Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 30 [iu] (not less than); 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] (not less than); haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (covalently bonded to tetanus toxoid 20 - 40micrograms) - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 30 [iu] (not less than) 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] (not less than) excipient: aluminium medium 199 sodium chloride water for injection active: haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (covalently bonded to tetanus toxoid 20 - 40micrograms) excipient: aluminium as aluminium phosphate lactose - infanrix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and haemophilus influenzae type b.

Singapour - anglais - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - diphtheria toxoid; filamentous haemagglutinin; hepatitis b surface antigen (purified); hib purified capsular polysaccharide bound to tetanus toxoid; pertactin (69 kda omp); pertussis toxoid; poliovirus type 1 (inactivated); poliovirus type 2 (inactivated); poliovirus type 3 (inactivated) - injection - min 30 iu/0.5 ml - diphtheria toxoid min 30 iu/0.5 ml; filamentous haemagglutinin 25 mcg/0.5 ml; hepatitis b surface antigen (purified) 10 mcg/0.5 ml; hib purified capsular polysaccharide bound to tetanus toxoid 10 mcg/0.5 ml; pertactin (69 kda omp) 8 mcg/0.5 ml; pertussis toxoid 25 mcg/0.5 ml; poliovirus type 1 (inactivated) 40 du/0.5 ml; poliovirus type 2 (inactivated) 8 du/0.5 ml; poliovirus type 3 (inactivated) 32 du/0.5 ml

Union européenne - anglais - EMA (European Medicines Agency)

mcm vaccine b.v. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae types 2 and 3, hepatitis b surface antigen produced in yeast cells, poliovirus (inactivated): type 1 (mahoney), type 2 (mef-1), type 3 (saukett) produced in vero cells/ haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein. - meningitis, haemophilus; poliomyelitis; tetanus; diphtheria; whooping cough; hepatitis b - vaccines - vaxelis (dtap-hb-ipv-hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and invasive diseases caused by haemophilus influenzae type b (hib). the use of vaxelis should be in accordance with official recommendations.

Canada - anglais - Health Canada

glaxosmithkline inc - hepatitis b surface antigen (recombinant) - suspension - 20mcg - hepatitis b surface antigen (recombinant) 20mcg - vaccines

Canada - anglais - Health Canada

glaxosmithkline inc - hepatitis b surface antigen (recombinant) - suspension - 10mcg - hepatitis b surface antigen (recombinant) 10mcg - vaccines

États-Unis - anglais - 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)] .

Australie - anglais - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml; pertactin, quantity: 16 microgram/ml; poliovirus, quantity: 16 dagu; pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; diphtheria toxoid, quantity: 30 iu; tetanus toxoid, quantity: 40 iu; pertussis toxoid, quantity: 50 microgram/ml; poliovirus, quantity: 80 dagu; poliovirus, quantity: 64 dagu - injection, suspension - excipient ingredients: aluminium phosphate; aluminium hydroxide hydrate; polymyxin b sulfate; water for injections; sodium chloride; neomycin sulfate; glucose monohydrate; ascorbic acid; polysorbate 80; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; monobasic potassium phosphate; dibasic sodium phosphate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - indications: infanrix penta is indicated for immunisation of infants from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis b and poliomyelitis. infanrix penta may also be used as a booster dose at 18 months of age if boosting with hepatitis b and poliomyelitits, as well as diphtheria, tetanus and pertussis is required.

États-Unis - anglais - NLM (National Library of Medicine)

dynavax technologies corporation - 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 20 ug in 0.5 ml - heplisav-b is indicated for prevention of infection caused by all known subtypes of hepatitis b virus. heplisav-b is approved for use in adults 18 years of age and older. do not administer heplisav-b 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 heplisav-b, including yeast [see description (11)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to heplisav-b during pregnancy. women who receive heplisav-b during pregnancy are encouraged to contact 1-844-443-7734. 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 clinical studies of heplisav-b in pregnant women. available human data on heplisav- b administered to pregnant wo

Canada - anglais - Health Canada

glaxosmithkline inc - hepatitis b surface antigen (recombinant) - suspension - 10mcg - hepatitis b surface antigen (recombinant) 10mcg - vaccines

Canada - anglais - Health Canada

glaxosmithkline inc - hepatitis b surface antigen (recombinant) - suspension - 20mcg - hepatitis b surface antigen (recombinant) 20mcg - vaccines