GEMCITABINE FOR INJECTION POWDER FOR SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

Verfügbar ab:

TEVA CANADA LIMITED

ATC-Code:

L01BC05

INN (Internationale Bezeichnung):

GEMCITABINE

Dosierung:

200MG

Darreichungsform:

POWDER FOR SOLUTION

Zusammensetzung:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

5ML

Verschreibungstyp:

Prescription

Therapiebereich:

ANTINEOPLASTIC AGENTS

Produktbesonderheiten:

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

Berechtigungsstatus:

CANCELLED POST MARKET

Berechtigungsdatum:

2018-04-30

Fachinformation

PRODUCT MONOGRAPH
PR
GEMCITABINE FOR INJECTION
Gemcitabine Hydrochloride for Injection
200 mg or 1 g gemcitabine per vial
Antineoplastic Agent
Teva Canada Limited
Date of Revision:
30 Novopharm Court
June 9, 2014
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
CONTROL NO. 174568
Page 2
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
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 26
PART II: SCIENTIFIC INFORMATION
...............................................................................
27
PHARMACEUTICAL INFORMATION
.................................................................................
27
CLI