País: Singapur
Idioma: inglés
Fuente: HSA (Health Sciences Authority)
ONDANSETRON HYDROCHLORIDE DIHYDRATE EQV ONDANSETRON
SANDOZ SINGAPORE PTE. LTD.
A04AA01
4 mg/2 ml
INJECTION
ONDANSETRON HYDROCHLORIDE DIHYDRATE EQV ONDANSETRON 2 mg/mL
INTRAVENOUS, INTRAMUSCULAR
Prescription Only
GlaxoSmithKline Manufacturing S.P.A
ACTIVE
1990-10-16
ZOFRAN™ INJECTION ONDANSETRON QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL of aqueous solution contains 2 mg ondansetron as hydrochloride dihydrate. PHARMACEUTICAL FORM A clear, colourless, sterile solution for injection or infusion. CLINICAL PARTICULARS INDICATIONS _ADULTS _ _ZOFRAN_ injection is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. _ZOFRAN_ is also indicated for the prevention and treatment of post-operative nausea and vomiting. PAEDIATRIC POPULATION INJECTION AND ORAL FORMULATIONS: _ZOFRAN_ is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy. No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post-operative nausea and vomiting; IV injection is recommended for this purpose. DOSAGE AND ADMINISTRATION _ZOFRAN_ is available for oral and parenteral use to allow the route of administration and dosing to be flexible. CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING (CINV AND RINV) The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The selection of dose regimen should be determined by the severity of the emetogenic challenge. • CINV AND RINV IN ADULTS The recommended intravenous (IV) or intramuscular (IM) dose of _ZOFRAN_ is 8 mg administered immediately before treatment. For highly emetogenic chemotherapy, a maximum initial ondansetron dose of 16 mg IV infused over 15 minutes may be used. A single IV dose greater than 16 mg should not be given due to dose-dependent increase of QT prolongation risk (_see Warnings and Precautions, _ _Adverse Reactions, Pharmacodynamic Effects_). The efficacy of _ZOFRAN_ in highly emetogen Leer el documento completo
Page 1 of 15 TRADE NAME Zofran TM DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM A clear, colourless, sterile solution for injection or infusion. Each 1 mL of aqueous solution contains 2 mg ondansetron as hydrochloride dihydrate. ACTIVE SUBSTANCE Ondansetron EXCIPIENTS Ampoules contain: Sodium chloride Citric acid monohydrate Sodium citrate Water for Injection INDICATIONS ADULTS _ZOFRAN_ injection is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. _ZOFRAN_ is also indicated for the prevention and treatment of post-operative nausea and vomiting. PAEDIATRIC POPULATION_ _ INJECTION AND ORAL FORMULATIONS:_ _ _ZOFRAN_ is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy. No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post-operative nausea and vomiting; IV injection is recommended for this purpose. DOSAGE REGIMEN AND ADMINISTRATION Page 2 of 15 DOSING REGIMEN CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING (CINV AND RINV) The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The selection of dose regimen should be determined by the severity of the emetogenic challenge. CINV AND RINV IN ADULTS The recommended intravenous (IV) or intramuscular (IM) dose of _ZOFRAN_ is 8 mg administered immediately before treatment. For highly emetogenic chemotherapy, a maximum initial ondansetron dose of 16 mg IV infused over 15 minutes may be used. A single IV dose greater than 16 mg should not be given due to dose- dependent increase of QT prolongation risk (see sections WARNINGS AND PRECAUTIONS, ADVERSE DRUG REACTIONS, CLINICAL PHARMACOLOGY). The efficacy of _ZOFRAN_ in highly emetogenic chemotherapy may be enhanced by the addition of a single IV dose of dexamethasone sodium phosphate 20 mg, administered prior to chemotherapy. IV doses greater than 8 mg and up to a maximum of 16 mg must Leer el documento completo