BENEFIX - (500IU) KIT

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

COAGULATION FACTOR IX (RECOMBINANT); WATER

Διαθέσιμο από:

WYETH CANADA

Φαρμακολογική κατηγορία (ATC):

B02BD04

INN (Διεθνής Όνομα):

COAGULATION FACTOR IX

Δοσολογία:

500UNIT; 5ML

Φαρμακοτεχνική μορφή:

KIT

Σύνθεση:

COAGULATION FACTOR IX (RECOMBINANT) 500UNIT; WATER 5ML

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

PACKAGED AS A KIT

Τρόπος διάθεσης:

Schedule D

Θεραπευτική περιοχή:

HEMOSTATICS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0233010002; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2008-06-19

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
BENEFIX
®
COAGULATION FACTOR IX (RECOMBINANT)
INN= NONACOG ALFA
BENEFIX
® COAGULATION FACTOR IX (RECOMBINANT), IS PREPARED IN FOUR
LYOPHILIZED POWDER DOSAGE FORMS NOMINALLY CONTAINING 250, 500, 1000
AND
2000 IU PER VIAL. THE RECONSTITUTED PRODUCT CONTAINS APPROXIMATELY:
50, 100,
200 AND 400 IU/ML, RESPECTIVELY.
WORLD HEALTH ORGANIZATION (WHO) INTERNATIONAL STANDARD FOR FACTOR IX
CONCENTRATE
ANTIHEMORRHAGIC BLOOD COAGULATION FACTOR IX
©WYETH CANADA,
MONTREAL, CANADA
DATE OF APPROVAL:
MARCH 21, 1997
DATE OF REVISION:
APRIL 5, 2007
CONTROL#: 105598
DATE OF APPROVAL: APRIL 13, 2007
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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
.........................................................................................................
7
DRUG INTERACTIONS
.......................................................................................................
11
DOSAGE AND ADMINISTRATION
..................................................................................
11
OVERDOSAGE
......................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 14
STORAGE AND STABILITY
...............................................................................................
16
SPECIAL HANDLING INSTRUCTIONS
...........................................................................
16
DOSAGE FORMS, C