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

merck sharp & dohme (australia) pty ltd - hepatitis b surface antigen recombinant, quantity: 10 microgram/ml - injection, suspension - excipient ingredients: aluminium; borax; sodium chloride; water for injections - h-b-vax ii is indicated for immunisation against infection caused by all known subtypes of hepatitis b virus. adolescent vaccination is not necessary for children who have received a primary course of hepatitis b vaccine. vaccination is recommended in adults who ar at substantial risk of hepatitis b virus infection and have demonstrated or judged to be susceptible. vaccination of individuals who have antibodies against hepatitis b virus from a previous infection is not necessary.

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

merck sharp & dohme (australia) pty ltd - hepatitis b surface antigen recombinant, quantity: 5 microgram - injection, suspension - excipient ingredients: borax; water for injections; sodium chloride; aluminium - for use in the immunisation against infection caused by all known subtypes of hepatitis b virus. indications as at 17 november 2000: h-b-vax ii is indicated for immunisation against infection caused by all known subtypes of hepatitis b virus. adolescent vaccination is not necessary for children who have received a primary course of hepatitis b vaccine. vaccination is recommended in adults who are at substantial risk of hepatitis b virus infection and have demonstrated or judged to be susceptible. vaccination of individuals who have antibodies against hepatitis b virus from a previous infection is not necessary.

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

merck sharp & dohme (australia) pty ltd - hepatitis b surface antigen recombinant, quantity: 10 microgram/ml - injection, suspension - excipient ingredients: borax; sodium chloride; aluminium; water for injections - h-b-vax ii is indicated for immunisation against infection caused by all known subtypes of hepatitis b virus. adolescent vaccination is not necessary for children who have received a primary course of hepatitis b vaccine. vaccination is recommended in adults who ar at substantial risk of hepatitis b virus infection and have demonstrated or judged to be susceptible. vaccination of individuals who have antibodies against hepatitis b virus from a previous infection is not necessary.

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

merck sharp & dohme (australia) pty ltd - hepatitis b surface antigen recombinant, quantity: 40 microgram/ml - injection, suspension - excipient ingredients: borax; sodium chloride; aluminium; water for injections - h-b-vax ii is indicated for immunisation against infection caused by all known subtypes of hepatitis b virus. adolescent vaccination is not necessary for children who have received a primary course of hepatitis b vaccine. vaccination is recommended in adults who ar at substantial risk of hepatitis b virus infection and have demonstrated or judged to be susceptible. vaccination of individuals who have antibodies against hepatitis b virus from a previous infection is not necessary.

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

merck sharp & dohme (australia) pty ltd - hepatitis b surface antigen recombinant, quantity: 5 microgram - injection, suspension - excipient ingredients: aluminium; water for injections; sodium chloride; borax - for use in the immunisation against infection caused by all known subtypes of hepatitis b virus. indications as at 17 november 2000: h-b-vax ii is indicated for immunisation against infection caused by all known subtypes of hepatitis b virus. adolescent vaccination is not necessary for children who have received a primary course of hepatitis b vaccine. vaccination is recommended in adults who are at substantial risk of hepatitis b virus infection and have demonstrated or judged to be susceptible. vaccination of individuals who have antibodies against hepatitis b virus from a previous infection is not necessary.

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

vbi vaccines (delaware) inc. - recombinant hepatitis b surface antigen (isoform s) (unii: 2u8266yw9l) (recombinant hepatitis b surface antigen (isoform s) - unii:2u8266yw9l), recombinant hepatitis b surface antigen (isoform m) (unii: snd8hl4kqg) (recombinant hepatitis b surface antigen (isoform m) - unii:snd8hl4kqg), recombinant hepatitis b surface antigen (isoform l) (unii: c6pfs5dx5y) (recombinant hepatitis b surface antigen (isoform l) - unii:c6pfs5dx5y) - prehevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis b virus. prehevbrio is approved for use in adults 18 years of age and older. do not administer prehevbrio to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis b vaccine or to any component of prehevbrio [see description ( 11)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to prehevbrio during pregnancy. women who receive prehevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free). risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in clinically recognized pregnancies in the us general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20%. there are no adequate and well-controlled studies of prehevbrio in pregnant women. available human data on prehevbrio administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. a developmental toxicity study has been performed in female rats administered the equivalent of a single human dose of prehevbrio on four occasions; twice prior to mating, twice during gestation. the study revealed no evidence of harm to the fetus due to the vaccine [see animal data below]. data animal data a developmental toxicity study has been performed in female rats using a dose equivalent to the adult human dose. in the study, female rats received 0.5 ml (2 x 0.25 ml injections) of a vaccine formulation containing 10 mcg hbsag (s, pre-s1, pre-s2) adsorbed on to aluminum hydroxide by intramuscular injection 30 days and 15 days prior to mating and on gestation days 4 and 15. no adverse effects of pre-weaning development were observed. there was no evidence of fetal malformations or variations. risk summary it is not known whether prehevbrio is excreted in human milk. data are not available to assess the effects of prehevbrio on the breastfed infant or on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for prehevbrio and any potential adverse effects on the breastfed child from prehevbrio or from the underlying maternal condition. for preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine. safety and effectiveness of prehevbrio have not been established in individuals less than 18 years of age. study 1 included 296 adults 65 through 86 years of age who received prehevbrio. among subjects who received prehevbrio, a seroprotective level of antibody to hbsag was achieved in 83.6% of those ≥ 65 years of age compared to 94.8% in adults 45 through 64 years of age and 99.2% in adults 18 through 44 years of age [see evaluation of immunogenicity ( 14.1)]. frequencies of local and systemic solicited adverse reactions were generally lower in elderly subjects ≥65 years of age than in younger subjects [see adverse reactions ( 6)]. safety and effectiveness of prehevbrio have not been established in adults on hemodialysis.

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - hepatitis b vaccine, rdna 10 µg/ml - suspension for injection - 10 mcg/ml - active: hepatitis b vaccine, rdna 10 µg/ml excipient: aluminium as amorphous aluminum hydroxyphosphate sulphate borax formaldehyde potassium thiocyanate sodium chloride water for injection - immunisation against infection caused by all known subtypes of hepatitis b virus. hbvaxpro should also prevent hepatitis d (caused by the delta virus) since hepatitis d does not occur in the absence of hepatitis b infection.

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - hepatitis b vaccine, rdna 40 µg/ml - suspension for injection - 40 mcg/ml - active: hepatitis b vaccine, rdna 40 µg/ml excipient: aluminium as amorphous aluminum hydroxyphosphate sulphate borax formaldehyde potassium thiocyanate sodium chloride water for injection - immunisation against infection caused by all known subtypes of hepatitis b virus. hbvaxpro should also prevent hepatitis d (caused by the delta virus) since hepatitis d does not occur in the absence of hepatitis b infection.

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

merck sharp & dohme llc - hepatitis b virus subtype adw hbsag surface protein antigen (unii: xl4hlc6jh6) (hepatitis b virus subtype adw hbsag surface protein antigen - unii:xl4hlc6jh6) - hepatitis b virus subtype adw hbsag surface protein antigen 5 ug in 0.5 ml - recombivax hb® [hepatitis b vaccine, recombinant] is indicated for prevention of infection caused by all known subtypes of hepatitis b virus. recombivax hb is approved for use in individuals of all ages. recombivax hb dialysis formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older. do not administer recombivax hb to individuals with a history of severe allergic or hypersensitivity reactions (e.g. , anaphylaxis) after a previous dose of any hepatitis b-containing vaccine or to any component of recombivax hb, including yeast [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us 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 designed to evaluate recombivax hb in pregnant women. available post-approval data do not suggest an in

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

a-s medication solutions - hepatitis b virus subtype adw hbsag surface protein antigen (unii: xl4hlc6jh6) (hepatitis b virus subtype adw hbsag surface protein antigen - unii:xl4hlc6jh6) - hepatitis b virus subtype adw hbsag surface protein antigen 10 ug in 1 ml - recombivax hb® [hepatitis b vaccine, recombinant] is indicated for prevention of infection caused by all known subtypes of hepatitis b virus. recombivax hb is approved for use in individuals of all ages. recombivax hb dialysis formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older. do not administer recombivax hb to individuals with a history of severe allergic or hypersensitivity reactions (e.g. , anaphylaxis) after a previous dose of any hepatitis b-containing vaccine or to any component of recombivax hb, including yeast [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us 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 designed to evaluate recombivax hb in pregnant women. available post-approval data do not suggest an in