Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

glaxosmithkline biologicals sa-nv - hepatitis b virus surface antigen (recombinant) 10 µg/dose - suspension for injection - 10 µg/0,5 ml - hepatitis b virus surface antigen, recombinant 10 µg/dose - hepatitis b, purified antigen

Namibia - English - Namibia Medicines Regulatory Council

serum institute of india ltd - purified hepatitis b surface antigen adsorbed on aluminium hydroxide - injection - each dose of 1 ml contains 20 mcg of purified hepatitis b surface antigen ; adsorbed on aluminium hydroxide

Namibia - English - Namibia Medicines Regulatory Council

serum institute of india ltd - purified hepatitis b surface antigen - injection - each dose of 0.5 ml contains 10 mcg of purified hepatitis b surface antigen adsorbed on aluminium hydroxide

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

glaxosmithkline australia pty ltd - hepatitis a virus antigen; hepatitis b surface antigen recombinant -

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous haemagglutinin, pertactin, hepatitis b surface antigen, inactivated poliovirus type 1, inactivated poliovirus type 2, inactivated poliovirus type 3, haemophilus influenzae type b polysaccharide (conjugated to tetanus toxoid) - powder and suspension for suspension for injection - not less than 30iu/dose+ not less than 40iu/dose+ 25mcg/dose+ 25mcg/dose+ 8mcg/dose+ 10mcg/dose+ 40d-antigen unit/dose+ 8d-antig

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.

European Union - English - EMA (European Medicines Agency)

sanofi pasteur europe - filamentous haemagglutinin, haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate), hepatitis b surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (mahoney strain) produced on vero cells, poliovirus (inactivated) type 2 (mef-1 strain) produced on vero cells, poliovirus (inactivated) type 3 (saukett strain) produced on vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, diphtheria toxoid - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines - hexyon (dtap-ipv-hb-hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and invasive diseases caused by haemophilus influenzae type b (hib).the use of this vaccine should be in accordance with official recommendations.

Canada - English - Health Canada

glaxosmithkline inc - haemophilus influenzae type b-prp; filamentous haemagglutinin; pertactin; hepatitis b surface antigen (recombinant); diphtheria toxoid; tetanus toxoid; poliovirus type 1 mahoney (inactivated); poliovirus type 2 mef1 (inactivated); poliovirus type 3 saukett (inactivated); pertussis toxoid; tetanus toxoid adsorbed - suspension - 10mcg; 25mcg; 8mcg; 10mcg; 25lf; 10lf; 40unit; 8unit; 32unit; 25mcg; 40mcg - haemophilus influenzae type b-prp 10mcg; filamentous haemagglutinin 25mcg; pertactin 8mcg; hepatitis b surface antigen (recombinant) 10mcg; diphtheria toxoid 25lf; tetanus toxoid 10lf; poliovirus type 1 mahoney (inactivated) 40unit; poliovirus type 2 mef1 (inactivated) 8unit; poliovirus type 3 saukett (inactivated) 32unit; pertussis toxoid 25mcg; tetanus toxoid adsorbed 40mcg - vaccines

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 30 [iu]; hepatitis b surface antigen, recombinant 10ug; pertactin 8ug; pertussis filamentous haemagglutinin 25ug; pertussis toxoid, adsorbed 25ug; polio virus type 1 40 dagu (/dose); polio virus type 2 8 dagu (/dose); polio virus type 3 32 dagu (/dose); tetanus toxoid, adsorbed 40 [iu] - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 30 [iu] hepatitis b surface antigen, recombinant 10ug pertactin 8ug pertussis filamentous haemagglutinin 25ug pertussis toxoid, adsorbed 25ug polio virus type 1 40 dagu (/dose) polio virus type 2 8 dagu (/dose) polio virus type 3 32 dagu (/dose) tetanus toxoid, adsorbed 40 [iu] excipient: aluminium hydroxide aluminium phosphate formaldehyde glycine medium 199 monobasic potassium phosphate neomycin sulfate polymyxin b sulfate polysorbate 20 potassium chloride sodium chloride sodium phosphate (32p) water for injection - infanrix®-penta is indicated for immunisation against diphtheria, tetanus, pertussis, hepatitis b and poliomyelitis in infants from the age of 6 weeks and may also be given to infants who received a first dose of hepatitis b vaccine at birth.

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

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant -