THROMBATE III POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ANTITHROMBIN III (HUMAN)

Available from:

GRIFOLS THERAPEUTICS LLC

ATC code:

B01AB02

INN (International Name):

ANTITHROMBIN

Dosage:

1000UNIT

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

ANTITHROMBIN III (HUMAN) 1000UNIT

Administration route:

INTRAVENOUS

Units in package:

1000 IU

Prescription type:

Schedule D

Therapeutic area:

DIRECT THROMBIN INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0124256002; AHFS:

Authorization status:

APPROVED

Authorization date:

2005-06-08

Summary of Product characteristics

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PRODUCT MONOGRAPH
THROMBATE III

Antithrombin III (Human)
I.V. Injection, 500, IU
Manufacturer’s Standard
Anticoagulant
Manufactured by:
Grifols Therapeutics Inc.
8368 US 70 Bus. Hwy West
Clayton, NC 27520
Distributed and Imported by:
Grifols Canada Ltd.
5060 Spectrum Way,
Suite 405
Mississauga, Ontario
L4W 5N5
Submission Control No: 158117 Date of Approval: April 3, 2013
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Page 2 of 20
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
DESCRIPTION....................................................................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................12
PART II: SCIENTIFIC INFORMATION
................................................................................14
PHARMACEUTICAL INFORMATION
..........................................................................14
CLINICAL TRIALS
..................................................................