New Zealand - English - Medsafe (Medicines Safety Authority)

takeda new zealand limited - octocog alfa 2000 [iu];   - injection with diluent - 2000 iu - active: octocog alfa 2000 [iu]   excipient: calcium chloride dihydrate glutathione histidine mannitol polysorbate 80 sodium chloride trehalose dihydrate trometamol water for injection - advate is indicated for use in haemophilia a for prevention and control of haemorrhagic episodes. patients with haemophilia a may be treated with advate as perioperative management. advate is not indicated in von willebrand's disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - efmoroctocog alfa 2000 [iu];   - powder for infusion - 2000 iu - active: efmoroctocog alfa 2000 [iu]   excipient: calcium chloride dihydrate histidine polysorbate 20 sodium chloride sucrose water for injection - eloctate is a long-acting antihaemophilic factor (recombinant) indicated in adults and children with haemophilia a (congenital factor viii deficiency) for: · control and prevention of bleeding episodes · routine prophylaxis to prevent or reduce the frequency of bleeding episodes · perioperative management (surgical prophylaxis). eloctate does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand's disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - octocog alfa 2000 [iu] (recombinant factor viii) - injection with diluent - 2000 iu - active: octocog alfa 2000 [iu] (recombinant factor viii) excipient: calcium chloride glycine histidine polysorbate 80 sodium chloride sucrose water for injection water for injection - kogenate fs is indicated in congenital factor viii deficiency (haemophilia a) for the treatment and prophylaxis of bleeding in untreated and previously treated patients without inhibitors.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - epoetin beta 2000 [iu] (in 0.3ml) - solution for injection - 2000 iu/0.3ml - active: epoetin beta 2000 [iu] (in 0.3ml) excipient: calcium chloride dihydrate dibasic sodium phosphate dodecahydrate glutamic acid glycine isoleucine leucine monobasic sodium phosphate dihydrate phenylalanine polysorbate 20 sodium chloride threonine urea water for injection - - for the treatment of anaemia associated with chronic kidney disease in patients on dialysis and symptomatic patients not yet undergoing dialysis - for the prevention of anaemia of prematurity in infants with a birth weight of 750 g to 1500 g and a gestational age of less than 34 weeks - for the treatment of anaemia in patients with non-myeloid malignancies, where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate. - to increase the yield of autologous blood from patients in a pre-donation programme initiated to avoid the use of homologous blood

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - moroctocog alfa 2000 [iu] equivalent to 180 µg;   - injection with diluent - 2000 iu - active: moroctocog alfa 2000 [iu] equivalent to 180 µg   excipient: calcium chloride dihydrate histidine polysorbate 80 sodium chloride sucrose sodium chloride water for injection - xyntha is indicated for the control and prevention of haemorrhagic episodes in patients with haemophilia a, including control and prevention of bleeding in surgical settings. xyntha does not contain von willebrand factor and should not be used by patients with von willebrand's disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - eftrenonacog alfa 2000 [iu];   - powder for infusion - 2000 iu - active: eftrenonacog alfa 2000 [iu]   excipient: histidine mannitol polysorbate 20 sucrose sodium chloride water for injection - alprolix is a long-acting anti-haemophilic factor (recombinant) indicated in adults and children with haemophilia b (congenital factor ix deficiency) for: - control and prevention of bleeding episodes - routine prophylaxis to prevent or reduce the frequency of bleeding episodes - perioperative management (surgical prophylaxis)

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

ge healthcare inc. - human albumin microspheres (unii: t8c6w1n6nw) (human albumin microspheres - unii:t8c6w1n6nw), perflutren (unii: ck0n3wh0sr) (perflutren - unii:ck0n3wh0sr) - human albumin microspheres 10 mg in 1 ml - optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. do not administer optison to patients with known or suspected hypersensitivity to perflutren or albumin [see warnings and precautions (5.5)] . risk summary there are no data with optison use in pregnant women to inform any drug-associated risks. no adverse developmental outcomes were observed in animal reproduction studies with intravenous administration of optison to pregnant rats and rabbits during organogenesis at doses up to at least 5 and 10 times the recommended human dose based on body surface area (see data ). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data optison was administered intravenously to rats at doses of 0.25, 5 and 10 ml/kg/day (approximately 0.2, 5 and 10 times the recommended maximum human dose of 8.7 ml, respectively, based on body surface area) and to rabbits at 0.25, 2.5 and 5 ml/kg/day (approximately 0.5, 5 and 10 times the recommended maximum human dose, respectively, based on body surface area) during organogenesis. no significant findings attributable solely to a direct effect on the fetus were detected in the studies. there are no data on the presence of perflutren protein-type a microspheres in human milk, the effects 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 optison and any potential adverse effects on the breastfed infant from optison or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. of the total number of subjects in a clinical study of optison, 35% were 65 and over, while 14% were 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

European Union - English - EMA (European Medicines Agency)

ge healthcare as - perflutren - echocardiography - contrast media - this medicinal product is for diagnostic use only.optison is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left-ventricular-endocardial-border delineation with resulting improvement in wall-motion visualisation.optison should only be used in patients where the study without contrast enhancement is inconclusive.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

sipcam pacific australia pty. limited - diflufenican - suspension concentrate - diflufenican anilide/aniline-nicotinanilide active 500.0 g/l - herbicide - clover pasture | field pea | lentil | lupin | poppy oilseed | drug poppy | oilseed poppy | opium poppy | pulse | subterranean cl - amsinckia - suppression | capeweed - suppression | charlock | chickweed - suppression | corn gromwell - suppression | crassula - suppression | deadnettle | hedge or wild mustard | hyssop loosestrife - suppression | indian hedge mustard | marshmallow - suppression | mouse-ear chickweed - suppression | night-scented stock - suppression | paterson's curse - suppression | pheasant's-eye or adonis | prickly lettuce | rough poppy - suppression | shepherd's purse - suppression | skeleton weed - suppression | sorrel - suppression | speedwell (v. hederifolia) - suppression | stinging nettle - suppression | toad rush - suppression | turnip weed | wild radish or radish weed | wild turnip - brassica tournefortii | wireweed, hogweed - suppression | adonis annua | adonis dentatus | brassica kaber | brassica sinapistrum | buglossoides arvense | crambling mustard | giant mustard | hedge mustard | henbit deadnettle | iron weed | ivyleaf speedwell | ivyleaved speedwell | jointed charlock | knotweed | marsh mallow | mouse-eared

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

bayer australia ltd - damoctocog alfa pegol, quantity: 2000 iu - injection, powder for - excipient ingredients: glycine; histidine; sucrose; calcium chloride dihydrate; sodium chloride; polysorbate 80 - jivi, damoctocog alfa pegol, is a long-acting recombinant factor viii concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with haemophilia a for:,? routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes,? on-demand treatment and control of bleeding episodes,? per-operative management of bleeding (surgical prophylaxis),jivi does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand?s disease.