国家: 加拿大
语言: 英文
来源: Health Canada
C1 ESTERASE INHIBITOR (HUMAN)
CSL BEHRING CANADA INC
B06AC01
C1-INHIBITOR, PLASMA DERIVED
1500UNIT
KIT
C1 ESTERASE INHIBITOR (HUMAN) 1500UNIT
INTRAVENOUS
3ML
Schedule D
COMPLEMENT INHIBITORS
Active ingredient group (AIG) number: 0152746002; AHFS:
APPROVED
2014-12-23
Page 1 of 45 PRODUCT MONOGRAPH BERINERT ® 500 / BERINERT ® 1500 C1 ESTERASE INHIBITOR, HUMAN Powder and Diluent for Solution for Injection For Intravenous Administration 500 IU/vial, reconstituted with 10 mL of diluent 1500 IU/vial, reconstituted with 3 mL of diluent CSL Behring Canada, Inc. 55 Metcalfe Street, Suite 1460 Ottawa, Ontario K1P 6L5 Date of Initial Approval: May 31, 2010 Date of Revision: February 14, 2020 Submission Control No: 235563 Page 2 of 45 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 DESCRIPTION................................................................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 ADVERSE REACTIONS ................................................................................................... 6 DRUG INTERACTIONS ................................................................................................. 12 DOSAGE AND ADMINISTRATION ............................................................................. 12 OVERDOSAGE ............................................................................................................... 15 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 15 STORAGE AND STABILITY ......................................................................................... 18 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 18 PART II: SCIENTIFIC INFORMATION .............................................................................. 19 PHARMACEUTICAL INFORMATION ......................................................................... 19 CLINICAL TRIAL 阅读完整的文件