AJ-GEMCITABINE POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

Tersedia dari:

AGILA JAMP CANADA INC

Kode ATC:

L01BC05

INN (Nama Internasional):

GEMCITABINE

Dosis:

2G

Bentuk farmasi:

POWDER FOR SOLUTION

Komposisi:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 2G

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

100ML

Jenis Resep:

Prescription

Area terapi:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0133122004; AHFS:

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2015-11-03

Karakteristik produk

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
......