AJ-GEMCITABINE POWDER FOR SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

Tilgjengelig fra:

AGILA JAMP CANADA INC

ATC-kode:

L01BC05

INN (International Name):

GEMCITABINE

Dosering :

1G

Legemiddelform:

POWDER FOR SOLUTION

Sammensetning:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1G

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

50ML

Resept typen:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0133122003; AHFS:

Autorisasjon status:

CANCELLED PRE MARKET

Autorisasjon dato:

2015-11-03

Preparatomtale

PRODUCT MONOGRAPH
PR
AJ-GEMCITABINE
GEMCITABINE FOR INJECTION, USP
200 MG, 1 G AND 2 G PER VIAL
38 MG/ML GEMCITABINE (AS GEMCITABINE HYDROCHLORIDE)
STERILE LYOPHILIZED POWDER
ANTINEOPLASTIC AGENT
DATE OF PREPARATION:
AGILA JAMP CANADA INC.
1380 – 203 Newton
Boucherville, Québec
Canada J4B 5H2
July 18, 2013
SUBMISSION CONTROL NUMBER: 165924
AJ-GEMCITABINE Product Monograph
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
...........................................................................................................
7
DRUG INTERACTIONS
.........................................................................................................
20
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
........................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
24
STORAGE AND STABILITY
.................................................................................................
25
DOSAGE FORMS, COMPOSITION AND
PACKAGING..................................................... 26
PART II: SCIENTIFIC INFORMATION
...............................................................................
27
PHARMACEUTICAL INFORMATION
.................................................................................
27
CLINICAL TRIALS
......