NIASTASE POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

EPTACOG ALFA (ACTIVATED)

Disponibil de la:

NOVO NORDISK CANADA INC

Codul ATC:

B02BD08

INN (nume internaţional):

COAGULATION FACTOR VIIa

Dozare:

2.4MG

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

EPTACOG ALFA (ACTIVATED) 2.4MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

2.4MG

Tip de prescriptie medicala:

Schedule D

Zonă Terapeutică:

HEMOSTATICS

Rezumat produs:

Active ingredient group (AIG) number: 0136061002; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2013-07-22

Caracteristicilor produsului

PRODUCT MONOGRAPH
Schedule D
NIASTASE
®
eptacog alfa (activated)
activated recombinant human blood coagulation Factor VII
Lyophilized Powder
1.2 mg per vial (60 KIU/vial)
2.4 mg per vial (120 KIU/vial)
4.8 mg per vial (240 KIU/vial)
Professed
Coagulation Factor
NOVO NORDISK CANADA INC.
300-2680 Skymark Avenue
Mississauga, Ontario
L4W 5L6 Canada
Submission Control No. 125799
DATE OF APPROVAL:
January 28, 2009
_NIASTASE_
_®_
_ Product Monograph _
Page 2
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
.......................................................................................................7
DRUG
INTERACTIONS......................................................................................................11
DOSAGE
AND
ADMINISTRATION..................................................................................12
OVERDOSAGE....................................................................................................................15
ACTION
AND
CLINICAL
PHARMACOLOGY
................................................................15
STORAGE
AND
STABILITY
.............................................................................................16
SPECIAL
HANDLING
INSTRUCTIONS...........................................................................17
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ........................................