Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
VINORELBINE (VINORELBINE TARTRATE)
GENERIC MEDICAL PARTNERS INC
L01CA04
VINORELBINE
10MG
SOLUTION
VINORELBINE (VINORELBINE TARTRATE) 10MG
INTRAVENOUS
1ML/5ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0126071001; AHFS:
APPROVED
2014-09-04
_Page 1 of 32_ PRODUCT MONOGRAPH PR VINORELBINE INJECTION, USP (10 mg/1 mL and 50 mg/5 mL) 10 mg/mL vinorelbine (as vinorelbine tartrate) Sterile Solution for Injection Concentrate: Solution Must Be Diluted Before Use Antineoplastic Agent Generic Medical Partners Inc. 251 Consumers Road, Suite 1200 Date of Preparation: Toronto, Ontario September 03, 2014 M2J 4R3 Control # 163682 _Page 2 of 32_ PRODUCT MONOGRAPH PR VINORELBINE INJECTION, USP (10 mg/1 mL and 50 mg/5 mL) 10 mg/mL vinorelbine (as vinorelbine tartrate) Sterile Solution for Injection Concentrate: Solution Must Be Diluted Before Use THERAPEUTIC CLASSIFICATION Antineoplastic Agent CAUTION VINORELBINE 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 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 _Page 3 of 32_ respiration; and nucleic acid a Baca dokumen lengkap