GEMZAR (200MG/VIAL) POWDER FOR SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

Dostupné z:

ELI LILLY CANADA INC

ATC kód:

L01BC05

INN (Medzinárodný Name):

GEMCITABINE

Dávkovanie:

200MG

Forma lieku:

POWDER FOR SOLUTION

Zloženie:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200MG

Spôsob podávania:

INTRAVENOUS

Počet v balení:

5ML

Typ predpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Prehľad produktov:

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

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2015-03-11

Súhrn charakteristických

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..........