Vinorelbine 50mg/5ml concentrate for solution for infusion vials

Country: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Vinorelbine tartrate

Доступно од:

medac UK

АТЦ код:

L01CA04

INN (Међународно име):

Vinorelbine tartrate

Дозирање:

10mg/1ml

Фармацеутски облик:

Solution for infusion

Пут администрације:

Intravenous

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 08010400; GTIN: 4037353001428

Карактеристике производа

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