Prospect: Information for the User

Remsima 120 mg injectable solution in pre-filled pen

infliximab

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• Your doctor will also give you a patient information leaflet, which contains important safety information that you need to know before and during your treatment with Remsima.
• When starting a new leaflet, keep this leaflet as a reference for 4 months after your last dose of Remsima.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

Remsima contains the active ingredient infliximab. Infliximab is a monoclonal antibody – a type of protein that binds to a specific target in the body called TNF (tumor necrosis factor) alpha.

Remsima belongs to a group of medicines called “TNF blockers”. It is used in adults for the following inflammatory diseases:

• Arthritis rheumatoid.
• Psoriatic arthritis
• Ankylosing spondylitis (Bechterew's disease)
• Poriasis
• Crohn's disease
• Ulcerative colitis.

Remsima acts by selectively binding to TNF alpha and blocking its action. TNF alpha is involved in the body's inflammatory processes, so blocking it can reduce inflammation in the body.

Arthritis rheumatoid

Arthritis rheumatoid is an inflammatory disease of the joints. If you have active rheumatoid arthritis, you will first be given other medicines. If these medicines do not work well enough, you will be given Remsima with another medicine called methotrexate to:

• Reduce the signs and symptoms of your disease,
• Delay damage to your joints,

• Improve your physical condition.

Psoriatic arthritis

Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis, you will first be given other medicines. If these medicines do not work well enough, you will be given Remsima to:

• Reduce the signs and symptoms of your disease,
• Decrease damage to your joints,
• Improve your physical condition.

Ankylosing spondylitis (Bechterew's disease)

Ankylosing spondylitis is an inflammatory disease of the spine. If you have ankylosing spondylitis, you will first be given other medicines. If these medicines do not work well enough, you will be given Remsima to:

• Reduce the signs and symptoms of your disease,
• Improve your physical condition.

Poriasis

Poriasis is an inflammatory disease of the skin. If you have plaque psoriasis, moderate to severe, you will first be given other medicines or treatments such as phototherapy. If these medicines or treatments do not work well enough, you will be given Remsima to reduce the signs and symptoms of your disease.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the intestine. If you have ulcerative colitis, you will first be given other medicines. If these medicines do not work well enough, you will be given Remsima to treat your disease.

Crohn's disease

Crohn's disease is an inflammatory disease of the intestine. If you have Crohn's disease, you will first be given other medicines. If these medicines do not work well enough, you will be given Remsima to:

• Treat active Crohn's disease,
• Reduce the number of abnormal channels (fistulas) between your intestine and your skin, which have not been controlled by other medicines or surgery.

You should not use Remsima if:

• You are allergic to infliximab or any of the other components of Remsima (listed in section 6),
• You are allergic to proteins derived from mice,
• You have tuberculosis (TB) or another serious infection such as pneumonia or septicemia (a serious blood infection),
• You have moderate to severe heart failure.

If any of the above applies to you, do not use Remsima. If you are unsure, consult your doctor before Remsima is administered to you.

Warnings and precautions

Consult your doctor before or during treatment with Remsima if:

You have previously received treatment with any medicine containing infliximab

• Inform your doctor if you have received treatment with medicines containing infliximab in the past and are now starting treatment with Remsima again.
• If you have stopped treatment with infliximab for more than 16 weeks, there is a higher risk of allergic reactions when you start treatment again.

Local reactions at the injection site

• Some patients who have received infliximab by injection under the skin have experienced local reactions at the injection site. The signs of a local reaction at the injection site may include redness, pain, itching, swelling, hardness, hematomas, hemorragia, sensation of coldness, sensation of numbness, irritation, rash, ulcer, blisters, and scabs on the skin at the injection site.
• Most of these reactions are mild to moderate and most of them resolve on their own within a day.

Infections

• Before Remsima is administered to you, inform your doctor if you have an infection, even a mild one.
• Before Remsima is administered to you, inform your doctor if you have ever lived in or traveled to an area where infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common. These infections are caused by specific types of fungi that can affect the lungs or other parts of your body.
• You may be more susceptible to infections while being treated with Remsima. If you are 65 or older, you are at higher risk.
• These infections can be serious and include tuberculosis, infections caused by viruses, fungi, bacteria, or other organisms in the environment, and septicemia, which can be potentially fatal.

Inform your doctor immediately if you notice signs of infection during treatment with Remsima, such as fever, cough, flu-like symptoms, general feeling of illness, redness, or sensation of heat on the skin, wounds, or dental problems. Your doctor may recommend temporarily stopping treatment with Remsima.

Tuberculosis (TB)

• It is very important to inform your doctor if you have ever had TB or have been in close contact with someone who has had or has TB.

• Your doctor will perform a test to see if you have TB. Cases of TB have been reported in patients treated with infliximab, even in patients who have already been treated with TB medications. Your doctor will note these tests on your patient information card.
• If your doctor considers you to be at risk of developing TB, you may be treated with TB medications before Remsima is administered to you.

Inform your doctor immediately if you notice signs of TB during treatment with Remsima. The signs include persistent cough, weight loss, feeling tired, fever, night sweats.

Hepatitis B virus

• Before using Remsima, inform your doctor if you are a carrier of hepatitis B or have had it in the past.
• Inform your doctor if you think you may be at risk of contracting hepatitis B.
• Your doctor should perform tests for the hepatitis B virus.
• Treatment with TNF blockers, such as Remsima, can cause reactivation of the hepatitis B virus in patients who are carriers of this virus, which in some cases can be potentially fatal.
• If you experience reactivation of hepatitis B, your doctor may need to interrupt your treatment, and you may be given effective antiviral therapy with supportive treatment.

Heart problems

• Inform your doctor if you have any heart problems, such as mild heart failure.
• Your doctor will closely monitor your heart.

Inform your doctor immediately if you notice new or worsening heart problems during treatment with Remsima. The signs include difficulty breathing or swelling of the feet.

Cancer and lymphoma

• Before Remsima is administered to you, inform your doctor if you have or have had any type of cancer, including lymphoma (a type of blood cancer).
• Patients with severe rheumatoid arthritis who have had the disease for a long time may be at higher risk of developing lymphoma.
• Patients treated with Remsima may be at higher risk of developing lymphoma or other types of cancer.
• Some patients who have received TNF blockers, including infliximab, have developed a rare type of cancer called hepatosplenic T-cell lymphoma. Most of these patients were adolescent boys or young men and had Crohn's disease or ulcerative colitis. This type of cancer is usually fatal. Almost all of these patients had also received azathioprine or 6-mercaptopurine, in addition to TNF blockers.
• Some patients treated with infliximab have developed certain types of skin cancer. Inform your doctor if you notice any changes in your skin or growths on your skin during or after treatment.
• Some women treated with infliximab for rheumatoid arthritis have developed cervical cancer. Women treated with Remsima, even those over 60 years old, may be recommended to have regular cervical cancer screenings.

Lung disease or heavy smokers

• Before Remsima is administered to you, inform your doctor if you have a lung disease called chronic obstructive pulmonary disease (COPD) or if you are a heavy smoker.

• Patients with COPD and heavy smokers may be at higher risk of developing cancer with Remsima treatment.

Neurological disorders

• Inform your doctor if you have or have had any neurological disorder before Remsima is administered to you. This includes multiple sclerosis, Guillain-Barré syndrome, if you have seizures or have been diagnosed with "optic neuritis."

Inform your doctor immediately if you notice symptoms of neurological disease during treatment with Remsima. The symptoms may include changes in vision, weakness in the arms or legs, numbness or tingling in any part of the body.

Abnormal skin openings

• Consult your doctor if you have any abnormal skin ulcers (fistulas) before Remsima is administered to you.

Vaccinations

• Consult your doctor if you have recently had or are scheduled to have a vaccination.
• Before starting treatment with Remsima, you should receive recommended vaccinations. You may receive some vaccinations during treatment with Remsima, but you should not receive live vaccines (vaccines that contain a weakened live agent) while using Remsima because they may cause infections.
• If you received Remsima while pregnant, your baby may be at higher risk of contracting an infection with live vaccines, such as the BCG vaccine (used to prevent tuberculosis), for up to six months after birth. It is essential to inform your baby's doctors and other healthcare professionals about your treatment with Remsima to decide when your baby can be vaccinated, including live vaccines.
• If you are breastfeeding, it is essential to inform your baby's doctors and other healthcare professionals about your treatment with Remsima before your baby is vaccinated.

For more information, see the section on Pregnancy and breastfeeding

Therapeutic infectious agents

• Inform your doctor if you have recently received or are about to receive treatment with an infectious agent (such as a BCG instillation used for cancer treatment).

Surgeries or dental procedures

• Inform your doctor if you are scheduled to have any surgery or dental procedure.
• Inform your surgeon or dentist that you are being treated with Remsima and show them your patient information card.

Liver problems

• Some patients who received Remsima have developed severe liver problems.
• Inform your doctor immediately if you notice symptoms of liver problems during treatment with Remsima. The symptoms may include yellowing of the skin and eyes, dark brown urine, pain or swelling in the upper right abdomen, joint pain, skin rashes, or fever.

Low blood cell counts

• In some patients who receive Remsima, the body cannot produce enough blood cells that help fight infections or stop bleeding.
• Inform your doctor immediately if you notice symptoms of low blood cell counts during treatment with Remsima. The symptoms may include persistent fever, bleeding, or appearance of petechiae (small red or purple spots caused by bleeding under the skin), or pallor.

Immune system disorders

• Some patients who received Remsima have developed symptoms of an immune system disorder called lupus.
• Inform your doctor immediately if you develop symptoms of lupus during treatment with Remsima. The symptoms may include joint pain or a rash on the cheeks or arms due to sensitivity to sunlight.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age since there is no evidence that this medicine is safe and effective in this age group.

Other medicines and Remsima

Patients with inflammatory diseases are already taking medicines to treat their condition. These medicines may cause side effects. Your doctor will advise you on which other medicines you should continue to take while being treated with Remsima.

Inform your doctor if you are using, have used recently, or may need to use any other medicine, including any other medicine for the treatment of Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis, or over-the-counter medicines, such as vitamins or herbal supplements.

Particularly, inform your doctor if you are using any of the following medicines:

• Medicines that affect your immune system.
• Kineret (which contains anakinra). Remsima and Kineret should not be used together.
• Orencia (which contains abatacept). Remsima and Orencia should not be used together.

You should not receive live vaccines while using Remsima. If you were using Remsima during pregnancy, inform your baby's doctors and other healthcare professionals about your treatment with Remsima before your baby is vaccinated.

If you are unsure about anything, consult your doctor, pharmacist, or nurse before starting to use Remsima.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Remsima should only be used during pregnancy or breastfeeding if your doctor considers it necessary for you.
• You should avoid becoming pregnant while being treated with Remsima and for up to 6 months after stopping treatment. Discuss contraceptive measures with your doctor during that time.
• If you received Remsima during pregnancy, your baby may be at higher risk of contracting an infection.
• It is essential to inform your baby's doctors and other healthcare professionals about your treatment with Remsima before your baby is vaccinated. If you received Remsima while pregnant, the BCG vaccine (used to prevent tuberculosis) should not be given to your baby within 6 months after birth. For more information, see the section on vaccinations.
• If you are breastfeeding, it is essential to inform your baby's doctors and other healthcare professionals about your treatment with Remsima before your baby is vaccinated.
• In children born to mothers treated with infliximab during pregnancy, a severe decrease in white blood cell count has been reported. If your baby has persistent fever or infections, contact your baby's doctor immediately.

Driving and using machines

It is unlikely that Remsima will affect your ability to drive or use tools or machines. If you feel tired, dizzy, or unwell after Remsima is administered to you, do not drive or use tools or machines.

Remsima contains sodium and sorbitol

This medicine contains less than 1 mmol of sodium (23 mg) per dose; that is, it is essentially "sodium-free" and 45 mg of sorbitol in each 120 mg dose.

Follow exactly the administration instructions of this medication as indicated by your doctor.

In case of doubt, consult your doctor again.

Rheumatoid Arthritis

Your doctor will start your treatment with or without two intravenous infusion doses of Remsima 3 mg per each kilogram of body weight (administered in a vein, usually in the arm, for a period of 2 hours). If the intravenous infusion doses of Remsima are administered to initiate treatment, they are administered with a 2-week interval by intravenous infusion. Four weeks after the last intravenous infusion, Remsima will be administered by subcutaneous injection.

The recommended dose of subcutaneous Remsima injection is 120 mg once every 2 weeks, regardless of body weight.

Psoriatic Arthritis, Ankylosing Spondylitis (Bechterew's Disease) and Psoriasis

Your doctor will start your treatment with two intravenous infusion doses of Remsima 5 mg per each kilogram of body weight (administered in a vein, usually in the arm, for a period of 2 hours). They are administered with a 2-week interval by intravenous infusion. Four weeks after the last intravenous infusion, Remsima will be administered by subcutaneous injection.

The recommended dose of subcutaneous Remsima injection is 120 mg once every 2 weeks, regardless of body weight.

Crohn's Disease and Ulcerative Colitis

Your doctor will start your treatment with two intravenous infusion doses of Remsima 5 mg per each kilogram of body weight (administered in a vein, usually in the arm, for a period of 2 hours). They are administered with a 2-week interval by intravenous infusion. Four weeks after the last intravenous infusion, Remsima will be administered by subcutaneous injection.

The recommended dose of subcutaneous Remsima injection is 120 mg once every 2 weeks, regardless of body weight.

How Remsima will be administered

• Remsima 120 mg injectable solution is administered by subcutaneous injection only. It is essential to check the product labels to ensure that the correct formulation is administered according to the prescription.
• Your doctor may start your treatment with Remsima with or without two intravenous infusion doses of Remsima. For patients with Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, or psoriasis, two intravenous infusion doses of Remsima will be administered to initiate treatment with Remsima.
• If treatment with Remsima is initiated without two intravenous infusion doses of Remsima, the following table indicates the frequency with which Remsima is normally administered after the first dose.

• If your doctor or nurse administer two intravenous infusion doses of Remsima to initiate treatment, they will be administered with a 2-week interval, and the first subcutaneous injection of Remsima will be administered 4 weeks after the last intravenous infusion, followed by subcutaneous injections of Remsima administered every 2 weeks.
• The first subcutaneous injection of Remsima will be administered under the supervision of your doctor.
• After proper training, if you feel well-trained and confident to inject Remsima yourself, your doctor may allow you to inject the subsequent doses of Remsima at home.
• Consult your doctor if you have any questions about how to administer an injection to yourself. You will find “Instructions for use” detailed at the end of the leaflet.

If you use more Remsima than you should

If more Remsima than you should have been used (either by injecting too much in one go or using it too frequently), speak to a doctor, pharmacist, or nurse immediately. Always carry the medication packaging with you, even if it is empty.

If you forget to use Remsima

Missed dose up to 7 days

If you miss a dose of Remsima up to 7 days after the originally scheduled dose, take the missed dose immediately. Take the next dose on the originally scheduled date and then follow the original dosing schedule.

Missed dose 8 or more days

If you miss a dose of Remsima 8 or more days after the originally scheduled dose, do not take the missed dose. Take the next dose on the originally scheduled date and then follow the original dosing schedule.

If you are unsure when to inject Remsima, call your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Most side effects are mild to moderate. However, some patients may experience severe side effects that may require treatment. Side effects can also occur after your treatment with Remsima has ended.

Inform your doctor immediately if you notice any of the following:

• Signs of an allergic reactionsuch as swelling of the face, lips, mouth, or throat, which may cause difficulty swallowing or breathing, skin rash, urticaria, swelling of the hands, feet, or ankles. Some of these reactions can be severe or potentially life-threatening. An allergic reaction can occur within 2 hours of your injection or later. Other allergic side effects may occur up to 12 days after your injection, such as muscle pain, fever, joint pain or jaw pain, sore throat, or headache.
• Signs of a local reaction at the injection sitesuch as redness, pain, itching, swelling, hardness, hematomas, hemorrhage, feeling of coldness, feeling of numbness, irritation, rash, ulcer, blisters, and scabs.
• Signs of a heart problemsuch as chest pain or discomfort, arm pain, stomach pain, difficulty breathing, anxiety, dizziness, fainting, sweating, nausea (feeling sick), vomiting, palpitations or pounding in the chest, rapid or slow heart rate, and swelling of the feet.
• Signs of infection (including TB)such as fever, fatigue, persistent cough, difficulty breathing, flu-like symptoms, weight loss, night sweats, diarrhea, wounds, accumulation of pus in the abdomen or around the anus (abscess), dental problems, or burning sensation while urinating.
• Possible signs of cancerincluding, but not limited to, lymph node inflammation, weight loss, fever, rare skin nodules, changes in moles or skin color, or rare vaginal bleeding.
• Signs of a lung problemsuch as cough, difficulty breathing, or chest tightness.
• Signs of a nervous system problem (including eye problems)such as signs of a stroke (sudden numbness or weakness in the face, arm, or leg, especially on one side of the body; sudden confusion, difficulty speaking or understanding; sudden difficulty seeing in one or both eyes, sudden difficulty walking, dizziness, loss of balance or coordination, or severe headache), seizures, numbness or tingling in any part of the body, or weakness in the arms or legs, eye changes such as double vision or other eye problems.
• Signs of a liver problem(including hepatitis B infection, when you have had hepatitis B previously) such as yellow skin and eyes, dark brown urine, upper right abdominal pain or swelling, joint pain, skin rash, or fever.
• Signs of an immune system disordersuch as joint pain or sun-sensitive rash on the cheeks or arms (lupus) or cough, difficulty breathing, fever, or skin rash (sarcoidosis).
• Signs of low blood cell countssuch as persistent fever, bleeding, or easy bruising, small red or purple spots caused by bleeding under the skin, or paleness.
• Signs of severe skin problemssuch as red, ring-shaped spots with central blisters on the trunk, large areas of skin that are peeled and lifted, mouth, throat, nose, genital, and eye ulcers, or small pus-filled bumps that can spread throughout the body. These skin reactions may be accompanied by fever.

Inform your doctor immediately if you notice any of the above.

The following side effects have been observed with Remsima:

Very common:may affect more than 1 in 10 people

• Stomach pain, nausea
• Viral infections such as herpes or flu
• Upper respiratory tract infections such as sinusitis
• Headache
• Side effect due to injection
• Pain.

Common:may affect up to 1 in 10 people

• Liver function changes, increased liver enzymes (shown in blood tests)
• Pneumonia or chest infections, such as bronchitis or pneumonia
• Difficulty breathing or painful breathing, chest pain
• Stomach or intestinal bleeding, diarrhea, indigestion, heartburn, constipation
• Urticaria (hives), skin rash with itching or dry skin
• Balance problems or feeling dizzy
• Fever, increased sweating
• Circulation problems such as low or high blood pressure
• Cardenals, shortness of breath or nasal bleeding, heat, skin redness (rubefaction)
• Feeling tired or weak
• Bacterial infections such as septicemia, abscess, or skin infection (cellulitis)
• Fungal skin infection
• Blood problems such as anemia or low white blood cell count
• Lymph node inflammation
• Depression, difficulty sleeping
• Eye problems, including red eyes and infections
• Fast heart rate (tachycardia) or palpitations
• Joint, muscle, or back pain
• Urinary tract infection
• Poriasis, skin problems such as eczema, and hair loss
• Reactions at the injection site such as pain, swelling, redness, or itching
• Chills, accumulation of fluid under the skin causing swelling
• Feeling numb or tingling.

Uncommon:may affect up to 1 in 100 people

• Poor blood circulation, swelling of a vein
• Bleeding outside of blood vessels (hematoma) or cardenals
• Skin problems such as blisters, warts, abnormal skin color or pigmentation, swollen lips, skin thickening, redness, scaly and peeling skin
• Severe allergic reactions (e.g. anaphylaxis), immune system disorder called lupus, allergic reactions to foreign proteins
• Slow-healing wounds
• Liver inflammation (hepatitis) or bile duct inflammation, liver damage
• Feeling forgetful, irritable, confused, nervous
• Eye problems, including blurred or reduced vision, swollen or puffy eyes
• Heart problems or worsening of the same, decreased heart rate
• Fainting
• Seizures, nervous system problems
• Intestinal ulcer or intestinal obstruction, stomach pain or cramps.

• Pancreatitis (inflammation of the pancreas)
• Fungal infections such as Candida infection or fungal nail infection
• Pulmonary problems (such as edema)
• Fluid around the lungs (pleural effusion)
• Narrowing of the airways in the lungs, causing difficulty breathing
• Inflammation of the membrane that protects the lung, causing severe chest pain that worsens with breathing (pleurisy)
• Tuberculosis
• Renal infections
• Low platelet count, too many white blood cells in the blood, hematomas or dark spots or blue spots
• Vaginal infections
• Abnormal blood test results showing "antibodies" against your own body.
• Changes in cholesterol and fat levels in the blood.

Rare:may affect up to 1 in 1,000 people

• A type of blood cancer (lymphoma)
• Your blood does not provide enough oxygen to your body, circulation problems such as narrowing of a blood vessel
• Inflammation of the membranes that protect the brain (meningitis)
• Infections due to a weakened immune system
• Infection by hepatitis B, when you have had hepatitis B previously
• Inflammation of the liver caused by a problem with the immune system (autoimmune hepatitis)
• Liver problem causing yellow skin and eyes (jaundice)
• Swelling or abnormal growth of tissues
• Severe allergic reaction that can cause loss of consciousness and may be life-threatening (anaphylactic shock)
• Inflammation of small blood vessels (vasculitis)
• Immune system disorders that can affect the lungs, skin, and lymph nodes (such as sarcoidosis)
• Cellular accumulations as a result of an inflammatory response (granulomatous lesions)
• Lack of interest or emotion
• Severe skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and generalized acute pustular psoriasis
• Other skin problems such as erythema multiforme, blisters, and peeling skin, or furunculosis (boils)
• Severe nervous system problems such as transverse myelitis, multiple sclerosis-like disease, optic neuritis, and Guillain-Barré syndrome
• Inflammation in the eye that can cause vision changes, including blindness
• Fluid in the membrane that protects the heart (pericardial effusion)
• Severe lung problems (such as interstitial lung disease)
• Melanoma (a type of skin cancer)
• Cervical cancer
• Low blood cell counts, including severe decrease in white blood cell count
• Small red or purple spots caused by bleeding under the skin
• Abnormal values of a blood protein called "complement factor" that is part of the immune system
• Lichenoid reactions (pruritic, red-brown, and/or thick white-gray lines on mucous membranes).

Frequency not known:cannot be estimated from available data

• Cancer

• A rare type of blood cancer that mainly affects young men (hepatosplenic T-cell lymphoma)
• Liver failure
• Carcinoma of Merkel cells (a type of skin cancer)
• Kaposi's sarcoma, a rare cancer related to human herpesvirus 8 infection. Kaposi's sarcoma usually manifests as purple skin lesions
• Worsening of a disease called dermatomyositis (manifesting as skin rash accompanied by muscle weakness)
• Heart attack
• Stroke
• Temporary loss of vision during or within 2 hours of infusion
• Infection due to a live vaccine because of a weakened immune system.

Reporting of side effects

Sif you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the label and on the box after CAD. The expiration date is the last day of the month indicated.
• Store in the refrigerator (between 2°C and 8°C). Do not freeze. Store the medication in the original packaging to protect it from light.
• This medication can also be stored in the original box outside the refrigerator for a maximum of 25°C for a single period of up to 28 days, but without exceeding the initial expiration date. In this situation, it should not be stored refrigerated again. Write the new expiration date on the box including day/month/year. Dispose of this medication if it has not been used by the new expiration date or the expiration date printed on the box, whichever occurs first.
• Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Remsima

• The active ingredient is infliximab. Each pre-filled syringe of a dose of 1 ml contains 120 mg of infliximab.
• The other components are acetic acid, sodium acetate trihydrate, sorbitol, polisorbate 80, and water for injection.

Appearance of the product and contents of the pack

Remsima is a transparent to opalescent, colourless to pale brown solution that is presented in a single-use pre-filled syringe.

Each pack contains 1 pre-filled syringe with 2 alcohol wipes, 2 pre-filled syringes with 2 alcohol wipes, 4 pre-filled syringes with 4 alcohol wipes, or 6 pre-filled syringes with 6 alcohol wipes.

Not all pack sizes may be marketed.

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

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics: {MM/AAAA}

Other sources of information

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

This summary of product characteristics can be found on the website of the European Medicines Agency in all languages of the European Union/European Economic Area.

7. Instructions for use

Read these instructions carefully before using the Remsima syringe. Consult your healthcare professional if you have any questions about the use of the Remsima syringe.

Important information

• Use the syringe ONLY if your healthcare professional has trained you in the correct way to prepare and administer an injection.
• Ask your healthcare professional how often you will need to administer an injection.
• Rotate the injection site each time you administer an injection. Each new injection site should be at least 3 cm away from the previous injection site.
• Do notuse the syringe if it has fallen or is visibly damaged. A damaged syringe may not function correctly.
• Do notre-use the syringe.
• Do notshake the syringe at any time.

About the Remsima syringe

Parts of the syringe (seeFigure A):

Figure A

• Do notremove the cap until you are ready to administer the injection. Once you remove the cap,do notreplace the syringe.

Preparing for the injection

1. Gather the injection supplies.

1. Prepare a clean and flat surface, such as a table or countertop, in a well-lit area.
2. Remove the syringe from the refrigerator.
3. Ensure you have the following supplies:

• Syringe
• Alcohol wipe
• Cotton ball or gauze*
• Adhesive bandage*
• Sharps container*

*Items not included in the package..

2. Inspect the syringe.

Do notuse the syringe if:

• It is cracked or damaged.
• The expiration date has passed.

3. Inspect the medication (seeFigure B).

4. Wait 30 minutes.

1. Leave the syringe at room temperature for 30 minutes to allow it to come to room temperature naturally.

Do notheat the syringe using a heat source, such as warm water or a microwave.

5. Choose an injection site (seeFigure C).

6. Wash your hands.

1. Wash your hands with soap and water, and dry them thoroughly.

7. Clean the injection site.

1. Wipe the injection site with an alcohol wipe.
2. Allow the skin to dry before administering the injection.

Do notsneeze or touch the injection site before administering the injection.

Administer the injection

8. Remove the cap (seeFigure D).

9. Place the syringe in the injection site (seeFigure E).

10. Begin the injection (seeFigure F).

11. Finish the injection (seeFigure G).

12. Remove the syringe from the injection site.

After the injection

13. Dispose of the syringe (seeFigure J).