BENEFIX POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

COAGULATION FACTOR IX (RECOMBINANT)

Available from:

PFIZER CANADA ULC

ATC code:

B02BD04

INN (International Name):

COAGULATION FACTOR IX

Dosage:

3000UNIT

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

COAGULATION FACTOR IX (RECOMBINANT) 3000UNIT

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Schedule D

Therapeutic area:

HEMOSTATICS

Product summary:

Active ingredient group (AIG) number: 0152202005; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-09-05

Summary of Product characteristics

_ _
_BeneFIX_
_®_
_ (coagulation factor IX) Product Monograph _
_Page 1 of 30 _
PRODUCT MONOGRAPH
BENEFIX
®
COAGULATION FACTOR IX (RECOMBINANT)
INN= NONACOG ALFA
BENEFIX
 COAGULATION FACTOR IX (RECOMBINANT), IS PREPARED IN SIX LYOPHILIZED
POWDER DOSAGE FORMS NOMINALLY CONTAINING 250, 500, 1000, 1500, 2000
AND
3000 IU PER VIAL. THE RECONSTITUTED PRODUCT CONTAINS APPROXIMATELY:
50, 100,
200, 300, 400 AND 600 IU/ML, RESPECTIVELY.
WORLD HEALTH ORGANIZATION (WHO) INTERNATIONAL STANDARD FOR FACTOR IX
CONCENTRATE
ANTIHEMORRHAGIC BLOOD COAGULATION FACTOR IX
®
T.M. GENETICS INSTITUTE LLC
PFIZER CANADA INC., LICENSEE
17,300 TRANS-CANADA HIGHWAY
KIRKLAND, QUEBEC H9J 2M5
SUBMISSION CONTROL NO: 200822 DATE OF APPROVAL: JULY 21, 2017
©
PFIZER CANADA INC.
_ _
_BeneFIX_
_®_
_ (coagulation factor IX) Product Monograph _
_Page 2 of 30 _
_ _
_BeneFIX_
_®_
_ (coagulation factor IX) Product Monograph _
_Page 3 of 30 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 4
SUMMARY PRODUCT INFORMATION
.............................................................................
4
INDICATIONS AND CLINICAL USE
...................................................................................
4
CONTRAINDICATIONS..........................................................................................................
5
WARNINGS AND PRECAUTIONS
........................................................................................
5
ADVERSE REACTIONS
..........................................................................................................
8
DRUG INTERACTIONS
........................................................................................................
10
DOSAGE AND ADMINISTRATION
....................................................................................
10
OVERDOSAGE
........................................................................................................................
14
ACTION AND CLINICAL
PHARMACOLOGY...........