BIVALIRUDIN FOR INJECTION POWDER FOR SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-04-2021
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Active ingredient:
BIVALIRUDIN
Available from:
JUNO PHARMACEUTICALS CORP.
ATC code:
B01AE06
INN (International Name):
BIVALIRUDIN
Dosage:
250MG
Pharmaceutical form:
POWDER FOR SOLUTION
Composition:
BIVALIRUDIN 250MG
Administration route:
INTRAVENOUS
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
DIRECT THROMBIN INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0148342001; AHFS:
Authorization status:
APPROVED
Authorization date:
2021-01-22
Summary of Product characteristics
Page 1 of 44
PRODUCT
MONOGRAPH PR
BIVALIRUDIN FOR INJECTION
Lyophilized
Powder
250 mg/vial
Direct Thrombin Inhibitor
Intravenous Injection
JUNO PHARMACEUTICALS CORP.
402-2233 Argentia Road
Mississauga, Ontario L5N 2X7
Date of Preparation:
April 12, 2021
Control No: 249905
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
....................
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