GEMZAR (1GM/VIAL) POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

Disponibil de la:

ELI LILLY CANADA INC

Codul ATC:

L01BC05

INN (nume internaţional):

GEMCITABINE

Dozare:

1G

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1G

Calea de administrare:

INTRAVENOUS

Unități în pachet:

25ML TO 50ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTINEOPLASTIC AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2015-11-01

Caracteristicilor produsului

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..........