Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Ondansetron hydrochloride dihydrate
Novartis Ireland Limited
A04AA; A04AA01
Ondansetron hydrochloride dihydrate
8mg/4 millilitre(s)
Solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Serotonin (5HT3) antagonists; ondansetron
Marketed
1990-06-27
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ZOFRAN® 4 MG/2 ML (OR 8 MG/4 ML) SOLUTION FOR INJECTION OR INFUSION ondansetron (as hydrochloride dihydrate) 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. - 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 Solution for Injection or Infusion is and what it is used for 2 What you need to know before you have Zofran Solution for Injection or Infusion 3 How to have Zofran Solution for Injection or Infusion 4 Possible side effects 5 How to store Zofran Solution for Injection or Infusion 6 Contents of the pack and other information 1. WHAT ZOFRAN SOLUTION FOR INJECTION OR INFUSION IS AND WHAT IT IS USED FOR Zofran Solution for Injection or Infusion (called ‘Zofran injection’ in this leaflet) contains a medicine called ondansetron (as hydrochloride dihydrate). This belongs to a group of medicines called anti- emetics. Zofran injection is used for: • preventing nausea and vomiting caused by chemotherapy or radiotherapy for cancer in adults • preventing and treating nausea and vomiting after surgery in adults • preventing nausea and vomiting caused by chemotherapy for cancer in children and adolescents aged from 6 months to 17 years • preventing and treating nausea and vomiting after surgery in children and adolescents aged 1 month to 17 years Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses. Zofran injection should start to work soon after having the injection. 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 HAVE ZOFRAN SOLUTION FOR INJECTION OR INFUSION DO NOT HAVE ZOFRAN INJECTION IF: • if y Прочетете целия документ
Health Products Regulatory Authority 15 December 2021 CRN00CN3K Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zofran 8mg/4ml Solution for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 2mg ondansetron as hydrochloride dihydrate (8mg/4ml). For a full list of excipients, see sections 6.1. 3 PHARMACEUTICAL FORM Solution for injection or infusion. Clear, colourless solutions. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS Zofran Solution for Injection or Infusion is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Zofran Solution for Injection or Infusion is also indicated for the prevention and treatment of post-operative nausea and vomiting. PAEDIATRIC POPULATION Zofran Solution for Injection or Infusion is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy in children and adolescents aged from 6 months to 17 years. IV Zofran injection is indicated for the prevention or treatment of post-operative nausea and vomiting in children and adolescents aged from 1 month to 17 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Zofran is also available for oral 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 dose range of Zofran Solution for Injection or Infusion is 8 to 32 mg a day and selected as shown below. The recommended intravenous or intramuscular dose of Zofran is 8mg administered immediately before treatment. _Highly emetogenic chemotherapy:_ For patients receiving highly emetogenic chemotherapy, a maximum initial ondansetron dose of 16 mg IV infused over 15 minutes may be used. A sin Прочетете целия документ