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

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml; hepatitis a virus antigen, quantity: 720 elisa unit/ml - injection, suspension - excipient ingredients: aluminium hydroxide hydrate; aluminium phosphate; polysorbate 20; water for injections; neomycin sulfate; monobasic sodium phosphate; trometamol; sodium chloride; dibasic sodium phosphate heptahydrate; formaldehyde solution; acetic acid; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate; glycine - twinrix (720/20) is indicated for active immunisation against hepatitis a and hepatitis b virus infection in adults and children from 1 year of age. twinrix junior (360/10) is indicated for use in children aged 1 to 15 years. twinrix (720/20) is indicated for active immunisation against hepatitis a and hepatitis b virus infection in adults and children from 1 year of age. twinrix junior (360/10) is indicated for use in children aged 1 to 15 years.

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

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml; hepatitis a virus antigen, quantity: 720 elisa unit/ml - injection, suspension - excipient ingredients: trometamol; aluminium hydroxide hydrate; sodium chloride; polysorbate 20; neomycin sulfate; water for injections; formaldehyde solution; aluminium phosphate; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate; acetic acid; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate; glycine - twinrix (720/20) is indicated for active immunisation against hepatitis a and hepatitis b virus infection in adults and children from 1 year of age. twinrix junior (360/10) is indicated for use in children aged 1 to 15 years. twinrix (720/20) is indicated for active immunisation against hepatitis a and hepatitis b virus infection in adults and children from 1 year of age. twinrix junior (360/10) is indicated for use in children aged 1 to 15 years.

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

glaxosmithkline australia pty ltd - hepatitis a virus antigen, quantity: 720 elisa unit - injection, suspension - excipient ingredients: aluminium hydroxide hydrate; aluminium; polysorbate 20; dibasic sodium phosphate heptahydrate; monobasic potassium phosphate; sodium chloride; potassium chloride; water for injections; acetic acid; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate; glycine - havrix is indicated for active immunisation against hepatitis a virus (hav) infection in susceptible subjects at risk of exposure to hav. havrix junior is indicated in subjects aged 2 to 15 years and havrix 1440 is indicated in subjects aged 16 years and older. in areas of low prevalence of hepatitis a, immunisation with havrix is particularly recommended in the following subjects: travellers : persons travelling to areas of intermediate or high endemicity for hepatitis a. these areas include africa, asia, india, the pacific islands, the mediterranean basin, the middle east, central and south america. armed forces : armed forces personnel who travel to higher endemicity areas or to areas where hygiene is poor, have an increased risk of hav infection. persons for whom hepatitis a is an occupational hazard or for whom there is an increased risk of transmission. these include: employees in day-care centres particularly in situations where children have not been toilet trained; teachers and other close contacts o

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

glaxosmithkline australia pty ltd - hepatitis a virus antigen, quantity: 720 elisa unit - injection, suspension - excipient ingredients: aluminium hydroxide hydrate; aluminium; polysorbate 20; dibasic sodium phosphate heptahydrate; monobasic potassium phosphate; sodium chloride; potassium chloride; water for injections; acetic acid; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate; glycine - havrix is indicated for active immunisation against hepatitis a virus (hav) infection in susceptible subjects at risk of exposure to hav. havrix junior is indicated in subjects aged 2 to 15 years and havrix 1440 is indicated in subjects aged 16 years and older. in areas of low prevalence of hepatitis a, immunisation with havrix is particularly recommended in the following subjects: travellers : persons travelling to areas of intermediate or high endemicity for hepatitis a. these areas include africa, asia, india, the pacific islands, the mediterranean basin, the middle east, central and south america. armed forces : armed forces personnel who travel to higher endemicity areas or to areas where hygiene is poor, have an increased risk of hav infection. persons for whom hepatitis a is an occupational hazard or for whom there is an increased risk of transmission. these include: employees in day-care centres particularly in situations where children have not been toilet trained; teachers and other close contacts of the intellectually disabled; staff and residents of residential facilities for the intellectually disabled; health workers and teachers in remote aboriginal and torres strait islander communities; nursing staff and other healthcare workers in contact with patients in paediatric wards, infectious diseases wards, emergency rooms and intensive care units sewerage workers ; food handlers, since food hygiene procedures and food processing methods are not always adequate to protect from contamination from food handlers. homosexual men : increased incidence of hepatitis a infection among homosexual males suggests that the disease may be sexually transmitted in this group. contacts of infected persons : since virus shedding from infected persons may occur for a prolonged period, active immunisation of close contacts is recommended. the use of vaccine in outbreak control has been shown to be more effective than the use of immunoglobulin. specific population groups known to have a higher incidence of hepatitis a: eg. australian aboriginals, recognised community-wide hav epidemics. individuals with chronic liver disease and recipients of liver transplants, as hepatitis a infections is likely to be more severe in these groups. many injecting drug users will have pre-existing liver disease from hepatitis b or hepatitis c infection. recipients of blood products, such as factor viii eg. haemophiliacs. havrix will not prevent hepatitis infection caused by other agents such as hepatitis b virus, hepatitis c virus, hepatitis d virus, hepatitis e or other pathogens known to infect the liver.

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

glaxosmithkline australia pty ltd - hepatitis a virus antigen, quantity: 1440 elisa unit - injection, suspension - excipient ingredients: polysorbate 20; dibasic sodium phosphate heptahydrate; monobasic potassium phosphate; sodium chloride; potassium chloride; water for injections; aluminium hydroxide hydrate; acetic acid; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate; glycine - havrix is indicated for active immunisation against hepatitis a virus (hav) infection in susceptible subjects at risk of exposure to hav. havrix junior is indicated in subjects aged 2 to 15 years and havrix 1440 is indicated in subjects aged 16 years and older. in areas of low prevalence of hepatitis a, immunisation with havrix is particularly recommended in the following subjects: travellers : persons travelling to areas of intermediate or high endemicity for hepatitis a. these areas include africa, asia, india, the pacific islands, the mediterranean basin, the middle east, central and south america. armed forces : armed forces personnel who travel to higher endemicity areas or to areas where hygiene is poor, have an increased risk of hav infection. persons for whom hepatitis a is an occupational hazard or for whom there is an increased risk of transmission. these include: employees in day-care centres particularly in situations where children have not been toilet trained; teachers and other close contacts o

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

glaxosmithkline australia pty ltd - hepatitis a virus antigen, quantity: 1440 elisa unit - injection, suspension - excipient ingredients: polysorbate 20; dibasic sodium phosphate heptahydrate; monobasic potassium phosphate; sodium chloride; potassium chloride; water for injections; aluminium hydroxide hydrate; acetic acid; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate; glycine - havrix is indicated for active immunisation against hepatitis a virus (hav) infection in susceptible subjects at risk of exposure to hav. havrix junior is indicated in subjects aged 2 to 15 years and havrix 1440 is indicated in subjects aged 16 years and older. in areas of low prevalence of hepatitis a, immunisation with havrix is particularly recommended in the following subjects: travellers : persons travelling to areas of intermediate or high endemicity for hepatitis a. these areas include africa, asia, india, the pacific islands, the mediterranean basin, the middle east, central and south america. armed forces : armed forces personnel who travel to higher endemicity areas or to areas where hygiene is poor, have an increased risk of hav infection. persons for whom hepatitis a is an occupational hazard or for whom there is an increased risk of transmission. these include: employees in day-care centres particularly in situations where children have not been toilet trained; teachers and other close contacts of the intellectually disabled; staff and residents of residential facilities for the intellectually disabled; health workers and teachers in remote aboriginal and torres strait islander communities; nursing staff and other healthcare workers in contact with patients in paediatric wards, infectious diseases wards, emergency rooms and intensive care units sewerage workers ; food handlers, since food hygiene procedures and food processing methods are not always adequate to protect from contamination from food handlers. homosexual men : increased incidence of hepatitis a infection among homosexual males suggests that the disease may be sexually transmitted in this group. contacts of infected persons : since virus shedding from infected persons may occur for a prolonged period, active immunisation of close contacts is recommended. the use of vaccine in outbreak control has been shown to be more effective than the use of immunoglobulin. specific population groups known to have a higher incidence of hepatitis a: eg. australian aboriginals, recognised community-wide hav epidemics. individuals with chronic liver disease and recipients of liver transplants, as hepatitis a infections is likely to be more severe in these groups. many injecting drug users will have pre-existing liver disease from hepatitis b or hepatitis c infection. recipients of blood products, such as factor viii eg. haemophiliacs. havrix will not prevent hepatitis infection caused by other agents such as hepatitis b virus, hepatitis c virus, hepatitis d virus, hepatitis e or other pathogens known to infect the liver.

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

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml; hepatitis a virus antigen, quantity: 720 elisa unit/ml - injection, suspension - excipient ingredients: dibasic sodium phosphate heptahydrate; neomycin sulfate; aluminium hydroxide hydrate; formaldehyde solution; trometamol; aluminium phosphate; water for injections; polysorbate 20; monobasic sodium phosphate; sodium chloride; acetic acid; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate; glycine - twinrix (720/20) is indicated for active immunisation against hepatitis a and hepatitis b virus infection in adults and children from 1 year of age. twinrix junior (360/10) is indicated for use in children aged 1 to 15 years.

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

glaxosmithkline australia pty ltd - hepatitis a virus antigen, quantity: 720 elisa unit/ml; hepatitis b surface antigen recombinant, quantity: 20 microgram/ml - injection, suspension - excipient ingredients: trometamol; aluminium hydroxide hydrate; water for injections; polysorbate 20; dibasic sodium phosphate heptahydrate; neomycin sulfate; monobasic sodium phosphate; formaldehyde solution; aluminium phosphate; sodium chloride; acetic acid; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate; glycine - twinrix (720/20) is indicated for active immunisation against hepatitis a and hepatitis b virus infection in adults and children from 1 year of age. twinrix junior (360/10) is indicated for use in children aged 1 to 15 years.

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.

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.