Страна: Канада
мова: англійська
Джерело: Health Canada
EPTACOG ALFA (ACTIVATED)
NOVO NORDISK CANADA INC
B02BD08
COAGULATION FACTOR VIIa
8MG
KIT
EPTACOG ALFA (ACTIVATED) 8MG
INTRAVENOUS
100
Schedule D
HEMOSTATICS
Active ingredient group (AIG) number: 0136061006; AHFS:
APPROVED
2018-01-19
_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 Прочитайте повний документ