Država: Kanada
Jezik: angleščina
Source: Health Canada
VINORELBINE (VINORELBINE TARTRATE)
TEVA CANADA LIMITED
L01CA04
VINORELBINE
10MG
SOLUTION
VINORELBINE (VINORELBINE TARTRATE) 10MG
INTRAVENOUS
1/5ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0126071001; AHFS:
APPROVED
2014-04-01
PRODUCT MONOGRAPH Pr VINORELBINE TARTRATE FOR INJECTION Vinorelbine tartrate for injection 10 mg vinorelbine per mL Antineoplastic Agent Teva Canada Limited Date of Preparation: 30 Novopharm Court March 20, 2014 Toronto, Canada M1B 2K9 Control No. 172255 _Page 2 of 32_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ............................................................. 3 SUMMARY PRODUCT INFORMATION ................................................................................... 3 INDICATIONS AND CLINICAL USE ......................................................................................... 3 CONTRAINDICATIONS .............................................................................................................. 4 WARNINGS AND PRECAUTIONS ............................................................................................. 4 ADVERSE REACTIONS ............................................................................................................... 7 DRUG INTERACTIONS ............................................................................................................. 12 DOSAGE AND ADMINISTRATION ......................................................................................... 12 OVERDOSAGE ........................................................................................................................... 14 ACTION AND CLINICAL PHARMACOLOGY ....................................................................... 15 STORAGE AND STABILITY ..................................................................................................... 16 SPECIAL HANDLING INSTRUCTIONS .................................................................................. 16 PART II: SCIENTIFIC INFORMATION ................................................................................... 18 PHARMACEUTICAL INFORMATION ..................................................................................... 18 CLINICAL TRIALS ............................................... Preberite celoten dokument