Χώρα: Κύπρος
Γλώσσα: Ελληνικά
Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
VINORELBINE TARTRATE
PIERRE FABRE MEDICAMENT (0000003610) 45 PLACE ABEL GANCE, BOULOGNE, 92100
L01CA04
VINORELBINE
50MG/5ML
CONCENTRATE FOR SOLUTION FOR INFUSION
VINORELBINE TARTRATE (8000002466) 69.250000000000MG
INTRAVENOUS USE
Εθνική Διαδικασία
VINORELBINE
Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 10 VIALS X 5ML (980000901) 10.00 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή
SUMMARY OF PRODUCT CHARACTERISTICS NAVELBINE, CONCENTRATE FOR SOLUTION FOR INFUSION 1. NAME OF THE MEDICINAL PRODUCT Navelbine 10mg/ml, concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Navelbine is a clear colourless to pale yellow solution with a pH range from 3.3 to 3.8. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Non-small cell lung cancer. Advanced breast cancer. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Method of administration Strictly intravenous administration after appropriate dilution. Intra-thecal administration of NAVELBINE ® may be fatal. Instructions for use and handling: see section 6.6. It is recommended to infuse NAVELBINE ® over 6-10 minutes after dilution in 20-50 ml of sodium chloride 9 mg/ml (0.9%) solution for injection or in glucose solution for injection 5%. Administration should always be followed with at least 250 ml of an isotonic solution infusion to flush the vein. Posology _cy_9800009_spc.doc_ ACTIVE INGREDIENT FORMULATION 10 mg/1ml 50 mg/5 ml vinorelbine tartrate (mg) 13.85 69.25 equivalent to vinorelbine (INN) base (mg) 10.00 50.00 1 - NON-SMALL CELL LUNG CANCER AND ADVANCED BREAST CANCER In monotherapy the usual dose given is 25-30 mg/m² once weekly. In combination chemotherapy the usual dose (25-30 mg/m²) is usually maintained, while the frequency of administration is reduced e.g. day 1 and 5 every 3 weeks or day 1 and 8 every 3 weeks according to treatment protocol. Special populations - ADMINISTRATION IN THE ELDERLY Clinical experience has not identified relevant differences among elderly patients with regard to the response rate, although greater sensitivity in some of these patients cannot be excluded. Age does not modify the pharmacokinetics of vinorelbine (see section 5.2). - ADMINISTRATION IN PATIENTS WITH LIVER INSUFFICIENCY The pharmacokinetics of NAVELBINE ® is not modified in patients presenting moderate or seve Διαβάστε το πλήρες έγγραφο