Austrália - angličtina - 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.

Austrália - angličtina - 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.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

australian nuclear science and technology organisation t/a ansto - sodium iodide(123i), quantity: 1 mbq - capsule - excipient ingredients: dibasic sodium phosphate heptahydrate; sodium bicarbonate; sodium thiosulfate pentahydrate; sodium hydroxide; purified water; sunset yellow fcf; quinoline yellow; titanium dioxide; brilliant blue fcf; carmoisine; gelatin; ethanol; shellac; pharmaceutical glaze; carbon black - sodium iodide [123] diagnostic capsules are for diagnostic imaging of thyroid tissue.

Singapur - angličtina - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - immunology - immunoassay for the in vitro quantitative determination of placental growth factor (plgf) in human serum. the plgf assay is used in combination with the elecsys sflt‑1 assay to determine the sflt‑1/plgf ratio. the sflt‑1/plgf ratio is intended for use as an aid in the diagnosis of preeclampsia in conjunction with other diagnostic and clinical information. in addition the sflt‑1/plgf ratio is intended for use as an aid in short-term prediction of preeclampsia (rule-out and rule-in) in pregnant women with suspicion of preeclampsia in conjunction with other diagnostic and clinical information. this assay is intended for the use as one component, in combination with other parameters, to evaluate the risk of early-onset preeclampsia during the first trimester of pregnancy. the electrochemiluminescence immunoassay “eclia” is intended for use on cobas e immunoassay analyzers.

Singapur - angličtina - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - immunology - immunoassay for the in vitro quantitative determination of soluble fms‑like tyrosine kinase‑1 (sflt‑1) in human serum. the elecsys sflt‑1 assay is used in combination with the elecsys plgf assay to determine the sflt‑1/plgf ratio. the sflt‑1/plgf ratio is intended for use as an aid in the diagnosis of preeclampsia in conjunction with other diagnostic and clinical information. in addition the sflt‑1/plgf ratio is intended for use as an aid in short-term prediction of preeclampsia (rule-out and rule-in) in pregnant women with suspicion of preeclampsia in conjunction with other diagnostic and clinical information. the electrochemiluminescence immunoassay “eclia” is intended for use on cobas e immunoassay analyzers.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - dasatinib propylene glycol, quantity: 116 mg (equivalent: dasatinib, qty 100 mg) - tablet, film coated - excipient ingredients: hydrogenated castor oil; lactose; silicon dioxide; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin - dasatinib dr.reddy's is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib dr.reddy's is indicated for the treatment of paediatric patients with: ? ph+ cml in the chronic phase. ? newly diagnosed ph+ all in combination with chemotherapy.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - dasatinib propylene glycol, quantity: 23.2 mg (equivalent: dasatinib, qty 20 mg) - tablet, film coated - excipient ingredients: lactose; croscarmellose sodium; triacetin; hydrogenated castor oil; magnesium stearate; titanium dioxide; silicon dioxide; microcrystalline cellulose; hypromellose - dasatinib dr.reddy's is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib dr.reddy's is indicated for the treatment of paediatric patients with: ? ph+ cml in the chronic phase. ? newly diagnosed ph+ all in combination with chemotherapy.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - dasatinib propylene glycol, quantity: 81.2 mg (equivalent: dasatinib, qty 70 mg) - tablet, film coated - excipient ingredients: silicon dioxide; croscarmellose sodium; magnesium stearate; triacetin; titanium dioxide; microcrystalline cellulose; lactose; hydrogenated castor oil; hypromellose - dasatinib dr.reddy's is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib dr.reddy's is indicated for the treatment of paediatric patients with: ? ph+ cml in the chronic phase. ? newly diagnosed ph+ all in combination with chemotherapy.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - dasatinib propylene glycol, quantity: 58 mg (equivalent: dasatinib, qty 50 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; hydrogenated castor oil; magnesium stearate; hypromellose; titanium dioxide; lactose; triacetin; silicon dioxide - dasatinib dr.reddy's is indicated for the treatment of adults aged 18 years or over with: ? newly diagnosed philadelphia chromosome positive (ph+) chronic myeloid leukaemia in the chronic phase. ? chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib. ? newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy. ? philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.,dasatinib dr.reddy's is indicated for the treatment of paediatric patients with: ? ph+ cml in the chronic phase. ? newly diagnosed ph+ all in combination with chemotherapy.

Singapur - angličtina - HSA (Health Sciences Authority)

ortho-clinical diagnostics singapore pte. ltd. - immunology - for the qualitative determination of total (igg and igm) antibodies to treponema pallidum (tp) specific antigens in human serum and plasma (heparin, edta and citrate) using the vitros eci/eciq/3600 immunodiagnostic systems and the vitros 5600/xt 7600 integrated systems.the presence of antibodies to treponema pallidum (tp) specific antigens, in conjunction with non-treponemal laboratory tests and clinical findings may aid in the diagnosis of recent, past or treated syphilis infection.