BERINERT 500 KIT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

C1 ESTERASE INHIBITOR (HUMAN)

Available from:

CSL BEHRING CANADA INC

ATC code:

B06AC01

INN (International Name):

C1-INHIBITOR, PLASMA DERIVED

Dosage:

500UNIT

Pharmaceutical form:

KIT

Composition:

C1 ESTERASE INHIBITOR (HUMAN) 500UNIT

Administration route:

INTRAVENOUS

Units in package:

10ML

Prescription type:

Schedule D

Therapeutic area:

COMPLEMENT INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0152746001; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-12-23

Summary of Product characteristics

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