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

glaxosmithkline australia pty ltd - hepatitis a virus antigen, quantity: 720 elisa unit/ml; hepatitis b surface antigen recombinant, quantity: 20 microgram/ml - injection, suspension - excipient ingredients: trometamol; aluminium hydroxide hydrate; water for injections; polysorbate 20; dibasic sodium phosphate heptahydrate; neomycin sulfate; monobasic sodium phosphate; formaldehyde solution; aluminium phosphate; sodium chloride; acetic acid; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate; glycine - twinrix (720/20) is indicated for active immunisation against hepatitis a and hepatitis b virus infection in adults and children from 1 year of age. twinrix junior (360/10) is indicated for use in children aged 1 to 15 years.

Australia - English - 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.

Singapore - English - 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.

Australia - English - 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.

Australia - English - 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.

Singapore - English - 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.

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

antares pharma, inc. - hyaluronidase (human recombinant) (unii: 743quy4vd8) (hyaluronidase (human recombinant) - unii:743quy4vd8) - hyaluronidase (human recombinant) 150 [usp'u] in 1 ml - hylenex recombinant is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. hylenex recombinant is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs. hylenex recombinant is indicated as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. hylenex recombinant is contraindicated in patients with known hypersensitivity to hyaluronidase or any of the excipients in hylenex recombinant. discontinue hylenex recombinant if sensitization occurs. risk summary there are no adequate and well-controlled studies of hylenex recombinant administration in pregnant women to inform a drug-associated risk. subcutaneous administration of hylenex recombinant to pregnant mice throughout organogenesis did not produce teratogenic effects at clinically relevant doses. administration of hylenex recombinant to mice in a pre-/postnatal study did not produce adverse effects on offspring at clinically relevant doses. human data limited available data with hylenex recombinant in pregnant women have not identified any potential risks. animal data in an embryofetal development study, subcutaneous administration of hyaluronidase to pregnant mice throughout organogenesis produced reduced fetal weight and increased numbers of fetal resorptions at daily doses greater or equal to 3 mg/kg (approximately 360,000 usp units/kg). no malformations were produced at any dose up to approximately 18 mg/kg (approximately 2,200,000 usp units/kg). these doses are several orders of magnitude greater than the maximum recommended human dose (5 usp units/kg). in a pre- and postnatal development study, mice were dosed daily by subcutaneous injection with hyaluronidase at dose levels up to 9 mg/kg (approximately 1,100,000 usp units/kg). the study found no adverse effects on sexual maturation, learning and memory of offspring, or their ability to produce another generation of offspring. risk summary there is no information regarding the presence of hylenex recombinant in human milk, the effects on the breastfed infants, or the effects on milk production to inform risk of hylenex recombinant to an infant during lactation. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for hylenex recombinant. clinical hydration requirements for children can be achieved through administration of subcutaneous fluids facilitated with hylenex recombinant. the dosage of subcutaneous fluids administered is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. the potential for chemical or physical incompatibilities should be kept in mind [see drug interactions (7)]. the rate and volume of subcutaneous fluid administration should not exceed those employed for intravenous infusion. for premature infants or during the neonatal period, the daily dosage should not exceed 25 ml/kg of body weight, and the rate of administration should not be greater than 2 ml per minute. during subcutaneous fluid administration, special care must be taken in pediatric patients to avoid over hydration by controlling the rate and total volume of the infusion [see dosage and administration (2.1)]. no overall differences in safety or effectiveness have been observed between elderly and younger adult patients.

Singapore - English - 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.

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

al falah pharmacy store llc dubai-s12 - n/a - device - combination - medical devices-medical devices

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

mgc diagnostics australia pty ltd - 13680 - spirometer, diagnostic - a device intended to measure lung air volume and airflow rate for pulmonary disease diagnosis and screening. these measurements provide information about a patient's pulmonary function which may be compared with normal values or the patient's former values.