OPSUMIT FILM-COATED TABLET 10MG

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

Macitentan (micronized)

Διαθέσιμο από:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Φαρμακολογική κατηγορία (ATC):

C02KX04

Φαρμακοτεχνική μορφή:

TABLET, FILM COATED

Σύνθεση:

Macitentan (micronized) 10.00mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

Patheon Italia S.p.A.

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2015-07-15

Αρχείο Π.Χ.Π.

1
PRODUCT MONOGRAPH
OPSUMIT
®
macitentan
10 mg film-coated tablet
Endothelin Receptor Antagonist
2
OPSUMIT
®
macitentan
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
INDICATIONS AND CLINICAL USE
OPSUMIT
®
(macitentan)
is
indicated
for
the
long-term
treatment
of
pulmonary
arterial
hypertension (PAH, WHO Group l) to reduce morbidity in patients of WHO
Functional Class II
or III whose PAH is either idiopathic or heritable, or associated with
connective tissue disease or
corrected simple congenital heart disease.
OPSUMIT
®
is effective when used as monotherapy or in combination with
phosphodiesterase-5
inhíbitors.
GERIATRICS (≥ 65 YEARS OF AGE):
Of the total number of subjects in the clinical study of
OPSUMIT
®
for PAH, 14% were ≥65 years of age.
PEDIATRICS (<18 YEARS OF AGE):
The safety and efficacy of OPSUMIT
®
in children and adolescents
<18 years of age has not yet been established.
CONTRAINDICATIONS
OPSUMIT
®
(macitentan) is contraindicated in:
•
Patients who are hypersensitive to this drug or to any ingredient in
the formulation or
component of the container. For a complete listing, see the Dosage
Forms, Composition
and Packaging section of the Product Monograph.
•
Women who are or may become pregnant. (
_see Warnings and Precautions, Special _
_Populations, Pregnant Women_
).
•
Nursing women (
_see Warnings and Precautions, Special Populations, Nursing Women)._
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
NONMEDICINAL INGREDIENTS
Oral
10 mg film-coated
tablet
lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polysorbate 80,
povidone, and sodium starch glycolate Type
A, polyvinyl alcohol, soya lecithin, talc,
titanium dioxide, and xanthan gum
3
WARNINGS AND PRECAUTIONS
HEPATIC/BILIARY/PANCREATIC
Elevations of liver aminotransferases (AST, ALT) have been associated
with PAH and with
endothelin receptor antagonists (ERAs). In a long-term double blind,
placebo-controlled Phase
III outcome study of OPSUMIT
®
, the incidence of an increase in ALT of >3 ti