מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Riociguat
BAYER CO. (MALAYSIA) SDN. BHD.
Riociguat
14tablet Tablets; 56tablet Tablets; 42 (3 x 14's)tablet Tablets
BAYER AG
ADEMPAS ® Riociguat (0.5 mg film-coated tablets,1.0 mg film-coated tablets,1.5 mg film-coated tablets,2.0 mg film-coated tablets,2.5 mg film-coated tablets) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _Adempas_ is used for 2. How _Adempas_ works 3. Before you use _Adempas_ 4. How to use _Adempas_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Adempas_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _ADEMPAS_ IS USED FOR _Chronic-thromboembolic _ _pulmonary _ _hypertension (CTEPH, WHO Group 4) _ _Adempas_ is used to treat adult patients with CTEPH, a disease where high blood pressure in lung vessels (pulmonary arteries) is caused by fixed blood clots narrowing or blocking the blood flow. High pulmonary blood pressure in the lung vessels means that the heart needs to work harder to pump blood through the lungs. This causes people to feel tired, dizzy and short of breath. _Adempas_ is intended for use in patients with CTEPH who cannot be operated (inoperable CTEPH) or in patients with persistent or recurrent high pulmonary blood pressure after surgical treatment. _Adempas_ lowers high blood pressure in the lung vessels and leads to an increase in exercise capacity (will increase a patient’s ability to walk further). _ _ _Pulmonary arterial hypertension (PAH, _ _WHO Group 1) _ _Adempas_ is used to treat adult patients with PAH, a disease characterized by high blood pressure in blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs. In patients with PAH, these arteries get narrower, so the heart has to work harder to pump blood through them. This causes people to feel tired, dizzy and short of breath. _Adempas_ lowers the high blood pressure in the lung vessels and leads to an increase in exercise capacity (will increase a patient’s ability to walk further). _Adempas_ can be taken alone or together with certain medicines used to treat PAH (endothelin receptor antagonists or קרא את המסמך השלם
ADEMPAS ® FILM-COATED TABLET 1. NAME OF THE MEDICINAL PRODUCT Adempas 0.5 mg film-coated tablets Adempas 1.0 mg film-coated tablets Adempas 1.5 mg film-coated tablets Adempas 2.0 mg film-coated tablets Adempas 2.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains either 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg riociguat. For the full list of excipient(s) see section ’list of excipients’. 3. PHARMACEUTICAL FORM Adempas 0.5 mg film-coated tablets: White, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 0.5 and an “R” on the other side. Adempas 1.0 mg film-coated tablets: Pale yellow, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 1 and an “R” on the other side. Adempas 1.5 mg film-coated tablets: Yellow-orange, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 1.5 and an “R” on the other side. Adempas 2.0 mg film-coated tablets: Pale orange, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 2 and an “R” on the other side. Adempas 2.5 mg film-coated tablets: Red-orange, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 2.5 and an “R” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Chronic thromboembolic pulmonary hypertension (CTEPH) Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with • inoperable CTEPH, • persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity (see section 5.1). Pulmonary arterial hypertension (PAH) Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity. Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease ( קרא את המסמך השלם