カナダ - 英語 - Health Canada

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

欧州連合 - 英語 - EMA (European Medicines Agency)

sanofi pasteur - hepatitis b surface antigen, diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens pertussis toxoid filamentous haemagglutinin, poliovirus (inactivated) type 1 (mahoney) type 2 (mef-1) type 3 (saukett), haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines, bacterial and viral vaccines, combined - hexacima (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.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

diasorin australia pty ltd - 60812 - hepatitis b virus surface antigen neutralization ivd, kit, chemiluminescent immunoassay - the hbsag confirmatory test is an in vitro neutralization assay for confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum and plasma samples found repeatedly reactive for hbsag by liaison? xl murex hbsag quant or liaison? hbsag. ivd neutralization assay for confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum and plasma samples found repeatedly reactive for hbsag by liaison? xl murex hbsag quant or liaison? hbsag.

オーストラリア - 英語 - 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.

カナダ - 英語 - Health Canada

merck canada inc - hepatitis b surface antigen (recombinant) - solution - 40mcg - hepatitis b surface antigen (recombinant) 40mcg - vaccines

カナダ - 英語 - Health Canada

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

カナダ - 英語 - Health Canada

merck canada inc - hepatitis b surface antigen (recombinant) - suspension - 40mcg - hepatitis b surface antigen (recombinant) 40mcg - vaccines

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

a-s medication solutions - hepatitis b virus subtype adw2 hbsag surface protein antigen (unii: 9gcj1l5d1p) (hepatitis b virus subtype adw2 hbsag surface protein antigen - unii:9gcj1l5d1p) - engerix-b is indicated for immunization against infection caused by all known subtypes of hepatitis b virus. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis b-containing vaccine, or to any component of engerix-b, including yeast, is a contraindication to administration of engerix-b [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 engerix-b 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 engerix-b during pregnancy (see data) . there are no animal studies with engerix-b to inform use during pregnancy. a developmental toxicity study was performed in female rats administered a vaccine with the same hepatitis b surface antigen component and quantity as engerix-b 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: in an evaluation of pre- and post-licensure clinical trials of engerix-b, 58 pregnant women were inadvertently administered engerix-b following their last menstrual period. after excluding elective terminations (n = 6), those with an unknown outcome (n = 3), those with exposure in the third trimester (n = 1), and those with an unknown exposure timing (n = 22), there were 26 pregnancies with known outcomes with exposure in the first or second trimester. miscarriage was reported in 11.5% of pregnancies with exposure prior to 20 weeks of gestation (3/26) and major birth defects were reported in 0% (0/23) of live births born to women with exposure during the first or second trimester. the rates of miscarriage and major birth defects were consistent with estimated background rates. no pregnancy registry for engerix-b was conducted. twinrix [hepatitis a & hepatitis b (recombinant) vaccine] is a bivalent vaccine containing the same hepatitis b surface antigen component and quantity as used in engerix-b. therefore, clinical data accrued with twinrix are relevant to engerix-b. a pregnancy exposure registry was maintained for twinrix 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. animal data: in a developmental toxicity study, female rats were administered twinrix, which contains the same hepatitis b surface antigen component and quantity as engerix-b, 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 engerix-b 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 engerix-b and any potential adverse effects on the breastfed child from engerix-b or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. safety and effectiveness of engerix-b have been established in all pediatric age-groups. maternally transferred antibodies do not interfere with the active immune response to the vaccine. [see adverse reactions (6), clinical studies (14.1, 14.3, 14.4).] the timing of the first dose in infants weighing less than 2,000 g at birth depends on the hbsag status of the mother. [see warnings and precautions (5.3).] clinical studies of engerix-b used for licensure did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. however, in later studies it has been shown that a diminished antibody response and seroprotective levels can be expected in persons older than 60 years.5 [see clinical studies (14.2).]

欧州連合 - 英語 - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - hepatitis b, recombinant surface antigen - hepatitis b; immunization - vaccines - 5 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-b virus. the specific at-risk categories to be immunised are to be determined on the basis of the official recommendations. it can be expected that hepatitis d will also be prevented by immunisation with hbvaxpro as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis-b infection. 10 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-b virus. the specific at-risk categories to be immunised are to be determined on the basis of the official recommendations. it can be expected that hepatitis d will also be prevented by immunisation with hbvaxpro as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis-b infection. 40 micrograms hbvaxpro is indicated for the active immunisation against hepatitis-b-virus infection caused by all known subtypes in predialysis and dialysis adult patients. it can be expected that hepatitis d will also be prevented by immunisation with hbvaxpro as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection.,

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

siemens healthcare pty ltd - 42000 - hepatitis b virus surface antigen ivd, control - the material is a recalcified human plasma negative and positive control for hbsag. a quality control for in vitro diagnostic use in monitoring the performance of the atellica im hbsii and hbsii conf assays.