HUMATE-P POWDER FOR SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ANTIHEMOPHILIC FACTOR (HUMAN); VON WILLEBRAND FACTOR (HUMAN)

제공처:

CSL BEHRING CANADA INC

ATC 코드:

B02BD06

INN (국제 이름):

VON WILLEBRAND FACTOR AND COAG. FACT. VIII IN COMB

복용량:

1200UNIT; 3360UNIT

약제 형태:

POWDER FOR SOLUTION

구성:

ANTIHEMOPHILIC FACTOR (HUMAN) 1200UNIT; VON WILLEBRAND FACTOR (HUMAN) 3360UNIT

관리 경로:

INTRAVENOUS

패키지 단위:

15ML

처방전 유형:

Schedule D

치료 영역:

HEMOSTATICS

제품 요약:

Active ingredient group (AIG) number: 0250427003; AHFS:

승인 상태:

APPROVED

승인 날짜:

2004-12-06

제품 특성 요약

_ _
_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
.....