AJ-FLUDARABINE SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
24-07-2013
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Active ingredient:
FLUDARABINE PHOSPHATE
Available from:
AGILA JAMP CANADA INC
ATC code:
L01BB05
INN (International Name):
FLUDARABINE
Dosage:
25.0MG
Pharmaceutical form:
SOLUTION
Composition:
FLUDARABINE PHOSPHATE 25.0MG
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:
CANCELLED PRE MARKET
Authorization date:
2015-11-03
Summary of Product characteristics
PRODUCT MONOGRAPH
Pr
AJ-FLUDARABINE
FLUDARABINE PHOSPHATE INJECTION
House Standard
(Fludarabine Phosphate)
25 mg/mL
(2 mL per vial)
Antineoplastic
AGILA-JAMP CANADA INC.
1380-203 Newton
Boucherville, Québec
Canada J4B 5H2
Submission Control No: 165926
Date of Preparation:
July 18, 2013
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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
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
.......................................................................
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