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VINORELBINE TARTARATE USP
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DOSAGE FORM: Liquid Injection, 10mg/1ml, 50mg/5ml

BIOLOGICAL SIGNIFICANCE

Vinorelbine is a semisynthetic vinca alkaloid, derived from vinblastine, with a broad spectrum of antitumour activity. It is a derivative of vinblastine and has structural modifications distinctly different from other vinca alkaloids and a spectrum of activity similar to either vincristine or vinblastine.

CLINICAL USE

1. Treatment of Non Small Cell Lung Carcinoma - Vinorelbine can be used for ambulatory patients with advanced NSCLC who are not candidates for potentially curative regional therapy (example, surgery or radiation therapy) or because of the extent of their disease.

In patients with Stage IV NSCLC, vinorelbine is indicated as a single agent or in combination

In patients with Stage III NSCLC, vinorelbine is indicated in combination with cisplatin

2. Other uses Breast carcinoma, Hodgkin's disease, ovarian carcinoma, squamous cell carcinoma of the head & neck, cervical, SCLC, renal cell cancer and Kaposis sarcoma.

MODE OF ACTION

The primary mechanism of action of vinorelbine is binding to tubulin, which inhibits microtubule assembly. It may be more specific than vinca alkaloids for mitotic microtubules.

SPECIFICATIONS
COMPLIES TO USP
PARAMETER LIMIT
ASSAY NLT 92.5% AND NMT 105%
BACTERIAL ENDOTOXIN NMT 3.0 USP ENDOTOXIN UNITS PER MG OF VINORELBANE
PH 3.3 – 3.8
STERILITY SHOULD COMPLY USP
PARTICULATE MATTER SHOULD COMPLY USP
   
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