GEMCITABINE INJECTION SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

Mevcut itibaren:

SANDOZ CANADA INCORPORATED

ATC kodu:

L01BC05

INN (International Adı):

GEMCITABINE

Doz:

40MG

Farmasötik formu:

SOLUTION

Kompozisyon:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 40MG

Uygulama yolu:

INTRAVENOUS

Paketteki üniteler:

5/25/50ML

Reçete türü:

Prescription

Terapötik alanı:

ANTINEOPLASTIC AGENTS

Ürün özeti:

Active ingredient group (AIG) number: 0133122005; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2013-09-23

Ürün özellikleri

_ _
_Gemcitabine Injection _
_Page 1 of 56 _
PRODUCT MONOGRAPH
PR
GEMCITABINE INJECTION
CONCENTRATE STERILE SOLUTION FOR INJECTION
GEMCITABINE (AS GEMCITABINE HYDROCHLORIDE)
40 MG GEMCITABINE PER ML
200 MG/5 ML, 1 G/25 ML, 2 G/50 ML
ANTINEOPLASTIC AGENT
Sandoz Canada Inc.
Date of Revision:
145 Jules-Léger
August 14, 2014
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 176204
_ _
_Gemcitabine Injection _
_Page 2 of 56 _
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
........................................................................................................................................
22
DOSAGE
AND
ADMINISTRATION
....................................................................................................................
23
OVERDOSAGE
......................................................................................................................................................
26
ACTION
AND
CLINICAL
PHARMACOLOGY
...................................................................................................
26
STORAGE
AND
STABILITY
.......................................................................................