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|Flebogamma

Immune Globulin (Human) Injection (IV)

Flebogamma is used for:

Providing antibodies to help prevent infection in certain patients who have a weakened immune system. It may also be used for other conditions as determined by your doctor.

Flebogamma is an immune globulin. It works by providing antibodies which fight infection.

Do NOT use Flebogamma if:

• you are allergic to any ingredient in Flebogamma
• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to sorbitol, thimerosal, blood, or products that are produced from blood
• you have had an allergic reaction to gamma globulin or anti-immunoglobulin A (IgA) antibodies
• you have IgA deficiency or antibodies to IgA

Contact your doctor or health care provider right away if any of these apply to you.

Before using Flebogamma :

Some medical conditions may interact with Flebogamma . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have recently received any vaccinations
• if you have heart problems, blood vessel problems (eg, narrowed arteries), thick blood, or a history of stroke, heart attack, or blood clots
• if you have kidney problems, diabetes, dehydration or low blood volume, a blood infection, abnormal proteins in the blood, or asthma

Some MEDICINES MAY INTERACT with Flebogamma . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney.
• Hydantoins (eg, phenytoin) because the risk of side effects may be increased
• Vaccinations (eg, measles, mumps, and rubella) because effectiveness may be decreased by Flebogamma

This may not be a complete list of all interactions that may occur. Ask your health care provider if Flebogamma may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Flebogamma :

Use Flebogamma as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Flebogamma is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Flebogamma at home, carefully follow the injection procedures taught to you by your health care provider.
• If Flebogamma contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Flebogamma , contact your doctor for instructions.

Ask your health care provider any questions you may have about how to use Flebogamma .

Important safety information:

• Flebogamma may cause lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Flebogamma . Using Flebogamma alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Aseptic meningitis syndrome (AMS) has been reported to occur rarely in association with the use of Flebogamma . This syndrome usually begins within several hours to 2 days following treatment. Symptoms include severe headache, neck stiffness, drowsiness, fever, painful eye movements, sensitivity to light, nausea, and vomiting.
• Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are using Flebogamma . Vaccinations may be less effective.
• Diabetes patients - Flebogamma may cause incorrect test results with some blood and urine glucose tests. Check with your doctor before you adjust the dose of your diabetes medicine or change your diet.
• Some of these products contain latex in the packaging. If you are allergic to latex, ask your doctor or pharmacist if your product contains latex.
• Flebogamma is made from human plasma. There is an extremely low risk of developing a viral infection or Creutzfeldt-Jakob disease (CJD) after using Flebogamma . Discuss any questions or concerns with your doctor.
• LAB TESTS, including kidney function, blood thickness, and antibody levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Flebogamma with caution in the ELDERLY because they may be more sensitive to its effects, especially kidney failure.
• Use Flebogamma with extreme caution in CHILDREN. Safety and effectiveness of certain products have not been established for certain age groups. Check with your doctor or pharmacist if you have questions about the use of Flebogamma in a child.
• PREGNANCY and BREAST-FEEDING: It is unknown if Flebogamma can cause harm to the fetus. If you become pregnant while taking Flebogamma , discuss with your doctor the benefits and risks of using Flebogamma during pregnancy. It is unknown if Flebogamma is excreted in breast milk. If you are or will be breast-feeding while you are using Flebogamma , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Flebogamma :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; diarrhea; headache; pain, swelling, muscle stiffness, or redness at the injection site; sore throat; stuffy nose.

Severe allergic reactions (rash; itching; hives; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, hands, face, lips, eyes, throat, or tongue); bloating; calf pain or tenderness; chest pain; confusion; dark urine; decreased urination; fainting; fast or irregular heartbeat; fever or chills; flushing; hoarseness; lower back or flank pain; nausea; numbness of an arm or a leg; one-sided weakness; painful eye movements; red, swollen, blistered, or peeling skin; seizures; sensitivity to light; severe headache, dizziness, or stomach pain; shortness of breath; speech problems; stiff neck; sudden weight gain; swelling; unusual drowsiness; vision problems; vomiting; weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Flebogamma is usually handled and stored by a health care provider. If you are using Flebogamma at home, store Flebogamma as directed by your pharmacist or health care provider. Keep Flebogamma out of the reach of children and away from pets.

General information:

• If you have any questions about Flebogamma , please talk with your doctor, pharmacist, or other health care provider.
• Flebogamma is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Flebogamma . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.