VINORELBINE INJECTION, USP SOLUTION
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
14-08-2023
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Werkstoffen:
VINORELBINE (VINORELBINE TARTRATE)
Beschikbaar vanaf:
FRESENIUS KABI CANADA LTD
ATC-code:
L01CA04
INN (Algemene Internationale Benaming):
VINORELBINE
Dosering:
10MG
farmaceutische vorm:
SOLUTION
Samenstelling:
VINORELBINE (VINORELBINE TARTRATE) 10MG
Toedieningsweg:
INTRAVENOUS
Eenheden in pakket:
15G/50G
Prescription-type:
Prescription
Therapeutisch gebied:
ANTINEOPLASTIC AGENTS
Product samenvatting:
Active ingredient group (AIG) number: 0126071001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2021-01-25
Productkenmerken
Vinorelbine Injection, USP- Product Monograph
Page 1 of 35
PRODUCT MONOGRAPH
PR
VINORELBINE INJECTION, USP
Sterile Solution for Injection
10 mg vinorelbine (as vinorelbine tartrate) per mL
SOLUTION MUST BE DILUTED BEFORE USE
Antineoplastic Agent
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Revision:
August 14, 2023
Submission Control No: 273007
Vinorelbine Injection, USP- Product Monograph
Page 2 of 35
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
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................16
SPECIAL HANDLING INSTRUCTIONS
.......................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
................................................................................18
PHARMACEUTICAL INFORMATION
...............................
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