GEMCITABINE FOR INJECTION, USP POWDER FOR SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

제공처:

MYLAN PHARMACEUTICALS ULC

ATC 코드:

L01BC05

INN (국제 이름):

GEMCITABINE

복용량:

2G

약제 형태:

POWDER FOR SOLUTION

구성:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 2G

관리 경로:

INTRAVENOUS

패키지 단위:

100ML

처방전 유형:

Prescription

치료 영역:

ANTINEOPLASTIC AGENTS

제품 요약:

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

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2017-05-08

제품 특성 요약

Gemcitabine for Injection, USP Product Monograph
1
PRODUCT MONOGRAPH
PR 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
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 175281
Date of Revision: July 07, 2014
Gemcitabine for Injection, USP 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
...........................................................................................................
8
DRUG INTERACTIONS
.........................................................................................................
21
DOSAGE AND ADMINISTRATION
.....................................................................................
21
OVERDOSAGE
........................................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
25
STORAGE AND STABILITY
.................................................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 27
PART II: SCIENTIFIC INFORMATION
...............................................................................
28
PHARMACEUTICAL INFORMATION
.............................................................................