GEMCITABINE INJECTION SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

から入手可能:

SANDOZ CANADA INCORPORATED

ATCコード:

L01BC05

INN（国際名）:

GEMCITABINE

投薬量:

40MG

医薬品形態:

SOLUTION

構図:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 40MG

投与経路:

INTRAVENOUS

パッケージ内のユニット:

5/25/50ML

処方タイプ:

Prescription

治療領域:

ANTINEOPLASTIC AGENTS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2013-09-23

製品の特徴

_ _
_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
.......................................................................................