BIVALIRUDIN FOR INJECTION POWDER FOR SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

BIVALIRUDIN

Disponible desde:

JUNO PHARMACEUTICALS CORP.

Código ATC:

B01AE06

Designación común internacional (DCI):

BIVALIRUDIN

Dosis:

250MG

formulario farmacéutico:

POWDER FOR SOLUTION

Composición:

BIVALIRUDIN 250MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

DIRECT THROMBIN INHIBITORS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2021-01-22

Ficha técnica

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
....................