VINORELBINE TARTRATE FOR INJECTION SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Cumpara asta acum

Ingredient activ:

VINORELBINE (VINORELBINE TARTRATE)

Disponibil de la:

TEVA CANADA LIMITED

Codul ATC:

L01CA04

INN (nume internaţional):

VINORELBINE

Dozare:

10MG

Forma farmaceutică:

SOLUTION

Compoziție:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

1/5ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTINEOPLASTIC AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2014-04-01

Caracteristicilor produsului

                                PRODUCT MONOGRAPH
Pr
VINORELBINE TARTRATE FOR INJECTION
Vinorelbine tartrate for injection
10 mg vinorelbine per mL
Antineoplastic Agent
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
March 20, 2014
Toronto, Canada
M1B 2K9
Control No. 172255
_Page 2 of 32_
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
...............................................................................................................
7
DRUG INTERACTIONS
.............................................................................................................
12
DOSAGE AND ADMINISTRATION
.........................................................................................
12
OVERDOSAGE
...........................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
15
STORAGE AND STABILITY
.....................................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
..................................................................................
16
PART II: SCIENTIFIC INFORMATION
...................................................................................
18
PHARMACEUTICAL INFORMATION
.....................................................................................
18
CLINICAL TRIALS
...............................................
                                
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