VINORELBINE INJECTION, USP SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

VINORELBINE (VINORELBINE TARTRATE)

Disponible des:

FRESENIUS KABI CANADA LTD

Codi ATC:

L01CA04

Designació comuna internacional (DCI):

VINORELBINE

Dosis:

10MG

formulario farmacéutico:

SOLUTION

Composición:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

ANTINEOPLASTIC AGENTS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2021-01-25

Fitxa tècnica

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
...............................