ALPHA1-PROTEINASE INHIBITOR (HUMAN) POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ALPHA1-PROTEINASE INHIBITOR (HUMAN)

Available from:

GRIFOLS THERAPEUTICS LLC

ATC code:

B02AB02

INN (International Name):

ALFA1 ANTITRYPSIN

Dosage:

1G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

ALPHA1-PROTEINASE INHIBITOR (HUMAN) 1G

Administration route:

INTRAVENOUS

Units in package:

100

Prescription type:

Schedule D

Therapeutic area:

ENZYMES

Product summary:

Active ingredient group (AIG) number: 0120888002; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-02-02

Summary of Product characteristics

PRODUCT MONOGRAPH
ALPHA
1
-PROTEINASE INHIBITOR (HUMAN)
I.V. Injection
500, 1000 mg
Alpha
1
- Antitrypsin Replenisher
Manufactured by:
Talecris Biotherapeutics, Inc.
8368 US 70 West
Clayton, NC 27520
U.S.A.
Distributed and imported by:
Bayer Inc.
Healthcare Division
77 Belfield Road
Etobicoke, ON M9W 1G6
Canada
Prepared for:
Canadian Blood Services
Ottawa, ON K1G 4J5
Canada
Prepared for:
Héma-Québec
Saint-Laurent, Québec
H4R 2W7 CANADA
Date of Preparation:
Control No. 099007
June 13, 2005
2
PRODUCT MONOGRAPH
ALPHA
1
-PROTEINASE INHIBITOR (HUMAN)
I.V. Injection
500, 1000 mg
THERAPEUTIC CLASSIFICATION
Alpha
1
- Antitrypsin Replenisher
ACTION AND CLINICAL PHARMACOLOGY
ALPHA
1
-PROTEINASE INHIBITOR (HUMAN) is a sterile, stable, lyophilized
preparation of purified human Alpha
1
-Proteinase Inhibitor (alpha
1
-PI), also known
as alpha
1
-antitrypsin. ALPHA
1
-PROTEINASE INHIBITOR (HUMAN) is intended
for use in therapy of congenital alpha
1
-antitrypsin deficiency.
Alpha
1
-antitrypsin deficiency is a chronic, hereditary, usually fatal,
autosomal
recessive disorder in which a low concentration of alpha
1
-PI (alpha
1
-antitrypsin) is
associated with slowly progressive severe panacinar emphysema that
most often
manifests itself in the third to fourth decades of life.
2-9
[Although the terms "Alpha
1
-
Proteinase Inhibitor" and "alpha
1
-antitrypsin" are used interchangeably in the
scientific literature, the hereditary disorder associated with a
reduction in the serum
level of alpha
1
-PI is conventionally referred to as "alpha
1
-antitrypsin deficiency"
while the deficient protein is referred to as “Alpha
1
-Proteinase Inhibitor”
10
]. The
emphysema is typically worse in the lower lung zones.
4,8,9
The pathogenesis of
development of emphysema in alpha
1
-antitrypsin deficiency is not well understood
at this time. It is believed, however, to be due to a chronic
biochemical imbalance
between elastase (an enzyme capable of degrading elastin tissues,
released by
inflammatory cells, primarily neutrophils, in the lower