BENEFIX POWDER FOR SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

COAGULATION FACTOR IX (RECOMBINANT)

から入手可能:

PFIZER CANADA ULC

ATCコード:

B02BD04

INN（国際名）:

COAGULATION FACTOR IX

投薬量:

3000UNIT

医薬品形態:

POWDER FOR SOLUTION

構図:

COAGULATION FACTOR IX (RECOMBINANT) 3000UNIT

投与経路:

INTRAVENOUS

パッケージ内のユニット:

15G/50G

処方タイプ:

Schedule D

治療領域:

HEMOSTATICS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2012-09-05

製品の特徴

_ _
_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...........