FLUDARA POWDER FOR SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

FLUDARABINE PHOSPHATE (FLUDARABINE PHOSPHATE SODIUM)

זמין מ:

SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC

קוד ATC:

L01BB05

INN (שם בינלאומי):

FLUDARABINE

כמות:

50MG

טופס פרצבטיות:

POWDER FOR SOLUTION

הרכב:

FLUDARABINE PHOSPHATE (FLUDARABINE PHOSPHATE SODIUM) 50MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

2ML

סוג מרשם:

Prescription

איזור תרפויטי:

ANTINEOPLASTIC AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0123842001; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2011-03-31

מאפייני מוצר

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_Page 1 of 49 _
PRODUCT MONOGRAPH
PR
FLUDARA
®
fludarabine phosphate for injection
50 mg per vial as sodium salt
and
fludarabine phosphate tablets
10 mg
Antineoplastic
Genzyme Canada Inc.
800-2700 Matheson Blvd. East, West Tower
Mississauga, ON
L4W 4V9
Canada
www.genzyme.ca
DATE OF REVISION:
April 19, 2011
SUBMISSION CONTROL NO: 143857
© 2009, Genzyme Canada Inc.
® FLUDARA is a registered trademark exclusively licensed to Genzyme
Corporation.
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_Page 2 of 49 _
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....................................................................................................8
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND
ADMINISTRATION..............................................................................11
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND
STABILITY..........................................................................................14
SPECIAL HANDLING INSTRUCTIONS
.......................................................................15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................15
PART II: SCIENTIFIC INFORMATION
................................................................................17
PHARMACEUTICAL
INFORMATIO