Maa: Kanada
Kieli: englanti
Lähde: Health Canada
RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN
SANOFI-AVENTIS CANADA INC
B02BD04
COAGULATION FACTOR IX
1000UNIT
KIT
RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 1000UNIT
INTRAVENOUS
15G/50G
Schedule D
HEMOSTATICS
Active ingredient group (AIG) number: 0155510003; AHFS:
APPROVED
2017-05-17
_ALPROLIX, Coagulation Factor IX (Recombinant), Fc Fusion Protein _ _Page 1 of 42 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION ALPROLIX ® Coagulation Factor IX (Recombinant), Fc Fusion Protein Lyophilized Powder for Solution 250, 500, 1000, 2000, 3000 and 4000 IU/vial Antihemorrhagic Blood Coagulation Factor IX sanofi-aventis Canada Inc. 2905 Place Louis R.-Renaud Laval, Quebec H7V 0A3 Date of Initial Authorization: March 20, 2014 Date of Revision: November 5, 2021 SUBMISSION CONTROL NUMBER: 246919 _ _ _Alprolix Coagulation Factor IX (Recombinant), Fc Fusion Protein _ _Page 2 of 42_ RECENT MAJOR LABEL CHANGES 1 INDICATIONS 09/2021 7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics 09/2021 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES............................................................................................ 2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS .............................................................................................................. 4 1.1 Pediatrics .......................................................................................................... 4 1.2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION................................................................................. 4 4.1 Dosing Considerations ....................................................................................... 4 4.2 Recommended Dose and Dosage Adjustment..................................................... 4 4.4 Administration................................................................................................... 7 5 OVERDOSAGE .... Lue koko asiakirja