Canada - English - Health Canada

natco pharma (canada) inc - granisetron (granisetron hydrochloride) - tablet - 1mg - granisetron (granisetron hydrochloride) 1mg - 5-ht3 receptor antagonists

New Zealand - English - Medsafe (Medicines Safety Authority)

rex medical ltd - granisetron hydrochloride 0.112 mg/ml - solution for injection - 0.1 mg/ml - active: granisetron hydrochloride 0.112 mg/ml excipient: citric acid monohydrate hydrochloric acid sodium chloride sodium hydroxide water for injection - granisetron is indicated for the prevention of acute and delayed nausea and vomiting associated with cytostatic therapy, and for the prevention and treatment of post-operative nausea and vomiting.

New Zealand - English - Medsafe (Medicines Safety Authority)

rex medical ltd - granisetron hydrochloride 1.12 mg/ml - solution for injection - 1 mg/ml - active: granisetron hydrochloride 1.12 mg/ml excipient: citric acid monohydrate hydrochloric acid methyl hydroxybenzoate propyl hydroxybenzoate sodium chloride sodium hydroxide water for injection - granisetron is indicated for the prevention of acute and delayed nausea and vomiting associated with cytostatic therapy, and for the prevention and treatment of post-operative nausea and vomiting.

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

Ireland - English - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - granisetron hydrochloride - concentrate for soln for inf - 1 mg/ml - serotonin (5ht3) antagonists

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

medis pharma pty ltd - irinotecan hydrochloride trihydrate, quantity: 40 mg - injection, concentrated - excipient ingredients: (s)-lactic acid; water for injections; sodium hydroxide; sorbitol - for use as a component of first line therapy for patients with metastatic carcinoma of the colon or rectum and in patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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

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

fresenius kabi australia pty ltd - irinotecan hydrochloride trihydrate, quantity: 40 mg - injection, concentrated - excipient ingredients: lactic acid; sorbitol; sodium hydroxide; water for injections - irinotecan injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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

fresenius kabi australia pty ltd - irinotecan hydrochloride trihydrate, quantity: 100 mg - injection, concentrated - excipient ingredients: water for injections; lactic acid; sodium hydroxide; sorbitol - irinotecan injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.