Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ondansetron hydrochloride dihydrate
Novartis Pharmaceuticals UK Ltd
A04AA01
Ondansetron hydrochloride dihydrate
2mg/1ml
Solution for injection
Intravenous; Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 5000123106271
- 1 - NOVARTIS (LOGO) PACKAGE LEAFLET: INFORMATION FOR THE USER ZOFRAN ® FLEXI-AMP ® INJECTION 2 MG/ML 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. 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 leaflet, please tell 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 injection is and what it is used for 2 What you need to know before you have Zofran injection 3 How to have Zofran injection 4 Possible side effects 5 How to store Zofran injection 6 Contents of the pack and other information 1 WHAT ZOFRAN INJECTION IS AND WHAT IT IS USED FOR Zofran injection contains a medicine called ondansetron. This belongs to a group of medicines called anti-emetics. Zofran 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, nurse or pharmacist if you would like any further explanation about these uses. 2 WHAT YOU NEED TO KNOW BEFORE YOU HAVE ZOFRAN INJECTION DO NOT HAVE ZOFRAN INJECTION 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 injection (listed in Section 6). If you are not sure, talk to your doctor, nurse or pharmacist before having Zofran injection. WARNINGS AND PRECAUTIONS Check with your doctor, nurse or pharmacist before having Zofran injection if: you have e Leggi il documento completo
OBJECT 1 ZOFRAN FLEXI-AMP INJECTION Summary of Product Characteristics Updated 13-Oct-2017 | Novartis Pharmaceuticals UK Ltd 1. Name of the medicinal product Zofran ® Injection 2 mg/ml. Zofran Flexi-amp Injection 2 mg/ml. 2. Qualitative and quantitative composition Zofran Injection 2 mg/ml: 2 ml glass ampoules each containing 4 mg ondansetron (as hydrochloride dihydrate) in aqueous solution for intramuscular or intravenous administration. 4 ml glass ampoules each containing 8 mg ondansetron (as hydrochloride dihydrate) in aqueous solution for intravenous or intramuscular administration. Zofran Flexi-amp injection 2 mg/ml: 2 ml plastic ampoules each containing 4 mg ondansetron (as hydrochloride dihydrate) in aqueous solution for intramuscular or intravenous administration. 4 ml plastic ampoules each containing 8 mg ondansetron (as hydrochloride dihydrate) in aqueous solution for intravenous or intramuscular administration. Excipients with a known effect: This product contains 7 mg of sodium per 4 mg dose (see section 4.4). For a full list of excipients see section 6.1. 3. Pharmaceutical form Injection (aqueous solution). 4. Clinical particulars 4.1 Therapeutic indications _Adults:_ Zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Zofran is indicated for the prevention and treatment of post-operative nausea and vomiting (PONV). _Paediatric Population:_ Zofran 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 Zofran should be flexible in the range of 8-32 mg a day and selected as shown below. _Emetogenic chemotherapy and radiothera Leggi il documento completo