Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Ondansetron
Rowex Ltd
A04AA; A04AA01
Ondansetron
Syrup
Serotonin (5HT3) antagonists; ondansetron
Not marketed
1998-04-17
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ZOFRAN® 4 MG/5 ML SYRUP ondansetron READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 syrup is and what it is used for 2 What you need to know before you take Zofran syrup 3 How to take Zofran syrup 4 Possible side effects 5 How to store Zofran syrup 6 Contents of the pack and other information 1. WHAT ZOFRAN SYRUP IS AND WHAT IT IS USED FOR Zofran syrup contains a medicine called ondansetron. This belongs to a group of medicines called anti- emetics. Zofran syrup is used for: • preventing nausea and vomiting caused by chemotherapy or radiotherapy for cancer in ADULTS • preventing nausea and vomiting after surgery in ADULTS • preventing nausea and vomiting caused by chemotherapy for cancer in CHILDREN AND ADOLESCENTS aged 6 months to 17 years Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses. Zofran syrup 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 TAKE ZOFRAN SYRUP DO NOT TAKE ZOFRAN SYRUP 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 syrup (listed in Section 6). If you are not sure, talk to your doctor, nurse or pharmacist before taking Zofran syrup. WARNINGS AND PRECAUTIONS Check with your doctor or pharmacis Preberite celoten dokument
Health Products Regulatory Authority 23 February 2023 CRN00DC7H Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zofran 4 mg/5 ml syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml contains 4mg ondansetron (as ondansetron hydrochloride dihydrate). Excipients with known effect: Each 5 ml also contains 2.1g of Sorbitol (E420) and 3.75mg of ethanol, and 10mg of sodium benzoate For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral solution. Clear, colourless to light yellow liquid with characteristic strawberry odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS Zofran Syrup is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Zofran Syrup is also indicated for the prevention of post-operative nausea and vomiting. PAEDIATRIC POPULATION Orally administered Zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy in children and adolescents aged from 6 months to 17 years. No studies have been conducted in children on the use of orally administered Zofran in the prevention or treatment of post-operative nausea and vomiting; IV injection may be recommended for this purpose. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Zofran is also available for parenteral and rectal 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 oral dose is 8 mg (two 5 ml spoonfuls) 1-2 hours before treatment, followed by 8 mg (two 5 ml spoonfuls) orally 12 hours later. _Highly emetogenic chemotherapy:_ For patients receiving highly emetogenic chemotherapy a single oral dose of up to 24 mg (six 5 ml spoonfuls) ondansetron t Preberite celoten dokument