TRASYLOL SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

APROTININ (BOVINE)

Available from:

NORDIC GROUP B.V.

ATC code:

B02AB01

INN (International Name):

APROTININ

Dosage:

10000UNIT

Pharmaceutical form:

SOLUTION

Composition:

APROTININ (BOVINE) 10000UNIT

Administration route:

INTRAVENOUS

Units in package:

50ML/200ML

Prescription type:

Prescription

Therapeutic area:

HEMOSTATICS

Product summary:

Active ingredient group (AIG) number: 0152585001; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-08-14

Summary of Product characteristics

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_Page 1 of 33 _
PRODUCT MONOGRAPH
PR
TRASYLOL
®
Aprotinin
Intravenous solution, 10,000 KIU/mL
Hemostatic Agent
Nordic Group b.v.
Hoofddorp, Netherlands
2132WT
Imported by: Methapharm Inc.
Brantford, Ontario, N3S 7X6
Date of Revision:
September 19, 2014
Date of Authorization:
September 26, 2014
Submission Control No: 176839
2014, Nordic Group
_ _
_Page 2 of 33 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
DESCRIPTION....................................................................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................16
STORAGE AND STABILITY
..........................................................................................18
SPECIAL HANDLING INSTRUCTIONS
.......................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................18
PART II: SCIENTIFIC INFORMATION
................................................................................19
PHA