VINORELBINE INJECTION, USP SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

VINORELBINE (VINORELBINE TARTRATE)

Dostupné z:

FRESENIUS KABI CANADA LTD

ATC kód:

L01CA04

INN (Medzinárodný Name):

VINORELBINE

Dávkovanie:

10MG

Forma lieku:

SOLUTION

Zloženie:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Spôsob podávania:

INTRAVENOUS

Počet v balení:

15G/50G

Typ predpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2021-01-25

Súhrn charakteristických

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