VINORELBINE INJECTION, USP SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

VINORELBINE (VINORELBINE TARTRATE)

Commercializzato da:

FRESENIUS KABI CANADA LTD

Codice ATC:

L01CA04

INN (Nome Internazionale):

VINORELBINE

Dosaggio:

10MG

Forma farmaceutica:

SOLUTION

Composizione:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Via di somministrazione:

INTRAVENOUS

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Area terapeutica:

ANTINEOPLASTIC AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2021-01-25

Scheda tecnica

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