VINORELBINE INJECTION SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

VINORELBINE (VINORELBINE TARTRATE)

Disponible depuis:

FRESENIUS KABI CANADA LTD

Code ATC:

L01CA04

DCI (Dénomination commune internationale):

VINORELBINE

Dosage:

10MG

forme pharmaceutique:

SOLUTION

Composition:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

1ML/5 ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2021-07-20

Résumé des caractéristiques du produit

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 _
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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
.....................................................