País: Canadà
Idioma: anglès
Font: Health Canada
VINORELBINE (VINORELBINE TARTRATE)
SANDOZ CANADA INCORPORATED
L01CA04
VINORELBINE
10MG
SOLUTION
VINORELBINE (VINORELBINE TARTRATE) 10MG
INTRAVENOUS
100
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0126071001; AHFS:
CANCELLED PRE MARKET
2018-08-01
_Vinorelbine Tartrate Injection 10 mg/mL Page 1 of 26_ PRODUCT MONOGRAPH PR VINORELBINE TARTRATE INJECTION USP VINORELBINE TARTRATE USP SOLUTION FOR INJECTION, 10 MG/ML ANTINEOPLASTIC AGENT Sandoz Canada Inc. Date of Preparation: 145 Jules-Léger June 15, 2009 Boucherville, QC, Canada J4B 7K8 Submission Control No: 119033 _Vinorelbine Tartrate Injection 10 mg/mL Page 2 of 26_ VINORELBINE TARTRATE INJECTION USP 10 MG/ML VINORELBINE TARTRATE USP VINORELBINE TARTRATE INJECTION USP IS A CYTOTOXIC DRUG AND SHOULD BE USED ONLY BY PHYSICIANS EXPERIENCED WITH CANCER CHEMOTHERAPEUTIC DRUGS. BLOOD COUNTS SHOULD BE TAKEN PRIOR TO THE NEXT DOSE. DISCONTINUE OR REDUCE THE DOSAGE UPON EVIDENCE OF ABNORMAL DEPRESSION OF THE BONE MARROW. THIS PREPARATION IS FOR INTRAVENOUS ADMINISTRATION ONLY. INTRATHECAL ADMINISTRATION OF OTHER VINCA ALKALOIDS RESULTED IN DEATH. SYRINGES CONTAINING THIS PRODUCT SHOULD BE LABELLED “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 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 antitumour activity of vinorelbine is thought to be due primarily to inhibition of mitosis at metaphase through its interaction with tubulin. Vinorelbine 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. P HARMACOKINETICS Following intravenous administration, vinorelbine concentration in plasma decays in a triphasic manner. The initial rapid decline represents distribution of drug to peripheral compartments and metabolism of the drug. The pro Llegiu el document complet