Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION
**Posology** Slow injection by the i.m. route. If large doses (> 5 ml) are required, it is advisable to administer them in divided doses at different sites. - Post-exposure prophylaxis: After exposure to material containing or with a high risk of containing HBs-antigen in a non-vaccinated person, the usual practice is to inject 12 international units to 20 international units per kg of body weight as soon as possible, preferably within 24 hours and initiate hepatitis B vaccination. After exposure in a vaccinated person who is known not to have responded to the primary vaccine series, give either a single dose (12 – 20 international units/kg) of human antihepatitis B immunoglobulin and a dose of hepatitis B vaccine as soon as possible or two doses of human antihepatitis B immunoglobulin (one given in the first 24 hours and the second 1 month later). If the exposed person has already been vaccinated and the response is unknown, test for anti-HBs antibodies. If the response is inadequate (< 10 milli-international units/ml) give one dose of human antihepatitis B immunoglobulin immediately and a booster of vaccine. If the response is adequate, there is no necessity of treatment. If facilities are not available for testing, immediately give one dose of human antihepatitis B immunoglobulin. - Prophylaxis in neonates of HBsAg positive mother: 40 international units/kg body weight within 12 hours of birth and the first dose of hepatitis B vaccine. The administration of hepatitis B vaccine should be at a different site of the body with separate lymphatic drainage. HBsAg positive persons should not be given antihepatitis B immunoglobulin as no prophylactic effect will be expected.
INTRAMUSCULAR
Medical Information
**Therapeutic indications** Igantibe® 100 international units/0.5 ml, 600 international units/3 ml and 1000 international units/5 ml: - Post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regime is incomplete or when the antibody level is inadequate (i.e. < 10 milli-international units/ml). This passive immunisation in persons at increased risk of infection should be concomitant with vaccination. This post-exposure prophylaxis should be considered following either parenteral exposure, direct mucous membrane contact, oral ingestion, sexual exposure to an HBsAg positive person, and for infants < 12 months of age if the mother or the primary contact person has acute hepatitis B virus infection. Igantibe® 100 international units/0.5 ml and 600 international units/3 ml: - Prophylaxis for infants born to HBsAg positive mothers. Infants should receive human antihepatitis B immunoglobulin and the first dose of hepatitis B vaccine at the same time.
**Contraindications** Intolerance to homologous immunoglobulins. Allergic response related to any of the components. The human antihepatitis B immunoglobulin should not be administered to patients suffering from severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
J06BB04
hepatitis B immunoglobulin
Manufacturer Information
GRIFOLS ASIA PACIFIC PTE. LTD.
INSTITUTO GRIFOLS, S.A.
Grifols Biologicals LLC (alternate manufacturing site for Fraction II+III)
Active Ingredients
Documents
Package Inserts
Igantibe PI (24 Oct 2014).pdf
Approved: October 24, 2014