VINORELBINE INJECTION SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

VINORELBINE (VINORELBINE TARTRATE)

Διαθέσιμο από:

FRESENIUS KABI CANADA LTD

Φαρμακολογική κατηγορία (ATC):

L01CA04

INN (Διεθνής Όνομα):

VINORELBINE

Δοσολογία:

10MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

VINORELBINE (VINORELBINE TARTRATE) 10MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

1ML/5 ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2021-07-20

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
VINORELBINE INJECTION
10 mg vinorelbine per mL as vinorelbine tartrate
Solution for Injection
USP
Antineoplastic Agent
FRESENIUS KABI CANADA LTD.
Date of Preparation:
45 Vogell Rd, Suite 200
March 12, 2015
Richmond Hill, ON L4B 3P6
Submission Control No: 182371
_ _
_Vinorelbine-PM-ENG-v2.0 _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................16
STORAGE AND STABILITY
..........................................................................................16
SPECIAL HANDLING INSTRUCTIONS
.......................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTICAL INFORMATION
..........................................................................18
CLINICAL TRIALS
.....................................................