GEMCITABINE SUN FOR INJECTION POWDER FOR 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:

TARO PHARMACEUTICALS INC

ATCコード:

L01BC05

INN（国際名）:

GEMCITABINE

投薬量:

200MG

医薬品形態:

POWDER FOR SOLUTION

構図:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200MG

投与経路:

INTRAVENOUS

パッケージ内のユニット:

10ML

処方タイプ:

Prescription

治療領域:

ANTINEOPLASTIC AGENTS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2011-09-13

製品の特徴

Gemcitabine SUN for Injection Product Monograph
Page 1 of 55
PRODUCT MONOGRAPH
PR
GEMCITABINE SUN FOR INJECTION
Gemcitabine for Injection, Manufacturer’s Standard
200 mg and 1 g gemcitabine (as gemcitabine hydrochloride) per vial
Sterile lyophilized powder
For intravenous use only
Antineoplastic Agent
Taro Pharmaceuticals Inc.
Date of Revision:
130 East Drive
October 26, 2021
Brampton, Ontario
L6T 1C1
Control No: 252769
Gemcitabine SUN for Injection Product Monograph
Page 2 of 55 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
..............................................................22
OVERDOSAGE
..............................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
.............................................25
STORAGE AND STABILITY
.........................................................................27
SPECIAL HANDLING INSTRUCTIONS
……………………………………27
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................27
PART II: SCIENTIFIC INFORMATION
................................................................28
PHARMACEUTICAL INFORMATION
.........................................................28
CLINICAL TRIALS
.......................................................................................28
DETAILED PHARMACOLOGY
.......................................