Prospecto: information for the user

Remicade100mg powder for concentrate for solution for infusion

infliximab

Read this prospect carefully before starting to use this medication, 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 Remicade.
• If you have any questions, consult your doctor.
• This medication has been prescribed to you alone, and you must not give it to other people 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 are not listed in this prospect. See section4.

1.What is Remicade and what it is used for

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

3.How you will be administered Remicade

4.Possible adverse effects

5.Storage of Remicade

6.Contents of the package and additional information

Remicade 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.

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

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

Remicade is also used in adults and children aged 6 years and older for:

• Crohn's disease
• Ulcerative colitis.

Remicade 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.

Rheumatoid Arthritis

Rheumatoid arthritis is an inflammatory disease of the joints. If you have active rheumatoid arthritis, you will first be given other medications. If these medications do not work well enough, you will be given Remicade in combination with another medication called methotrexate to:

• Reduce the symptoms and signs 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 medications. If these medications do not work well enough, you will be given Remicade to:

• Reduce the symptoms and signs 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 medications. If these medications do not work well enough, you will be given Remicade to:

• Reduce the symptoms and signs 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 medications or treatments, such as phototherapy. If these medications or treatments do not work well enough, you will be given Remicade to reduce the symptoms and signs 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 medications. If these medications 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 medications. If these medications do not work well enough, you will be given Remicade to:

• Treat active Crohn's disease

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

You should not receive Remicade if:

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

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

Warnings and precautions

Consult your doctor before or during treatment with Remicade if:

You have received Remicade before

• Inform your doctor if you have received Remicade in the past and are now starting treatment with Remicade again.

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

Infections

• Inform your doctor if you have an infection, even a mild one, before receiving Remicade.
• Inform your doctor if you have ever lived 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 receiving Remicade. If you are over 65 years old, 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 Remicade, such as fever, cough, flu-like symptoms, general feeling of illness, redness or warmth in the skin, wounds, or dental problems. Your doctor may recommend temporarily stopping treatment with Remicade.

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 Remicade, even in patients who have already been treated with medications for TB. Your doctor will note these tests on your patient information card.
• If your doctor notes that you are at risk of TB, you may be treated with medications for TB before receiving Remicade.

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

Hepatitis B virus

• Inform your doctor if you are a carrier of hepatitis B or have had it before receiving Remicade.
• 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 Remicade, can cause reactivation of the hepatitis B virus in patients who are carriers of this virus, which in some cases can be potentially fatal.

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 Remicade. The signs include difficulty breathing or swelling of the feet.

Cancer and lymphoma

• 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.
• Children and adults treated with Remicade may be at 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 boys or young men and had Crohn's disease or ulcerative colitis. This type of cancer is usually fatal. Almost all 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 Remicade for rheumatoid arthritis have developed cervical cancer. Women treated with Remicade, even those over 60 years old, may be recommended to have regular cervical cancer screenings.

Lung disease or heavy smokers

• 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 Remicade treatment.

Neurological disorders

• Inform your doctor if you have or have had any neurological disorder before receiving Remicade. 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 Remicade. The symptoms may include changes in vision, weakness in your arms or legs, numbness or tingling in any part of your body.

Abnormal skin openings

• Inform your doctor if you have any abnormal skin ulcers (fistulas) before receiving Remicade.

Vaccinations

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

• If you are breastfeeding, it is essential to 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 breastfeeding.

Therapeutic infectious agents

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

Surgeries or dental procedures

• Inform your doctor if you are scheduled to have a surgery or dental procedure.
• Inform your surgeon or dentist that you are being treated with Remicade by showing them your patient information card.

Liver problems

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

Inform your doctor immediately if you notice symptoms of liver problems during treatment with Remicade. 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 receiving Remicade, the body may not be able to 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 Remicade. The symptoms may include persistent fever, bleeding or bruising easily, small red or purple spots caused by bleeding under the skin, or paleness.

Immune system disorders

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

Inform your doctor immediately if you develop symptoms of lupus during treatment with Remicade. The symptoms may include joint pain or a rash on your cheeks or arms due to sensitivity to the sun.

Children and adolescents

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

• Some children and adolescents treated with TNF blockers, including Remicade, have developed cancers, even rare types, which in some cases have been fatal.
• More children treated with Remicade developed infections compared to adults.
• Children should receive recommended vaccinations before starting treatment with Remicade. Children may receive some vaccinations during treatment with Remicade, but they should not receive live vaccines while using Remicade.

If you are unsure whether anything above applies to you, consult your doctor before receiving Remicade.

Other medications and Remicade

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

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

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

• Medications that affect your immune system.
• Kineret (anakinra). Remicade and Kineret should not be used together.
• Orencia (abatacept). Remicade and Orencia should not be used together.

You should not receive live vaccines while using Remicade. If you were using Remicade during pregnancy or are receiving Remicade during breastfeeding, 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 breastfeeding.

If you are unsure whether anything above applies to you, consult your doctor or pharmacist before using Remicade.

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 medication. Remicade 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 Remicade and for 6 months after stopping treatment. Discuss birth control options with your doctor during that time.
• If you received Remicade 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 Remicade before your baby is vaccinated. If you received Remicade while pregnant, the BCG vaccine (used to prevent tuberculosis) should not be given to your baby within 12 months of birth, unless your baby's doctor recommends otherwise. 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 Remicade before your baby is vaccinated. Live vaccines, such as the BCG vaccine, should not be given to your baby while breastfeeding, unless your baby's doctor recommends otherwise.
• Children born to women treated with Remicade during pregnancy may have a severe decrease in white blood cell count. If your baby has persistent fever or infections, contact your baby's doctor immediately.

Driving and using machines

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

Remicade contains sodium

Remicade contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free." However, before receiving Remicade, it is mixed with a solution that contains sodium. Consult your doctor if you follow a low-sodium diet.

Rheumatoid Arthritis

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

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

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

How You Will Receive Remicade

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

How Much Remicade You Will Receive

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

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 Remicade has ended.

Inform 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 swallowing or breathing, skin rash, urticaria, swelling of your hands, feet, or ankles. Some of these reactions can be severe or potentially life-threatening. An allergic reaction can occur within 2hours of your injection or later. Additional signs of allergic reactions may occur up to 12días after your injection, such as muscle pain, fever, joint pain, or jaw pain, or headache.
• Signs of a heart problemsuch as chest pain or discomfort, arm pain, stomach pain, difficulty breathing, anxiety, dizziness, lightheadedness, sweating, nausea(feeling sick), vomiting, palpitations or chest beating, rapid or slow heart rate, and swelling of your 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 your abdomen or around your anus(abscess), dental problems, or a 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 assigns of a stroke (sudden numbness or weakness in your face, arm, or leg, especially on one side of your body; sudden confusion, difficulty speaking or understanding; difficulty seeing in one or both eyes, difficulty walking, dizziness, loss of balance or coordination, or severe headache), seizures, numbness or tingling in any part of your body, or weakness in your arms or legs, eye changes such as double vision or other eye problems.
• Signs of a liver problem(including hepatitisB, when you have had hepatitisB 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 a sun-sensitive rash on your 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 your skin, or paleness.
• Signs of severe skin problemssuch as circular red patches with central blisters on your trunk, large areas of skin that are flaking and raised, mouth, throat, nose, genital, or eye ulcers, or small pus-filled bumps that can spread throughout your 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 Remicade:

Very common: may affect more than 1in 10people

• Abdominal pain, nausea
• Viruses such as herpes or flu
• Upper respiratory tract infections such as sinusitis
• Headache
• Side effect due to infusion
• Pain.

Common: may affect up to 1in 10people

• Liver function changes, increased liver enzymes (shown in blood tests)
• Pulmonary or chest infections, such as bronchitis or pneumonia
• Difficult 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 dizziness
• Fever, increased sweating
• Circulation problems such as low or high blood pressure
• Cardenals, shortness of breath, nasal bleeding, heat, skin redness (rubefaction)
• Feeling tired or weak
• Bacterial infections such as septicemia, abscess, or skin infection (cellulitis)

• Skin infection due to a fungus

• Blood problems such as anemia or low white blood cell count
• Lymph node inflammation
• Depression, sleep problems
• Eye problems, including red eyes and infections
• Fast heart rate or palpitations(tachycardia)
• Joint, muscle, or back pain
• Urinary tract infection
• Psoriasis, 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
• Numbness or tingling.

Uncommon: may affect up to 1in 100people

• 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, thickened skin, redness, scaly and flaking skin
• Severe allergic reactions (e.g., anaphylaxis), autoimmune disorders such as 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, or eye infections
• Heart problems or worsening of the same, decreased heart rate
• Loss of consciousness
• Seizures, nervous system problems
• Intestinal ulcer or intestinal obstruction, stomach pain or cramps
• Pancreatitis (inflammation of the pancreas)
• Fungal infections such as Candida or fungal nail infections
• Pulmonary problems (such as edema)
• Liquid 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
• Vaginal infections
• Abnormal blood test results showing “antibodies” against your own body.
• Changes in cholesterol and fat levels in the blood
• Weight gain (for most patients, weight gain was small).

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

• 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 hepatitisB, when you have had hepatitisB previously
• Liver inflammation caused by an immune system problem(autoimmune hepatitis)
• Jaundice (yellow skin and eyes)
• 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)
• Accumulations of immune cells 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, lichenoid reactions (pruritic red and/or purple rash and/or thick white and/or gray lines on mucous membranes), blisters, and skin peeling, or furunculosis
• 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
• Liquid 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 levels of a blood protein called “complement factor” that is part of the immune system.

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

• Cancer in children and adults
• A rare type of blood cancer that mainly affects adolescent boys or 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 infection with human herpesvirus 8. 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 2hours of infusion
• Infection due to a weakened immune system caused by a live vaccine.

Other side effects in children and adolescents

Children 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 frequently in children were: low red blood cell count (anemia), blood in stool, low total white blood cell count (leucopenia), facial redness or flush (rubefaction), viral infections, low white blood cell count that fights infection (neutropenia), bone fractures, bacterial infections, and respiratory tract allergic reactions.

Reporting of side effects

If 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 thenational reporting system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Remicade is generally stored by healthcare professionals. The storage details if needed are as follows:

• 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 in the box after CAD or EXP. The expiration date is the last day of the month indicated.
• Store in the refrigerator (2 °C – 8 °C).
• 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 six months, but not beyond the initial expiration date. In this situation, do not re-store refrigerated. 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.

• It is recommended that when preparing Remicade for infusion, use it as soon as possible (within 3 hours). However, if the solution is prepared in a germ-free environment, it can be stored in the 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 medication if there is a change in color or presence of particles.

Composition of Remicade

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

Aspect of the product and content of the package

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 packages of1, 2, 3, 4or5vials. Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Janssen Biologics B.V.

Einsteinweg101

2333CB Leiden

Netherlands

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:{MM/AAAA}.

Other sources of information

More detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

This information is intended solely for healthcare professionals:

Patients treated with Remicade should be given the patient information leaflet.

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 6months, but not exceeding the initial expiration date. The new expiration date must be written on the box. Once removed from refrigerated storage, Remicade should not be returned to refrigerated storage.

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

To improve the traceability of biological drugs, the commercial name and batch number of the administered drug must be clearly recorded.

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

2.Under aseptic conditions, reconstitute each vial of Remicade with 10ml of water for injection, using a syringe equipped with a 21gauge (0.8mm) or smaller needle. Remove the vial cap and clean the top with a cotton swab soaked in 70% alcohol. Insert the syringe needle into the vial in the center of the rubber stopper and direct the water for injection towards the glass wall of the vial. Gently remove the solution by rotating the vial to dissolve the lyophilized powder. Avoid vigorous agitation. DO NOT AGITATE. It is not uncommon for foam to form in the solution during reconstitution. Allow the reconstituted solution to stand for 5minutes. 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 change, or other foreign particles.

3.Dilute the total dose volume of the reconstituted Remicade solution to 250ml with infusion solution 9mg/ml(0.9%) of sodium chloride. Do not dilute the reconstituted Remicade solution with any other diluent. The dilution can be performed by extracting a volume of infusion solution 9mg/ml (0.9%) of sodium chloride from the glass vial or infusion bag of 250ml equal to the volume of reconstituted Remicade. Add the total volume of reconstituted Remicade solution slowly to the vial or infusion bag of 250ml. Mix gently. For volumes greater than 250ml, use a larger infusion bag (e.g., 500ml, 1,000ml) or use multiple infusion bags of 250ml to ensure that the concentration of the infusion solution does not exceed 4mg/ml. If the reconstituted and diluted solution is stored refrigerated, it should be allowed to come to room temperature at 25°C for 3hours before the Infusion4 (infusion) stage. Storage beyond 24hours at 2°C‑8°C applies only to the preparation of Remicade in the infusion bag.

4.Administer the infusion solution over a period not less than the recommended infusion time. Use only a perfusion set with a low-protein affinity filter, non-pyrogenic, and sterile (pore size 1.2micrometers or smaller). Since it does not contain preservatives, it is recommended that the administration of the infusion solution be initiated as soon as possible and within 3hours of reconstitution and dilution. If not used immediately, the times and storage conditions before use are the responsibility of the user and should not normally exceed 24hours at 2°C‑8°C, unless the reconstitution/dilution was carried out in controlled and validated aseptic conditions. Do not store any unused portion of the infusion solution for re-use.

5.No compatibility studies have been performed to evaluate the administration of Remicade with other agents. Do not infuse Remicade concomitantly with other agents in the same intravenous line.

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

7.The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.