BOSENTAN TABLETS

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

BOSENTAN (BOSENTAN MONOHYDRATE)

Διαθέσιμο από:

ACCORD HEALTHCARE INC

Φαρμακολογική κατηγορία (ATC):

C02KX01

INN (Διεθνής Όνομα):

BOSENTAN

Δοσολογία:

125MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

BOSENTAN (BOSENTAN MONOHYDRATE) 125MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

56/100/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

VASODILATING AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2015-06-02

Αρχείο Π.Χ.Π.

1
PRODUCT MONOGRAPH
Pr
Bosentan Tablets
Bosentan Monohydrate (film coated tablet)
Bosentan 62.5 mg and 125 mg
Professed standard
Endothelin Receptor Antagonist
Accord Healthcare Inc.
3535 boul. St. Charles, suite 704,
Kirkland, QC, H9H 5B9,
Canada
DATE OF PREPARATION:
June 13, 2014
SUBMISSION CONTROL NO: 169674
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
...............................................................................................................
7
DRUG INTERACTIONS
.............................................................................................................
15
DOSAGE AND ADMINISTRATION
.........................................................................................
17
OVERDOSAGE
...........................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
19
STORAGE AND STABILITY
.....................................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
..................................................................................
21
DOSAGE FORMS, COMPOSITION AND
PACKAGING......................................................... 21
PART II: SCIENTIFIC INFORMATION
..............................................................................
22
PHARMACEUTICAL INFORMATION
................