Maa: Uusi-Seelanti
Kieli: englanti
Lähde: Medsafe (Medicines Safety Authority)
Tropisetron hydrochloride 1.128 mg/mL equivalent to to 1 mg/mL tropisetron
Novartis New Zealand Ltd
Tropisetron hydrochloride 1.128 mg/mL (equiv. to 1 mg/mL tropisetron)
1 mg/mL
Solution for injection
Active: Tropisetron hydrochloride 1.128 mg/mL equivalent to to 1 mg/mL tropisetron
Ampoule, 2mL, 2 mL
Prescription
Prescription
Novartis Pharma AG
Package - Contents - Shelf Life: Ampoule, - 2 mL - 60 months from date of manufacture, Not Specified - Ampoule, - 5 mL - 60 months from date of manufacture, Not Specified
1991-06-17
__________________________________________________________________________________________________ NAVOBAN ® 1 NAVOBAN ® _5mg Capsule _ _2mg/2ml and 5mg/5ml Injection _ _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. All medicines have risks and benefits. Your doctor has weighed the risks of you using it 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 WITH THE MEDICINE. You may need to read it again. ________________________ WHAT NAVOBAN IS USED FOR ________________________ Navoban 5 mg ampoules and capsules are used in the treatment of cancer to help prevent nausea (feeling sick) and vomiting caused by chemotherapy medicines. Navoban 2 mg ampoules are used to treat nausea and vomiting which may happen after surgery. The active ingredient in Navoban is tropisetron. It works by stopping the action of a substance in the body called serotonin which is thought to bring about the nausea and vomiting. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY NAVOBAN HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. Navoban is only available with a doctor's prescription. It is not addictive. _____________________________ BEFORE YOU USE NAVOBAN ______________________ _ Lue koko asiakirja
DATA SHEET NAVOBAN ® TROPISETRON HYDROCHLORIDE 5MG CAPSULE 2MG/2ML AND 5MG/5ML INJECTION QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient is ((1 alphaH, 5 alphaH)-8-Methyl-8-azabicyclo(3.2.1)oct-3-alphayl) 1H- indole-3-carboxylate hydrochloride (= tropisetron hydrochloride). One capsule contains 5.64 mg tropisetron hydrochloride (= 5 mg tropisetron base). One ampoule contains 2.26 mg tropisetron hydrochloride (= 2 mg tropisetron base) per 2 mL, or 5.64 mg tropisetron hydrochloride (= 5 mg tropisetron base) per 5 mL. For a full list of excipients, see List of excipients. PHARMACEUTICAL FORM Capsule: hard gelatine capsules for oral administration; Ampoule: glass ampoule containing an aqueous-solution for intravenous administration. CLINICAL PARTICULARS _THERAPEUTIC INDICATIONS _ • Prevention of cancer-chemotherapy-induced nausea and vomiting (All dose forms). • Treatment of post-operative nausea and vomiting (2mg/2ml ampoule only). _DOSAGE AND METHOD OF ADMINISTRATION _ PREVENTION OF CANCER CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING ADULTS Navoban is recommended in adults as 6-day courses of 5 mg per day, given intravenously on day 1 shortly before cancer chemotherapy either as an infusion (diluted in a common infusion fluid such as normal saline, Ringer's solution, glucose 5%, or levulose 5%) or as a slow injection (not less than 1 minute), followed by oral administration on days 2 to 6. If tropisetron alone produces insufficient anti-emetic control, its therapeutic efficacy can be enhanced by dexamethasone. Capsules should be taken with water in the morning immediately upon rising, one hour before food intake. 1 TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING ADULTS Navoban is recommended as a 2 mg dose given intravenously either as an infusion (diluted in a common infusion fluid such as normal saline, Ringer's solution, glucose 5% or levulose 5%), or as a slow injection Lue koko asiakirja