Thursday, September 15, 2016

Baygam IGIM


Generic Name: immune globulin (intramuscular) (IGIM) (i MUNE GLOB ue lin (IN tra MUS cue lar))

Brand Names: GamaSTAN S/D


What is IGIM?

Immune globulin for intramuscular administration (IGIM) is a sterilized solution obtained from pooled human blood. It contains the immunoglobulins (or antibodies) to protect against infectious agents that cause various diseases. Antibodies are substances in the blood that fight infections.


IGIM is used to prevent or reduce the severity of infection by hepatitis A, measles, chickenpox (varicella), and rubella. IGIM is also used to prevent or reduce the severity of other infections in individuals with immunoglobulin deficiencies.


IGIM may also be used for purposes other than those listed here.


What is the most important information I should know about IGIM?


IGIM is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although IGIM is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using IGIM.


What should I discuss with my healthcare provider before using IGIM?


Do not use IGIM without first talking to your doctor if you have

  • IgA deficiency;




  • previously had an allergic reaction to an immune globulin product;




  • a low level of platelets in the blood (thrombocytopenia); or




  • a bleeding or blood clotting disorder.



You may not be able to use IGIM, or you may require a dosage adjustment or special monitoring during treatment.


IGIM is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use IGIM without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether IGIM passes into breast milk. Do not use IGIM without first talking to your doctor if you are breast-feeding a baby.

How should I use IGIM?


IGIM will be administered as an intramuscular (into a muscle) injection by a healthcare provider in a hospital or clinic setting.


Your doctor may want you to have blood tests or other forms of monitoring during treatment with IGIM to monitor progress and side effects.


Your healthcare provider will store IGIM as directed by the manufacturer. If you are storing IGIM at home, your healthcare provider will give you storage instructions.


What happens if I miss a dose?


Contact your healthcare provider if a dose of IGIM is missed.


What happens if I overdose?


Seek emergency medical attention or contact your healthcare provider if an overdose of IGIM is suspected.

No information is available regarding symptoms of an overdose of IGIM.


What should I avoid while taking IGIM?


Do not receive vaccines that use live strains of the virus (e.g., measles, mumps, and rubella or MMR) during and for three months following treatment with IGIM. These vaccines may not work properly when IGIM has been recently administered.

IGIM side effects


IGIM is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although IGIM is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using IGIM.


Notify your doctor immediately if you experience a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to IGIM.

Other less serious side effects may also occur. Upon injection of the medication, some patients experience pain, tenderness, or irritation at the injection site.


This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect IGIM?


Do not receive vaccines that use live strains of the virus (e.g., measles, mumps, and rubella or MMR) during and for three months following treatment with IGIM. These vaccines may not work properly when IGIM has been recently administered.

It is not known whether other medications will interact with IGIM. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products during treatment with IGIM.



Where can I get more information?


  • Your pharmacist can provide more information about immune globulin intramuscular.


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