BOSENTAN TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

BOSENTAN (BOSENTAN MONOHYDRATE)

Διαθέσιμο από:

PANDA PHARMACEUTICALS INC.

Φαρμακολογική κατηγορία (ATC):

C02KX01

INN (Διεθνής Όνομα):

BOSENTAN

Δοσολογία:

62.5MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

BOSENTAN (BOSENTAN MONOHYDRATE) 62.5MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30/60/100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

VASODILATING AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2017-09-22

Αρχείο Π.Χ.Π.

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