FLUDARABINE PHOSPHATE INJECTION SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
14-01-2017
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
FLUDARABINE PHOSPHATE
Available from:
FRESENIUS KABI CANADA LTD
ATC code:
L01BB05
INN (International Name):
FLUDARABINE
Dosage:
25MG
Pharmaceutical form:
SOLUTION
Composition:
FLUDARABINE PHOSPHATE 25MG
Administration route:
INTRAVENOUS
Units in package:
2ML
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0123842003; AHFS:
Authorization status:
APPROVED
Authorization date:
2015-06-04
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
FLUDARABINE PHOSPHATE INJECTION
25 mg/mL
USP
PR
FLUDARABINE PHOSPHATE FOR INJECTION
50 mg/vial
USP
Antineoplastic
FRESENIUS KABI CANADA LTD.
Date of Revision:
45 Vogell Rd, Suite 200
January 9, 2017
Richmond Hill, ON, L4B 3P6
Control No. 201501
_ _
Fludarabine Liq-PM-ENG-v2.0-Proposed PM_ _
_Page 2 of 57 _
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
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTICAL INFORMATION
..........................................................................18
CLINICAL TRIALS
..........................................................................................................19
DETAILED PHARMACOLOGY
...........................
Read the complete document
