Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
ondansetron hydrochloride dihydrate, Quantity: 10 mg (Equivalent: ondansetron, Qty 8 mg)
Alphapharm Pty Ltd
Ondansetron hydrochloride dihydrate
Injection, solution
Excipient Ingredients: citric acid monohydrate; sodium citrate dihydrate; sodium chloride; water for injections
Intravenous
5 x 4 mL ampoules
(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: Glass amber ampoule contains colourless clear liquid, practically odourless, free of visible particles; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2010-05-21
ONDANSETRON ALPHAPHARM _ondansetron hydrochloride dihydrate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you use ONDANSETRON ALPHAPHARM solution for injection. This leaflet answers some common questions about ONDANSETRON ALPHAPHARM. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ONDANSETRON ALPHAPHARM against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT ONDANSETRON ALPHAPHARM IS USED FOR ONDANSETRON ALPHAPHARM contains a medicine called ondansetron. This belongs to a group of medicines called Serotonin receptor-3 antagonists. ONDANSETRON ALPHAPHARM is used to help stop the nausea (sick feeling) and vomiting which can occur after medical treatments and operations. ONDANSETRON ALPHAPHARM should only be used to treat the nausea and vomiting for which it has been prescribed. Your doctor may have prescribed ONDANSETRON ALPHAPHARM for another reason. If you want more information, ask your doctor. ONDANSETRON ALPHAPHARM injection is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU ARE GIVEN ONDANSETRON ALPHAPHARM _WHEN YOU MUST NOT TAKE IT_ Do not take ONDANSETRON ALPHAPHARM if you have an allergy to: • any medicine containing (active ingredient) • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT TAKE THIS MEDICINE IF YOU ARE PREGNANT. It may affect your developing baby if you take it during pregnancy. DO NOT BREAST-FEED IF YOU ARE TAKING THIS MEDICINE. The active ingredient in ONDANSETRON ALPHAPHARM passes into Læs hele dokumentet
AUSTRALIAN PRODUCT INFORMATION ONDANSETRON ALPHAPHARM _Ondansetron hydrochloride dihydrate _ 1 NAME OF THE MEDICINE Ondansetron hydrochloride dihydrate 2 & 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Ondansetron Alphapharm solution for injection contains the following excipients: citric acid monohydrate, sodium citrate dihydrate, sodium chloride as well as 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 route of administration and dose of ondansetron 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. _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 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. Maximum initial intravenous doses of 16mg should be given by slow intravenous infusion over at least 15 minutes, since rapid intravenous administration of ondansetron has been associated with a higher incidence of transient vi Læs hele dokumentet