USA - engelsk - NLM (National Library of Medicine)

grifols usa, llc - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - albumin human 12.5 g in 50 ml - for restoration and maintenance of circulating blood volume where hypovolemia is demonstrated and colloid use is appropriate. when hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20-25% albumin solutions should be used.1,2,3 acute liver failure is a special situation in which both hypovolemia and hypoalbuminemia can be present. human albumin grifols® 25% can be used in such cases.1 human albumin grifols 25% may be of value in the treatment of shock or hypotension in renal dialysis patients.1 preoperative dilution of blood using albumin and crystalloid can be used in cardiopulmonary bypass procedures. albumin also may be used in the priming fluid.4,5,6 human albumin grifols 25% may be used to treat peripheral edema in patients with acute nephrosis who are refractory to cyclophosphamide, corticosteroid therapy or diuretics.1,2,7 human albumin grifols 25% may be indicated for subjects with hypoalbuminemia who are critically ill and/or actively bleeding. when

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - protein c, quantity: 1000 iu - injection, intravenous infusion - excipient ingredients: water for injections - ceprotin is indicated in purpura fulminas and coumarin induced skin necrosis in patients with severe congenital protein c deficiency. since safety and efficacy data are not available in conditions other than severe congenital deficiency, use should be limited to these conditions.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - protein c, quantity: 500 iu - injection, diluent for - excipient ingredients: water for injections - ceprotin is indicated in purpura fulminas and coumarin induced skin necrosis in patients with severe congenital protein c deficiency. since safety and efficacy data are not available in conditions other than severe congenital deficiency, use should be limited to these conditions.

Malta - engelsk - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - powder and solvent for solution for infusion - human plasma protein 9-14 g - blood substitutes and perfusion solutions

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - hepatitis b immunoglobulin, quantity: 400 iu; human immunoglobulin g, quantity: 160 mg/ml - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - hepatitis b immunoglobulin-vf is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (<10iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin-vf is also indicated for prophylaxis in infants born to hbsag-positive mothers.

USA - engelsk - NLM (National Library of Medicine)

csl behring llc - .alpha.1-proteinase inhibitor human (unii: f43i396ois) (.alpha.1-proteinase inhibitor human - unii:f43i396ois) - .alpha.1-proteinase inhibitor human 1000 mg in 20 ml - zemaira is an alpha1 -proteinase inhibitor (a1 -pi) indicated for chronic augmentation and maintenance therapy in adults with a1 -pi deficiency and clinical evidence of emphysema. zemaira increases antigenic and functional (anti-neutrophil elastase capacity [anec]) serum levels and lung epithelial lining fluid (elf) levels of a1 -pi. clinical data demonstrating the long-term effects of chronic augmentation therapy of individuals with zemaira are not available. the effect of augmentation therapy with zemaira or any a1 -pi product on pulmonary exacerbations and on the progression of emphysema in a1 -pi deficiency has not been demonstrated in randomized, controlled clinical studies. zemaira is not indicated as therapy for lung disease patients in whom severe a1 -pi deficiency has not been established. - zemaira is contraindicated in patients with a history of anaphylaxis or severe systemic reactions to zemaira or a1 -pi protein. - zemaira is contraindicated in immunoglobulin a (iga)-deficient patients with antibodies against iga, due to the risk of severe hypersensitivity [see warnings and precautions (5.2)] . risk summary no animal reproduction studies have been conducted with zemaira and its safety for use in human pregnancy has not been established in controlled clinical trials. since alpha1 -proteinase inhibitor is an endogenous human protein, it is considered unlikely that zemaira will cause harm to the fetus when given at recommended doses. however, zemaira should be given with caution to pregnant women. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no information regarding the excretion of zemaira in human milk, the effect on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for zemaira and any potential adverse effects on the breastfed infant from zemaira or from the underlying maternal condition. safety and effectiveness in the pediatric population have not been established. the safety and efficacy of zemaira in the geriatric population have not been established due to an insufficient number of subjects.

Malta - engelsk - Medicines Authority

baxter healthcare limited - human fibrinogen; aprotinin; human thrombin; calcium chloride dihydrate - solution for sealant - human fibrinogen 455 mg; aprotinin 1500 kiu/ml; human thrombin 2500 iu; calcium chloride dihydrate 200 mmol - antihemorrhagics

Malta - engelsk - Medicines Authority

baxter healthcare limited - human fibrinogen; aprotinin; human thrombin; calcium chloride dihydrate - solution for sealant - human fibrinogen 182 mg; aprotinin 6000 kiu/ml; human thrombin 1000 iu; calcium chloride dihydrate 80 µmol - antihemorrhagics

Australien - engelsk - APVMA (Australian Pesticides and Veterinary Medicines Authority)

bioproperties pty. ltd. - mycoplasma synoviae strain ms-h vaccine, living - misc. aural, ophthalmic, oro/naso pharyngeal - mycoplasma synoviae strain ms-h vaccine, living vaccine-general active 105.7 ccu/dose - immunotherapy - poultry broilers (meat for human consum) | poultry layers (eggs for human consump) | poultry pullets (growing chook) | breeding - airsacculitis | chronic respiratory disease | infectious synovitis | vaccine | equine rotavirus | ms

USA - engelsk - NLM (National Library of Medicine)

grifols usa, llc - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 0.165 g in 1 ml - gamastan is a human immune globulin indicated for: gamastan is indicated for prophylaxis following exposure to hepatitis a.(1,2) the prophylactic value of gamastan is greatest when given before or soon after exposure to hepatitis a. gamastan is not indicated in persons with clinical manifestations of hepatitis a or in those exposed more than 2 weeks previously. gamastan is indicated to prevent or modify measles in a susceptible person exposed fewer than 6 days previously.(3) a susceptible person is one who has not been vaccinated and has not had measles previously. - gamastan may be especially indicated for susceptible household contacts of measles patients, particularly contacts under 1 year of age, for whom the risk of complications is highest.(3) - gamastan is also indicated for pregnant women without evidence of immunity. - do not give gamastan and measles vaccine at the same time. if a child is older than 12 months and has received gamastan, give measles vaccine about five months later when the measles a