Country: Canada
Language: English
Source: Health Canada
GEMCITABINE (GEMCITABINE HYDROCHLORIDE)
ELI LILLY CANADA INC
L01BC05
GEMCITABINE
1G
POWDER FOR SOLUTION
GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1G
INTRAVENOUS
25ML TO 50ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0133122002; AHFS:
CANCELLED POST MARKET
2015-11-01
GEMZAR Product Monograph Page 1 of 52 PRODUCT MONOGRAPH Pr GEMZAR ® Gemcitabine Hydrochloride for Injection 200 mg or 1 g gemcitabine per vial Antineoplastic Agent © Eli Lilly Canada 3650 Danforth Ave. Toronto, Ontario M1N 2E8 1-888-545-5972 www.lilly.ca Date of Revision: April 28, 2014 Submission Control No. 171741 GEMZAR Product Monograph Page 2 of 52 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 ............................................................................................ 8 DRUG INTERACTIONS .......................................................................................... 20 DOSAGE AND ADMINISTRATION ...................................................................... 21 OVERDOSAGE ........................................................................................................ 24 ACTION AND CLINICAL PHARMACOLOGY ..................................................... 24 STORAGE AND STABILITY .................................................................................. 26 DOSAGE FORMS, COMPOSITION AND PACKAGING...................................... 26 PART II: SCIENTIFIC INFORMATION ....................................................................... 27 PHARMACEUTICAL INFORMATION .................................................................. 27 CLINICAL TRIALS .................................................................................................. 27 DETAILED PHARMACOLOGY ............................................................................. 38 TOXICOLOGY.......... Read the complete document