Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
ANTIHEMOPHILIC FACTOR (HUMAN); VON WILLEBRAND FACTOR (HUMAN)
CSL BEHRING CANADA INC
B02BD06
VON WILLEBRAND FACTOR AND COAG. FACT. VIII IN COMB
1200UNIT; 3360UNIT
POWDER FOR SOLUTION
ANTIHEMOPHILIC FACTOR (HUMAN) 1200UNIT; VON WILLEBRAND FACTOR (HUMAN) 3360UNIT
INTRAVENOUS
15ML
Schedule D
HEMOSTATICS
Active ingredient group (AIG) number: 0250427003; AHFS:
APPROVED
2004-12-06
_ _ _Appendix I - Product Monograph Template - Schedule D _ _Page 1 of 38_ PRODUCT MONOGRAPH HUMATE-P ® ANTIHEMOPHILIC FACTOR / VON WILLEBRAND FACTOR COMPLEX (HUMAN), DRIED, PASTEURIZED (200-300) IU * / (360-840) IU * , reconstituted with 5 mL diluent (400-600) IU * / (720-1680) IU * , reconstituted with 10mL diluent (810-1200) IU * / (1440-3360) IU * , reconstituted with 15 mL diluent _ _ Coagulation Factor (ATC Classification Code: B02BD05) CSL BEHRING CANADA, INC. 55 Metcalfe Street, Suite 1460 Ottawa, Ontario K1P 6L5 Date of Revision: September 08, 2017 Control #: 207271 Date of Approval: September 15, 2017 *An international unit (IU) is defined by current international standards. One IU Factor VIII or 1 IU vWF:RCof is approximately equal to the level of Factor VIII or vWF:RCof found in 1.0 mL of fresh-pooled plasma. _ _ _Page 2 of 38_ 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 ................................................................................................. 11 DOSAGE AND ADMINISTRATION ............................................................................. 11 OVERDOSAGE ............................................................................................................... 18 ACTION AND CLINICAL PHARMACOLOGY ..... Prečítajte si celý dokument