ZEMAIRA KIT

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ALPHA1-PROTEINASE INHIBITOR (HUMAN)

Fáanlegur frá:

CSL BEHRING CANADA INC

ATC númer:

B02AB02

INN (Alþjóðlegt nafn):

ALFA1 ANTITRYPSIN

Skammtar:

4000MG

Lyfjaform:

KIT

Samsetning:

ALPHA1-PROTEINASE INHIBITOR (HUMAN) 4000MG

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

100

Gerð lyfseðils:

Schedule D

Lækningarsvæði:

ENZYMES

Vörulýsing:

Active ingredient group (AIG) number: 0120888007; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2019-12-16

Vara einkenni

_ZEMAIRA® (Alpha1-Proteinase Inhibitor (Human))_
_ _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ZEMAIRA®
Alpha
1
-Proteinase Inhibitor (Human)
Powder and Diluent for Solution for Injection
For Intravenous Administration
Pharmacopeial
B02AB02
CSL Behring Canada, Inc.
55 Metcalfe Street, Suite 1460
Ottawa, Ontario
K1P 6L5
www.cslbehring.ca
Date of Initial Authorization:
SEP 21, 2016
Date of Revision:
MAY 18, 2023
Submission Control Number: 270961
_ _
_ZEMAIRA® (Alpha1-Proteinase Inhibitor (Human))_
_ _
_Page 2 of 36_
RECENT MAJOR LABEL CHANGES
4.4 Administration & Patient Medication
Information
12/2022
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
....................................................................