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NAVELBINE INJECTION 10 MG/ML [SIN06778P]

Active ingredients: NAVELBINE INJECTION 10 MG/ML

Last updated 26 October 2025

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Product Info
INDICATIONS
DOSAGE AND ADMINISTRATION

Product Info

NAVELBINE INJECTION 10 MG/ML

[SIN06778P]

Product information

Active Ingredient and Strength

VINORELBINE DITARTRATE EQV VINORELBINE (BASE) - 10 MG/ML

Dosage Form

INJECTION

Manufacturer and Country

FAREVA PAU - FRANCE

Registration Number

SIN06778P

Licence Holder

PIERRE FABRE SINGAPORE PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

L01CA04

INDICATIONS

  • Non-small cell lung cancer

  • Metastatic breast cancer

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.

CONTRA-INDICATIONS
This medicine is contra-indicated in the following cases:

  • Known hypersensitivity to vinorelbine or other vinca alkaloids, or to any of the constituents.

  • Neutrophil count < 1500/mm3 or severe infection current or recent (within 2 weeks)

  • Platelet count < 100000/mm3

  • Lactation

  • In combination with yellow fever vaccine