Země: Singapur
Jazyk: angličtina
Zdroj: HSA (Health Sciences Authority)
Riociguat micronized
BAYER (SOUTH EAST ASIA) PTE LTD
C02KX05
2.00mg
TABLET, FILM COATED
Riociguat micronized 2.00mg
ORAL
Prescription Only
Bayer AG, Leverkusen ( Mfg of bulk product,Pri&SecPackaging,QC & Stability Storage Testing)
ACTIVE
2014-11-24
Page: 1 of 27 Adempas_CCDS07_Jan 2022 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 or 2.5 mg riociguat. 3. PHARMACEUTICAL FORM Adempas 0.5 mg film-coated tablets: White tablets 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 tablets 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 tablets 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 tablets 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 tablets marked with the Bayer cross on one side and 2.5 and an “R” on the other side. Page: 2 of 27 Adempas_CCDS07_Jan 2022 4. CLINICAL PARTICULARS 4.1 INDICATION(S) Chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4): Adempas is indicated for the treatment of adult patients with WHO functional Class II to III symptoms • Inoperable CTEPH, • Persistent or recurrent CTEPH after surgical treatment to improve exercise capacity ( see section 5.1.2). Pulmonary arterial hypertension (PAH, WHO Group 1): Adempas is indicated for the treatment of adult patients with WHO functional class II to III PAH to improve exercise capacity ( see section 5.1.2). Efficacy was shown in patients on riociguat monotherapy or in combination with endothelin receptor antagonists or prostanoids. Studies establishing effectiveness included predominately patients with WHO functional class II-III and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease. 4.2 DOSAGE AND METHOD OF ADMINISTRATION 4.2.1 METHOD OF A Přečtěte si celý dokument
Page: 1 of 27 Adempas_CCDS07_April 2021 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 or 2.5 mg riociguat. 3. PHARMACEUTICAL FORM Adempas 0.5 mg film-coated tablets: White tablets 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 tablets 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 tablets 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 tablets 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 tablets marked with the Bayer cross on one side and 2.5 and an “R” on the other side. Page: 2 of 27 Adempas_CCDS07_April 2021 4. CLINICAL PARTICULARS 4.1 INDICATION(S) Chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4): Adempas is indicated for the treatment of adult patients with WHO functional Class II to III symptoms • Inoperable CTEPH, • Persistent or recurrent CTEPH after surgical treatment to improve exercise capacity ( see section 5.1.2). Pulmonary arterial hypertension (PAH, WHO Group 1): Adempas is indicated for the treatment of adult patients with WHO functional class II to III PAH to improve exercise capacity ( see section 5.1.2). Efficacy was shown in patients on riociguat monotherapy or in combination with endothelin receptor antagonists or prostanoids. Studies establishing effectiveness included predominately patients with WHO functional class II-III and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease. 4.2 DOSAGE AND METHOD OF ADMINISTRATION 4.2.1 METHOD Přečtěte si celý dokument