BERINERT 1500 KIT

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

C1 ESTERASE INHIBITOR (HUMAN)

Доступно од:

CSL BEHRING CANADA INC

АТЦ код:

B06AC01

INN (Међународно име):

C1-INHIBITOR, PLASMA DERIVED

Дозирање:

1500UNIT

Фармацеутски облик:

KIT

Састав:

C1 ESTERASE INHIBITOR (HUMAN) 1500UNIT

Пут администрације:

INTRAVENOUS

Јединице у пакету:

3ML

Тип рецептора:

Schedule D

Терапеутска област:

COMPLEMENT INHIBITORS

Резиме производа:

Active ingredient group (AIG) number: 0152746002; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2014-12-23

Карактеристике производа

Page 1 of 45
PRODUCT MONOGRAPH
BERINERT
® 500 / BERINERT
® 1500
C1 ESTERASE INHIBITOR, HUMAN
Powder and Diluent for Solution for Injection
For Intravenous Administration
500 IU/vial, reconstituted with 10 mL of diluent
1500 IU/vial, reconstituted with 3 mL of diluent
CSL Behring Canada, Inc.
55 Metcalfe Street, Suite 1460
Ottawa, Ontario
K1P 6L5
Date of Initial Approval: May 31, 2010
Date of Revision: February 14, 2020
Submission Control No: 235563
Page 2 of 45
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
ADVERSE REACTIONS
...................................................................................................
6
DRUG INTERACTIONS
.................................................................................................
12
DOSAGE AND ADMINISTRATION
.............................................................................
12
OVERDOSAGE
...............................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 15
STORAGE AND STABILITY
.........................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 18
PART II: SCIENTIFIC INFORMATION
..............................................................................
19
PHARMACEUTICAL INFORMATION
.........................................................................
19
CLINICAL TRIAL