Land: Malta
Sprache: Englisch
Quelle: Medicines Authority
ONDANSETRON HYDROCHLORIDE
Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland
A04AA01
ONDANSETRON HYDROCHLORIDE 2 mg/ml
SOLUTION FOR INJECTION/INFUSION
ONDANSETRON HYDROCHLORIDE 2 mg/ml
POM
ANTIEMETICS AND ANTINAUSEANTS
Withdrawn
2006-04-11
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZOFRAN® 4 MG/2 ML (OR 8MG/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, 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. See section 4. 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 use 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 • preventing nausea and vomiting after surgery. 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. HOW ZOFRAN SOLUTION FOR INJECTION OR INFUSION WORKS Ondansetron is a 5HT 3 receptor antagonist. It works by inhibiting the 5HT 3 receptors on neurons located in peripheral and central nervous system of the body. 2. WHAT YOU NEED TO KNOW BEFORE YOU HAVE ZOF Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Zofran 4mg/2ml Solution for Injection or Infusion Zofran 8mg/4ml Solution for Injection or Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 2mg ondansetron as hydrochloride dihydrate (4mg/2ml). Each ml contains 2mg ondansetron as hydrochloride dihydrate (8mg/4ml). For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection or infusion. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Zofran is also available for 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. ADULTS:- The dose range of Zofran Solution for Injection or Infusion is 8 to 32 mg a day and selected as shown below. 2 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 single IV dose greater than 16mg must not be given due to dose dependent increase of QT-prolongation risk (see sections 4.4, 4.8, 5.1 and 6.6) . • A single dose of 8mg by slow intravenous injection (in not less than 30 seconds) or intramuscular injection immediately before chemotherapy. • A dose of 8mg by slow intravenous injection (in not less than 30 sec Lesen Sie das vollständige Dokument