BOSENTAN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

BOSENTAN (BOSENTAN MONOHYDRATE)

Tersedia dari:

PANDA PHARMACEUTICALS INC.

Kode ATC:

C02KX01

INN (Nama Internasional):

BOSENTAN

Dosis:

125MG

Bentuk farmasi:

TABLET

Komposisi:

BOSENTAN (BOSENTAN MONOHYDRATE) 125MG

Rute administrasi :

ORAL

Unit dalam paket:

30/60/100

Jenis Resep:

Prescription

Area terapi:

VASODILATING AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0145922002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2017-09-22

Karakteristik produk

1
PRODUCT MONOGRAPH PR
BOSENTAN
62.5 mg and 125 mg Bosentan (as monohydrate)
(film coated) Tablet
Endothelin Receptor Antagonist
PANDA Pharmaceuticals Inc.
35 Nixon Road, Unit 10
Caledon, Ontario
L7E 1K1
Date of Preparation: SEPTEMBER 21, 2017
Submission Control No: 200531
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
8
DRUG INTERACTIONS
.........................................................................................................
15
DOSAGE AND ADMINISTRATION
.....................................................................................
18
OVERDOSAGE
........................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
19
STORAGE AND STABILITY
.................................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 21
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL INFORMATION
.................................................................................
23
CLINICAL TRIAL