ANTITHROMBIN III IMMUNO POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ANTITHROMBIN III (HUMAN); WATER

Available from:

BAXTER AG

ATC code:

B01AB02

INN (International Name):

ANTITHROMBIN

Dosage:

1650UNIT; 30ML

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

ANTITHROMBIN III (HUMAN) 1650UNIT; WATER 30ML

Administration route:

INTRAVENOUS

Units in package:

1350-1650 IU/VIAL

Prescription type:

Schedule D

Therapeutic area:

DIRECT THROMBIN INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0224213003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2011-10-07

Summary of Product characteristics

PRODUCT MONOGRAPH
ANTITHROMBIN III IMMUNO
ANTITHROMBIN III (HUMAN), E.P.
450 - 550 lU
1
/10 mL,
900 - 1100 lU
1
/20 mL,
1350 -1650 IU
1
/30 mL
Freeze-dried powder with diluent for intravenous injection/infusion
Anticoagulant
Manufactured by:
BAXTER AG
A-1220 Vienna, Austria
Imported and Distributed by:
Date of Revision: January 6, 2010
BAXTER CORPORATION
4 Robert Speck Parkway, Suite 700
Mississauga ON Canada L4Z 3Y4
Date of Approval: June 9, 2010
Submission Control #: 137766
ANTITHROMBIN III IMMUNO
ANTITHROMBIN III (HUMAN), E.P.
450 - 550 lU
1
/10 mL,
900 - 1100 lU
1
/20 mL,
1350 -1650 IU
1
/30 mL
Freeze-dried powder with diluent for intravenous injection/infusion
Anticoagulant
ACTION AND CLINICAL PHARMACOLOGY
Antithrombin III acts as a physiological inhibitor of blood
coagulation, particularly by inhibition of thrombin
and activated factor X, but also of factors lXa, XIa, XIIa, and
plasmin. This inhibitory effect of antithrombin
III (AT III) can occur in the absence of heparin, but is accelerated
within the presence of heparin.
Antithrombin III is an alpha-2 globulin with a molecular weight
ranging between 58,000 and 65,000 dalton.
Plasma concentrations from 140 μg to 300 μg /mL have been reported
in healthy adults. In adults, the
normal range of activity is between 80 and 120%, where 100% is
equivalent to the antithrombin III activity
as found in 1 mL of a human reference plasma pool. Normal levels in
newborns are approximately 50%.
Adult levels are usually reached by six months of life.
The fact that antithrombin III has a considerably reduced tolerance
range compared to the coagulation
factors is of clinical importance. Whereas the coagulation enzymes may
drop to 40% and below without
the occurrence of bleeding, even moderate decreases of antithrombin
III activity to 70% are associated
with an increased risk of thrombosis. ANTITHROMBIN III IMMUNO,
Antithrombin III (human), provides a
temporary increase in plasma levels of AT III and thus allows for
treatment and/or prophylaxis of
thrombotic or thromboembol