GamaSTAN

GamaSTAN

human normal immunoglobulin

Manufacturer:

Grifols

Distributor:

Luen Cheong Hong
Concise Prescribing Info
Contents
Human normal Ig
Indications/Uses
For prophylaxis following exposure to hepatitis A. To prevent or modify measles in a susceptible person exposed fewer than 6 days previously. To modify varicella. To modify rubella in exposed women who will not consider a therapeutic abortion.
Dosage/Direction for Use
IM Hepatitis A 0.1 mL/kg w/in 2 wk of prior exposure. Persons traveling to areas w/ endemic hepatitis A Administer before departure 0.1 mL/kg if the length of stay will be up to 1 mth; 0.2 mL/kg if the length of stay will be up to 2 mth, repeat every 2 mth for longer stays. Measles 0.25 mL/kg w/in 6 days of exposure. Immunocompromised child Immediately administer 0.5 mL/kg (max dose: 15 mL). Varicella 0.6-1.2 mL/kg. Administer promptly if Varicella-Zoster Immune Globulin (Human) is unavailable. Rubella Exposed pregnant women who will not consider a therapeutic abortion 0.55 mL/kg.
Contraindications
Anaphylactic or severe systemic hypersensitivity reactions to human Ig. IgA deficient patients w/ Ab(s) against IgA & a history of hypersensitivity.
Special Precautions
Not indicated for routine prophylaxis or treatment of HBV, rubella, poliomyelitis, mumps or varicella. Administer cautiously to patients w/ history of prior systemic allergic reactions following administration of human Ig prep. Do not perform skin tests. Do not administer IV or inject into a blood vessel. May carry a risk of transmitting infectious agents eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent & theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Thrombosis may occur. For patients at risk of thrombosis, do not exceed the recommended dose, ensure adequate hydration before administration. Monitor for signs & symptoms of thrombosis & assess blood viscosity in patients at risk for hyperviscosity.
Adverse Reactions
Fatigue. Allergic/hypersensitivity reactions; headache; nausea; inj site pain & inflammation, pyrexia.
Drug Interactions
Defer live vaccine administration for up to 6 mth after GamaSTAN administration.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J06BA01 - immunoglobulins, normal human, for extravascular adm. ; Belongs to the class of normal human immunoglobulins. Used in passive immunizations.
Presentation/Packing
Form
GamaSTAN soln for IM inj 16.5%
Packing/Price
10 mL x 1's;2 mL x 1's
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