GEMCITABINE FOR INJECTION, USP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

Available from:

HOSPIRA HEALTHCARE ULC

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:

2018-08-01

Summary of Product characteristics

_Gemcitabine for Injection, USP Product Monograph _
_Page 1 of 55_
PRODUCT MONOGRAPH
PR
GEMCITABINE FOR INJECTION, USP
200 mg, 1 g and 2 g gemcitabine (gemcitabine hydrochloride) per vial
Sterile
THERAPEUTIC CLASSIFICATION
Antineoplastic Agent
Hospira Healthcare Corporation
1111 Dr.-Frederik-Philips, Suite 600
Montreal, QC
H4M 2X6
Date of Revision: August 29, 2014
Control No: 177248
_ _
_Gemcitabine for Injection, USP Product Monograph _
_Page 2 of 55_
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
..................................................................................................21
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
............................................................25
STORAGE AND STABILITY
..........................................................................................27
SPECIAL HANDLING INSTRUCTIONS
.......................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................27
PART II: SCIENTIFIC INFORMATION
................................................................................28
PHARMACEUTICAL INFORMATION
..................