Posology : מינונים

3.2       Posology and method of administration

Strictly intravenous administration after appropriate dilution.
Intra-thecal administration of vinorelbine may be fatal.
Instructions for use and handling: refer to paragraph 6.6.
It is recommended to infuse vinorelbine 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.

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.

Hormone-resistant prostate cancer
The usual dose given is 30 mg/m2 on days 1 and 8 every 3 weeks with low doses of corticosteroids everyday (i.e. hydrocortisone 40 mg/day).

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.

Administration in patients with liver insufficiency
The pharmacokinetics of vinorelbine is not modified in patients presenting moderate or severe liver impairment. Nevertheless as a precautionary measure a reduced dose of 20 mg/m2 and close monitoring of haematological parameters is recommended in patient with severe liver impairment (refer to sections 4.4 and 5.2).

Administration in patients with renal insufficiency
Given the minor renal excretion, there is no pharmacokinetic justification for reducing the dose of vinorelbine in patients with renal insufficiency.

Administration in children
Safety and efficacy in children have not been established and administration is therefore not recommended (see section 5.1).