Singapore - English - HSA (Health Sciences Authority)

abbott laboratories (singapore ) private limited - immunology - the hbsag next qualitative assay is a chemiluminescent microparticle immunoassay (cmia) for the qualitative detection of hepatitis b surface antigen (hbsag) in human serum and plasma including specimens collected post mortem (non-heart-beating) on the architect isystem. the hbsag next qualitative assay is intended to be used as an aid in the diagnosis of hepatitis b virus (hbv) infection and as a screening test to prevent transmission of hbv to recipients of blood, blood components, cells, tissue and organs.

Singapore - English - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - immunology - immunoassay for in vitro confirmation of the presence of hepatitis b surface antigen in human serum and plasma samples repeatedly reactive when tested with the elecsys hbsag ii assay. the electrochemiluminescence immunoassay “eclia” is intended for use on cobas e immunoassay analyzers.

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

abbott australasia pty ltd diagnostic division - 48321 - hepatitis b virus surface antigen ivd, kit, chemiluminescent immunoassay - this assay is a one-step immunoassay for the qualitative detection of hbsag in human serum and plasma including specimens collected post mortem (non-heart-beating) using chemiluminescent microparticle immunoassay (cmia) technology. the hbsag next qualitative assay is a chemiluminescent microparticle immunoassay (cmia) used for the qualitative detection of hepatitis b surface antigen (hbsag) in human serum and plasma, including specimens collected post-mortem (non-heart-beating) that have been collected up to 24 hours after death, on the alinity i system.

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

roche diagnostics australia pty limited - 60812 - hepatitis b virus surface antigen neutralization ivd, kit, chemiluminescent immunoassay - the elecsys hbsag ii auto confirm assay is a fully automated confirmatory assay, based on the principle of specific antibody neutralization, intended to be used for samples repeatedly reactive in the elecsys hbsag ii assay. polyclonal hbsag specific antibodies bind to the immunodominant epitopes of hbsag and thereby block the binding sites for the antibodies used in the elecsys hbsag ii assay. immunoassay and control for in vitro confirmation of the presence of hepatitis b surface antigen in human serum and plasma samples repeatedly reactive when tested with the elecsys hbsag ii assay. these electrochemiluminescence immunoassays (eclia) are intended for use on cobas e immunoassay analysers.

Kenya - English - Pharmacy and Poisons Board

glaxosmithkline pharmaceutical kenya limited likoni rd industrial area p.o box 78392 - hepatitis b vaccine (purified hbsag) - suspension for injection - 10 g hbsag. - viral vaccines: hepatitisvaccines

Singapore - English - HSA (Health Sciences Authority)

alcotech pte ltd - clinical toxicology - the hbsag rapid test cassette is a rapid chromatographic immunoassay for the qualitative detection of hepatitis b surface antigen in human whole blood, serum or plasma to aid in the diagnosis of hbsag infection. the product is intended to be used by trained laboratory personnel. for laboratory use only. the test provides preliminary test results. negative results will not preclude hepatitis b virus infection and they can’t be used as the sole basis for treatment or other management decision. not for self-testing use. not for near-patient use. not for blood donor screening.

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

moraf pharmaceuticals limited, tanzania - hbsag rapid test strip -

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

moraf pharmaceuticals limited, tanzania - hbsag rapid test strip -

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

glaxosmithkline biologicals sa - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) (unii: qsn5xo8zsu) (bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) - unii:qsn5xo8zsu), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) (unii: 8c367iy4ey) (bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) - unii:8c367iy4ey), bordetella pertussis pertactin antigen (formaldehyde inactivated) (unii: i05o535nv6) (bordetella pertussis pertactin antigen (formaldehyde inactivated) - unii:i05o535nv6), hepatitis b virus subtype adw2 hbsag surface protein antigen (unii: 9gcj1l5d1p) (hepatitis b virus subtype adw2 hbsag surface protein antigen - unii:9gcj1l5d1p), poliovirus type 1 antigen (formaldehyde inactivated) (unii: 0lvy784c09) (poliovirus type 1 antigen (formaldehyde inactivated) - unii:0lvy784c09), poliovirus type 2 antigen (formaldehyde inactivated) (unii: 23je9kdf4r) (poliovirus type 2 antigen (formaldehyde inactivated) - unii:23je9kdf4r), poliovirus type 3 antigen (formaldehyde inactivated) (unii: 459rom8m9m) (poliovirus type 3 antigen (formaldehyde inactivated) - unii:459rom8m9m) - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) 25 [iu] in 0.5 ml - pediarix is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis b virus, and poliomyelitis. pediarix is approved for use as a 3-dose series in infants born of hepatitis b surface antigen (hbsag)-negative mothers. pediarix may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday). a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis antigen-, hepatitis b-, or poliovirus-containing vaccine or any component of this vaccine, including yeast, neomycin, and polymyxin b, is a contraindication to administration of pediarix [see description (11)] . encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including pediarix. progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, is a contraindication to administration of any pertussis-containing vaccine, including pediarix. pediarix should not be administered to individuals with such conditions until the neurologic status is clarified and stabilized. safety and effectiveness of pediarix were established in the age group 6 weeks through 6 months on the basis of clinical studies [see adverse reactions (6.1), clinical studies (14.1, 14.2)] . safety and effectiveness of pediarix in the age group 7 months through 6 years are supported by evidence in infants aged 6 weeks through 6 months. safety and effectiveness of pediarix in infants younger than 6 weeks and children aged 7 to 16 years have not been evaluated.

United States - English - 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).]