BENEFIX - (500IU) KIT

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

COAGULATION FACTOR IX (RECOMBINANT); WATER

Доступна з:

WYETH CANADA

Код атс:

B02BD04

ІПН (Міжнародна Ім'я):

COAGULATION FACTOR IX

Дозування:

500UNIT; 5ML

Фармацевтична форма:

KIT

Склад:

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

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

PACKAGED AS A KIT

Тип рецепту:

Schedule D

Терапевтична области:

HEMOSTATICS

Огляд продуктів:

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

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2008-06-19

Характеристики продукта

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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_Page 2 of 31 _
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