Држава: Израел
Језик: Енглески
Извор: Ministry of Health
RIOCIGUAT
BAYER ISRAEL LTD
C02KX05
FILM COATED TABLETS
RIOCIGUAT 2.5 MG
PER OS
Required
BAYER AG., GERMANY
RIOCIGUAT
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. 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.
2020-03-31
ناملأا تامولعم ةقاطب ةجلاعتملل ساپم ِ دأ ،غلم 1 ساپم ِ دأ ،غلم 0.5 ساپم ِ دأ غلم 2.5 ساپم ِ دأ ،غلم 2 ساپم ِ دأ ،غلم 1.5 יתוחיטב עדימ סיטרכ תלפוטמל ADEMPAS ® INITIAL TREATMENT SUMMARY Every two weeks (for a total of eight weeks) you will be assessed by your PH healthcare professional. After eight weeks you and your PH healthcare professional will have found the Adempas ® dose that is right for you After checking your blood pressure, signs and symptoms of low blood pressure (hypotension) and monitoring any treatment-related side effects, your PH healthcare professional will decide with you whether it’s best to increase, decrease or maintain your dose Remember, there is no right dose, just the dose that is right for you BP ADEMPAS ® INITIAL TREATMENT SUMMARY Every two weeks (for a total of eight weeks) you will be assessed by your PH healthcare professional. After eight weeks you and your PH healthcare professional will have found the Adempas ® dose that is right for you After checking your blood pressure, signs and symptoms of low blood pressure (hypotension) and monitoring any treatment-related side effects, your PH healthcare professional will decide with you whether it’s best to increase, decrease or maintain your dose Remember, there is no right dose, just the dose that is right for you BP ,ג”מ 1 סאפמדא ,ג”מ 0.5 סאפמדא ,ג”מ 2 סאפמדא ,ג”מ 1.5 סאפמדא ג”מ 2.5 סאפמדא הלולע ןוירה ךלהמב סאפמדא תליטנ .רבועל קיזהל וא ןוירהב ךנה םא סאפמדא לוטיל ןיא .ןוירהל סנכיהל תננכתמ תא םא היושעה תוירופה ליגב השיא ךנה םא תקידב עצבל ךממ שקבי ךאפור ,תורהל ,סאפמדאב לופיטה תליחת ינפל ןוירה תליטנ ךלהמב שדוח לכ יתרגש ןפואב .לופיטה םויס רחאל שדוח ןכו הפורתה תקידב Прочитајте комплетан документ
1 1. NAME OF THE MEDICINAL PRODUCT Adempas 0.5 mg film-coated tablets Adempas 1 mg film-coated tablets Adempas 1.5 mg film-coated tablets Adempas 2 mg film-coated tablets Adempas 2.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Adempas 0.5 mg film-coated tablets Each film-coated tablet contains 0.5 mg of riociguat. Adempas 1 mg film-coated tablets Each film-coated tablet contains 1 mg of riociguat. Adempas 1.5 mg film-coated tablets Each film-coated tablet contains 1.5 mg of riociguat. Adempas 2 mg film-coated tablets Each film-coated tablet contains 2 mg of riociguat. Adempas 2.5 mg film-coated tablets Each film-coated tablet contains 2.5 mg of riociguat. Excipients with known effect: _Adempas 0.5 mg film-coated tablets_ Each 0.5 mg film-coated tablet contains 39.8 mg lactose monohydrate, see section 4.4. _ _ _Adempas 1 mg film-coated tablets_ Each 1 mg film-coated tablet contains 39.2 mg lactose monohydrate, see section 4.4. _ _ _Adempas 1.5 mg film-coated tablets_ Each 1.5 mg film-coated tablet contains 38.7 mg lactose monohydrate, see section 4.4 _ _ _Adempas 2 mg film-coated tablets_ Each 2 mg film-coated tablet contains 38.2 mg lactose monohydrate, see section 4.4.. _ _ _Adempas 2.5 mg film-coated tablets_ Each 2.5 mg film-coated tablet contains 37.7 mg lactose monohydrate, see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Adempas 0.5 mg: 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 mg: 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. 2 Adempas 1.5 mg: 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 mg: 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: Red-orange, round, bicon Прочитајте комплетан документ