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    Remicade Vial

    GENERIC NAME(S): Infliximab

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    WARNINGS:

    This medication can decrease your body's ability to fight an infection. This effect can lead to very serious (possibly fatal) infections (such as fungal infections, bacterial infections including tuberculosis). You should have a tuberculosis (TB) skin test before and during treatment with this medication. Also tell your doctor your medical history, especially of past/recent/current infections. You should also tell your doctor if you have lived or traveled in areas where certain fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Areas where these types of fungal infections are commonly found include the Ohio and Mississippi River valleys and the southwestern United States. See Side Effects section for symptoms of infections to watch out for, and get medical help right away if you have any of these symptoms.

    The immune system also helps prevent and control cancer. There is a very small risk (especially in children/teens/young adults) of developing cancer (such as lymphoma, skin) due to this medication or due to your medical condition. A rare, mostly fatal cancer (hepatosplenic T-cell lymphoma) has occurred in people receiving this medication along with certain other drugs (azathioprine or 6-mercaptopurine) to treat Crohn's disease or ulcerative colitis. Talk to your doctor about the risks and benefits of treatment. Tell your doctor right away if you have symptoms such as unusual lumps/growths, swollen glands, swollen or painful abdomen, unexplained weight loss, unusual tiredness, loss of appetite, fever that doesn't go away, or night sweats.

    Who should not take Remicade Vial?
    See More

    Uses

    This medication is used to treat certain types of arthritis (rheumatoid arthritis, arthritis of the spine, psoriatic arthritis), certain bowel diseases (Crohn's disease, ulcerative colitis), and a certain severe skin disease (chronic plaque psoriasis). In these conditions, the body's defense system (immune system) attacks healthy tissues. Infliximab works by blocking the actions of a certain natural substance (tumor necrosis factor alpha) in the body. This helps to decrease swelling (inflammation) and weaken your immune system, which slows or stops the damage from the disease.

    How to use Remicade Vial

    Read the Medication Guide provided by your pharmacist before you start using infliximab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

    This medication is given by injection into a vein over at least 2 hours as directed by your doctor. The dosage is based on your medical condition, weight, and response to treatment. After the first dose, this medication is usually given again after 2 weeks and 6 weeks, then every 8 weeks (or every 6 weeks for arthritis of the spine), as directed by your doctor.

    If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Do not shake this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

    Your doctor may direct you to use other medications (to help prevent side effects) before using infliximab. Use those medications exactly as directed.

    Use this medication regularly to get the most benefit from it. To help you remember, mark the days on the calendar when you need to receive the medication.

    Tell your doctor if your condition lasts or gets worse.

    Side Effects

    See also Warning section.

    Headache, stomach pain, or nausea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

    Symptoms of an infusion reaction that may occur during infliximab treatment include pain/swelling at the injection site, shortness of breath, flushing, chills, fever, headache, and rash. If you have any of these symptoms, your healthcare professional may need to adjust/stop your infusion and treat your symptoms.

    Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

    Tell your doctor right away if you have any serious side effects, including: joint/muscle pain, swelling ankles/feet, easy bruising/bleeding, vision changes, seizures, confusion, muscle weakness, numbness/tingling of arms/legs, butterfly-shaped facial rash, chest pain, pain/redness/swelling of arms or legs, fast/slow/irregular heartbeat.

    Tell your doctor right away if you develop signs of infection while using this drug, such as: cough/sore throat that doesn't go away, fever, chills, night sweats, trouble breathing, painful/frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush).

    This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, such as: extreme tiredness, nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.

    A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, difficulty swallowing.

    This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

    In the US -

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

    In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

    Precautions

    Before using infliximab, tell your doctor or pharmacist if you are allergic to it; or to mouse proteins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

    Before using this medication, tell your doctor or pharmacist your medical history, especially of: tuberculosis (previous infection or positive skin test), past/recent/current infections (such as cold sores, valley fever), heart disease (such as heart failure), blood/bone marrow disorder (such as leukopenia, thrombocytopenia), nervous system disorder (such as numbness/tingling, seizures, multiple sclerosis), history of cancer (such as breast cancer, skin cancer, lymphoma), a certain lung disorder (chronic obstructive pulmonary disease-COPD), liver disease (such as hepatitis B), light treatment for psoriasis (phototherapy).

    Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

    Infliximab can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Call your doctor if you have been exposed to an infection or for more details.

    Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

    Older adults may be more sensitive to the side effects of this drug, especially risk for infections.

    During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Mothers who have used this medication during pregnancy should ask a doctor about immunizations/vaccinations for their newborn babies.

    It is unknown if this medication passes into breast milk. However, it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

    Interactions

    Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

    Some products that may interact with this drug are: other drugs that weaken the immune system/increase the risk of infection (such as abatacept, anakinra), treatment with weakened bacteria/viruses (such as live vaccines, BCG for bladder cancer).

    Overdose

    If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

    Notes

    Do not share this medication with others.

    Lab and/or medical tests (such as complete blood count, liver function test, skin exams) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

    Missed Dose

    For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, call your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

    Storage

    Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

    Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised November 2016. Copyright(c) 2016 First Databank, Inc.

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    Remicade 100 mg intravenous solution
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    Remicade 100 mg intravenous solution
    Remicade 100 mg intravenous solution

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    This medicine is a colorless, vial

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    Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

    CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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