GEMZAR (1GM/VIAL) POWDER FOR SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

Disponibbli minn:

ELI LILLY CANADA INC

Kodiċi ATC:

L01BC05

INN (Isem Internazzjonali):

GEMCITABINE

Dożaġġ:

1G

Għamla farmaċewtika:

POWDER FOR SOLUTION

Kompożizzjoni:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1G

Rotta amministrattiva:

INTRAVENOUS

Unitajiet fil-pakkett:

25ML TO 50ML

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ANTINEOPLASTIC AGENTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0133122002; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2015-11-01

Karatteristiċi tal-prodott

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..........