GEMCITABINE FOR INJECTION, USP POWDER

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE)

可用日期:

DR REDDY'S LABORATORIES LTD

ATC代码:

L01BC05

INN（国际名称）:

GEMCITABINE

剂量:

200MG

药物剂型:

POWDER

组成:

GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 200MG

给药途径:

INTRAVENOUS

每包单位数:

10ML

处方类型:

Prescription

治疗领域:

ANTINEOPLASTIC AGENTS

產品總結:

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

授权状态:

CANCELLED PRE MARKET

授权日期:

2022-07-13

产品特点

1
PRODUCT MONOGRAPH
PR
GEMCITABINE FOR INJECTION, USP
200 mg, 1 g or 2 g gemcitabine (as gemcitabine hydrochloride) per vial
Sterile lyophilized
powder
Antineoplastic Agent
Manufactured by:
DR. REDDY’S LABORATORIES LTD.
Bachupally–500 090 India
Imported and Distributed by:
DR. REDDY'S LABORATORIES CANADA INC.
Mississauga, Ontario L4W 4Y1 Canada
DATE OF PREPARATION:
February 6, 2015
DATE OF REVISION:
June 14, 2022
SUBMISSION CONTROL NO. 260011
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........................................................................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
........................................................................
29
PHARMACEUTICAL
INFORMATION..............................................................
29
CLINICAL
TRIALS............................................