Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Vinorelbine tartrate
medac UK
L01CA04
Vinorelbine tartrate
10mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010400; GTIN: 4037353001404
OBJECT 1 VINORELBINE 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 16-Feb-2018 | medac GmbH 1. Name of the medicinal product Vinorelbine 10 mg/ml concentrate for solution for infusion 2. Qualitative and quantitative composition Vinorelbine (as tartrate) 10 mg/ml Each 1 ml vial contains a total content of vinorelbine (as tartrate) of 10 mg Each 5 ml vial contains a total content of vinorelbine (as tartrate) of 50 mg For the full list of excipients, see section 6.1. 3. Pharmaceutical form Concentrate for solution for infusion (sterile concentrate) Clear, colourless to pale yellow solution. Single dose. 4. Clinical particulars 4.1 Therapeutic indications • As a single agent or in combination for the first line treatment of stage 3 or 4 non-small cell lung cancer. • Treatment of advanced breast cancer stage 3 and 4 relapsing after or refractory to an anthracycline containing regimen. 4.2 Posology and method of administration Posology • Vinorelbine is usually given at 25-30 mg/m² once weekly. In combination with other cytostatic agents the exact dose should be taken from the treatment protocol. Vinorelbine may be administered by slow bolus (6-10 minutes) after dilution in 20-50 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection or in 5 % (w/v) glucose solution for injection or by a short infusion (20-30 minutes) after dilution in 125 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection or in 5 % (w/v) glucose solution for injection. Administration should always be followed by a sodium chloride 9 mg/ml (0.9 %) infusion with at least 250 ml to flush the vein (see section 6.6). The maximum tolerated dose per administration: 35.4 mg/m² body surface area The maximum total dose per administration: 60 mg Dose modifications Vinorelbine metabolism and clearance are mostly hepatic: only 18.5 % is excreted unchanged in the urine. No prospective study relating altered metabolism of the active substance to its pharmacodynamic effects is available in order to est Leggi il documento completo