ALEMBIC-BOSENTAN TABLET
Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
Karatteristiċi tal-prodott
(SPC)
13-12-2021
Xi dokumenti għal dan il-prodott mhumiex disponibbli bħalissa, tista 'tibgħat talba lis-servizz tal-konsumatur tagħna u aħna ninnotifikawkom malli nkunu nistgħu niksbuhom.
Ibgħat talba.
Ibgħat talba.
Ingredjent attiv:
BOSENTAN (BOSENTAN MONOHYDRATE)
Disponibbli minn:
ALEMBIC PHARMACEUTICALS LIMITED
Kodiċi ATC:
C02KX01
INN (Isem Internazzjonali):
BOSENTAN
Dożaġġ:
125MG
Għamla farmaċewtika:
TABLET
Kompożizzjoni:
BOSENTAN (BOSENTAN MONOHYDRATE) 125MG
Rotta amministrattiva:
ORAL
Unitajiet fil-pakkett:
10/30/60/1000
Tip ta 'preskrizzjoni:
Prescription
Żona terapewtika:
VASODILATING AGENTS
Sommarju tal-prodott:
Active ingredient group (AIG) number: 0145922002; AHFS:
L-istatus ta 'awtorizzazzjoni:
APPROVED
Data ta 'l-awtorizzazzjoni:
2021-12-16
Karatteristiċi tal-prodott
______________________________________________________________________________
Alembic-Bosentan Page 1 of 42
PRODUCT MONOGRAPH
PR
ALEMBIC-BOSENTAN
Bosentan Tablets
62.5 mg and 125 mg Bosentan (as Bosentan Monohydrate)
Endothelin Receptor Antagonist
DATE OF REVISION:
December 13, 2021
MANUFACTURED BY:
Alembic Pharmaceuticals Limited
Alembic Road
Vadodara
–
390003
Gujarat, India
CANADIAN IMPORTER AND DISTRIBUTOR:
Alembic Pharmaceuticals Canada Ltd.
225
Gibraltar Road, Unit 5
Vaughn, Ontario
L4H 4P9
Control #
258718
______________________________________________________________________________
Alembic-Bosentan Page 2 of 42
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
..................................................................................................
17
DOSAGE AND ADMINISTRATION
..............................................................................
20
OVERDOSAGE
................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 22
STORAGE AND
STABILITY..........................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................
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