);
• hepatitis (inflammation of the liver);
• reactivation of hepatitis B virus infection;
• autoimmune hepatitis (inflammation of the liver caused by the body's own immune system);
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• Stevens-Johnson syndrome (a potentially life-threatening disease with flu-like symptoms and blistering rash);
• facial edema associated with allergic reactions;
• erythema multiforme (inflammatory rash on the skin);
• lupus-like syndrome;
• angioedema (localized skin swelling);
• lichenoid reaction on the skin (purple-red itchy rash).

Frequency Not Known(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 cancer related to human herpesvirus 8 infection. Kaposi's sarcoma usually manifests more frequently as purple-colored skin lesions;
• liver failure;
• worsening of a disease called dermatomyositis (seen as skin rash accompanied by muscle weakness);
• weight gain (for most patients, weight gain was reduced).

Some adverse effects observed in clinical studies with adalimumab do not have symptoms and can only be identified through a blood test. These include:

Very Common(may affect more than 1 in 10 people)

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

Common(may affect up to 1 in 10 people)

• high white blood cell count;
• low platelet count;
• increased uric acid in blood;
• abnormal sodium levels in blood;
• low calcium level in blood;
• low phosphate level in blood;
• high blood sugar;
• high lactate dehydrogenase levels in blood;
• presence of autoantibodies in blood;
• low potassium level in blood.

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 counts in blood for white blood cells, red blood cells and platelets.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the label/blister/box after "CAD" or "EXP". The expiration date is 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 (for example, when traveling), you can store Hyrimoz at room temperature (up to 25 °C) for a maximum period of 42 days (make sure to protect it from light). Once the pre-filled syringe has been removed from the refrigerator to store it at room temperature, it must be used within the next 42 days or discarded, even if it is later returned to the refrigerator. You must record the date on which you removed the pre-filled syringe from the refrigerator and the date after which it must be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Container Contents and Additional 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 injectable preparations (see section 2 "Hyrimoz contains sodium").

Appearance and Container Contents of the Product

Hyrimoz 40 mg injectable solution (injection) in a pre-filled syringe is supplied as 0.4 ml of a clear to slightly opalescent, colorless to slightly yellowish solution.

Hyrimoz is supplied in a Type I glass syringe, single-use, with a stainless steel needle of 29 gauge with a needle shield with wings, a rubber (thermoplastic elastomer) needle cap, and a plastic plunger, with 0.4 ml of solution.

Packs containing 1 and 2 pre-filled syringes of Hyrimoz.

Multipack containers with 6 (3 packs of 2) pre-filled syringes of Hyrimoz.

Only certain pack sizes may be marketed.

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

Marketing Authorization 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 obtain further information on this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet

Other Sources of Information

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

1. Instructions for Use

To help avoid possible infections and ensure correct use of the medicinal product, 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 have taught you how to prepare and inject Hyrimoz with the pre-filled syringe correctly before you use it for the first time. If you have any questions, consult your healthcare professional.

Your Hyrimoz Single-Use Pre-filled Syringe with Needle Shield and Wings

Figure A:Hyrimoz pre-filled syringe with needle shield and wings

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