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

glaxosmithkline llc - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron 4 mg in 5 ml - zofran® is indicated for the prevention of nausea and vomiting associated with: zofran is also indicated for the prevention of postoperative nausea and/or vomiting. zofran is contraindicated in patients: risk summary available data do not reliably inform the association of zofran and adverse fetal outcomes. published epidemiological studies on the association between ondansetron and fetal outcomes have reported inconsistent findings and have important methodological limitations hindering interpretation [see data ]. reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered during organogenesis at approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, based on body surface area, respectively [see data ]. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the us general population, the estimated background risk of major birth defects and miscarriages in clinically recognize

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

novartis pharmaceuticals corporation - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron 4 mg - zofran is indicated for the prevention of nausea and vomiting associated with: - highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 - initial and repeat courses of moderately emetogenic cancer chemotherapy - radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen zofran is also indicated for the prevention of postoperative nausea and/or vomiting. zofran is contraindicated in patients: - known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation [see adverse reactions (6.2)] - receiving concomitant apomorphine due to the risk of profound hypotension and loss of consciousness risk summary published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about the safety of ondansetron use in pre

Israel - English - Ministry of Health

novartis israel ltd - ondansetron as hydrochloride dihydrate - solution for injection - ondansetron as hydrochloride dihydrate 2 mg/ml - ondansetron - ondansetron - adults:zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. zofran is indicated for the prevention and treatment of post-operative nausea and vomiting (ponv). paediatric population:zofran is indicated for the management of chemotherapy-induced nausea and vomiting (cinv) in children aged ≥6 months, and for the prevention and treatment of ponv in children aged ≥ 1 month.

Israel - English - Ministry of Health

novartis israel ltd - ondansetron as hydrochloride dihydrate - tablets - ondansetron as hydrochloride dihydrate 8 mg - ondansetron - ondansetron - adults:zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. zofran is indicated for the prevention and treatment of post-operative nausea and vomiting (ponv). paediatric population:zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy.

Israel - English - Ministry of Health

novartis israel ltd - ondansetron as hydrochloride dihydrate - tablets - ondansetron as hydrochloride dihydrate 4 mg - ondansetron - ondansetron - adults:zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. zofran is indicated for the prevention and treatment of post-operative nausea and vomiting (ponv). paediatric population:zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - ondansetron hydrochloride dihydrate 2.5 mg/ml equivalent to to 2 mg/ml ondansetron base - solution for injection - 2 mg/ml - active: ondansetron hydrochloride dihydrate 2.5 mg/ml equivalent to to 2 mg/ml ondansetron base excipient: citric acid monohydrate sodium chloride sodium citrate dihydrate water for injection - zofran tablets, zofran solution for injection and zofran zydis wafers are indicated for: · management of nausea and vomiting induced by cytotoxic chemotherapy in children, adolescents and adults. · management of nausea and vomiting induced by radiotherapy in adults. zofran solution for injection is also indicated for: · prevention of post-operative nausea and vomiting in children, adolescents and adults. studies have not be conducted on the use of zofran tablets or zofran zydis wafers in the prevention of post-operative nausea and vomiting in the paediatric population.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - ondansetron hydrochloride dihydrate 4mg - tablet - 4 mg - active: ondansetron hydrochloride dihydrate 4mg excipient: hypromellose lactose magnesium stearate microcrystalline cellulose opaspray yellow m-1-8429 pregelatinised maize starch - zofran tablets, zofran solution for injection and zofran zydis wafers are indicated for: · management of nausea and vomiting induced by cytotoxic chemotherapy in children, adolescents and adults. · management of nausea and vomiting induced by radiotherapy in adults. zofran solution for injection is also indicated for: · prevention of post-operative nausea and vomiting in children, adolescents and adults. studies have not be conducted on the use of zofran tablets or zofran zydis wafers in the prevention of post-operative nausea and vomiting in the paediatric population.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - ondansetron hydrochloride dihydrate 8mg - tablet - 8 mg - active: ondansetron hydrochloride dihydrate 8mg excipient: hypromellose lactose magnesium stearate microcrystalline cellulose opaspray yellow m-1-8429 pregelatinised maize starch - zofran tablets, zofran solution for injection and zofran zydis wafers are indicated for: · management of nausea and vomiting induced by cytotoxic chemotherapy in children, adolescents and adults. · management of nausea and vomiting induced by radiotherapy in adults. zofran solution for injection is also indicated for: · prevention of post-operative nausea and vomiting in children, adolescents and adults. studies have not be conducted on the use of zofran tablets or zofran zydis wafers in the prevention of post-operative nausea and vomiting in the paediatric population.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - ondansetron 4mg - wafer - 4 mg - active: ondansetron 4mg excipient: aspartame gelatin mannitol sodium methyl hydroxybenzoate sodium propyl hydroxybenzoate strawberry flavour 17.c5.6217 - zofran tablets, zofran solution for injection and zofran zydis wafers are indicated for: · management of nausea and vomiting induced by cytotoxic chemotherapy in children, adolescents and adults. · management of nausea and vomiting induced by radiotherapy in adults. zofran solution for injection is also indicated for: · prevention of post-operative nausea and vomiting in children, adolescents and adults. studies have not be conducted on the use of zofran tablets or zofran zydis wafers in the prevention of post-operative nausea and vomiting in the paediatric population.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - ondansetron 8mg - wafer - 8 mg - active: ondansetron 8mg excipient: aspartame gelatin mannitol sodium methyl hydroxybenzoate sodium propyl hydroxybenzoate strawberry flavour 17.c5.6217 - zofran tablets, zofran solution for injection and zofran zydis wafers are indicated for: · management of nausea and vomiting induced by cytotoxic chemotherapy in children, adolescents and adults. · management of nausea and vomiting induced by radiotherapy in adults. zofran solution for injection is also indicated for: · prevention of post-operative nausea and vomiting in children, adolescents and adults. studies have not be conducted on the use of zofran tablets or zofran zydis wafers in the prevention of post-operative nausea and vomiting in the paediatric population.