Country: কানাডা
ভাষা: ইংরেজি
সূত্র: Health Canada
VINORELBINE (VINORELBINE TARTRATE)
PFIZER CANADA ULC
L01CA04
VINORELBINE
10MG
SOLUTION
VINORELBINE (VINORELBINE TARTRATE) 10MG
INTRAVENOUS
1ML/5ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0126071001; AHFS:
CANCELLED POST MARKET
2021-04-06
PRODUCT MONOGRAPH PR VINORELBINE TARTRATE FOR INJECTION (10 mg / 1 mL, 50 mg / 5 mL) 10 MG VINORELBINE PER ML Antineoplastic Agent Pfizer Canada Inc. 17300 Trans-Canada Highway Kirkland, Québec H9J 2M5 Date of Revision: July 21, 2017 Control # 206491 _Product Monograph - _ _Pr_ _Vinorelbine Tartrate for Injection _ _Page 2 of 31 _ PRODUCT MONOGRAPH PR VINORELBINE TARTRATE FOR INJECTION (10 mg/ 1 mL, 50 mg/ 5 mL) 10 MG VINORELBINE PER ML THERAPEUTIC CLASSIFICATION Antineoplastic Agent CAUTION VINORELBINE TARTRATE IS A CYTOTOXIC DRUG AND SHOULD BE USED ONLY BY PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC DRUGS. BLOOD COUNTS SHOULD BE TAKEN PRIOR TO EACH DOSE. THE DOSAGE SHOULD BE REDUCED OR THE DRUG DISCONTINUED UPON EVIDENCE OF ABNORMAL DEPRESSION OF THE BONE MARROW. THIS PREPARATION IS FOR INTRAVENOUS ADMINISTRATION ONLY. INTRATHECAL ADMINISTRATION OF OTHER VINCA ALKALOIDS HAS RESULTED IN DEATH. SYRINGES CONTAINING THIS PRODUCT SHOULD BE LABELED "WARNING - FOR INTRAVENOUS USE ONLY. FATAL IF GIVEN INTRATHECALLY”. CLINICAL PHARMACOLOGY Vinorelbine tartrate is a novel vinca alkaloid which interferes with microtubule assembly. Vinca alkaloids are structurally similar compounds comprising two multiringed units, vindoline and catharanthine. Vinorelbine tartrate is a vinca alkaloid in which the catharanthine unit is the site of structural modification. This structural change imparts unique pharmacologic properties which may translate into clinical benefits for patients with various malignancies. The antitumor activity of vinorelbine tartrate is thought to be due primarily to inhibition of mitosis at metaphase through its interaction with tubulin. Vinorelbine tartrate may also interfere with amino acid, cyclic AMP and glutathione metabolism; calmodulin-dependent Ca ++ -transport ATPase activity; cellular respiration; and nucleic acid and lipid biosynthesis. PHARMACOKINETICS Following intravenous administration, vinorelbine tartrate concentration in plasma decays in a triphasic manner. The initial rapid decline সম্পূর্ণ নথি পড়ুন