NIASTASE POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

EPTACOG ALFA (ACTIVATED)

Tersedia dari:

NOVO NORDISK CANADA INC

Kode ATC:

B02BD08

INN (Nama Internasional):

COAGULATION FACTOR VIIa

Dosis:

2.4MG

Bentuk farmasi:

POWDER FOR SOLUTION

Komposisi:

EPTACOG ALFA (ACTIVATED) 2.4MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

2.4MG

Jenis Resep:

Schedule D

Area terapi:

HEMOSTATICS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2013-07-22

Karakteristik produk

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 ........................................