Land: Neuseeland
Sprache: Englisch
Quelle: Medsafe (Medicines Safety Authority)
Ondansetron 8mg
Novartis New Zealand Ltd
Ondansetron 8 mg
8 mg
Wafer
Active: Ondansetron 8mg Excipient: Aspartame Gelatin Mannitol Sodium methyl hydroxybenzoate Sodium propyl hydroxybenzoate Strawberry Flavour 17.C5.6217
Blister pack, 4 wafers
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: Blister pack, - 4 wafers - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 10 wafers - 36 months from date of manufacture stored at or below 30°C
1996-09-25
1 CONSUMER MEDICINE INFORMATION ZOFRAN ® ZYDIS™ ONDANSETRON HYDROCHLORIDE DIHYDRATE WAFERS 4MG AND 8MG WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you start taking Zofran Zydis. This leaflet answers some common questions about Zofran Zydis. 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 taking Zofran Zydis 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 with your medication. You may need to read it again. WHAT ZOFRAN ZYDIS ARE USED FOR Zofran Zydis is used to help stop the nausea (sick feeling) and vomiting which can occur after certain treatments such as chemotherapy and radiotherapy. They are also used for the prevention of nausea and vomiting, which can occur after an operation. Zofran Zydis wafers should only be used to treat the nausea and vomiting for which they have been prescribed. Zofran Zydis wafers are not addictive. Zofran Zydis is only available on the prescription of a doctor. BEFORE YOU USE ZOFRAN ZYDIS _WHEN YOU MUST NOT USE THEM _ • Do not use Zofran Zydis if you are taking apomorphine (used to treat Parkinson’s disease) • Do not take Zofran Zydis if you have ever had an allergic reaction to ondansetron or any of the other ingredients in Zofran Zydis which are listed at the end of this leaflet. • Do not use Zofran Zydis 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 Zydi Lesen Sie das vollständige Dokument
1 DATA SHEET ZOFRAN ® _ONDANSETRON ZYDIS™ 4 MG AND 8 MG _ _ _ QUALITATIVE AND QUANTITATIVE COMPOSITION Zofran Zydis 4 mg: White, round, plano-convex, freeze dried, fast dispersing oral dosage form. Each Zydis contains ondansetron 4 mg. Zofran Zydis 8 mg: White, round, plano-convex, freeze dried, fast dispersing oral dosage form. Each Zydis contains ondansetron 8 mg. PHARMACEUTICAL FORM Freeze dried, fast dispersing tablets. CLINICAL PARTICULARS _THERAPEUTIC INDICATIONS _ Zofran Zydis is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Zofran Zydis is also indicated for the prevention of post-operative nausea and vomiting. _POSOLOGY AND METHOD OF ADMINISTRATION _ Zofran is also available for parenteral use to allow the route of administration and dosing to be flexible. Place the Zydis on top of the tongue, where it will disperse within seconds, then swallow. • 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 selection of dose regimen should be determined by the severity of the emetogenic challenge. 2 The recommended oral dose is 8 mg taken 1-2 hours before chemotherapy or radiation treatment, followed by 8 mg orally every 12 hours for a maximum of 5 days. For highly emetogenic chemotherapy a single oral dose of up to 24 mg Zofran taken together with 12 mg oral dexamethasone sodium phosphate, 1 to 2 hours before chemotherapy, may by used. After the first 24 hours, oral treatment with Zofran may be continued for up to 5 days after a course of treatment. The recommended oral dose is 8 mg to be taken twice daily. _CHILDREN AND AD Lesen Sie das vollständige Dokument