הממלכה המאוחדת - אנגלית - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - hepatitis b virus surface antigen - suspension for injection - 20microgram/1ml

הממלכה המאוחדת - אנגלית - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - hepatitis b virus surface antigen - suspension for injection - 40microgram/1ml

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

abbott australasia pty ltd diagnostic division - 48316 - hepatitis b virus surface total antibody ivd, kit, chemiluminescent immunoassay - the architect anti-hbs assay is a chemiluminescent microparticle immunoassay (cmia) for the quantitative determination of antibody to hepatitis b surface antigen (anti-hbs) in clinical specimens. a chemiluminescent microparticle immunoassay (cmia) for the quantitative determination of antibody to hepatitis b surface antigen (anti-hbs) in clinical specimens.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

diasorin australia pty ltd - 48315 - hepatitis b virus surface total antibody ivd, kit, enzyme immunoassay (eia) - a one-step assay based on the sandwich principle. inactivated hbsag is used as solid phase and as conjugate antigen. peroxidase-labelled hbsag binds to hbs-specific antibodies in the sample. these bind to the hbsag bound to the surface of the microtitration plate (antigen sandwich). the enzyme portion of the conjugate results in a blue colour. stopping this reaction causes colour change to yellow. intensity of yellow colour is proportional to the activity of specific antibody in sample. an enzyme immunoassay for the qualitative detection and quantitative determination of specific antibodies to the hepatitis b surface antigen (hbsag) in human serum and plasma.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

beckman coulter australia pty ltd - 48316 - hepatitis b virus surface total antibody ivd, kit, chemiluminescent immunoassay - paramagnetic particle, chemiluminescent immunoassay for quantitative determination of antibody levels hep b surface antigen the access hbs ab assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of antibody levels to hepatitis b surface antigen in human serum and plasma using the access immunoassay systems.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

siemens healthcare pty ltd - 48316 - hepatitis b virus surface total antibody ivd, kit, chemiluminescent immunoassay - the advia centaur anti-hbs2 assay is an antibody-capture microparticle direct chemiluminometric immunoassay used to measure the amount of antibody to hepatitis b surface antigen in human serum and plasma. an in vitro diagnostic immunoassay for the qualitative and quantitative determination of total antibodies to hepatitis b surface antigen in clinical specimens.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - hepatitis b virus subtype adw2 hbsag surface protein antigen (unii: 9gcj1l5d1p) (hepatitis b virus subtype adw2 hbsag surface protein antigen - unii:9gcj1l5d1p) - hepatitis b virus subtype adw2 hbsag surface protein antigen 10 ug in 0.5 ml - 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 ( 5.2).] 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).]

ארצות הברית - אנגלית - NLM (National Library of Medicine)

dispensing solutions inc. - hepatitis b virus subtype adw2 hbsag surface protein antigen (unii: 9gcj1l5d1p) (hepatitis b virus subtype adw2 hbsag surface protein antigen - unii:9gcj1l5d1p) - hepatitis b virus subtype adw2 hbsag surface protein antigen 20 ug in 1 ml - engerix-b is indicated for immunization against infection caused by all known subtypes of hepatitis b virus. as hepatitis d (caused by the delta virus) does not occur in the absence of hepatitis b infection, it can be expected that hepatitis d will also be prevented by engerix-b vaccination. engerix-b will not prevent hepatitis caused by other agents, such as hepatitis a, c, and e viruses, or other pathogens known to infect the liver. immunization is recommended in persons of all ages, especially those who are, or will be, at increased risk of exposure to hepatitis b virus,1 for example: - infants, including those born of hbsag-positive mothers (see dosage and administration.) - adolescents (see clinical pharmacology.) - healthcare personnel: dentists and oral surgeons. dental, medical, and nursing students. physicians, surgeons, and podiatrists. nurses. paramedical and ambulance personnel and custodial staff who may be exposed to the virus via blood or other patient specimens. dental hygienists and dental n

ארצות הברית - אנגלית - 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)] .

ארצות הברית - אנגלית - 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