HAEGARDA 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:

2000UNIT

Pharmaceutical form:

KIT

Composition:

C1 ESTERASE INHIBITOR (HUMAN) 2000UNIT

Administration route:

SUBCUTANEOUS

Units in package:

4ML

Prescription type:

Schedule D

Therapeutic area:

COMPLEMENT INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0152746003; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-09-01

Summary of Product characteristics

_HAEGARDA_
_®_
_, C1 Esterase Inhibitor Subcutaneous (Human) _
_Page 1 of 29_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION
INFORMATION
HAEGARDA
®
C1 Esterase Inhibitor Subcutaneous (Human)
Powder and Diluent for Solution for Injection
For Subcutaneous Administration
2000 IU/vial, reconstituted with 4 mL of diluent
3000 IU/vial, reconstituted with 5.6 mL of diluent
Pharmacopeial
B06AC01
_ _
_ _
CSL Behring Canada, Inc.
55 Metcalfe Street, Suite 1460
Ottawa, Ontario
K1P 6L5
www.cslbehring.ca
Date of Initial Authorization:
SEP 01, 2017
Date of Revision:
APR 13, 2022
Submission Control Number: 258112
_ _
_HAEGARDA_
_®_
_, C1 Esterase Inhibitor Subcutaneous (Human) _
_Page 2 of 29_
RECENT MAJOR LABEL CHANGES
1.1 Pediatrics
2021-03
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
RECENT MAJOR LABEL CHANGES
................................................................................
2
TABLE OF
CONTENTS.......................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 4
1
INDICATIONS
...........................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics
..........................................................................................................
4
2
CONTRAINDICATIONS
...........................................................................................
4
4
DOSAGE AND ADMINISTRATION
.........................................................................
4
4.1
Dosing
Considerations.....................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
.............................................. 4
4.3
Reconstitution....................................................