THROMBATE III POWDER FOR SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

ANTITHROMBIN III (HUMAN)

Pieejams no:

GRIFOLS THERAPEUTICS LLC

ATĶ kods:

B01AB02

SNN (starptautisko nepatentēto nosaukumu):

ANTITHROMBIN

Deva:

1000UNIT

Zāļu forma:

POWDER FOR SOLUTION

Kompozīcija:

ANTITHROMBIN III (HUMAN) 1000UNIT

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

1000 IU

Receptes veids:

Schedule D

Ārstniecības joma:

DIRECT THROMBIN INHIBITORS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2005-06-08

Produkta apraksts

_ _
Page 1 of 20
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
_ _
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
..................................................................