Australija - anglų - 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.

Australija - anglų - 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.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml - injection, suspension - excipient ingredients: monobasic sodium phosphate; water for injections; sodium chloride; dibasic sodium phosphate dihydrate; aluminium hydroxide hydrate - engerix-b is indicated for active immunisation against hepatitis b virus infection. the nh&mrc* recommend all infants, young children and unvaccinated adolescents receive a primary course of immunisation against hepatitis b. the nh&mrc also recommends immunisation for persons who are at substantial risk and have been demonstrated or judged to be susceptible to the hepatitis b virus. groups identified at increased risk of acquiring hbv infection include: infants born to carrier (hbsag-positive) mothers; individuals for whom post-exposure prophylaxis for hepatitis b is indicated; household contacts (other than sexual partners) of acute and chronic hepatitis b cases and carriers; susceptible sexual contacts. risk occurs in susceptible (anti-hbs negative) partners of hbv carriers and patients with acute hepatitis b; susceptible clients of std (sexually transmitted disease) clinics, and sexually active men who have sex with men are also at increased risk of infection; injecting drug users; haemodialysis patients, hiv-positive individuals and other immunosuppressed adults; patients receiving certain blood products especially patients with clotting disorders receiving blood product concentrates; individuals with chronic liver disease and / or hepatitis c; staff and residents of facilities for the intellectually disabled, including both residential and non-residential care of this group; liver transplant recipients. such individuals should be vaccinated prior to transplantation if seronegative for hepatitis b, as they may be at increased risk of infection from the transplanted organ; staff and inmates of long term correctional facilities; health care workers, dentists, embalmers, tattooists and body-piercers. all staff directly involved in patient care, embalming, or in the handling of human blood or tissue should be vaccinated; individuals adopting children from overseas. these children should be tested for hepatitis b, and if hbsag positive, members of the adoptive family should be vaccinated; others in whom vaccination may be justified include police, members of the armed forces and emergency services staff, depending on the risks of exposure associated with assigned duties. long term travellers to regions of high endemicity, and those residing for some time in such regions who may anticipate close personal contact with local residents, should be vaccinated. short-term tourists or business travellers are at very little risk of hepatitis b, provided they avoid exposure through sexual contact, injecting drug use, tattooing or body piercing. although the risk of hepatitis b infection in contact sports is low, immunisation of those involved should not be discouraged. as the risk in australian schools is very low, vaccination of classroom contacts is seldom indicated. nevertheless, vaccination of school children and adolescents should be encouraged; as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection, it can be expected that hepatitis d will also be prevented by vaccination with engerix-b. the vaccine will not protect against infection caused by hepatitis a, hepatitis c and hepatitis e viruses, and other pathogens known to infect the liver.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 10 microgram - injection, suspension - excipient ingredients: dibasic sodium phosphate dihydrate; aluminium hydroxide hydrate; sodium chloride; monobasic sodium phosphate; water for injections - engerix-b is indicated for active immunisation against hepatitis b virus infection. the nh&mrc* recommend all infants, young children and unvaccinated adolescents receive a primary course of immunisation against hepatitis b. the nh&mrc also recommends immunisation for persons who are at substantial risk and have been demonstrated or judged to be susceptible to the hepatitis b virus. groups identified at increased risk of acquiring hbv infection include: infants born to carrier (hbsag-positive) mothers; individuals for whom post-exposure prophylaxis for hepatitis b is indicated; household contacts (other than sexual partners) of acute and chronic hepatitis b cases and carriers; susceptible sexual contacts. risk occurs in susceptible (anti-hbs negative) partners of hbv carriers and patients with acute hepatitis b; susceptible clients of std (sexually transmitted disease) clinics, and sexually active men who have sex with men are also at increased risk of infection; injecting drug users; haemodialysis patients, hiv-positive individuals and other immunosuppressed adults; patients receiving certain blood products especially patients with clotting disorders receiving blood product concentrates; individuals with chronic liver disease and / or hepatitis c; staff and residents of facilities for the intellectually disabled, including both residential and non-residential care of this group; liver transplant recipients. such individuals should be vaccinated prior to transplantation if seronegative for hepatitis b, as they may be at increased risk of infection from the transplanted organ; staff and inmates of long term correctional facilities; health care workers, dentists, embalmers, tattooists and body-piercers. all staff directly involved in patient care, embalming, or in the handling of human blood or tissue should be vaccinated; individuals adopting children from overseas. these children should be tested for hepatitis b, and if hbsag positive, members of the adoptive family should be vaccinated; others in whom vaccination may be justified include police, members of the armed forces and emergency services staff, depending on the risks of exposure associated with assigned duties. long term travellers to regions of high endemicity, and those residing for some time in such regions who may anticipate close personal contact with local residents, should be vaccinated. short-term tourists or business travellers are at very little risk of hepatitis b, provided they avoid exposure through sexual contact, injecting drug use, tattooing or body piercing. although the risk of hepatitis b infection in contact sports is low, immunisation of those involved should not be discouraged. as the risk in australian schools is very low, vaccination of classroom contacts is seldom indicated. nevertheless, vaccination of school children and adolescents should be encouraged; as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection, it can be expected that hepatitis d will also be prevented by vaccination with engerix-b. the vaccine will not protect against infection caused by hepatitis a, hepatitis c and hepatitis e viruses, and other pathogens known to infect the liver.

Europos Sąjunga - anglų - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - influenza virus surface antigens (haemagglutinin and neuraminidase) of strain a/viet nam/1194/2004 (h5n1) - influenza, human - vaccines - active immunisation against h5n1 subtype of influenza a virus.; this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain.; prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.

Europos Sąjunga - anglų - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - influenza virus surface antigens (haemagglutinin and neuraminidase) of strain a/viet nam/1194/2004 (h5n1) - influenza, human, immunization, disease outbreaks - vaccines, - active immunisation against h5n1 subtype of influenza a virus., this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain., prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.,

Australija - anglų - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - 42000 - hepatitis b virus surface antigen ivd, control - a ready to use control serum based on human serum both in the negative and positive concentration range. for quality control of the elecsys hbsag ii and elecsys hbsag ii auto confirm immunoassays on the elecsys and cobas e immunoassay analysers.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

siemens healthcare pty ltd - 42000 - hepatitis b virus surface antigen ivd, control - quality control material for the advia centaur hbsag, hbsagii and hbsag confirmatory assays using direct chemiluminometric technology. for monitoring the performance of the advia centaur hbsag, hbsagii and hbsag confirmatory assays.

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

merck sharp & dohme corp. - 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 1 g in 1 g

Didžioji Britanija - anglų - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - hepatitis b virus surface antigen - suspension for injection - 40microgram/1ml