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

csl behring australia pty ltd - water for injections, quantity: 3 ml - injection, diluent for - excipient ingredients: - berinert iv is indicated for the treatment of acute attacks in patients with hereditary angioedema (hae).

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

csl behring australia pty ltd - water for injections, quantity: 10 ml - injection, diluent for - excipient ingredients: - berinert iv is indicated for the treatment of acute attacks in patients with hereditary angioedema (hae).

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

heron therapeutics, inc. - granisetron (unii: wzg3j2mcol) (granisetron - unii:wzg3j2mcol) - granisetron 10 mg in 0.4 ml - sustol is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (mec) or anthracycline and cyclophosphamide (ac) combination chemotherapy regimens. sustol is contraindicated in patients with hypersensitivity to granisetron, any of the components of sustol, or to any of the other 5-ht3 receptor antagonists [see warnings and precautions (5.3), description (11)] . risk summary there are no available data on the use of sustol in pregnant women. limited published data on granisetron use during pregnancy are not sufficient to inform a drug-associated risk. in animal reproduction studies, no adverse developmental effects were observed in pregnant rats and rabbits administered granisetron hydrochloride during organogenesis at intravenous doses up to 61 times and 41 times respectively the maximum recommended human dose (mrhd) of sustol 10 mg/week [see data] . the estimated b

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

sagent pharmaceuticals - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron hydrochloride injection, usp is a serotonin-3 (5-ht3 ) receptor antagonist indicated for: - the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (eg. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. teratogenic effects pregnancy category b reproduction studies have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not

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

yung shin pharmaceutical inc. co., ltd. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron hydrochloride injection, usp is a serotonin-3 (5-ht3 ) receptor antagonist indicated for: - the prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high- dose cisplatin. - the prevention and treatment of postoperative nausea and vomiting in adults. as with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients where nausea and/or vomiting must be avoided during the postoperative period, granisetron hydrochloride injection, usp is recommended even where the incidence of postoperative nausea and/or vomiting is low. granisetron hydrochloride injection is contraindicated in patients with known hypersensitivity (eg. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. teratogenic effects pregnancy category b reproduction studies have been performed in pregnant rats at intra

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

physicians total care, inc. - granisetron (unii: wzg3j2mcol) (granisetron - unii:wzg3j2mcol) - granisetron 3.1 mg in 24 h - sancuso® (granisetron transdermal system) is indicated for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration. sancuso is contraindicated in patients with known hypersensitivity to granisetron or to any of the components of the patch. pregnancy category b reproduction studies with granisetron hydrochloride have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, about 24 times the recommended human dose delivered by the sancuso patch, based on body surface area) and oral doses up to 125 mg/kg/day (750 mg/m2 /day, about 326 times the recommended human dose with sancuso based on body surface area). reproduction studies have been performed in pregnant rabbits at intravenous doses up to 3 mg/kg/day (36 mg/m2 /day, about 16 times the human dose with sancuso based on body surface area) and at oral doses up to 32 mg/kg/day (384 mg/m2 /day, about 167 times the human dose with san

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

kyowa kirin, inc. - granisetron (unii: wzg3j2mcol) (granisetron - unii:wzg3j2mcol) - granisetron 3.1 mg in 24 h - sancuso® is indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration. sancuso is contraindicated in patients with known hypersensitivity to granisetron or to any of the components of the transdermal system [see description (10)] . risk summary available published data and postmarketing reports with granisetron use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in a published ex vivo human placental perfusion model, no transplacental passage of granisetron was detected at a concentration (5 ng/ml) that mimics the plasma concentration achieved following transdermal application of sancuso. in animal reproduction studies, no adverse developmental effects were observed in pregnant rats and rabbits administered granisetron hydrochloride during organogenesis at intravenous doses up to 24 times and 16 times, respective

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

avera mckennan hospital - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 1 mg

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

natco pharma limited - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron hydrochloride tablets usp are indicated for the prevention of: nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation. granisetron hydrochloride is contraindicated in patients with known hypersensitivity to the drug or any of its components.

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

neo criticare phama co., ltd. - granisetron hydrochloride - injection