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|GamaSTAN S/D

Immune Globulin (Human) Injection (IM)

GamaSTAN S/D is used for:

Providing antibodies to help prevent infection in certain patients who have a weakened immune system, or who have been exposed to measles, hepatitis A, or chickenpox. It may also be used for other conditions as determined by your doctor.

GamaSTAN S/D is an immune globulin. It works by providing antibodies, which fight infection.

Do NOT use GamaSTAN S/D if:

• you are allergic to any ingredient in GamaSTAN S/D
• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to 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
• you have severely low blood platelet levels (thrombocytopenia) or other severe blood problems

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

Before using GamaSTAN S/D :

Some medical conditions may interact with GamaSTAN S/D . 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, low blood platelet levels, blood problems, or kidney problems

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

• Hydantoins (eg, phenytoin) because the risk of side effects may be increased
• Vaccinations (eg, measles, mumps, and rubella) because effectiveness may be decreased by GamaSTAN S/D

This may not be a complete list of all interactions that may occur. Ask your health care provider if GamaSTAN S/D 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 GamaSTAN S/D :

Use GamaSTAN S/D as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• GamaSTAN S/D is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using GamaSTAN S/D at home, carefully follow the injection procedures taught to you by your health care provider.
• If GamaSTAN S/D 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 GamaSTAN S/D , contact your doctor for instructions.

Ask your health care provider any questions you may have about how to use GamaSTAN S/D .

Important safety information:

• Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are using GamaSTAN S/D . Vaccinations may be less effective.
• 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.
• GamaSTAN S/D is made from human plasma. There is an extremely low risk of developing a viral infection or Creutzfeldt-Jakob disease (CJD) after using GamaSTAN S/D . Discuss any questions or concerns with your doctor.
• Use GamaSTAN S/D with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is unknown if GamaSTAN S/D can cause harm to the fetus. If you become pregnant while taking GamaSTAN S/D , discuss with your doctor the benefits and risks of using GamaSTAN S/D during pregnancy. It is unknown if GamaSTAN S/D is excreted in breast milk. If you are or will be breast-feeding while you are using GamaSTAN S/D , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of GamaSTAN S/D :

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:

Pain, swelling, tenderness, or redness at the injection site.

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).

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.

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

General information:

• If you have any questions about GamaSTAN S/D , please talk with your doctor, pharmacist, or other health care provider.
• GamaSTAN S/D 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 GamaSTAN S/D . 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.