Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
ONDANSETRON HYDROCHLORIDE DIHYDRATE
Claris Lifesciences (UK) Limited
A04AA01
ONDANSETRON HYDROCHLORIDE DIHYDRATE
2 Mg/Ml
Solution for Injection
Product subject to prescription which may not be renewed (A)
Serotonin (5HT3) antagonists
Authorised
2009-11-13
The name of your medicine is Ondansetron 2 mg/ml Solution for Injection, which will be called Ondansetron Injection or Ondansetron throughout this leaet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaet. You may need to read it again. - If you have any further questions about your illness or your medicine, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaet, please tell your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaet. See Section 4. WHAT IS IN THIS LEAFLET: 1. What Ondansetron Injection is and what it is used for 2. What you need to know before you have Ondansetron Injection 3. How to have Ondansetron Injection 4. Possible side effects 5. How to store Ondansetron Injection 6. Contents of the pack and other information 1. WHAT ONDANSETRON INJECTION IS AND WHAT IT IS USED FOR Ondansetron Injection is a clear solution containing the active ingredient ondansetron, which is an anti-emetic (prevents nausea [feeling sick] and vomiting). Ondansetron Injection is used for: □ preventing nausea and vomiting caused by chemotherapy (in adults and children) or radiotherapy for cancer (adults only) □ preventing nausea and vomiting after surgery. Ask your doctor, pharmacist or nurse if you would like any further explanation about these uses. 2. WHAT YOU NEED TO KNOW BEFORE YOU HAVE ONDANSETRON INJECTION DO NOT HAVE ONDANSETRON INJECTION IF: □ you are taking apomorphine (used to treat Parkinson's disease) □ you are allergic (hypersensitive) to ondansetron or to other selective 5HT3 receptor antagonists (e.g. granisetron, dolasetron) or any of the other ingredients in Ondansetron injection ( listed in section 6). If you are not sure, talk to yo read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ondansetron 2mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 2 mg ondansetron as ondansetron hydrochloride dihydrate. Each glass ampoule of 2ml contains 4mg ondansetron (as hydrochloride dihydrate) in aqueous solution for intramuscular or intravenous administration. Each glass ampoule of 5ml (containing 4 ml of solution) contains 8mg Ondansetron (as hydrochloride dihydrate) in aqueous solution for intramuscular or intravenous administration. Excipients with known effect Each ml of the solution contains 3.6 mg of Sodium. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for Injection. A clear colourless solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS: Ondansetron 2mg/ml Solution for Injection is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Ondansetron injection is indicated for the prevention and treatment of post- operative nausea and vomiting (PONV). _PAEDIATRIC POPULATION:_ Ondansetron injection is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged 6 months, and for the prevention and treatment of PONV in children aged 1 month. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING. ADULTS: The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The route of administration and dose of Ondansetron 2mg/ml Solution for Injection or infusion should be flexible in the range of 8-32 mg a day and selected as shown below. _Emetogenic chemotherapy and radiotherapy:_ Ondansetron can be given either by rectal, oral (tablets or syrup), intravenous or intramuscular administration. For most patients receiving emetogenic chemotherapy or radiotherapy, Ondansetron 8mg should be administered as a slow intravenous injection, (in not less than 30 read_full_document