FLUDARABINE PHOSPHATE INJECTION SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

FLUDARABINE PHOSPHATE

Verfügbar ab:

FRESENIUS KABI CANADA LTD

ATC-Code:

L01BB05

INN (Internationale Bezeichnung):

FLUDARABINE

Dosierung:

25MG

Darreichungsform:

SOLUTION

Zusammensetzung:

FLUDARABINE PHOSPHATE 25MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

2ML

Verschreibungstyp:

Prescription

Therapiebereich:

ANTINEOPLASTIC AGENTS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0123842003; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2015-06-04

Fachinformation

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
...........................