Land: Kanada
Sprache: Englisch
Quelle: Health Canada
ANTIHEMOPHILIC FACTOR (RECOMBINANT)
BAYER HEALTHCARE LLC
B02BD02
COAGULATION FACTOR VIII
3000UNIT
POWDER FOR SOLUTION
ANTIHEMOPHILIC FACTOR (RECOMBINANT) 3000UNIT
INTRAVENOUS
5ML
Schedule D
HEMOSTATICS
Active ingredient group (AIG) number: 0124180007; AHFS:
CANCELLED PRE MARKET
2017-08-01
_ _ _HELIXATE FS Product Monograph_ _Page 1 of 31 _ PRODUCT MONOGRAPH HELIXATE ® FS Antihemophilic Factor (Recombinant) _Formulated with Sucrose_ IV Injection, 250, 500, 1000, 2000, 3000 IU/vial Coagulation Factor Manufactured by: Bayer HealthCare LLC 100 Bayer Boulevard, Whippany New Jersey 07981, U.S.A. Imported and distributed by: CSL Behring Canada Inc. 55 Metcalfe St., Suite 1460 Ottawa, Ontario K1P 6L5 Date of Revision: June 5, 2014 Submission Control No.: 2014, CSL Behring Canada, Inc. ® HELIXATE is a registered trademark of CSL Behring L.L.C. CONTROL NO: 175403 DATE OF APPROVAL: JULY 04, 2014 _ _ _HELIXATE FS Product Monograph_ _Page 2 of 31 _ 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 ....................................................................................................9 DOSAGE AND ADMINISTRATION ................................................................................9 OVERDOSAGE ................................................................................................................16 ACTION AND CLINICAL PHARMACOLOGY ............................................................16 STORAGE AND STABILITY ..........................................................................................17 SPECIAL HANDLIN Lesen Sie das vollständige Dokument