GAMASTAN (human immune globulin) 1 x10ml. PreFillSyringe

GamaSTAN® S/D, Immune Globulin (Human)

Provides short-term pre-exposure or post-exposure protection for prevention against hepatitis A (HAV), an enterically transmitted viral infection. Hepatitis A is a reportable disease in all states in the US.    It remains a major public health problem in spite of improved hygienic and sanitary conditions. Extensive community-wide outbreaks of the disease are still prevalent in many segments of the US population.

GamaSTAN® S/D is convenient to use and provides short-term, temporary immunity against hepatitis A through the passive transfer of preformed antibodies. Treatment by passively immunizing with GamaSTAN® S/D modifies hepatitis A when given before or soon after exposure to HAV.

When administered in a timely fashion post-exposure to an infectious agent, passive immunization with GamaSTAN® S/D can prevent or modify measles (rubeola), varicella, and rubella and may prevent serious illness from bacterial infection in patients with certain types of immune deficiency.

Recommended Use of GamaSTAN® S/D

Travelers to developing countries are at substantial risk for acquiring hepatitis A. Tourists, military personnel, business travelers, students, and missionaries are all at risk in locations where there is high or intermediate endemicity. The prophylactic value of GamaSTAN® S/D is greatest when given before or soon after exposure to hepatitis A.

Travelers to developing countries and people in day care environments are among those most exposed to the hepatitis A virus. Others include individuals with multiple sex partners or intravenous (IV) drug users who share needles.

GamaSTAN® S/D is recommended as prophylaxis in susceptible persons (those who have not been vaccinated and have not had measles previously) exposed to measles within 6 days of contact.

GamaSTAN® S/D provides replacement therapy of antibodies in persons with hypogammaglobulinemia and agammaglobulinemia.

For Intramuscular Administration Only.

Product attributes

 Solvent/Detergent treatment for virus inactivation 

 Single dose vials for IM injection only

 Tamper-evident packaging

Contraindications, side effects, and precautions
  Use caution in persons with a history of prior systemic allergic reaction to human immune globulin products or a history of IgA deficiency

 Side effects such as local injection site reactions, urticaria, and angioedema may occur

 Administration of live virus vaccines (eg, MMR) should be deferred until approximately 3 months after immune globulin (human) administration

Important Safety Information

 GamaSTAN S/D should not be given to persons with isloated 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.

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

 GamaSTAN S/D should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.

 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 immunoglobulin preparations. Anaphylaxis is more likely to occur if GamaSTAN S/D is given intravenously therefore, GamaSTAN S/D must be administered only intramuscularly.

 Administration of live virus vaccines (e.g., MMR) should be deferred for approximately 3 months after immune globulin (human) administration.

 GamaSTAN S/D is made from human plasma. As with all plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease, cannot be totally eliminated. There is also the possibility that unknown infectious agents may be present in such products.