Land: Canada
Språk: engelsk
Kilde: Health Canada
SIMOCTOCOG ALFA; WATER
OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H
B02BD02
COAGULATION FACTOR VIII
500UNIT; 2.5ML
KIT
SIMOCTOCOG ALFA 500UNIT; WATER 2.5ML
INTRAVENOUS
30
Schedule D
HEMOSTATICS
Active ingredient group (AIG) number: 0256190002; AHFS:
APPROVED
2014-10-22
_ _ _Nuwiq Product Monograph _ _Page 1 of 42_ PRODUCT MONOGRAPH Nuwiq ® Antihemophilic Factor (Recombinant, B-Domain deleted) INN = simoctocog alfa Powder and solvent for solution for intravenous injection 250 IU FVIII/vial reconstituted with 2.5 mL of solvent 500 IU FVIII/vial reconstituted with 2.5 mL of solvent 1000 IU FVIII/vial reconstituted with 2.5 mL of solvent 1500 IU FVIII/vial reconstituted with 2.5 mL of solvent 2000 IU FVIII/vial reconstituted with 2.5 mL of solvent 2500 IU FVIII/vial reconstituted with 2.5 mL of solvent 3000 IU FVIII/vial reconstituted with 2.5 mL of solvent 4000 IU FVIII/vial reconstituted with 2.5 mL of solvent ATC code: B02BD02 Manufactured by: Octapharma AB Lars Forssells gata 23 112 75 Stockholm, SWEDEN Manufactured for: Octapharma Canada Inc. 308-214 King St W Toronto, Ontario, M5H 3S6, CANADA Date of Initial Approval: October 23, 2014 Date of Revision: December 29, 2022 Control #: 264181 _ _ _Nuwiq Product Monograph _ _Page 2 of 42_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ................................................ 3 SUMMARY PRODUCT INFORMATION .............................................................. 3 DESCRIPTION ....................................................................................................... 3 INDICATIONS AND CLINICAL USE.................................................................... 4 CONTRAINDICATIONS ........................................................................................ 4 WARNINGS AND PRECAUTIONS ....................................................................... 4 ADVERSE REACTIONS ........................................................................................ 6 DRUG INTERACTIONS......................................................................................... 9 DOSAGE AND ADMINISTRATION...................................................................... 9 OVERDOSAGE .....................................................................................................15 ACTI Les hele dokumentet