VINORELBINE INJECTION SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

VINORELBINE (VINORELBINE TARTRATE)

可用日期:

FRESENIUS KABI CANADA LTD

ATC代码:

L01CA04

INN（国际名称）:

VINORELBINE

剂量:

10MG

药物剂型:

SOLUTION

组成:

VINORELBINE (VINORELBINE TARTRATE) 10MG

给药途径:

INTRAVENOUS

每包单位数:

1ML/5 ML

处方类型:

Prescription

治疗领域:

ANTINEOPLASTIC AGENTS

產品總結:

Active ingredient group (AIG) number: 0126071001; AHFS:

授权状态:

CANCELLED POST MARKET

授权日期:

2021-07-20

产品特点

PRODUCT MONOGRAPH
PR
VINORELBINE INJECTION
10 mg vinorelbine per mL as vinorelbine tartrate
Solution for Injection
USP
Antineoplastic Agent
FRESENIUS KABI CANADA LTD.
Date of Preparation:
45 Vogell Rd, Suite 200
March 12, 2015
Richmond Hill, ON L4B 3P6
Submission Control No: 182371
_ _
_Vinorelbine-PM-ENG-v2.0 _
_Page 2 of 34 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................16
STORAGE AND STABILITY
..........................................................................................16
SPECIAL HANDLING INSTRUCTIONS
.......................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTICAL INFORMATION
..........................................................................18
CLINICAL TRIALS
.....................................................