国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
ondansetron hydrochloride dihydrate, Quantity: 4.99 mg (Equivalent: ondansetron, Qty 4 mg)
Accord Healthcare Pty Ltd
Ondansetron hydrochloride dihydrate
Injection, solution
Excipient Ingredients: water for injections; sodium hydroxide; citric acid monohydrate; sodium citrate dihydrate; hydrochloric acid; sodium chloride
Intravenous, Intramuscular
Pack of 5 Ampoules, Pack of 10 Ampoules
(S4) Prescription Only Medicine
Ondansetron injection is indicated ? For the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy. ? For the prevention and treatment of post-operative nausea and vomiting.
Visual Identification: Clear, colourless to almost colourless, sterile, isotonic, preservative-free solution in clear glass ampoules (type - 1).; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-05-05
Ondansetron Accord – version 6 1 ONDANSETRON ACCORD CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I BEING GIVEN ONDANSETRON ACCORD? Ondansetron Accord contains the active ingredient ondansetron. This belongs to a group of medicines called antiemetics/antinauseants. Ondansetron Accord is used to prevent the nausea (feeling sick) and vomiting that may occur after surgery or after therapy with anticancer medicines (chemotherapy) or radiation. For more information, see Section 1. Why am I being given Ondansetron Accord? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN ONDANSETRON ACCORD? Do not use if you have ever had an allergic reaction to an any medicine containing ondansetron or any of the ingredients listed at the end of this leaflet. You should also not be given it if you are taking apomorphine (used to treat Parkinson’s disease). TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Ondansetron Accord? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Ondansetron Accord and affect how it works. See Section 3. What if I am taking other medicines? in the full CMI. 4. HOW WILL I BE GIVEN ONDANSETRON ACCORD? Ondansetron Accord is an injection and will be given to you by your doctor or nurse. More instructions can be found in Section 4. How do I use Ondansetron Accord? in the full CMI. 5. WHAT SHOULD I KNOW WHILE BEING GIVEN ONDANSETRON ACCORD? THINGS YOU SHOULD DO Tell your doctor before you take any other medicines, whether they require a prescription or not For more information, see Section 5. What should I know while I am being given Ondansetron Accord? in the full CMI. 6. ARE THERE ANY SIDE EFFECTS? All medicines can have side effects. If you do experience 完全なドキュメントを読む
Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION ONDANSETRON ACCORD (ONDANSETRON) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Ondansetron hydrochloride dihydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ondansetron Accord Injection contains 2 mg/mL ondansetron (as ondansetron hydrochloride dihydrate). For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Ondansetron Accord Injection is a clear, colourless to almost colourless, sterile, isotonic, preservative-free solution. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Ondansetron Accord injection is indicated: • for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy. • for the prevention and treatment of post-operative nausea and vomiting. 4.2 D OSE AND METHOD OF ADMINISTRATION 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 should be flexible in the range of 8 to 32 mg a day and selected as shown below. The lowest effective dose should be used. The product is for single use in one patient only. Discard any residue. USE IN ADULTS _Emetogenic chemotherapy and radiotherapy:_ For the control of chemotherapy or radiotherapy induced emesis or nausea in adults, a single dose of ondansetron 8 mg should be administered as a slow intravenous injection in not less than 30 seconds, immediately before treatment. _Highly emetogenic chemotherapy:_ A single dose of ondansetron 8 mg by slow intravenous injection immediately before chemotherapy has been shown to be effective in many patients. Higher doses may be required in some patients, particularly those on high dose cisplatin, and the doses should be adjusted according to the severity of the emetogenic challenge. If required, additional intravenous doses may be given up to a maximum of 32 mg in 24 hours. Intravenous doses of more than 8 mg should be given by slow intravenous infusion over at l 完全なドキュメントを読む