United States - English - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) (unii: 5bfc8lz6lq) (hepatitis a virus strain hm175 antigen (formaldehyde inactivated) - unii:5bfc8lz6lq), hepatitis b virus subtype adw2 hbsag surface protein antigen (unii: 9gcj1l5d1p) (hepatitis b virus subtype adw2 hbsag surface protein antigen - unii:9gcj1l5d1p) - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) 720 [iu] in 1 ml - twinrix is indicated for active immunization against disease caused by hepatitis a virus and infection by all known subtypes of hepatitis b virus. twinrix is approved for use in persons 18 years of age or older. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis a-containing or hepatitis b-containing vaccine, or to any component of twinrix, including yeast and neomycin, is a contraindication to administration of twinrix [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. there are no adequate and well-controlled studies of twinrix in pregnant women in the u.s. available data do not suggest an increased risk of major birth defects and miscarriage in women who received twinrix within 28 days prior to conception or during pregnancy (see data) . a developmental toxicity study was performed in female rats administered twinrix prior to mating and during gestation (0.2 ml at each occasion). this study revealed no adverse effects on fetal or pre-weaning development (see data) . data human data: a pregnancy exposure registry was maintained from 2001 to 2015. the registry prospectively enrolled 245 women who received a dose of twinrix during pregnancy or within 28 days prior to conception. after excluding induced abortions (n = 6, including one of a fetus with congenital anomalies), those lost to follow-up (n = 142), those with exposure in the third trimester (n = 1), and those with an unknown exposure timing (n = 9), there were 87 pregnancies with known outcomes with exposure within 28 days prior to conception, or in the first or second trimesters. miscarriage was reported for 9.6% of pregnancies with exposure to twinrix prior to 20 weeks gestation (8/83). major birth defects were reported for 3.8% of live born infants whose mothers were exposed within 28 days prior to conception or during the first or second trimester (3/80). the rates of miscarriage and major birth defects were consistent with estimated background rates. in pre- and post-licensure clinical studies of twinrix, 45 pregnant women were inadvertently administered twinrix following their last menstrual period. among such pregnancies, after excluding elective terminations (n = 1) and those lost to follow-up (n = 1), there were 43 pregnancies with known outcomes all with exposure in the first trimester. miscarriage was reported in 16% of pregnancies (7/43) and major birth defects were reported in 2.6% of live births (1/38). the rates of miscarriage and major birth defects were consistent with estimated background rates. animal data: in a developmental toxicity study, female rats were administered twinrix by intramuscular injection on day 30 prior to mating and on gestation days 6, 8, 11, and 15. the total dose was 0.2 ml (divided) at each occasion (a single human dose is 1 ml). no adverse effects on pre-weaning development up to post-natal day 25 were observed. there were no fetal malformations or variations. risk summary there is no information regarding the presence of twinrix in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for twinrix and any potential adverse effects on the breastfed child from twinrix or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. safety and effectiveness in pediatric patients younger than 18 years have not been established. clinical studies of twinrix did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects [see clinical studies (14.1, 14.3)] .

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 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: 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: 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 b surface antigen recombinant, quantity: 20 microgram/ml - injection, suspension - excipient ingredients: monobasic sodium phosphate; water for injections; sodium chloride; dibasic sodium phosphate dihydrate; aluminium hydroxide hydrate - engerix-b is indicated for active immunisation against hepatitis b virus infection. the nh&mrc* recommend all infants, young children and unvaccinated adolescents receive a primary course of immunisation against hepatitis b. the nh&mrc also recommends immunisation for persons who are at substantial risk and have been demonstrated or judged to be susceptible to the hepatitis b virus. groups identified at increased risk of acquiring hbv infection include: infants born to carrier (hbsag-positive) mothers; individuals for whom post-exposure prophylaxis for hepatitis b is indicated; household contacts (other than sexual partners) of acute and chronic hepatitis b cases and carriers; susceptible sexual contacts. risk occurs in susceptible (anti-hbs negative) partners of hbv carriers and patients with acute hepatitis b; susceptible clients of std (sexually transmitted disease) clinics, and sexually active men who have sex with men are also at increased risk of infection; injecting drug users; haemodialysis patients, hiv-positive individuals and other immunosuppressed adults; patients receiving certain blood products especially patients with clotting disorders receiving blood product concentrates; individuals with chronic liver disease and / or hepatitis c; staff and residents of facilities for the intellectually disabled, including both residential and non-residential care of this group; liver transplant recipients. such individuals should be vaccinated prior to transplantation if seronegative for hepatitis b, as they may be at increased risk of infection from the transplanted organ; staff and inmates of long term correctional facilities; health care workers, dentists, embalmers, tattooists and body-piercers. all staff directly involved in patient care, embalming, or in the handling of human blood or tissue should be vaccinated; individuals adopting children from overseas. these children should be tested for hepatitis b, and if hbsag positive, members of the adoptive family should be vaccinated; others in whom vaccination may be justified include police, members of the armed forces and emergency services staff, depending on the risks of exposure associated with assigned duties. long term travellers to regions of high endemicity, and those residing for some time in such regions who may anticipate close personal contact with local residents, should be vaccinated. short-term tourists or business travellers are at very little risk of hepatitis b, provided they avoid exposure through sexual contact, injecting drug use, tattooing or body piercing. although the risk of hepatitis b infection in contact sports is low, immunisation of those involved should not be discouraged. as the risk in australian schools is very low, vaccination of classroom contacts is seldom indicated. nevertheless, vaccination of school children and adolescents should be encouraged; as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection, it can be expected that hepatitis d will also be prevented by vaccination with engerix-b. the vaccine will not protect against infection caused by hepatitis a, hepatitis c and hepatitis e viruses, and 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: 10 microgram - injection, suspension - excipient ingredients: dibasic sodium phosphate dihydrate; aluminium hydroxide hydrate; sodium chloride; monobasic sodium phosphate; water for injections - engerix-b is indicated for active immunisation against hepatitis b virus infection. the nh&mrc* recommend all infants, young children and unvaccinated adolescents receive a primary course of immunisation against hepatitis b. the nh&mrc also recommends immunisation for persons who are at substantial risk and have been demonstrated or judged to be susceptible to the hepatitis b virus. groups identified at increased risk of acquiring hbv infection include: infants born to carrier (hbsag-positive) mothers; individuals for whom post-exposure prophylaxis for hepatitis b is indicated; household contacts (other than sexual partners) of acute and chronic hepatitis b cases and carriers; susceptible sexual contacts. risk occurs in susceptible (anti-hbs negative) partners of hbv carriers and patients with acute hepatitis b; susceptible clients of std (sexually transmitted disease) clinics, and sexually active men who have sex with men are also at increased risk of infection; injecting drug users; haemodialysis patients, hiv-positive individuals and other immunosuppressed adults; patients receiving certain blood products especially patients with clotting disorders receiving blood product concentrates; individuals with chronic liver disease and / or hepatitis c; staff and residents of facilities for the intellectually disabled, including both residential and non-residential care of this group; liver transplant recipients. such individuals should be vaccinated prior to transplantation if seronegative for hepatitis b, as they may be at increased risk of infection from the transplanted organ; staff and inmates of long term correctional facilities; health care workers, dentists, embalmers, tattooists and body-piercers. all staff directly involved in patient care, embalming, or in the handling of human blood or tissue should be vaccinated; individuals adopting children from overseas. these children should be tested for hepatitis b, and if hbsag positive, members of the adoptive family should be vaccinated; others in whom vaccination may be justified include police, members of the armed forces and emergency services staff, depending on the risks of exposure associated with assigned duties. long term travellers to regions of high endemicity, and those residing for some time in such regions who may anticipate close personal contact with local residents, should be vaccinated. short-term tourists or business travellers are at very little risk of hepatitis b, provided they avoid exposure through sexual contact, injecting drug use, tattooing or body piercing. although the risk of hepatitis b infection in contact sports is low, immunisation of those involved should not be discouraged. as the risk in australian schools is very low, vaccination of classroom contacts is seldom indicated. nevertheless, vaccination of school children and adolescents should be encouraged; as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection, it can be expected that hepatitis d will also be prevented by vaccination with engerix-b. the vaccine will not protect against infection caused by hepatitis a, hepatitis c and hepatitis e viruses, and other pathogens known to infect the liver.

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - hepatitis b; hepatitis a; immunization - vaccines - ambirix is for use in non-immune persons from one year up to and including 15 years of age for protection against hepatitis-a and hepatitis-b infection.protection against hepatitis-b infections may not be obtained until after the second dose.therefore:ambirix should be used only when there is a relatively low risk of hepatitis-b infection during the vaccination course;it is recommended that ambirix should be administered in settings where completion of the two-dose vaccination course can be assured.