VINORELBINE INJECTION, USP SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

VINORELBINE (VINORELBINE TARTRATE)

Dostopno od:

FRESENIUS KABI CANADA LTD

Koda artikla:

L01CA04

INN (mednarodno ime):

VINORELBINE

Odmerek:

10MG

Farmacevtska oblika:

SOLUTION

Sestava:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Pot uporabe:

INTRAVENOUS

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

ANTINEOPLASTIC AGENTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2021-01-25

Lastnosti izdelka

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