BIVALIRUDIN POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BIVALIRUDIN

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

B01AE06

INN (International Name):

BIVALIRUDIN

Dosage:

250MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

BIVALIRUDIN 250MG

Administration route:

INTRAVENOUS

Units in package:

250 MG/VIAL

Prescription type:

Prescription

Therapeutic area:

DIRECT THROMBIN INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0148342001; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2018-08-01

Summary of Product characteristics

_ _
_Bivalirudin _
_Page 1 of 44_
PRODUCT MONOGRAPH
PR
BIVALIRUDIN
Bivalirudin for Injection
250 mg/vial
Professed Standard
Direct Thrombin Inhibitor
Intravenous Injection
Sandoz Canada Inc.
145 Jules-Leger street
Boucherville, Quebec
J4B 7K8
Date of Revision:
June 22, 2016
Control No: 195327
_ _
_Bivalirudin _
_Page 2 of 44_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL INFORMATION
..........................................................................25
CLINICAL TRIALS
..........................................................................................................26
DETAILED PHARMACOLOGY
............................