Source: FDA, National Drug Code (US) Revision Year: 2020
The polyclonal antibody in GAMASTAN is a passive immunizing agent to neutralize viruses, such as hepatitis A and measles viruses, to prevent or ameliorate disease.
The prophylactic value of GAMASTAN is greatest when given before or soon after exposure.
Peak levels of immunoglobulin G are obtained approximately two days after intramuscular injection of GAMASTAN.(16) The half-life of IgG in the circulation of individuals with normal IgG levels is 23 days.(17)
In a clinical study, 12 healthy human subjects received a 20 IU/kg intramuscular dose of HYPERRAB, (Rabies Immune Globulin (Human)), made using the same manufacturing process as GAMASTAN. Detectable passive rabies neutralizing antibody was present by 24 hours and persisted through the 21 day follow-up evaluation period. The figure below shows the mean levels of rabies virus antibodies in IU/mL across the 21 day evaluation period and indicates that the titer remains stable during this period.
Mean (Standard Deviation) Rabies Virus Antibody Levels (IU/mL) versus Time following a Single 20 IU/kg Dose of HYPERRAB (300 IU/mL) by Intramuscular Injection:
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