Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Tropisetron hydrochloride
Novartis Pharmaceuticals Australia Pty Ltd
Medicine Registered
NAVOBAN(R) 1 NAVOBAN(R) _tropisetron_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Navoban. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM WWW.NOVARTIS.COM.AU. THOSE UPDATES MAY CONTAIN IMPORTANT INFORMATION ABOUT THE MEDICINE AND ITS USE OF WHICH YOU SHOULD BE AWARE. All medicines have risks and benefits. Your doctor has weighed the risks of you having this medicine against the benefits they expect it will provide. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT NAVOBAN IS USED FOR Navoban is used to prevent nausea (feeling sick) and vomiting caused by surgery and by cancer chemotherapy. The active ingredient in Navoban is tropisetron. It works by stopping the action of a substance in the body called serotonin that is thought to cause the nausea and vomiting. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. Navoban is only available with a doctor's prescription. It is not addictive. There is not enough information to recommend its use in children. BEFORE YOU HAVE NAVOBAN _WHEN YOU MUST NOT HAVE IT_ DO NOT HAVE NAVOBAN IF YOU HAVE EVER HAD AN ALLERGY TO: * tropisetron (the active ingredient in Navoban) * any of the other ingredients listed at the end of this leaflet * similar medicines such as ondansetron and dolasetron Some of Læs hele dokumentet
_ _ NAVOBAN® (TROPISETRON) COMPOSITION Capsules containing 5.64 mg tropisetron hydrochloride (equivalent to 5 mg of the base) and ampoules (2 or 5 mL) containing 2.26 or 5.64 mg tropisetron hydrochloride (equivalent to 2 or 5 mg of the base respectively). DESCRIPTION Tropisetron hydrochloride is 1 α H,5 α H-tropan-3 α -yl indole-3-carboxylate hydrochloride. CAS - 89565-68-4 (tropisetron); CAS - 105826-92-4 (tropisetron hydrochloride). NH COO NCH 3 H . HCl Tropisetron hydrochloride is a white or off-white crystalline powder. It is soluble >5% in water, 1.6% in ethanol (95% v/v) and poorly soluble (0.02%) in acetone. The molecular weight of the free base is 284.4 and of the hydrochloride salt is 320.8. PHARMACOLOGY Tropisetron is a highly potent and selective competitive antagonist of the 5-HT 3 receptor, a subclass of serotonin receptors located on peripheral neurons and within the CNS. Surgery and treatment with certain substances, including some chemotherapeutic agents, may trigger the release of serotonin (5-HT) from enterochromaffin-like cells in the visceral mucosa and initiate the emesis reflex and its accompanying feeling of nausea. Tropisetron selectively blocks the excitation of the presynaptic 5-HT 3 receptors of the peripheral neurons in this reflex, and may exert additional direct actions within the CNS on 5-HT 3 receptors mediating the actions of vagal input to the area postrema. These effects are considered to be the underlying mechanism of action of the anti-emetic effect of tropisetron. Navoban has a 24-hour duration of action which allows once-a-day administration. In studies where Navoban has been administered over multiple chemotherapy cycles, treatment has remained effective. Navoban prevents nausea and vomiting induced by cancer chemotherapy or surgery without causing extrapyramidal side-effects. Page 1 of 7 _ _ Page 2 of 7 CLINICAL TRIALS ON USE IN POST-OPERATIVE NAUSEA AND VOMITING Læs hele dokumentet