البلد: نيوزيلاندا
اللغة: الإنجليزية
المصدر: Medsafe (Medicines Safety Authority)
Ondansetron hydrochloride dihydrate 4mg
Novartis New Zealand Ltd
Ondansetron hydrochloride dihydrate 4 mg
4 mg
Tablet
Active: Ondansetron hydrochloride dihydrate 4mg Excipient: Hypromellose Lactose Magnesium stearate Microcrystalline cellulose Opaspray yellow M-1-8429 Pregelatinised maize starch
Blister pack, 4 tablets
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 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 10 tablets - 36 months from date of manufacture stored at or below 30°C
1990-05-24
1 CONSUMER MEDICINE INFORMATION ZOFRAN ® TABLETS ONDANSETRON HYDROCHLORIDE DIHYDRATE TABLETS 4MG AND 8MG WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you start taking Zofran. This leaflet answers some common questions about Zofran Tablets. 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 Tablets 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 TABLETS. You may need to read it again. WHAT ZOFRAN TABLETS ARE USED FOR Zofran Tablets are 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 Tablets should only be used to treat the nausea and vomiting for which they have been prescribed. Zofran Tablets are not addictive. Zofran tablets are only available on the prescription of a doctor. BEFORE YOU USE ZOFRAN TABLETS _WHEN YOU MUST NOT USE THEM _ • Do not use Zofran Tablets 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 Tablets if the packaging is torn or shows signs of tampering or if the tablets look damaged or discoloured. • Do not use Zofran if you are taking apomorphine (used to treat Parkinson’s disease) • Do not take Zofran Tablets if you have ever had an allergic reaction اقرأ الوثيقة كاملة
1 DATA SHEET ZOFRAN ® TABLETS _ONDANSETRON HYDROCHLORIDE DIHYDRATE TABLETS 4 MG AND 8 MG _ QUALITATIVE AND QUANTITATIVE COMPOSITION Ondansetron tablets 4 mg: Yellow, oval, film coated tablet engraved “GXET3” on one face and plain on the other. Each tablet contains ondansetron 4 mg (as hydrochloride dihydrate). Ondansetron tablets 8 mg: Yellow, oval, film coated tablet engraved “GXET5” on one face and plain on the other. Each tablet contains ondansetron 8 mg (as hydrochloride dihydrate). PHARMACEUTICAL FORM Tablet. CLINICAL PARTICULARS _THERAPEUTIC INDICATIONS _ Ondansetron tablets are indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Ondansetron tablets are 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. • 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 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 2 hours before chemotherapy, may be 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 ADOLESCENTS (AGED 6 MONTHS TO 17 YEARS) _ In children with a body surface area اقرأ الوثيقة كاملة