YUFLYMA 40 mg Injectable Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the Patient

Yuflyma 40 mg Solution for Injection in Pre-filled Syringe

adalimumab

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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 you start using and during treatment with Yuflyma. Carry this patient information cardwith you during treatment and for 4 months after your last injection of Yuflyma.
• 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 Yuflyma and what is it used for
2. What you need to know before you use Yuflyma
3. How to use Yuflyma
4. Possible side effects
5. Storage of Yuflyma
6. Contents of the pack and other information
7. Instructions for use

1. What is Yuflyma and what is it used for

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

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

• Rheumatoid arthritis
• Polyarticular juvenile idiopathic arthritis
• Arthritis associated with enthesitis
• 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 Yuflyma, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that target a specific target.

The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune system (defence) and is found in high levels in the inflammatory diseases mentioned above. By targeting TNFα, Yuflyma reduces the inflammatory process in these diseases.

Rheumatoid Arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

Yuflyma is used to treat moderate to severe rheumatoid arthritis in adults. You may have been given other medicines that modify the disease, such as methotrexate, before. If you do not respond well to these medicines, you will be given Yuflyma.

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

Yuflyma can reduce the damage to your joints caused by the inflammatory disease and help you move more freely.

Your doctor will decide if Yuflyma should be used with methotrexate or alone.

Polyarticular Juvenile Idiopathic Arthritis

Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints.

Yuflyma is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years of age. You may have been given other medicines that modify the disease, such as methotrexate, before. If you do not respond well to these medicines, you will be given Yuflyma.

Your doctor will decide if Yuflyma should be used with methotrexate or alone.

Arthritis Associated with Enthesitis

Arthritis associated with enthesitis is an inflammatory disease of the joints and the sites where tendons attach to the bone.

Yuflyma is used to treat arthritis associated with enthesitis in patients from 6 years of age. You may have been given other medicines that modify the disease, such as methotrexate, before. If you do not respond well to these medicines, you will be given Yuflyma.

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.

Yuflyma is used to treat severe ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. You may have been given other medicines before. If you do not respond well to these medicines, you will be given Yuflyma.

Psoriatic Arthritis

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

Yuflyma is used to treat psoriatic arthritis in adults. Yuflyma can reduce the damage to your joints caused by the disease and help you move more freely. You may have been given other medicines before. If you do not respond well to these medicines, you will be given Yuflyma.

Plaque Psoriasis

Plaque psoriasis is a skin disease 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.

Yuflyma is used to treat

• chronic plaque psoriasis in adults and
• severe chronic plaque psoriasis in children and adolescents from 4 to 17 years of age who have not responded to or are not candidates for topical treatments and phototherapies.

Hidradenitis Suppurativa

Hidradenitis suppurativa (also known as inverse acne) is a chronic 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.

Yuflyma 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.

Yuflyma can reduce the number of nodules and abscesses caused by the disease, and the pain that is usually associated with this disease. You may have been given other medicines before. If you do not respond well to these medicines, you will be given Yuflyma.

Crohn's Disease

Crohn's disease is an inflammatory disease of the digestive tract. Yuflyma 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.

You may have been given other medicines before. If you do not respond well to these medicines, you will be given Yuflyma.

Ulcerative Colitis

Ulcerative colitis is an inflammatory disease of the large intestine. Yuflyma 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.

You may have been given other medicines before. If you do not respond well to these medicines, you will be given Yuflyma.

Non-infectious Uveitis

Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye. Yuflyma is used to treat

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

This inflammation can lead to a decrease in vision or the presence of floaters in the eye (black dots or thin lines that move across the field of vision). Yuflyma works by reducing this inflammation.

You may have been given other medicines before. If you do not respond well to these medicines, you will be given Yuflyma.

2. What you need to know before starting to use Yuflyma

Do not use Yuflyma:

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

• If you have active tuberculosis or other severe infections (see "Warnings and precautions"). It is important that you inform your doctor if you have symptoms of infection, such as fever, wounds, feeling of tiredness, dental problems.

• If you have moderate or severe heart failure. It is important that you inform your doctor if you have had or have a severe heart condition (see "Warnings and precautions").

Warnings and precautions

Consult your doctor or pharmacist before starting to use Yuflyma.

Allergic reactions

• If you have an allergic reaction with symptoms such as chest tightness, difficulty breathing, dizziness, swelling, or rash, discontinue the administration of Yuflyma and contact your doctor immediately, as these reactions can be life-threatening in rare cases.

Infections

• If you have any infection, including chronic infection or a localized infection in some part of the body (e.g., an ulcer on the leg), consult your doctor before starting treatment with Yuflyma. If you are unsure, contact your doctor.

• You may be more likely to contract infections while receiving treatment with Yuflyma. This risk may be greater if you have damaged lungs. These infections can be severe and include:
• tuberculosis
• infections caused by viruses, fungi, parasites, or bacteria
• severe blood infection (sepsis)

In rare cases, these infections could be life-threatening. It is essential that if you have symptoms such as fever, wounds, tiredness, or dental problems, you inform your doctor. Your doctor may indicate that you should stop using Yuflyma for some time.

• Inform your doctor if you live or travel in regions where fungal infections (e.g., histoplasmosis, coccidioidomycosis, or blastomycosis) are very common.

• Inform your doctor if you have had recurrent infections or other disorders that increase the risk of infections.

• If you are over 65 years old, you may be more susceptible to infections while being treated with Yuflyma. Both you and your doctor should pay special attention to the appearance of signs of infection while being treated with Yuflyma. It is essential that if you have symptoms of infections such as fever, wounds, tiredness, or dental problems, you inform your doctor.

Tuberculosis

? Since cases of tuberculosis have been reported in patients treated with Yuflyma, your doctor will examine you for signs or symptoms of tuberculosis before starting your treatment with Yuflyma. This will include a thorough medical evaluation, including your medical history and appropriate diagnostic tests (e.g., chest X-ray and tuberculin test). The performance and results of these tests should be recorded in your patient information card.

? Tuberculosis can develop during treatment, even if you have received treatment to prevent tuberculosis.

? If symptoms of tuberculosis appear (e.g., persistent cough, weight loss, lack of energy, low-grade fever) or any other infection during or after treatment, contact your doctor immediately.

Hepatitis B

• Inform your doctor if you are a carrier of the hepatitis B virus (HBV), if you have had active HBV infections, or if you think you may be at risk of contracting HBV.
• Your doctor should perform an analysis for HBV. In people carrying HBV, Yuflyma can cause the virus to become active again.
• In rare cases, especially if you are taking other medications that suppress the immune system, the reactivation of HBV can be life-threatening.

Surgery or dental intervention

• If you are going to undergo surgery or dental intervention, inform your doctor that you are taking Yuflyma. Your doctor may recommend that you temporarily discontinue treatment with Yuflyma.

Demyelinating disease

• If you have or develop a demyelinating disease (a disease that affects the insulation layer around nerves, such as multiple sclerosis), your doctor will decide whether you should be treated or continue treatment with Yuflyma. Inform your doctor immediately if you experience symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling in any part of the body.

Vaccinations

• Certain vaccines can cause infections and should not be administered if you are being treated with Yuflyma.

• Consult your doctor before receiving any vaccine.
• If possible, it is recommended that children receive the scheduled vaccines for their age before starting treatment with Yuflyma.
• If you have received Yuflyma while pregnant, your baby may be at higher risk of contracting an infection for approximately five months after the last dose of Yuflyma you received during pregnancy. It is essential that you inform your child's doctors and other healthcare professionals about your use of Yuflyma during pregnancy, so they can decide whether your child should receive any vaccine.

Heart failure,

• If you have mild heart failure and are being treated with Yuflyma, your doctor should continuously monitor your heart failure. It is essential that you inform your doctor if you have had or have any severe heart condition. 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. Your doctor will decide whether you should receive Yuflyma.

Fever, bruising, bleeding, or pale appearance

• In some patients, the body may be unable to produce enough blood cells that help the body fight infections or contribute to stopping bleeding. Your doctor may decide to suspend treatment. If you have persistent fever, easy bruising, bleed easily, or are very pale, consult your doctor immediately.

Cancer

• In very rare cases, certain types of cancer have been reported in children and adults treated with Yuflyma or other TNF-blocking agents.

• People with more severe rheumatoid arthritis and who have had the disease for a long time may have a higher-than-average risk of developing lymphoma (a cancer that affects the lymphatic system) and leukemia (a cancer that affects the blood and bone marrow).
• If you take Yuflyma, the risk of developing lymphoma, leukemia, or other types of cancer may increase. A rare and severe type of lymphoma has been observed in patients treated with Yuflyma. Some of these patients were also receiving treatment with azathioprine or 6-mercaptopurine.
• Inform your doctor if you are taking azathioprine or 6-mercaptopurine with Yuflyma.
• Cases of non-melanoma skin cancer have been observed in patients using Yuflyma.
• Inform your doctor if new skin lesions appear or existing ones change in appearance during or after treatment.

• Cancers other than lymphoma have been reported in patients with a certain lung disease, called Chronic Obstructive Pulmonary Disease (COPD), treated with another TNF-blocking agent. If you have COPD or are a heavy smoker, you should consult your doctor to determine if treatment with a TNF blocker is suitable for you.

Autoimmune disease

• In rare cases, treatment with Yuflyma could lead to a syndrome similar to lupus. Contact your doctor if you have symptoms such as unexplained persistent rash, fever, joint pain, or tiredness.

Children and adolescents

• Vaccination: if possible, your child should be up-to-date with all vaccines before using Yuflyma.

Use of Yuflyma with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine. You should not take Yuflyma with medicines that contain the following active substances due to an increased risk of severe infections:

• anakinra
• abatacept.

Yuflyma can be taken with:

• methotrexate
• certain disease-modifying antirheumatic drugs (e.g., sulfasalazine, hydroxychloroquine, leflunomide, and injectable gold salts)
• corticosteroids or pain medications, including non-steroidal anti-inflammatory drugs (NSAIDs).

If you have any questions, consult your doctor.

Pregnancy and breastfeeding

• You should consider using adequate contraceptive methods to avoid pregnancy and continue their use for at least 5 months after the last treatment with Yuflyma.
• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor about the use of this medicine.
• Yuflyma should be used during pregnancy only if necessary.
• According to a study in pregnancy, there was no increased risk of congenital defects when the mother had received treatment with Yuflyma during pregnancy compared to mothers with the same disease who did not receive treatment with Yuflyma.
• Yuflyma can be used during breastfeeding.
• If you receive Yuflyma while pregnant, your child may be at higher risk of contracting an infection.

Driving and using machines

Yuflyma may have a small effect on the ability to drive, ride a bicycle, or use machines. You may experience dizziness and vision disturbances after using Yuflyma.

YUFLYMA contains sodium

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

3. How to use Yuflyma

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

In the following table, the recommended doses of Yuflyma for each of its approved uses are indicated. Your doctor may prescribe a different dose of Yuflyma if you need a different dose.

Form and route of administration

Yuflyma is injected under the skin (subcutaneously).

In section 7 "Instructions for use", detailed instructions are provided on how to inject Yuflyma.

If you use more Yuflyma than you should

If you accidentally inject Yuflyma more frequently than scheduled by your doctor or pharmacist, inform your doctor or pharmacist. Always carry the outer packaging of the medication with you, even if it is empty.

If you forget to use Yuflyma

If you forget to administer an injection, you should inject the next dose of Yuflyma as soon as you remember. Then, the next dose will be administered as usual, as if a dose had not been missed.

If you interrupt treatment with Yuflyma

The decision to stop using Yuflyma should be discussed with your doctor. Symptoms may return if you stop using Yuflyma.

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. Side effects may appear at least up to 4 months after the last injection of Yuflyma.

Contact your doctor immediately if you notice any of the following effects

• severe rash, hives or other signs of allergic reaction
• swelling of the face, hands, feet
• difficulty breathing, swallowing
• shortness of breath with physical activity or when lying down or swelling of feet.

Contact your doctor as soon as possible if you notice any of the following effects

• signs of infection, such as fever, nausea, wounds, dental problems, burning sensation when urinating
• feeling of weakness or fatigue
• cough
• tingling
• numbness
• double vision
• weakness in arms or legs
• a lump or an open wound that does not heal
• signs and symptoms of blood disorders such as persistent fever, bruising, bleeding, and pallor

The symptoms described above may be signs of the side effects mentioned below, which have been observed with Yuflyma.

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

• reactions at the injection site (including pain, swelling, redness, or itching)
• respiratory tract infections (including colds, runny nose, sinusitis, pneumonia)
• headache
• abdominal pain
• nausea and vomiting
• skin rash
• musculoskeletal 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 infections
• oral infections (including dental infection and ulcers)
• 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
• nerve root compression (including lower back pain and leg pain)
• vision disturbances
• eye inflammation
• eyelid inflammation and eye swelling
• vertigo (feeling of dizziness or spinning)
• rapid pulse sensation
• high blood pressure
• flushing
• hematomas (blood accumulation outside blood vessels)
• cough
• asthma
• shortness of breath
• gastrointestinal bleeding
• dyspepsia (indigestion, bloating, and heartburn)
• acid reflux
• dry eye syndrome (including dryness in eyes and mouth)
• itching
• pruritic rash
• hematomas
• skin inflammation (such as eczema)
• breaking of fingernails and toenails
• increased sweating
• hair loss
• new onset or worsening of existing psoriasis
• muscle spasms
• blood in urine
• kidney problems
• chest pain
• edema (swelling)
• fever
• low platelet count in blood, which increases the risk of bleeding or bruising
• wound healing impairment

Uncommon(may affect up to 1 in 100 people)

• opportunistic 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
• cancer affecting the lymphatic system
• melanoma
• immune system disorders that can affect the lungs, skin, and lymph nodes (the most common presentation is sarcoidosis)
• vasculitis (inflammation of blood vessels)
• tremors (feeling shaky)
• neuropathy (nervous system disorder)
• stroke
• hearing loss, tinnitus
• irregular pulse sensation 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
• pulmonary 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 (swelling of the face)
• gallbladder inflammation, gallstones
• fatty liver
• night sweats
• scarring
• abnormal muscle breakdown
• systemic lupus erythematosus (including skin inflammation, heart, lungs, joints, and other organs)
• sleep disturbances
• impotence
• inflammations

Rare(may affect up to 1 in 1000 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 that can cause muscle weakness, abnormal sensations, tingling in arms and upper body)
• cardiac arrest
• pulmonary fibrosis (scarring in the lung)
• intestinal perforation (hole in the intestine)
• hepatitis
• reactivation of hepatitis B virus
• autoimmune hepatitis (liver inflammation caused by the body's own immune system)
• cutaneous vasculitis (inflammation of blood vessels in the skin)
• Stevens-Johnson syndrome (early symptoms include discomfort, fever, headache, and rash)
• facial edema (swelling of the face) associated with allergic reactions
• erythema multiforme (inflammatory skin rash)
• lupus-like syndrome
• angioedema (localized skin swelling)
• lichenoid reaction in the skin (purple-red rash with itching)

Frequency Not Known(cannot be estimated from available data)

• hepatosplenic T-cell lymphoma (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 appears as purple-colored lesions on the skin.
• 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 with Yuflyma may not have symptoms and can only be identified through a blood test. These include:

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

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

Common(may affect up to 1 in 10 people)

• 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)

• elevated bilirubin levels (liver function test in blood)

Rare(may affect up to 1 in 1000 people)

• low counts in blood for white cells, red 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 Yuflyma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after "EXP".

Store in a refrigerator (between 2 °C - 8 °C). Do not freeze.

Store the pre-filled syringe with needle protector in the outer packaging to protect it from light.

Alternative storage:

When necessary (e.g., when traveling), you can store a pre-filled syringe with needle protector of Yuflyma at room temperature (up to 25 °C) for a maximum period of 31 days (make sure to protect it from light). Once the syringe is removed from the refrigerator to store it at room temperature, you must use it within the next 31 days or discard it, even if you put it back in the refrigerator.

You must note the date you removed the syringe from the refrigerator and the date after which you must discard the syringe.

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

6. Container Contents and Additional Information

Yuflyma Composition

The active ingredient is adalimumab.

The other components are acetic acid, sodium acetate trihydrate, glycine, polysorbate 80, and water for injections.

Appearance of the Yuflyma Pre-filled Syringe with Needle Protector and Container Contents

Yuflyma 40 mg solution for injection in a pre-filled syringe with a needle protector is supplied as a sterile solution of 40 mg of adalimumab dissolved in 0.4 ml of solution.

The Yuflyma pre-filled syringe is a glass syringe containing an adalimumab solution. Each pre-filled syringe container comes with 2 alcohol pads (1 spare). Each container contains 2, 4, or 6 pre-filled syringes, and each pre-filled syringe comes with 1 alcohol pad.

The Yuflyma pre-filled syringe with a needle protector is a glass syringe with a needle protector containing an adalimumab solution. Each pre-filled syringe with a needle protector container comes with 2 alcohol pads (1 spare). Each container contains 2, 4, or 6 pre-filled syringes with needle protectors, and each pre-filled syringe with a needle protector comes with 1 alcohol pad.

Only some pack sizes may be marketed.

Yuflyma may be available in the form of a pre-filled syringe or pre-filled pen.

Marketing Authorisation Holder

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B torony

Hungary

Manufacturer

Millmount Healthcare Ltd.

Block 7

City North Business Campus

Stamullen, Co. Meath K32 YD60

Ireland

Nuvisan GmbH

Wegenerstraße 13,

89231 Neu Ulm,

Germany

Nuvisan France SARL

2400, Route des Colles,

06410, Biot,

France

You can request more information about this medicinal product by contacting the local representative of the marketing authorisation 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

• The following instructions explain how to administer a subcutaneous injection of Yuflyma using the pre-filled syringe. First, read the instructions carefully and then follow them step by step.

• Your doctor, nurse, or pharmacist will show you the technique for injecting yourself.

• Do notattempt to inject yourself until you are sure you understand how to prepare and administer the injection.

• After you have been properly trained, you or another person, such as a family member or friend, can give the injection.

• Use each pre-filled syringe only for one injection.

Yuflyma Pre-filled Syringe

Do not use the pre-filled syringe if:

• it is cracked or damaged.
• the expiry date has passed.
• it has been dropped onto a hard surface.

Do not remove the needle cap until just before the injection. Keep Yuflyma out of sight and reach of children.

Yuflyma Pre-filled Syringe with Needle Protector

Do not use the pre-filled syringe if:

• it is cracked or damaged.
• the expiry date has passed.
• it has been dropped onto a hard surface.

Do not remove the needle cap until just before the injection. Keep Yuflyma out of sight and reach of children.