BIVALIRUDIN FOR INJECTION POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

BIVALIRUDIN

Tersedia dari:

JUNO PHARMACEUTICALS CORP.

Kode ATC:

B01AE06

INN (Nama Internasional):

BIVALIRUDIN

Dosis:

250MG

Bentuk farmasi:

POWDER FOR SOLUTION

Komposisi:

BIVALIRUDIN 250MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

DIRECT THROMBIN INHIBITORS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2021-01-22

Karakteristik produk

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