hepatitis b immunoglobulin


Kedrion S.p.A.


Concise Prescribing Info
Human hepatitis B Ig
Prevention of HBV recurrence after liver transplantation for HBV induced liver failure in combination w/ antiviral therapy. Immunoprophylaxis of hepatitis B.
Dosage/Direction for Use
Infuse IV at initial rate of 0.46-0.92 mL/kg/hr for 20-30 min; may be increased gradually to a max of 1.85 mL/kg/hr. Prevention of hepatitis B re-infection after liver transplantation for hepatitis B-induced liver failure Adult 10,000 IU on the day of transplantation perioperative; then 2,000-10,000 IU/day for 7 days & as necessary. Childn 10,000 IU/1.73 m2 BSA. Immunoprophylaxis of hepatitis B: Prevention of hepatitis B in case of accidental exposure in non-immunised subjects At least 500 IU w/in 24-72 hr of exposure. Immunoprophylaxis of hepatitis B in haemodialysis patients 8-12 IU/kg w/ a max of 500 IU every 2 mth until seroconversion following vaccination. Immunoprophylaxis of hepatitis B: Prevention of hepatitis B in the newborn of a HBV carrier-mother, at birth or as soon as possible after birth 30-100 IU/kg. IM route is preferred whenever repeated administration is required to achieve seroconversion after vaccination.
Special Precautions
Discontinue immediately in case of allergic or anaphylactic type reactions. Patients w/ thrombotic risk factors. Regularly monitor for serum anti-HBs Ab levels. Increased risk of certain adverse reactions w/ high infusion rate, or in patients w/ hypo- or agammaglobulinemia w/ or w/o IgA deficiency. Patients on a controlled Na diet. Patients at risk of acute renal failure. IgA deficient individuals may develop IgA Abs & have anaphylactic reactions after administration. Monitor for clinical signs & symptoms of haemolysis. Interference w/ serological tests eg, antiglobulin test (Coombs' test). Renal impairment. Pregnancy & lactation.
Adverse Reactions
Hypersensitivity, anaphylactic shock; headache; tachycardia; hypotension; nausea, vomiting; skin reaction, erythema, pruritus; arthralgia; acute renal failure; fever, malaise, chills.
Drug Interactions
May interfere w/ development of immune response to live attenuated virus vaccines (allow at least 3 mth interval).
ATC Classification
J06BB04 - hepatitis B immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
Venbig inj 50 IU/mL
10 mL x 1's
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