GamaSTAN® S/D
Immune Globulin (Human)

Immediate protection


Solution of immune globulin for intramuscular administration for postexposure prophylaxis for hepatitis A

 

 

Indications: The prophylactic value of GamaSTAN® S/D is greatest when given before or soon after exposure to hepatitis A. GamaSTAN® S/D is not indicated in persons with clinical manifestations of hepatitis A or in those exposed more than two weeks previously.

Broad Pathogen Safety Margin:

  • Precipitation
  • Depth Filtration
  • Solvent / Detergent Treatment
  • FDA-approved labeling for removal of pathogenic prions

GamaSTAN® S/D is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.

Related Information:

  • Mercury (thimerosal) free and latex free
  • GamaSTAN® S/D provides tamper-evident packaging.
  • Vaccines can take weeks to build efficacy, which can protect for years. GamaSTAN® S/D provides immediate protection.
  • This allows the vaccine the time needed to establish active immunity for your patients in high-risk situations, such as:
    • Travelers to developing countries, especially tourists, military personnel, business travelers, students, and missionaries
    • Children in daycare centers
    • People with multiple sex partners
    • Intravenous (IV) drug users who share needles
  • When used in combination with a vaccine, GamaSTAN S/D offers maximum postexposure immune protection.

How Supplied:

 Fill Size  NDC Number
2.0mL vial (10 pack) 13533-635-02
2.0mL vial 13533-635-04
10mL vial (10 pack) 13533-635-10
10mL vial 13533-635-12

Storage conditions:

  • Between 2°C-8°C (36°F-46°F) up to 3 years.
  • Do not freeze.

IMPORTANT SAFETY INFORMATION for GamaSTAN® S/D

GamaSTAN® S/D (immune globulin [human]) is indicated for prophylaxis of hepatitis A infection, prevention or modification of measles (rubeola), and passive immunization against varicella in immunosuppressed patients, and also possibly for prophylaxis of rubella in early pregnancy (for women who will not consider a therapeutic abortion).

The prophylactic value of GamaSTAN S/D is greatest when given before or soon after exposure to hepatitis A. GamaSTAN S/D is not indicated in persons with clinical manifestations of hepatitis A or in those exposed more than 2 weeks previously.

GamaSTAN S/D should be given to prevent or modify measles in a susceptible person exposed fewer than 6 days previously. A susceptible person is one who has not been vaccinated and has not had measles previously. GamaSTAN S/D and measles vaccine should not be given at the same time.

Thrombosis may occur with immune globulin products, including GamaSTAN S/D. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.  For patients at risk of thrombosis, do not exceed the recommended dose of GamaSTAN S/D. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Do not give GamaSTAN S/D to persons with isolated immunoglobulin A (IgA) deficiency. Such persons have the potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.

Do not give GamaSTAN S/D to patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.

Administer GamaSTAN S/D cautiously to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.

GamaSTAN S/D is made from human plasma. Because GamaSTAN S/D is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases or CJD have ever been identified for GamaSTAN S/D.

Do not administer immune globulin (human) subcutaneously or intravenously because of the potential for serious reactions (eg, renal dysfunction/failure/hemolysis, transfusion-related acute lung injury (TRALI)]. Do not inject into a blood vessel.

Do not perform skin tests. In most patients the intradermal injection of concentrated gamma globulin solution with its buffers causes a localized area of inflammation, which can be misinterpreted as a positive allergic reaction. In actuality, this does not represent an allergy; rather, it is localized tissue irritation of a chemical nature. Misinterpretation of the results of such tests can lead the physician to withhold beneficial human immunoglobulin from a patient who is not actually allergic to this material. Although true allergic responses to human gamma globulin given in the prescribed intramuscular manner are rare, have epinephrine available for treatment of acute allergic symptoms, should they occur.

Passive transfer of antibodies may transiently impair the immune responses to live attenuated virus vaccines such as mumps, rubella, and varicella for up to 6 months, and for a year or more to measles (rubeola). Inform the immunizing physician of recent therapy with GamaSTAN S/D so that appropriate precautions can be taken. No interactions with other products are known.

Local pain and tenderness at the injection site, urticaria, and angioedema may occur. Anaphylactic reactions, although rare, have been reported following the injection of human immune globulin preparations. Anaphylaxis is more likely to occur if GamaSTAN S/D is given intravenously; therefore, GamaSTAN S/D must be administered only intramuscularly.

Please see accompanying GamaSTAN S/D full Prescribing Information for complete prescribing details.  

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Prescribing Information

  • 31 Aug, 2017

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