REMICADE 100 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Remicade100mg powder for concentrate for solution for infusion

infliximab

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 also give you a patient information card, which contains important safety information that you need to know before and during your treatment with Remicade.
• If you have any further questions, ask your doctor.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Remicade and what is it used for
2. What you need to know before you use Remicade
3. How Remicade will be given to you
4. Possible side effects
5. Storing Remicade
6. Contents of the pack and other information

1. What is Remicade and what is it used for

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

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

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis (Bechterew's disease)
• Psoriasis.

Remicade is also used in adults and children from 6 years of age for:

• Crohn's disease
• Ulcerative colitis.

Remicade works by binding selectively to TNF alpha and blocking its action. TNF alpha is involved in inflammatory processes in the body, so blocking it can reduce inflammation in your body.

Rheumatoid Arthritis

Rheumatoid arthritis 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 Remicade in combination with another medicine called methotrexate to:

• Reduce the signs and symptoms of your disease
• Slow down the damage to your joints
• Improve your physical function.

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 Remicade to:

• Reduce the signs and symptoms of your disease
• Reduce the damage to your joints
• Improve your physical function.

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 Remicade to:

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

Psoriasis

Psoriasis is an inflammatory disease of the skin. If you have moderate to severe plaque psoriasis, 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 Remicade 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 Remicade 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 Remicade to:

• Treat your active Crohn's disease

• Reduce the number of abnormal channels (fistulas) between your intestine and your skin, that have not been controlled by other medicines or surgery.

2. What you need to know before you use Remicade

You must not be given Remicade if:

• You are allergic to infliximab or any of the other ingredients of Remicade (listed in section 6).
• You are allergic (hypersensitive) to proteins that come from mice.
• You have tuberculosis (TB) or another serious infection such as pneumonia or sepsis.
• You have moderate or severe heart failure.

If any of the above applies to you, do not use Remicade. If you are not sure, consult your doctor before you are given Remicade.

Warnings and precautions

Consult your doctor before or during treatment with Remicade if:

You have been treated with Remicade before

• Tell your doctor if you have been treated with Remicade in the past and are now starting treatment again with Remicade.

If you have stopped treatment with Remicade for more than 16 weeks, there is a greater risk of allergic reactions when you start treatment again.

Infections

• Before you are given Remicade, tell your doctor if you have an infection, even if it is minor.
• Before you are given Remicade, tell your doctor if you have ever lived or travelled in 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 catch infections more easily while being treated with Remicade. If you are over 65 years old, you have a greater risk.
• These infections can be serious and include tuberculosis, infections caused by viruses, fungi, bacteria or other organisms in the environment and sepsis, which can be life-threatening.

Tell your doctor immediately if you notice signs of infection during treatment with Remicade, such as fever, cough, flu-like symptoms, general feeling of being unwell, redness or feeling of warmth on the skin, wounds or dental problems. Your doctor may recommend temporarily stopping treatment with Remicade.

Tuberculosis (TB)

• It is very important that you tell your doctor if you have ever had TB or if you have been in close contact with someone who has had or has TB.
• Your doctor will do a test to see if you have TB. Cases of TB have been reported in patients treated with Remicade, even in patients who have been treated with medicines for TB. Your doctor will record these tests on your patient information card.
• If your doctor thinks you are at risk of TB, you may be treated with medicines for TB before you are given Remicade.

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

Hepatitis B virus

• Before you are given Remicade, tell your doctor if you are a carrier of hepatitis B or if you have had hepatitis B.
• Tell your doctor if you think you may be at risk of getting hepatitis B.
• Your doctor should do tests for the hepatitis B virus.
• Treatment with TNF blockers, such as Remicade, may cause reactivation of the hepatitis B virus in patients who are carriers of this virus, which in some cases can be life-threatening.

Heart problems

• Tell your doctor if you have any heart problems, such as mild heart failure.
• Your doctor will want to keep a close check on your heart.

Tell your doctor immediately if you notice new or worsening signs of heart failure during treatment with Remicade. The signs include difficulty breathing or swelling of the feet.

Cancer and lymphoma

• Before you are given Remicade, tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
• Patients with severe rheumatoid arthritis who have had the disease for a long time may have a higher risk of developing lymphoma.
• Children and adults treated with Remicade may have a higher risk of developing lymphoma or other types of cancer.
• Some patients who have received TNF blockers, including Remicade, have developed a rare type of cancer called hepatosplenic T-cell lymphoma. Most of these patients were adolescent or young adult males with Crohn's disease or ulcerative colitis, and most were taking azathioprine or 6-mercaptopurine in addition to a TNF blocker. This type of cancer is usually fatal.
• Some patients treated with infliximab have developed certain types of skin cancer. Tell your doctor if there are any changes in your skin or growths on your skin during or after treatment.
• Some women treated with Remicade for rheumatoid arthritis have developed cervical cancer. Women treated with Remicade, including those over 60 years of age, may be recommended regular cervical cancer screening by their doctor.

Lung disease or heavy smoking

• Before you are given Remicade, tell 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 patients who are heavy smokers may have a higher risk of developing cancer with treatment with Remicade.

Nervous system disease

• Tell your doctor if you have or have ever had a problem that affects your nervous system before you are given Remicade. This includes multiple sclerosis, Guillain-Barré syndrome, if you have had seizures or have been diagnosed with “optic neuritis”.

Tell your doctor immediately if you notice symptoms of nervous system disease during treatment with Remicade. The symptoms can be changes in your vision, weakness in your arms or legs, numbness or tingling in any part of your body.

Abnormal skin openings

• Tell your doctor if you have any abnormal skin openings (fistulas) before you are given Remicade.

Vaccines

• Consult your doctor if you have recently had or are due to have a vaccine.
• Before you start treatment with Remicade, you should receive all recommended vaccines. You can receive some vaccines during treatment with Remicade but you must not receive live vaccines (vaccines that contain a live, weakened infectious agent) while you are using Remicade because they may cause infections.
• If you received Remicade while you were pregnant, your baby may also have a higher risk of getting an infection as a result of receiving a live vaccine in the first year of life. It is important that you inform your baby's doctors and other healthcare professionals about your treatment with Remicade so that they can decide when your baby can be vaccinated, including live vaccines such as the BCG vaccine (used to prevent tuberculosis).

• If you are breast-feeding, it is important that you inform your baby's doctors and other healthcare professionals about your treatment with Remicade before your baby is vaccinated. For more information, see the section on pregnancy and breast-feeding.

Therapeutic infectious agents

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

Surgery or dental procedures

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

Liver problems

• Some patients who received Remicade have developed serious liver problems.

Tell your doctor immediately if you notice symptoms of liver problems during treatment with Remicade. The symptoms can be yellowing of the skin and eyes, dark brown urine, pain or swelling in the upper right side of the stomach, pain in the joints, skin rash or fever.

Low blood cell counts

• In some patients who receive Remicade, the body may not be able to produce enough blood cells that help to fight infections or help to stop bleeding.

Tell your doctor immediately if you notice symptoms of low blood cell counts during treatment with Remicade. The symptoms can be persistent fever, bleeding or bruising easily, small red or purple spots caused by bleeding under the skin, or paleness.

Immune system disorder

• Some patients who received Remicade have developed symptoms of an immune system disorder called lupus.

Tell your doctor immediately if you develop symptoms of lupus during treatment with Remicade. The symptoms can be joint pain or a rash on your cheeks or arms due to sun sensitivity.

Children and adolescents

The above information also applies to children and adolescents. Additionally:

• Some children and adolescents treated with TNF blockers, such as Remicade, have developed cancers, including rare types, that in some cases were fatal.
• More children treated with Remicade developed infections compared to adults.
• Children should receive all recommended vaccines before starting treatment with Remicade. Children can receive some vaccines during treatment with Remicade but must not receive live vaccines while they are using Remicade.

If you are not sure if any of the above applies to you, consult your doctor before you are given Remicade.

Other medicines and Remicade

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

Tell your doctor if you are using or have recently used any other medicines, including any other medicines for the treatment of Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis, or medicines obtained without a prescription, such as vitamins or herbal remedies.

In particular, tell your doctor if you are using any of the following medicines:

• Medicines that affect your immune system.
• Kineret (anakinra). Remicade and Kineret must not be used at the same time.
• Orencia (abatacept). Remicade and Orencia must not be used at the same time.

You must not receive live vaccines while you are using Remicade. If you were using Remicade during pregnancy or if you are receiving Remicade during breast-feeding, inform your baby's doctor and other healthcare professionals about your treatment with Remicade before your baby receives any vaccine.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before using Remicade.

Pregnancy, breast-feeding and fertility

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Remicade should only be used during pregnancy or breast-feeding if your doctor considers it necessary for you.
• You should avoid becoming pregnant while being treated with Remicade and for 6 months after treatment has finished. Discuss the use of contraceptive measures during this time with your doctor.
• If you received Remicade during your pregnancy, your baby may have a higher risk of getting an infection.
• It is important that you inform your baby's doctors and other healthcare professionals about your treatment with Remicade before your baby is vaccinated. If you received Remicade while you were pregnant, giving the BCG vaccine (used to prevent tuberculosis) to your baby within 12 months after birth may cause infection with serious complications, including death. Live vaccines, such as the BCG vaccine, must not be given to your baby within 12 months after birth unless your baby's doctor recommends otherwise. For more information, see the section on vaccines.
• If you are breast-feeding, it is important that you inform your baby's doctors and other healthcare professionals about your treatment with Remicade before your baby is vaccinated. Live vaccines must not be given to your baby while you are breast-feeding unless your baby's doctor recommends otherwise.
• In children born to women treated with Remicade during pregnancy, a serious decrease in the number of white blood cells in the blood has been reported. If your baby has fevers or infections that keep coming back, contact your baby's doctor immediately.

Driving and using machines

Remicade is unlikely to affect your ability to drive or use tools or machines. If you feel tired, dizzy, or unwell after you are given Remicade, do not drive or use tools or machines.

Remicade contains sodium

Remicade contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”. However, before you are given Remicade, it is mixed with a solution that contains sodium. Consult your doctor if you are on a low-salt diet.

3. How Remicade will be administered to you

Rheumatoid Arthritis

The usual dose is 3 mg per kilogram of body weight.

Psoriatic Arthritis, Ankylosing Spondylitis (Bechterew's disease), Psoriasis, Ulcerative Colitis, and Crohn's Disease

The usual dose is 5 mg per kilogram of body weight.

How Remicade will be administered to you

• Remicade will be administered to you by your doctor or nurse.
• Your doctor or nurse will prepare the medicine for infusion.
• The medicine will be administered as an infusion (drip) (over 2 hours) into one of your veins, usually in your arm. After the third treatment, your doctor may decide to administer your dose of Remicade over 1 hour.
• You will be monitored while you are given Remicade and for 1 to 2 hours afterwards.

How much Remicade will be administered to you

• Your doctor will decide your dose and how often you will be given Remicade. This will depend on your disease, weight, and how you respond to Remicade.
• The table below shows how often you will usually be given this medicine after your first dose.

Use in children and adolescents

Remicade should only be used in children if they are being treated for Crohn's disease or ulcerative colitis. These children must be 6 years of age or older.

If you are given too much Remicade

Since this medicine is being given to you by your doctor or nurse, it is unlikely that you will be given too much Remicade. The effects of overdose with Remicade are not known.

If you miss or do not attend a Remicade infusion

If you miss or do not attend a scheduled infusion, make an appointment as soon as possible.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some patients may experience serious side effects and may need treatment. Side effects can also occur after your treatment with Remicade has finished.

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

• Signs of an allergic reactionsuch as swelling of your face, lips, mouth, or throat, which may cause difficulty in swallowing or breathing, skin rash, hives, swelling of hands, feet, or ankles. Some of these reactions can be serious or potentially life-threatening. An allergic reaction can occur within 2 hours of your injection or later. More signs of allergic side effects can 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 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, fast or slow heartbeat, and swelling of the feet.
• Signs of infection (including TB)such as fever, tiredness, persistent cough, difficulty breathing, flu-like symptoms, weight loss, night sweats, diarrhea, wounds, pus accumulation in the abdomen or around the anus (abscess), dental problems, or a burning sensation when urinating.
• Possible signs of cancerincluding, but not limited to, swollen lymph nodes, weight loss, fever, unusual skin nodules, changes in moles, or skin discoloration, or unusual vaginal bleeding.
• Signs of a lung problemsuch as coughing, difficulty breathing, or chest tightness.
• Signs of a nervous system problem (including eye problems)such as signs of a stroke (sudden numbness or weakness of your face, arm, or leg, especially on one side of your body; sudden confusion, difficulty speaking or understanding; difficulty seeing with one or both eyes, difficulty walking, dizziness, loss of balance or coordination, or a severe headache), seizures, numbness/tingling in any part of your body, or weakness in arms or legs, vision changes such as double vision or other eye problems.
• Signs of a liver problem(including hepatitis B infection when you have had hepatitis B before) such as yellowing of the skin and eyes, dark brown urine, pain or swelling in the upper right side of the stomach, joint pain, skin rash, or fever.
• Signs of an immune system disordersuch as joint pain or a sun-sensitive rash on the cheeks or arms (lupus) or coughing, difficulty breathing, fever, or skin rash (sarcoidosis).
• Signs of low blood cell countssuch as persistent fever, bleeding or bruising easily, small red or purple spots on the skin caused by bleeding under the skin, or paleness.
• Signs of serious skin problemssuch as red or circular patches on the skin, often with central blisters on the trunk, large areas of peeling skin, or ulcers in the mouth, throat, nose, genitals, and eyes, or small pus-filled bumps that can spread across the body. These skin reactions can be accompanied by fever.

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

The following side effects have been observed with Remicade:

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
• Infusion reaction
• Pain.

Common: may affect up to 1 in 10 people

• Changes in liver function, increased liver enzymes (shown in blood tests)
• Lung or chest infections, such as bronchitis or pneumonia
• Difficulty breathing or painful breathing, chest pain
• Bleeding in the stomach or intestines, diarrhea, indigestion, heartburn, constipation
• Hives (nettle rash), itchy skin rash, or dry skin
• Balance or dizziness problems
• Fever, increased sweating
• Circulation problems such as low or high blood pressure
• Bruising, flushing, or nosebleeds, feeling hot or redness of the skin (flushing)
• 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
• Swollen lymph nodes
• Depression, sleep problems
• Eye problems, including red eyes and infections
• Fast heartbeat (tachycardia) or palpitations
• Joint, muscle, or back pain
• Urinary tract infection
• Psoriasis, skin problems such as eczema, and hair loss
• Injection site reactions such as pain, swelling, redness, or itching
• Chills, fluid accumulation under the skin causing swelling
• Feeling numb or tingling.

Uncommon: may affect up to 1 in 100 people

• Lack of blood flow, swelling of a vein
• Blood accumulation outside blood vessels (hematoma) or bruising
• Skin problems such as blisters, warts, unusual skin color or pigmentation, or swollen lips, or thickening of the skin, or 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 vision or reduced vision, or swollen eyes or with styes
• Heart problems or worsening of existing heart problems, slow heartbeat
• Fainting
• Seizures, nerve problems
• Intestinal ulcers or obstruction, stomach pain or cramps
• Pancreas inflammation (pancreatitis)
• Fungal infections such as Candida or fungal nail infections
• Lung 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 sharp chest pain that worsens with breathing (pleurisy)
• Tuberculosis
• Kidney infections
• Low platelet count, too many white blood cells in the blood
• Vaginal infections
• Blood test result showing "antibodies" against your own body.
• Changes in cholesterol and fat levels in the blood
• Weight gain (for most patients, the weight gain was small).

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

• A type of blood cancer (lymphoma)
• Lack of blood flow, 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
• Hepatitis B infection when you have had hepatitis B before
• Liver inflammation caused by an immune system problem (autoimmune hepatitis)
• Liver problem that causes yellowing of the skin and eyes (jaundice)
• Swelling or abnormal growth of tissues
• Severe allergic reaction that can cause loss of consciousness and can 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)
• Accumulation of immune cells as a result of an inflammatory response (granulomatous lesions)
• Lack of interest or emotion
• Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and acute generalized exanthematous pustulosis
• Other skin problems such as erythema multiforme, lichenoid reactions (itchy red-purple rash and/or thick gray-white lines on the mucous membranes), blisters, and peeling skin, or boils (furunculosis)
• Serious nervous system problems such as transverse myelitis, multiple sclerosis-like disease, optic neuritis, and Guillain-Barré syndrome
• Inflammation in the eye that can cause changes in vision, including blindness
• Fluid around the heart (pericardial effusion)
• Serious lung problems (such as interstitial lung disease)
• Melanoma (a type of skin cancer)
• Cervical cancer
• Low blood cell counts, including a severe decrease in the number of white blood cells in the blood
• Small red or purple spots on the skin caused by bleeding under the skin
• Abnormal blood test results showing "complement factor" which is part of the immune system.

Frequency not known: frequency cannot be estimated from the available data

• Cancer in children and adults
• A rare type of blood cancer that mainly affects young adolescent boys or young men (hepatosplenic T-cell lymphoma)
• Liver failure
• Merkel cell carcinoma (a type of skin cancer)
• Kaposi's sarcoma, a rare cancer related to human herpesvirus 8 infection. Kaposi's sarcoma usually occurs more frequently as purple skin lesions
• Worsening of a disease called dermatomyositis (manifested as a 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.

Other side effects in children and adolescents

Children who were treated with Remicade for Crohn's disease showed some differences in side effects compared to adults treated with Remicade for Crohn's disease. The side effects that occurred more often in children were: low red blood cell count (anemia), blood in stool, low total white blood cell count (leukopenia), redness or flushing of the face (flushing), viral infections, low white blood cell count that fights infection (neutropenia), bone fracture, bacterial infection, and allergic reactions of the respiratory tract.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Remicade

Remicade will usually be stored by healthcare professionals. If you need to store it, the storage details are as follows:

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month shown.
• Store in a refrigerator (2°C-8°C).
• This medicine can also be stored in the original carton outside the refrigerator at up to 25°C for a single period of up to 6 months, but not beyond the initial expiry date. In this situation, it must not be refrigerated again. Write the new expiry date on the carton including day/month/year. Discard this medicine if it has not been used by the new expiry date or the expiry date printed on the carton, whichever is earlier.

• It is recommended that when Remicade is prepared for infusion, it should be used as soon as possible (within 3 hours). However, if the solution is prepared under sterile conditions, it can be stored in a refrigerator between 2°C and 8°C for up to 28 days and for an additional 24 hours at 25°C once removed from the refrigerator.
• Do not use this medicine if it has changed color or if particles are present.

6. Container contents and additional information

Composition of Remicade

• The active substance is infliximab. Each vial contains 100 mg of infliximab. After preparation, each ml contains 10 mg of infliximab.
• The other components are sucrose, polysorbate 80, sodium phosphate monobasic, and sodium phosphate dibasic.

Appearance and container contents of the product

Remicade is presented in a glass vial containing a powder for concentrate for solution for infusion. The powder is a lyophilized white granule.

Remicade is available in packs of 1, 2, 3, 4, or 5 vials. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Janssen Biologics B.V.

Einsteinweg 101

2333 CB Leiden

Netherlands

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

Date of last revision of this leaflet:{MM/AAAA}.

Other sources of information

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

This information is intended for healthcare professionals only:

Patient information cards should be given to patients treated with Remicade.

Instructions for use and handling – storage conditions

Store at 2°C-8°C.

Remicade can be stored at temperatures up to a maximum of 25°C for a single period of up to 6 months, but without exceeding the initial expiry date. The new expiry date should be written on the carton. Once removed from refrigeration, Remicade should not be returned to refrigeration.

Instructions for use and handling – reconstitution, dilution, and administration

In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered product should be clearly recorded.

1. Calculate the dose and number of Remicade vials needed. Each Remicade vial contains 100 mg of infliximab. Calculate the total volume of reconstituted Remicade solution needed.

1. In aseptic conditions, reconstitute each Remicade vial with 10 ml of water for injections, using a syringe equipped with a 21-gauge (0.8 mm) or smaller needle. Remove the vial cap and clean the top with a cotton swab moistened with 70% alcohol. Insert the syringe needle into the vial through the center of the rubber stopper and direct the water for injections towards the glass wall of the vial. Gently swirl the solution by rotating the vial to dissolve the lyophilized powder. Avoid prolonged or vigorous agitation. DO NOT SHAKE. It is not unusual for foam to form on the solution during reconstitution. Allow the reconstituted solution to stand for 5 minutes. Check that the solution is colorless to pale yellow and opalescent. The solution may contain a few fine translucent particles, as infliximab is a protein. Do not use if the solution contains opaque particles, color alteration, or other foreign particles.

1. Dilute the total dose volume of the reconstituted Remicade solution to 250 ml with 9 mg/ml (0.9%) sodium chloride solution for infusion. Do not dilute the reconstituted Remicade solution with any other diluent. The dilution can be performed by removing a volume of the sodium chloride solution for infusion from the 250 ml glass bottle or infusion bag equal to the volume of the reconstituted Remicade. Slowly add the total volume of the reconstituted Remicade solution to the 250 ml glass bottle or infusion bag. Gently mix. For volumes greater than 250 ml, use a larger infusion bag (e.g., 500 ml, 1000 ml) or use multiple 250 ml infusion bags to ensure that the concentration of the infusion solution does not exceed 4 mg/ml. If refrigerated after reconstitution and dilution, allow the infusion solution to reach room temperature (25°C) over a period of 3 hours before administration (Step 4). Storage beyond 24 hours at 2°C-8°C applies only to the preparation of Remicade in the infusion bag.

1. Administer the infusion solution over a period of no less than the recommended infusion time. Use only an infusion set with a low-protein-binding filter (pore size 1.2 μm or less), which is non-pyrogenic and sterile. Since it does not contain preservatives, it is recommended that the administration of the infusion solution begins as soon as possible and within 3 hours of reconstitution and dilution. If not used immediately, the times and conditions of storage before use are the responsibility of the user and should normally not exceed 24 hours at 2°C-8°C, unless the reconstitution/dilution has been carried out under controlled and validated aseptic conditions. Do not store any unused portion of the infusion solution for reuse.

1. No physical and biochemical compatibility studies have been conducted to evaluate the administration of Remicade with other agents. Do not infuse Remicade concomitantly with other agents in the same intravenous line.

1. Before administration, visually inspect Remicade for particles or color alteration. Do not use if visible opaque particles, color alteration, or other foreign particles are observed.

1. The disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.