RIASTAP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FIBRINOGEN (HUMAN)

Available from:

CSL BEHRING CANADA INC

ATC code:

B02BB01

INN (International Name):

FIBRINOGEN, HUMAN

Dosage:

1000MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

FIBRINOGEN (HUMAN) 1000MG

Administration route:

INTRAVENOUS

Units in package:

50ML

Prescription type:

Schedule D

Therapeutic area:

HEMOSTATICS

Product summary:

Active ingredient group (AIG) number: 0153289001; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-09-13

Summary of Product characteristics

_Appendix I - Product Monograph Template - Schedule D _
_Page 1 of 27_
PRODUCT MONOGRAPH
RIASTAP
®
FIBRINOGEN CONCENTRATE (HUMAN), FCH
Lyophilized powder for reconstitution and infusion
900 to 1300 mg Fibrinogen/vial
CSL BEHRING CANADA, INC.
55 Metcalfe Street, Suite 1460
Ottawa, Ontario
K1P 6L5
Date of initial approval: September 13, 2012
Control Number: 237751
Date of Revision: May 27, 2020
_Appendix I - Product Monograph Template - Schedule D _
_Page 2 of 27_
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
...................................................................................................
6
DRUG INTERACTIONS
...................................................................................................
8
DOSAGE AND ADMINISTRATION
...............................................................................
8
OVERDOSAGE
...............................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 12
STORAGE AND STABILITY
.........................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
......................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 14
PART II: SCIENTIFI