NIASTASE RT KIT

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

EPTACOG ALFA (ACTIVATED)

Dostępny od:

NOVO NORDISK CANADA INC

Kod ATC:

B02BD08

INN (International Nazwa):

COAGULATION FACTOR VIIa

Dawkowanie:

8MG

Forma farmaceutyczna:

KIT

Skład:

EPTACOG ALFA (ACTIVATED) 8MG

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

100

Typ recepty:

Schedule D

Dziedzina terapeutyczna:

HEMOSTATICS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0136061006; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2018-01-19

Charakterystyka produktu

_NIASTASE RT_
®
_ _
_Product Monograph _
Page 1
PRODUCT MONOGRAPH
Schedule D
NIASTASE RT
®
eptacog alfa (activated)
Activated Recombinant Human Blood Coagulation Factor VII
Room Temperature Stable
Lyophilized Powder
1.0 mg per vial (50 KIU/vial)
2.0 mg per vial (100 KIU/vial)
5.0 mg per vial (250 KIU/vial)
8.0 mg per vial (400 KIU/vial)
Professed
Coagulation Factor
NOVO NORDISK CANADA INC.
101-2476 Argentia Road
Mississauga, Ontario
L5N 6M1 Canada
DATE OF REVISION:
October 01, 2018
Submission Control No: 220117
_NIASTASE RT_
®
_ _
_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......................................................................................8
DRUG INTERACTIONS
....................................................................................15
DOSAGE AND ADMINISTRATION
................................................................16
OVERDOSAGE
..................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
..............................................21
STORAGE AND
STABILITY............................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................23
PART II: SCIENTIFIC INFORMATION
....................................................................25
PHARMACEUTICAL
INFORMATION............................................................25
CLINICAL TRIAL