GEMZAR (200MG/VIAL) POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

Available from:

ELI LILLY CANADA INC

ATC code:

L01BC05

INN (International Name):

GEMCITABINE

Dosage:

200MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200MG

Administration route:

INTRAVENOUS

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0133122001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2015-03-11

Summary of Product characteristics

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..........