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

mgi pharma - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - injection - 0.25 mg in 5 ml - aloxi is indicated for: • moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses • highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses aloxi is indicated for: • prevention of postoperative nausea and vomiting (ponv) for up to 24 hours following surgery. efficacy beyond 24 hours has not been demonstrated. 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 vomiting must be avoided during the postoperative period, aloxi is recommended even where the incidence of postoperative nausea and/or vomiting is low. aloxi is contraindicated in patients known to have hypersensitivity to the drug or any of its components. [see adverse reactions (6.2 )] teratogenic effects: category b teratology studies have been perfo

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

helsinn therapeutics (u.s.), inc. - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - aloxi capsules are indicated in adults for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. aloxi is contraindicated in patients known to have hypersensitivity to palonosetron [see warnings and precautions (5.1)]. risk summary there are no available data on palonosetron hcl use in pregnant women to inform a drug-associated risk. in animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral palonosetron hcl during the period of organogenesis at doses up to 921 and 1,841 times the recommended human oral dose in rats and rabbits, respectively (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized p

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

juniper biologics sdn. bhd. - palonosetron hydrochloride; netupitant -

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

chugai pharma uk ltd - palonosetron hydrochloride; netupitant - capsule - 500microgram ; 300mg

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

cipla australia pty ltd - palonosetron hydrochloride, quantity: 280.8 microgram (equivalent: palonosetron, qty 250 microgram) - injection, solution - excipient ingredients: hydrochloric acid; disodium edetate; sodium citrate dihydrate; sodium hydroxide; water for injections; mannitol; citric acid monohydrate - indicated for prevention of nausea and vomiting induced by cytotoxic chemotherapy.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

accord healthcare sdn.bhd. - palonosetron (as hydrochloride) -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

medispec (m) sdn.bhd - palonosetron (as hydrochloride) -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

unimed sdn bhd - palonosetron (as hydrochloride) -

Kenya - English - Pharmacy and Poisons Board

themis medicare ltd themis medicare ltd 11/12 udyog nagar s.v. road - palonosetron hydrochloride - injection - palonosetron hydrochloride - antiemetics and antinauseants: serotonin (5-ht3)

Kenya - English - Pharmacy and Poisons Board

themis medicare ltd 11/12 udyog nagar s.v road goregaon (w) mumbai - palonosetron hydrochloride - injection - palonosetron hydrochloride 0.250mg/ 5 ml - antiemetics and antinauseants: serotonin (5-ht3)