Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Ondansetron
Novartis Ireland Limited
A04AA; A04AA01
Ondansetron
16 milligram(s)
Suppository
Product subject to prescription which may not be renewed (A)
Serotonin (5HT3) antagonists; ondansetron
Not marketed
1998-05-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ZOFRAN® 16 MG SUPPOSITORIES ondansetron READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions about your illness or your medicine, ask your doctor, nurse or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1 What Zofran suppositories are and what they are used for 2 What you need to know before you use Zofran suppositories 3 How to use Zofran suppositories 4 Possible side effects 5 How to store Zofran suppositories 6 Contents of the pack and other information 1. WHAT ZOFRAN SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR Zofran suppositories contain a medicine called ondansetron. This belongs to a group of medicines called anti-emetics. ZOFRAN SUPPOSITORIES ARE FOR USE IN YOUR BACK PASSAGE ONLY (RECTAL USE). THEY SHOULD NOT BE SWALLOWED. Zofran suppositories are used for: • preventing nausea and vomiting caused by chemotherapy or radiotherapy for cancer Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses. Zofran suppositories should start to work within one or two hours of taking a dose. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ZOFRAN SUPPOSITORIES DO NOT USE ZOFRAN SUPPOSITORIES IF: • if you are taking apomorphine (used to treat Parkinson’s Disease) • you are allergic (hypersensitive) to ondansetron or any of the other ingredients in Zofran suppositories (listed in section 6). If you are not sure, talk to your doctor, nurse or pharmacist before using Zofran suppositories. WARNINGS AND PRECAUTIONS Check with your doctor Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 15 December 2021 CRN00CN3K Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zofran 16 mg Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains 16.00 mg of ondansetron. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Suppositories. White, smooth, homogeneous suppository with a torpedo shape. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zofran Suppositories are indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Zofran is also available for parenteral and oral 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 dose of Zofran Suppositories is one 16mg suppository given 1-2 hours before treatment. To protect against delayed or prolonged emesis after the first 24 hours, rectal treatment with Zofran should be continued for up to 3 days, or oral treatment for up to 5 days after a course of treatment. The recommended daily dose of Zofran Suppositories is one 16mg suppository. _PAEDIATRIC POPULATION: _ CINV IN CHILDREN AND ADOLESCENTS (AGED 6 MONTHS TO 17 YEARS) The use of Zofran Suppositories in children is not recommended. The usual method of administration is a single intravenous dose immediately before chemotherapy, followed by an oral dose twelve hours later. Oral therapy should be continued for up to 5 days after a course of treatment. In paediatric clinical studies, ondansetron was given by IV infusion diluted in 25 to 50 ml of saline or other compatible infusion fluid (see section 6.6 Instructions for Use and Handling) and infused over n Lesen Sie das vollständige Dokument