ANTITHROMBIN III NF KIT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ANTITHROMBIN III (HUMAN)

Available from:

TAKEDA CANADA INC

ATC code:

B01AB02

INN (International Name):

ANTITHROMBIN

Dosage:

550UNIT

Pharmaceutical form:

KIT

Composition:

ANTITHROMBIN III (HUMAN) 550UNIT

Administration route:

INTRAVENOUS

Units in package:

1 VIAL OF POWDER AND 10 ML VIAL OF WATER

Prescription type:

Schedule D

Therapeutic area:

DIRECT THROMBIN INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0124256001; AHFS:

Authorization status:

APPROVED

Authorization date:

1999-11-08

Summary of Product characteristics

_Antithrombin III NF (Antithrombin III (Human), E.P.) _
_Page 1 of 19_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ANTITHROMBIN III NF
Antithrombin III (Human)
Freeze-dried powder with diluent for intravenous injection/infusion
450 - 550 IU/10 mL AT RELEASE
900 - 1100 IU/20 mL AT RELEASE
European Pharmacopoeia
Anticoagulant
Takeda Canada Inc.
22 Adelaide Street West, Suite 3800
Toronto Ontario M5H 4E3
Date of Initial Approval:
Jul 13, 2018
Date of Revision:
Apr 29, 2021
Submission Control No: 246332
TAKEDA
TM
and the TAKEDA Logo
®
are trademarks of Takeda Pharmaceutical Company
Limited, used under license.
_ _
_Antithrombin III NF (Antithrombin III (Human)) _
_Page 2 of 19_
RECENT MAJOR LABEL CHANGES - NOT APPLICABLE
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED_ . _
TABLE OF CONTENTS
...................................................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION ..............................................................................................
4
1
INDICATIONS
......................................................................................................................................................
4
1.1
PEDIATRICS
.............................................................................................................................................................
4
2
CONTRAINDICATIONS
....................................................................................................................................
4
4
DOSAGE AND ADMINISTRATION ...............................................................................................................
4
4.1
DOSING CONSIDERATIONS ...................................................................................................................................
4
4.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
...........................................