VINORELBINE INJECTION SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

VINORELBINE (VINORELBINE TARTRATE)

Disponible desde:

FRESENIUS KABI CANADA LTD

Código ATC:

L01CA04

Designación común internacional (DCI):

VINORELBINE

Dosis:

10MG

formulario farmacéutico:

SOLUTION

Composición:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

1ML/5 ML

tipo de receta:

Prescription

Área terapéutica:

ANTINEOPLASTIC AGENTS

Resumen del producto:

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

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2021-07-20

Ficha técnica

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 _
_Page 2 of 34 _
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
.....................................................