HYRIMOZ 40 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN

Introduction

Package Leaflet: Information for the Patient

Hyrimoz 40 mg solution for injection in pre-filled pen

Adalimumab

40 mg/0.8 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 card during 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. Storing 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 as described below:

• rheumatoid arthritis,
• juvenile idiopathic polyarticular arthritis,
• enthesitis-related arthritis,
• ankylosing spondylitis
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• psoriatic arthritis,
• psoriasis,
• hidradenitis suppurativa,
• Crohn's disease,
• ulcerative colitis and
• 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, before. 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 prior 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 and Enthesitis-Related Arthritis

Juvenile idiopathic polyarticular arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually appear for the first time in childhood.

Hyrimoz is used to treat juvenile idiopathic polyarticular arthritis in children and adolescents from 2 to 17 years of age and enthesitis-related arthritis in children from 6 to 17 years of age. Patients may have received other disease-modifying medicines, such as methotrexate, before. If these medicines have not worked well enough, patients will receive Hyrimoz to treat their juvenile idiopathic polyarticular arthritis or enthesitis-related arthritis.

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.

Psoriasis in Adults and Children

Plaque psoriasis is an inflammatory disease of the skin that causes red, scaly, crusty, and silvery-scaled areas. 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 secrete 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 hidradenitis suppurativa in adults and adolescents from 12 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 before. 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 Crohn's disease in adults and children 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 children from 6 to 17 years of age. If you have ulcerative colitis, you may be given other medicines first. If these medicines do not work well enough, you will be given Hyrimoz to reduce the signs and symptoms of your disease.

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.

2. What you need to know before you start using Hyrimoz

Do not use Hyrimoz

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

• If you have a severe infection, including tuberculosis, sepsis (blood poisoning), or other opportunistic infections (uncommon infections associated with weakened immune system). If you have 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 you have moderate or severe heart failure. It is essential that you tell your doctor if you have had or have any serious heart problems (see "Warnings and precautions").

Warnings and precautions

Consult your doctor or pharmacist before starting to use Hyrimoz.

Allergic reaction

• If you have 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.

Infection

• If you have 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, you may be more likely to get infections. This risk may be higher if you have reduced lung function. 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 you have 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 you for signs or symptoms of tuberculosis before starting your treatment with Hyrimoz. This includes a thorough medical evaluation, including your 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 patient information card. It is crucial that you inform your doctor if you have had tuberculosis or have been in contact with a tuberculosis patient. Tuberculosis can develop during treatment, even if you have received preventive treatment for tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, general malaise, low-grade fever) or any other infection appear during or after treatment, contact your doctor immediately.

Travel/infection recurrence

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

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

Hepatitis B virus

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

Age over 65 years

• If you are over 65 years old, you 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 while being treated with Hyrimoz. It is essential that you inform your doctor if you have symptoms of infections, such as fever, wounds, fatigue, or dental problems.

Dental procedures or surgery

• If you are going to undergo a surgical or dental intervention, inform your doctor that you are using Hyrimoz. Your doctor may recommend temporarily stopping treatment with Hyrimoz.

Demyelinating disease

• If you have or develop a demyelinating disease (a disease that affects the insulating layer surrounding nerves, such as multiple sclerosis), your doctor will decide whether you should be treated or continue treatment with Hyrimoz. Inform your doctor immediately if you have 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, attenuated forms of bacteria or viruses that cause diseases and should not be administered during treatment with Hyrimoz, as they may cause infections. Consult your doctor before administering any type of vaccine. It is recommended that children receive all scheduled vaccinations for their age before starting treatment with Hyrimoz. If you receive Hyrimoz while pregnant, your child may have a higher risk of contracting infections during the approximately 5 months following the last dose of Hyrimoz you received during 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 you have had or have serious heart problems. If you have mild heart failure and are being treated with Hyrimoz, your doctor should continuously monitor your heart failure. If new symptoms of heart failure appear or existing ones worsen (e.g., difficulty breathing or swelling of the feet), you should contact your 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 those that help stop bleeding (platelets). If you have persistent fever, bruising, or bleeding easily, or are very pale, consult your doctor immediately. Your 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 you are being treated with Hyrimoz, the risk of developing 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 receiving treatment with azathioprine or mercaptopurine. Inform your doctor if you are taking azathioprine or mercaptopurine with Hyrimoz.

• Additionally, 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 you have COPD or are a heavy smoker, you should consult your doctor to determine whether treatment with a TNFα blocker is suitable for you.

Autoimmune diseases

• In rare cases, treatment with Hyrimoz may lead to a lupus-like syndrome. Contact your doctor if you have 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 vaccinations before using Hyrimoz.
• Do not administer Hyrimoz to children under 2 years old with polyarticular juvenile idiopathic arthritis.

Other medicines and Hyrimoz

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Hyrimoz can be taken with methotrexate or with 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

• You 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 you are pregnant, think you may be pregnant, or plan to have a baby, ask your 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 you use Hyrimoz while pregnant, your child may have a higher risk of contracting infections.
• It is essential that you inform your child's doctor and other healthcare professionals about your use of Hyrimoz during pregnancy before your child receives any vaccine (for more information on vaccines, see the "Warnings and precautions" section).

Driving and using machines

The influence of Hyrimoz on the ability to drive, ride a bicycle, or use machines is small. You may experience dizziness and vision disturbances after using Hyrimoz.

Hyrimoz contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 0.8 ml dose; it is essentially "sodium-free".

3. How to use Hyrimoz

Follow the administration instructions of this medication exactly as indicated by your doctor. In case of doubt, consult your doctor again.

Hyrimoz is available as a 40 mg pen and as 20 mg and 40 mg prefilled syringes for patients to administer a complete dose of 20 mg or 40 mg.

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 medication 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, the next dose will be administered 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 when exercising or 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 infections;
• fungal infections;
• joint infections;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergy);
• dehydration;
• mood changes (including depression);
• anxiety;
• drowsiness and difficulty sleeping;
• sensory disturbances such as tingling, pricking, 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 (heartburn, bloating, and discomfort);
• 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 or worsening 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;
• low platelet count in blood, 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);
• tremor;
• neuropathy (nerve damage);
• stroke;
• double vision;
• hearing loss, tinnitus;
• 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 lung 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 (fat accumulation in liver cells);
• night sweats;
• scars;
• abnormal muscle crisis;
• systemic lupus erythematosus (an immune system 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 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 lungs);
• 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 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;
• high lipid levels in blood;
• high liver enzymes.

Common(may affect up to 1 in 10 people)

• high white blood cell count;
• low platelet count;
• high uric acid levels in blood;
• abnormal sodium levels in blood;
• low calcium levels in blood;
• low phosphate levels in blood;
• high blood sugar;
• high lactate dehydrogenase levels in blood;
• presence of autoantibodies in blood;
• low potassium levels 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 is not listed 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 stated 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 pen in the outer packaging to protect it from light.

Alternative storage:

When necessary (e.g., when traveling), you can store Hyrimoz at room temperature (up to 25 °C) for a maximum period of 21 days (make sure to protect it from light). Once the pre-filled pen is removed from the refrigerator to store at room temperature, it must be used within the next 21 days or discarded, even if it is later returned to the refrigerator. You must record the date you removed the pre-filled pen 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 you no longer need. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Hyrimoz

• The active substance is adalimumab. Each pre-filled pen contains 40 mg of adalimumab in 0.8 ml of solution.
• The other ingredients are: adipic acid, citric acid monohydrate, sodium chloride, mannitol (E 421), polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524), and water for injections.

Appearance and Container Contents of the Product

Hyrimoz 40 mg solution for injection (injection) in a pre-filled pen is supplied as 0.8 ml of a clear to slightly opalescent, colorless to slightly yellowish solution.

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 stainless steel needle of 29 gauge and an inner needle cap made of rubber (thermoplastic elastomer), with 0.8 ml of solution.

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

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

Only certain pack sizes may be marketed.

Hyrimoz is available in a pre-filled syringe and 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 more information about this medicinal product from the local representative of the marketing authorisation holder:

Date of Last Revision of this Prospectus

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 correctly with the 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

In Figure A, the pen is shown once the cap has been removed. Do notremove the cap until you are ready to administer the injection.

It is important that:

• Do notopen the outer carton until you are ready to use the pen.
• Do not usethe pen if the outer carton seal or the pen's security seal is broken.
• Neverleave the pen unattended in places where others may handle it.

• If you drop the pen, do not use itif it is damaged or if it has been dropped without the needle cap in place.

• To make the injection more comfortable, inject Hyrimoz 15-30 minutes after taking it out of the refrigerator.
• • Discard the used syringe immediately after use. Do not reuse the pen.See “4. Disposal of Used Pens”at the end of these instructions for use.

Storage of the Pen

• Store the pen in the carton in a refrigerator at 2°C to 8°C.
• When necessary (e.g., when traveling), you can store Hyrimoz at room temperature (up to 25°C) for a maximum of 21 days (make sure to protect it from light). Once you have taken the pre-filled pen out of the refrigerator to store it at room temperature, the pre-filled pen must be used within 21 days or discarded, even if it is put back in the refrigerator later. You must write down the date when you took the pre-filled pen out of the refrigerator and the date after which it must be discarded.
• Keep the pen in its original packaging until you are ready to use it to protect it from light.
• Do not expose the pen to extreme heat or cold.
• Do not freeze the pen.

Keep Hyrimoz and all medicines out of the reach of children.

What You Need for Injection

Place the following items on a clean, flat surface.

The carton includes:

• Hyrimoz pre-filled pen(s) (see Figure A). Each pen contains 40 mg/0.8 ml of Hyrimoz.

The carton does not include (see Figure B):

• Alcohol swab
• Cotton or gauze
• Sharps disposal container

Figure B: items not included in the carton

See “8. Disposal of Used Pens”at the end of these instructions for use.

Before Injection

Preparing the Pen

• To make the injection more comfortable, take the pen out of the refrigerator 15-30 minutes before injecting Hyrimoz to allow it to reach room temperature.
• Look through the viewing window. The solution should be colorless to slightly yellowish and clear to slightly opalescent. Do not use itif you see particles or color changes. If you are concerned about the appearance of the solution, consult your pharmacist.

Figure C: safety checks

before injection

• Check the expiration date (EXP) on the pen. Do not use the pen after the expiration date.
• Do not use it if the security seal is broken.

If the syringe does not pass any of the above checks, contact your pharmacist.

1. Choosing the Injection Site:

1. Cleaning the Injection Site:

1. Removing the Pen Cap:

1. Holding the Pen:

Injection

1. Starting the Injection:

1. Completing the Injection:

After Injection

1. Check that the Green Indicator Fills the Entire Viewing Window(see Figure J):

1. Disposal of Used Pens:

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