VINORELBINE TARTRATE FOR INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VINORELBINE (VINORELBINE TARTRATE)

Available from:

TEVA CANADA LIMITED

ATC code:

L01CA04

INN (International Name):

VINORELBINE

Dosage:

10MG

Pharmaceutical form:

SOLUTION

Composition:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Administration route:

INTRAVENOUS

Units in package:

1/5ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2014-04-01

Summary of Product characteristics

PRODUCT MONOGRAPH
Pr
VINORELBINE TARTRATE FOR INJECTION
Vinorelbine tartrate for injection
10 mg vinorelbine per mL
Antineoplastic Agent
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
March 20, 2014
Toronto, Canada
M1B 2K9
Control No. 172255
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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
.............................................................................................................
12
DOSAGE AND ADMINISTRATION
.........................................................................................
12
OVERDOSAGE
...........................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
15
STORAGE AND STABILITY
.....................................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
..................................................................................
16
PART II: SCIENTIFIC INFORMATION
...................................................................................
18
PHARMACEUTICAL INFORMATION
.....................................................................................
18
CLINICAL TRIALS
...............................................