Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
ondansetron hydrochloride dihydrate, Quantity: 2.5 mg/mL (Equivalent: ondansetron, Qty 2 mg/mL)
Fresenius Kabi Australia Pty Ltd
Ondansetron hydrochloride dihydrate
Injection, solution
Excipient Ingredients: water for injections; sodium chloride; citric acid monohydrate; sodium citrate dihydrate
Intravenous, Intramuscular
4mL x 5, 4mL x 10, 4mL x 1
Medicine Registered
(S4) Prescription Only Medicine
Ondansetron injection 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 and colourless solution.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure and restricted flow insert
Licence status A
2012-11-28
CMI for Ondansetron Kabi Injection Dec 2016 Filename: Ondansetron CMI (2016-12) - clean Page 1 of 2 Change: PI Update ONDANSETRON KABI Ondansetron hydrochloride dihydrate CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you use Ondansetron Kabi Injection. This leaflet answers some common questions about Ondansetron Kabi Injection. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the expected benefits of you taking Ondansetron Kabi Injection against the risks this medicine could have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT ONDANSETRON KABI IS USED FOR Ondansetron Kabi Injection contains a medicine called ondansetron. This belongs to a group of medicines called serotonin receptor-3 antagonists. Ondansetron Kabi Injection is used to help stop the nausea (sick feeling) and vomiting which can occur after medical treatments and operations. Ondansetron Kabi Injection should only be used to treat the nausea and vomiting for which it has been prescribed. Your doctor may have prescribed Ondansetron Kabi Injection for another reason. If you want more information, ask your doctor. Ondansetron Kabi Injection is not addictive. BEFORE YOU ARE GIVEN ONDANSETRON KABI _DO NOT TAKE IF: _ You must not take Ondansetron Kabi Injection if: you are taking apomorphine (used to treat Parkinson’s disease). you have ever had an allergic reaction to ondansetron or any of the ingredients listed toward the end of this leaflet (See "Ingredients"). you are pregnant, trying to become pregnant or breast feeding, unless your doctor says it is safe. the expiry date (EXP) printed on the pack has passed. the packaging is torn or shows signs of tampering the injection solution is coloured, cloudy or lumpy. _TELL YOUR DOCTOR Izlasiet visu dokumentu
Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION ONDANSETRON KABI (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 1 NAME OF THE MEDICINE Ondansetron hydrochloride dihydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION / 3 PHARMACEUTICAL FORM Ondansetron takes the form of a white to off-white powder with a melting point of 177°C. It is sparingly soluble in water and in alcohol, soluble in methanol and slightly soluble in methylene chloride. It is soluble in saline (0.9% w/v) to about 8 mg/mL. The pKa of ondansetron hydrochloride dihydrate as determined by a solubility procedure is 7.4. The distribution coefficient between n-octanol and water is pH dependent with log D = 2.2 at a pH of 10.6 and log D= 0.6 at a pH of 5.95. Each ampoule of Ondansetron Kabi contains 2 mg/mL ondansetron (as hydrochloride dihydrate) as the active ingredient and the following excipients: sodium chloride, citric acid monohydrate, sodium citrate dihydrate, water for injections. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ondansetron injection 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 DOSE AND METHOD OF ADMINISTRATION The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The 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. 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. 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 i Izlasiet visu dokumentu