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.

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

abbott australasia pty ltd diagnostic division - 48321 - hepatitis b virus surface antigen ivd, kit, chemiluminescent immunoassay - a chemiluminescent microparticle(cmia)assay for the qualitative detection of hepatitis b surface antigen in human clinical specimens. the architect hbsag qualitative ii 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 up to 24 hours post-mortem (non-heart-beating).

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

biomerieux australia pty ltd - 48319 - hepatitis b virus surface antigen ivd, kit, enzyme immunoassay (eia) - for the detection of hepatitis b surface antigen (hbs ag) in human serum or plasma, using the elfa technique (enzyme linked fluorescent assay). an automated qualitative test for use on the vidas family instruments for the detection of hepatitis b surface antigen (hbs ag) in human serum or plasma, using the elfa technique (enzyme linked fluorescent assay).

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

beckman coulter australia pty ltd - 48321 - hepatitis b virus surface antigen ivd, kit, chemiluminescent immunoassay - paramagnetic particle, chemiluminescent immunoassay for qualitative detection of surface antigen hepatitis b virus hbs ag the access hbs ag assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection of the surface antigen of the hepatitis b virus (hbs ag) in human serum and plasma using the access immunoassay systems.

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

biomerieux australia pty ltd - 48319 - hepatitis b virus surface antigen ivd, kit, enzyme immunoassay (eia) - supplementary vidas hbs ag ultra kit for confirmation of the presence of hepatitis b surface antigen in human serum or plasma found to be repeatedly positive with the vidas hbs ag ultra kit (ref. 30315). supplementary vidas hbs ag ultra kit for confirmation of the presence of hepatitis b surface antigen in human serum or plasma found to be repeatedly positive with the vidas hbs ag ultra kit (ref. 30315).

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

actavis pharma, inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 30 mg in 1.5 ml - testosterone topical solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. - primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone concentrations and gonadotropins (fsh, lh) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum concentrations but have gonadotropins in the normal or low range. limitations of use: - safety and efficacy of testosterone topical solution in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been establi

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.

Malta - English - Malta Medicines Authority

glaxo smithkline ireland limited 12, riverwalk, citywest business campus, dublin 24, ireland - hepatitis b, surface antigen, recombinant - suspension for injection in pre-filled syringe - hepatitis b surface antigen, recombinant 10 µg - vaccines

Malta - English - Malta Medicines Authority

glaxo smithkline ireland limited 12, riverwalk, citywest business campus, dublin 24, ireland - hepatitis b, surface antigen, recombinant - suspension for injection - hepatitis b surface antigen, recombinant 20 µg/l - vaccines

Malta - English - Malta Medicines Authority

glaxo smithkline ireland limited 12, riverwalk, citywest business campus, dublin 24, ireland - hepatitis b, surface antigen, recombinant - suspension for injection - hepatitis b surface antigen, recombinant 20 µg/l - vaccines