VINORELBINE TARTRATE FOR INJECTION SOLUTION
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
12-10-2016
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Werkstoffen:
VINORELBINE (VINORELBINE TARTRATE)
Beschikbaar vanaf:
TEVA CANADA LIMITED
ATC-code:
L01CA04
INN (Algemene Internationale Benaming):
VINORELBINE
Dosering:
10MG
farmaceutische vorm:
SOLUTION
Samenstelling:
VINORELBINE (VINORELBINE TARTRATE) 10MG
Toedieningsweg:
INTRAVENOUS
Eenheden in pakket:
1/5ML
Prescription-type:
Prescription
Therapeutisch gebied:
ANTINEOPLASTIC AGENTS
Product samenvatting:
Active ingredient group (AIG) number: 0126071001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2014-04-01
Productkenmerken
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
_Page 2 of 32_
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
...............................................
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