BOSENTAN TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

BOSENTAN (BOSENTAN MONOHYDRATE)

Dostopno od:

PANDA PHARMACEUTICALS INC.

Koda artikla:

C02KX01

INN (mednarodno ime):

BOSENTAN

Odmerek:

62.5MG

Farmacevtska oblika:

TABLET

Sestava:

BOSENTAN (BOSENTAN MONOHYDRATE) 62.5MG

Pot uporabe:

ORAL

Enote v paketu:

30/60/100

Tip zastaranja:

Prescription

Terapevtsko območje:

VASODILATING AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0145922001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2017-09-22

Lastnosti izdelka

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