hepatitis b immunoglobulin


Green Cross


Full Prescribing Info
Human hepatitis B immuneglobulin.
Hepabig is a sterile solution containing hepatitis B immune globulin (HBIG) which is prepared by Cohn fractionation method from plasma of individuals with high titers of anti-HBs and whose plasma does not show serologic evidence of HBsAg.
Also, donor units found to be negative to anti-HIV ½ and anti-HCV are only used in the preparation of Hepabig. (See table.)

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For prophylaxis of hepatitis B after exposure to HBsAg e.g., by accidental "needle-stick" or direct mucous membrane contact by accidental splash, or oral ingestion (pipetting accident) involving HBsAg-positive materials such as blood, plasma or serum.
For prophylaxis of hepatitis B in neonates.
Dosage/Direction for Use
Following exposure to HBsAg: The recommended dose for adult is 1,000 to 2,000 I.U. intramuscularly and if necessary, the dose should be increased or repeated.
In children inject 32-48 I.U. per kg of body weight.
Hepabig should be administered within 7 days after exposure to HBsAg (preferably within 48 hours).
In neonates: The recommended initial dose is 100-200 I.U.
The first dose should be administered within 5 days after birth (preferably within 48 hours) and booster dose should be 32-48 I.U. per kg body weight.
The booster dose should be administered between 2 and 3 months after the first administration.
Hepabig should not be administered to HBsAg-positive individuals. But in neonates, Hepabig may be administered regardless of testing result of HBsAg.
Special Precautions
Hepabig should be administered very carefully to patients with IgA deficiency syndrome.
Hepabig should be administered intramuscularly only and not intravenously.
In neonates who are administered one dose of 1 mL, Hepabig is injected at two different sites (0.5 ml/site).
Do not reuse or save for future use. This product contains no preservative; therefore, partially used vials should be discarded immediately.
Adverse Reactions
Adverse reactions are infrequent, mild and transient following administration of HBIG.
Local pain, swelling and induration may occur at the injection site.
Rash and fever may also occur occasionally.
Drug Interactions
Antibodies present in HBIG may interfere with the immune response to live virus vaccines such as measles, mumps and rubella.
Vaccination with live virus vaccines should be deferred until approximately 3 months after administration of HBIG.
Re-vaccination to persons who received HBIG is necessary shortly after live virus vaccination.
Hepatitis B vaccine may be administered at the same time, but at a different injection site, without interfering with the immune response.
No interactions with other products are known.
Store at 2- 8°C. Do not freeze.
Maximum validity: 30 months from the manufacturing date.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J06BB04 - hepatitis B immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
Vaccine (vial) 100 IU/0.5 mL x 1's, 10's. 200 IU/mL x 1's, 10's.
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