ANTITHROMBIN III NF KIT

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ANTITHROMBIN III (HUMAN)

Disponibil de la:

TAKEDA CANADA INC

Codul ATC:

B01AB02

INN (nume internaţional):

ANTITHROMBIN

Dozare:

550UNIT

Forma farmaceutică:

KIT

Compoziție:

ANTITHROMBIN III (HUMAN) 550UNIT

Calea de administrare:

INTRAVENOUS

Unități în pachet:

1 VIAL OF POWDER AND 10 ML VIAL OF WATER

Tip de prescriptie medicala:

Schedule D

Zonă Terapeutică:

DIRECT THROMBIN INHIBITORS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

1999-11-08

Caracteristicilor produsului

_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
...........................................