NAVELBINE INJECTION 10 mg/ml

ORIENT EUROPHARMA PTE LTD

PIERRE FABRE SINGAPORE PTE LTD

Therapeutic

Prescription Only

INJECTION

**DOSAGE AND ADMINISTRATION** **Strictly intravenous administration after appropriate dilution. Intrathecal administration of NAVELBINE® may be fatal. See section INSTRUCTIONS FOR USE AND HANDLING** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. As a single agent, the usual dose is 25 to 30 mg/m2 administered 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. NAVELBINE® 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% glucose solution for injection. Administration should always be followed with at least 250 ml of an isotonic solution infusion to flush the vein. _Administration in the elderly:_ Clinical experience has not identified relevant differences in the elderly with regards to response rate, although greater sensitivity of some these patients cannot be excluded. Age does not modify the pharmacokinetics of vinorelbine. _Administration in patients with liver insufficiency:_ The pharmacokinetics of NAVELBINE® 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. _Administration in patients with renal insufficiency:_ Given the minor renal excretion, there is no pharmacokinetic justification for reducing the dose of NAVELBINE® in patients with renal insufficiency. _Administration in children:_ Safety and efficacy in children have not been established and administration is therefore not recommended.