Nazione: Singapore
Lingua: inglese
Fonte: HSA (Health Sciences Authority)
Macitentan (micronized)
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
C02KX04
TABLET, FILM COATED
Macitentan (micronized) 10.00mg
ORAL
Prescription Only
Patheon Italia S.p.A.
ACTIVE
2015-07-15
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 Leggi il documento completo