PMS-BOSENTAN TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
21-09-2018
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Aktiv bestanddel:
BOSENTAN (BOSENTAN MONOHYDRATE)
Tilgængelig fra:
PHARMASCIENCE INC
ATC-kode:
C02KX01
INN (International Name):
BOSENTAN
Dosering:
125MG
Lægemiddelform:
TABLET
Sammensætning:
BOSENTAN (BOSENTAN MONOHYDRATE) 125MG
Indgivelsesvej:
ORAL
Enheder i pakken:
60/100
Recept type:
Prescription
Terapeutisk område:
VASODILATING AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0145922002; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2012-05-29
Produktets egenskaber
PRODUCT MONOGRAPH
PR
PMS-BOSENTAN
Bosentan Monohydrate (Film-Coated) Tablets
Bosentan 62.5 mg and 125 mg
ENDOTHELIN RECEPTOR ANTAGONIST
PHARMASCIENCE INC.
6111 Royalmount Avenue, suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION:
September 20, 2018
Submission Control No: 219197
_ _
_pms-BOSENTAN Product Monograph _
_Page 2 of 38_
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 .................................................................................................................
14
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
........................................................
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