Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
ondansetron hydrochloride dihydrate, Quantity: 4.988 mg (Equivalent: ondansetron, Qty 4 mg)
AFT Pharmaceuticals Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; citric acid; sodium citrate; sodium chloride; nitrogen
Intravenous, Intramuscular
5 ampoules, 1 ampoule, 10 ampoules
(S4) Prescription Only Medicine
Ondansetron is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy. Ondansetron (injection) is also indicated for the prevention and treatment of post-operative nausea and vomiting.
Visual Identification: Clear, colourless, transparent solution, practically free from visible particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius
Registered
2019-07-04
Ondansetron-AFT 1 ONDANSETRON-AFT 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 USING ONDANSETRON-AFT? Ondansetron-AFT contains the active ingredient ondansetron. Ondansetron-AFT is used to help stop nausea (feeling sick) and vomiting which can occur after medical treatments and operations. For more information, see Section 1. Why am I using Ondansetron-AFT? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ONDANSETRON-AFT? Do not use if you have ever had an allergic reaction to Ondansetron-AFT or any of the ingredients listed at the end of the CMI. 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-AFT? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Ondansetron-AFT and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW IS ONDANSETRON-AFT GIVEN? • Your doctor will decide how much Ondansetron-AFT you should receive and for how long you should receive it. More instructions can be found in Section 4. How is Ondansetron-AFT given? in the full CMI. 5. WHAT SHOULD I KNOW WHILE RECEIVING ONDANSETRON-AFT? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are receiving Ondansetron-AFT. • Keep all of your doctor’s appointments, so that your progress can be checked. THINGS YOU SHOULD NOT DO • Do not take any other medicines whether they require a prescription or not without first telling your doctor. DRIVING OR USING MACHINES • Be careful before you drive or use any machines or tools until you know how Ondansetron-AFT affects you. • Ondansetron-AFT may cause dizziness or drowsiness in some people. LOOKING AFTER YOUR MEDICINE • Ondansetron-AF Прочитайте повний документ
AUSTRALIAN PI – ONDANSETRON-AFT (ONDANSETRON (AS HYDROCHLORIDE DIHYDRATE)) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Ondansetron (as hydrochloride dihydrate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ondansetron (as hydrochloride dihydrate) 4 mg/2 mL or 8 mg/4 mL For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless, transparent solution, practically free from visible particles. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Ondansetron is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy. Ondansetron (injection) is also indicated for the prevention and treatment of post-operative nausea and vomiting. 4.2 D OSE AND METHOD OF ADMINISTRATION Note that other dosage forms including tablets, syrup, suppositories and wafers can be available from other brands. 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-AFT should be flexible in the range of 8 – 32 mg a day and selected as shown below. The lowest effective dose should be used. ADULTS: EMETOGENIC CHEMOTHERAPY AND RADIOTHERAPY _ _ For the control of chemotherapy or radiotherapy induced emesis or nausea in adults, a single dose of 8 mg of ondansetron should be administered as a slow intravenous injection in not less than 30 seconds, immediately before treatment. To protect against delayed emesis after the first 24 hours, ondansetron should be continued orally at a dosage of 8 mg TWICE DAILY, or given rectally as a 16 mg suppository once daily, for up to 5 days after a course of treatment. HIGHLY EMETOGENIC CHEMOTHERAPY _ _ A single dose of ondansetron 8 mg by slow intravenous injection in not less than 30 seconds, 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 cisp Прочитайте повний документ