FLUDARABINE PHOSPHATE INJECTION SOLUTION
Țară: Canada
Limbă: engleză
Sursă: Health Canada
Caracteristicilor produsului
(SPC)
14-01-2017
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Ingredient activ:
FLUDARABINE PHOSPHATE
Disponibil de la:
FRESENIUS KABI CANADA LTD
Codul ATC:
L01BB05
INN (nume internaţional):
FLUDARABINE
Dozare:
25MG
Forma farmaceutică:
SOLUTION
Compoziție:
FLUDARABINE PHOSPHATE 25MG
Calea de administrare:
INTRAVENOUS
Unități în pachet:
2ML
Tip de prescriptie medicala:
Prescription
Zonă Terapeutică:
ANTINEOPLASTIC AGENTS
Rezumat produs:
Active ingredient group (AIG) number: 0123842003; AHFS:
Statutul autorizaţiei:
APPROVED
Data de autorizare:
2015-06-04
Caracteristicilor produsului
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
...........................
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