VINORELBINE TARTRATE FOR INJECTION SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

VINORELBINE (VINORELBINE TARTRATE)

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

L01CA04

INN (Διεθνής Όνομα):

VINORELBINE

Δοσολογία:

10MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

1/5ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2014-04-01

Αρχείο Π.Χ.Π.

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