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

dr reddys laboratories australia pty ltd - palonosetron hydrochloride, quantity: 280 microgram (equivalent: palonosetron, qty 250 microgram) - injection, solution - excipient ingredients: mannitol; sodium acetate trihydrate; water for injections; hydrochloric acid; sodium hydroxide - palonosetron injection is indicated for prevention of nausea and vomiting induced by cytotoxic chemotherapy.

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

dr.reddy's laboratories limited - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron 0.05 mg in 1 ml - palonosetron hydrochloride injection is indicated in adults for prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). - acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (hec). - 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, palonosetron hydrochloride is recommended even where the incidence of postoperative nausea and/or vomiting is low. palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: - acute nausea and vomiting associated with initial and repea

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

sandoz inc - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron 0.25 mg in 5 ml - palonosetron injection is indicated in adults for prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). - acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (hec). - 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, palonosetron is recommended even where the incidence of postoperative nausea and/or vomiting is low. palonosetron hcl injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: • acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemoth

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

fresenius kabi usa, llc - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron 0.25 mg in 5 ml - palonosetron hydrochloride (hcl) injection 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 palonosetron hcl injection 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, palonosetron hcl injection is recommended even where the incidence of postoperative nausea and/or vomiting is low.  palonosetron hcl injection is contraindicated in patients known to have hypersensitivity to the drug or any of its compon

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

west-ward pharmaceuticals corp - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron .25 mg in 2 ml - palonosetron hydrochloride (hcl) injection 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 palonosetron hcl injection is contraindicated in patients known to have hypersensitivity to the drug or any of its components [see adverse reactions (6.2)] . r i sk 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 to rats and rabbits during organogenesis at doses up to 1894 and 3789 times the recommended human intravenous dose, respectively [see data]. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown.  in the u.s. general popula

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

accord healthcare, inc. - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron 0.25 mg in 5 ml - palonosetron hydrochloride injection 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 palonosetron hydrochloride injection is indicated for prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. palonosetron hydrochloride injection 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, palonosetron hydrochlorid

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

teva parenteral medicines, inc. - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron 0.25 mg in 5 ml - palonosetron hydrochloride injection is indicated in adults for prevention of: - acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (mec). - acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (hec). - 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, palonosetron hydrochloride injection is recommended even where the incidence of postoperative nausea and/or vomiting is low. palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: - acute nausea and vomiting associated with initial

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

cipla usa inc. - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron 0.25 mg in 5 ml - palonosetron hydrochloride injection 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 palonosetron hydrochloride injection is indicated for prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. palonosetron hydrochloride injection 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, palonosetron

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

dr reddys laboratories australia pty ltd - palonosetron hydrochloride, quantity: 280 microgram (equivalent: palonosetron, qty 250 microgram) - injection, solution - excipient ingredients: mannitol; sodium acetate trihydrate; water for injections; hydrochloric acid; sodium hydroxide - palonosetron injection is indicated for prevention of nausea and vomiting induced by cytotoxic chemotherapy.

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

dr reddys laboratories australia pty ltd - palonosetron hydrochloride, quantity: 280 microgram (equivalent: palonosetron, qty 250 microgram) - injection, solution - excipient ingredients: sodium acetate trihydrate; water for injections; mannitol; hydrochloric acid; sodium hydroxide - palonosetron injection is indicated for prevention of nausea and vomiting induced by cytotoxic chemotherapy.