Australia - English - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - hepatitis b immunoglobulin, quantity: 400 iu; human immunoglobulin g, quantity: 160 mg/ml - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - hepatitis b immunoglobulin-vf is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (<10iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin-vf is also indicated for prophylaxis in infants born to hbsag-positive mothers.

Israel - English - Ministry of Health

kamada ltd, israel - human hepatitis b immunoglobulin - solution for injection - human hepatitis b immunoglobulin 500 iu - hepatitis b immunoglobulin - hepatitis b immunoglobulin - prevention of hepatitis b virus (hbv) re-infection in hbsag and hbv-dna negative adult patients at least one week after liver transplantation for hepatitis b induced liver failure.hbv-dna negative status should be confirmed within the last 3 months prior to olt. patients should be hbsag negative before treatment start.the concomitant use of adequate virostatic agents should be considered as standard of hepatitis b re-infection prophylaxis.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bio products laboratory ltd - hepatitis b immunoglobulin human - solution for injection - 100unit/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bio products laboratory ltd - hepatitis b immunoglobulin human - solution for injection - 100unit/1ml

New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - hepatitis b immunoglobulin, human 160 mg/ml ((>= 98% )as human plasma proteins (exnz)) - solution for injection - 100 iu - active: hepatitis b immunoglobulin, human 160 mg/ml ((>= 98% )as human plasma proteins (exnz)) excipient: glycine water for injection - hepatitis b immunoglobulin-vf is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (< 10 iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin-vf is also indicated for prophylaxis in infants born to hbsag-positive mothers.

New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - hepatitis b immunoglobulin, human 160 mg/ml (( >= 98%) as human plasma proteins (ex nz)) - solution for injection - 400 iu - active: hepatitis b immunoglobulin, human 160 mg/ml (( >= 98%) as human plasma proteins (ex nz)) excipient: glycine water for injection - hepatitis b immunoglobulin-vf is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (< 10 iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin-vf is also indicated for prophylaxis in infants born to hbsag-positive mothers.

Australia - English - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - human immunoglobulin g, quantity: 160 mg/ml; hepatitis b immunoglobulin, quantity: 100 iu - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - indications as at 8 august 2002 : hepatitis b immunoglobulin is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (<10iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive material or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin is also indicated for prophylaxis in infants born to hbsag-positive mothers. hepatitis b immunoglobulin-vf is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (<10iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin-vf is also indicated for prophylaxis in infants born to hbsag-positive mothers.

Israel - English - Ministry of Health

kamada ltd, israel - human hepatitis b immunoglobulin - solution for infusion - human hepatitis b immunoglobulin 50 mg / 1 ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - prophylaxis against hepatitis b in adults and children over 2 years of age who have not been vaccinated against hepatitis b (including persons whose vaccination is incomplete or missing) who are at risk of infection with hepatitis b by accidental contact with hepatitis b virus containing material following: - percutaneous exposure (e.g. accidental needle stick). - direct mucous membrane contact. when the administration of an intramuscular hepatitis b immunoglobulin is not possible. the immunoglobulin should be administered in association with hepatitis b vaccine. prophylaxis against re-infection of a transplanted liver in patients who carry the surface antigen of the hepatitis b virus. immunoprophylaxis of hepatitis b in the newborn of a hepatitis b virus carrier mother.

European Union - English - EMA (European Medicines Agency)

cangene europe limited - human hepatitis b immunoglobulin - immunization, passive; hepatitis b - specific immunoglobulins - immunoprophylaxis of hepatitis b - in case of accidental exposure in non-immunised subjects (including persons whose vaccination isincomplete or status unknown).- in haemodialysed patients, until vaccination has become effective.- in the newborn of a hepatitis b virus carrier-mother.- in subjects who did not show an immune response (no measurable hepatitis b antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis b.consideration should also be given to other official guidance on the appropriate use of human hepatitis b immunoglobulin for intramuscular use.

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - human hepatitis, b immunoglobulin, human plasma, protein - solution for injection - human hepatitis b immunoglobulin 200 iu human plasma protein 100-170 mg - immune sera and immunoglobulins