Land: New Zealand
Sprog: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Ondansetron hydrochloride dihydrate 2.5 mg/mL equivalent to to 2 mg/mL ondansetron base
Novartis New Zealand Ltd
Ondansetron hydrochloride dihydrate 2.5 mg/mL (equiv. to 2 mg/mL ondansetron base)
2 mg/mL
Solution for injection
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
Ampoule, plastic, 2 mL
Prescription
Prescription
Glaxo Wellcome Manufacturing Pte Ltd
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.
Package - Contents - Shelf Life: Ampoule, plastic, - 2 mL - 36 months from date of manufacture stored at or below 30°C - Ampoule, plastic, - 4 mL - 36 months from date of manufacture stored at or below 30°C - Ampoule, plastic, 4mL - 5 dose units - 36 months from date of manufacture stored at or below 30°C - Ampoule, plastic, 2mL - 5 dose units - 36 months from date of manufacture stored at or below 30°C - Ampoule, plastic, 4mL - 10 dose units - 36 months from date of manufacture stored at or below 30°C - Ampoule, plastic, 2mL - 10 dose units - 36 months from date of manufacture stored at or below 30°C
1995-01-12
1 CONSUMER MEDICINE INFORMATION ZOFRAN ® INJECTION ONDANSETRON HYDROCHLORIDE DIHYDRATE INJECTION 4MG/2ML AND 8MG/4ML WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you start using Zofran. This leaflet answers some common questions about Zofran Injection. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Sometimes new risks are found even when a medicine has been used for many years. Your doctor has weighed the risks of you using Zofran Injection against the benefits they expect it will have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. KEEP THIS INFORMATION LEAFLET. You may need to read it again. WHAT ZOFRAN IS USED FOR Zofran is used to help stop the nausea (sick feeling) and vomiting which can occur after certain treatments such as chemotherapy and radiotherapy. It is also used for prevention of nausea and vomiting, which can occur after an operation. Zofran should only be used to treat the nausea and vomiting for which it has been prescribed. Zofran is not addictive. BEFORE YOU USE ZOFRAN _WHEN YOU MUST NOT USE IT _ • Do not use Zofran after the expiry or "use by" date (EXP) printed on the pack. If you take it after the expiry date it may not work as well. • Do not use Zofran if the packaging is torn or shows signs of tampering or if the solution in the injection looks cloudy, lumpy or discoloured. • Do not give your Zofran Injection to anyone else. • Do not use Zofran if you are taking apomorphine (used to treat Parkinson’s disease) • Do not take Zofran if you have ever had an allergic reaction to ondansetron or any of the other ingredients in Zofran which are li Læs hele dokumentet
1 DATA SHEET ZOFRAN ® INJECTION _ZOFRAN (ONDANSETRON HYDROCHLORIDE DIHYDRATE) INJECTION 4 MG _ _AND 8 MG _ QUALITATIVE AND QUANTITATIVE COMPOSITION Zofran injection is a clear, colourless, sterile solution. Each 1 mL of aqueous solution contains 2 mg ondansetron as the hydrochloride dihydrate. Zofran injection is available in plastic ampoules containing ondansetron 4 mg in 2 mL or ondansetron 8 mg in 4 mL. PHARMACEUTICAL FORM Solution for IM or IV administration. CLINICAL PARTICULARS _THERAPEUTIC INDICATIONS _ Ondansetron injection is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Ondansetron injection is also indicated for the prevention and treatment of post-operative nausea and vomiting. _POSOLOGY AND METHOD OF ADMINISTRATION _ Zofran is also available for oral use to allow the route of administration and dosing to be flexible. • CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING (CINV AND RINV) _ADULTS _ The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The dose range of Zofran injection is 8 to 32 mg a day and selected as shown below:- The recommended intravenous or intramuscular dose of Zofran is 8 mg administered immediately before treatment. For highly emetogenic chemotherapy, a maximum initial Zofran dose of 16 mg intravenous infused over 15 minutes may be used. A single intravenous dose greater than 16 mg should not be given. 2 The efficacy of Zofran in highly emetogenic chemotherapy may be enhanced by the addition of a single intravenous dose of dexamethasone sodium phosphate 20 mg, administered prior to chemotherapy. Intravenous doses greater than 8 mg and up to a maximum of 16 mg must be diluted in Læs hele dokumentet