GEMCITABINE FOR INJECTION USP POWDER FOR SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

Verfügbar ab:

GENERIC MEDICAL PARTNERS INC

ATC-Code:

L01BC05

INN (Internationale Bezeichnung):

GEMCITABINE

Dosierung:

200MG

Darreichungsform:

POWDER FOR SOLUTION

Zusammensetzung:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

10ML

Verschreibungstyp:

Prescription

Therapiebereich:

ANTINEOPLASTIC AGENTS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2013-07-24

Fachinformation

Page 1 of 54
PRODUCT
MONOGRAPH
PR
GEMCITABINE FOR INJECTION, USP
Gemcitabine Hydrochloride for Injection
200 mg or 1 g gemcitabine per vial
38 mg/mL gemcitabine (as gemcitabine hydrochloride)
Sterile Lyophilized Powder
Antineoplastic Agent
Generic Medical Partners Inc.
251 Consumers Road, Suite 1200
Toronto, Ontario M2J 4R3
DATE OF REVISION:
October 23, 2017
SUBMISSION CONTROL NO. 209228
Page 2 of 54
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
..................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................... 27
PART II: SCIENTIFIC INFORMATION
.......................................................................
28
PHARMACEUTICAL
INFORMATION..................................................................
28
CLINICAL TRIALS
..................................................................................................
29
DETAILED PHARMACOLOGY
...........................................................