Details

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Manufacturer
GC Biopharma Corp.(KOREA,SOUTH)

Registraction Number
MAL19890003AZ

Content:

• Active Ingredient: Hepatitis B Immune Globulin (HBIG)
• Other Ingredients: Aminoacetic acid (11.25 mg), Sodium chloride (2.5 mg), Water for injection

 Indications:

• Prevention of Hepatitis B: Used for passive immunization against hepatitis B infection. It is administered to:
  • Adults exposed to HBsAg-positive blood
  • Infants born to HBsAg-positive mothers
  • Individuals with sexual exposure to HBsAg-positive persons
  • Household contacts of individuals with acute HBV infection
• Post-Liver Transplant Prophylaxis: Prevents hepatitis B recurrence after liver transplantation.

 Instructions:

1. Dosage for Adults: 500 IU given as a single dose, preferably within 48 hours of exposure.
2. Dosage for Children:
   • <5 years: 200 IU
   • 5-9 years: 300 IU
   • >10 years: 500 IU
3. Administration: Injected intramuscularly (IM) or subcutaneously (SC). The preferred site for IM injection is the deltoid muscle for adults and the anterolateral aspect of the thigh for children under 36 months.
4. Storage: Store in a refrigerator at 2°C to 8°C. Shake gently before use.
5. Timing: Administer as soon as possible after exposure and within 48 hours if possible.