Šalis: Nyderlandai
kalba: olandų
Šaltinis: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
BOSENTAN 1-WATER SAMENSTELLING overeenkomend met ; BOSENTAN
Ferrer International S.A. Gran Via Carlos III, 94 08028 BARCELONA (SPANJE)
C02KX01
BOSENTAN 1-WATER COMPOSITION corresponding to ; BOSENTAN
Filmomhulde tablet
ETHYLCELLULOSE (E 462) ; GLYCEROLDIBEHENAAT ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT ; POLOXAMEER 188 ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), ETHYLCELLULOSE (E 462) ; GLYCEROLDIBEHENAAT ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLOXAMEER 188 ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Bosentan
Hulpstoffen: ETHYLCELLULOSE (E 462); GLYCEROLDIBEHENAAT; GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMZETMEELGLYCOLAAT (E468); POLOXAMEER 188; POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
2018-02-08
1 PACKAGE LEAFLET: INFORMATION FOR THE USER BOSENTAN FERRER 62,5 MG FILMOMHULDE TABLETTEN BOSENTAN FERRER 125 MG FILMOMHULDE TABLETTEN Bosentan READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, please ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Bosentan Ferrer is and what it is used for 2. What you need to know before you take Bosentan Ferrer] 3. How to take Bosentan Ferrer 4. Possible side effects 5. How to store Bosentan Ferrer 6. Contents of the pack and other information 1. WHAT BOSENTAN FERRER IS AND WHAT IT IS USED FOR Bosentan Ferrer tablets contain bosentan, which blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow. Bosentan Ferrer therefore causes blood vessels to expand and belongs to the class of medicines called “endothelin receptor antagonists”. Bosentan Ferrer is used to treat: - PULMONARY ARTERIAL HYPERTENSION (PAH): PAH is a disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs. This pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult. Bosentan Ferrer widens the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers the blood pressure and relieves the symptoms. Bosentan Ferrer is used to treat patients with class III pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity) and sy Perskaitykite visą dokumentą
1 1. NAME OF THE MEDICINAL PRODUCT Bosentan Ferrer 62,5 mg filmomhulde tabletten Bosentan Ferrer 125 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 62.5 mg bosentan (corresponding to 64.541 mg bosentan monohydrate) Each film-coated tablet contains 125 mg bosentan (corresponding to 129.082 mg bosentan monohydrate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet: 62.5 mg: Light orange, round, biconvex film-coated tablets of 6 mm 125 mg: Light orange, oval, biconvex film-coated tablets of 11 x 5 mm 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III. Efficacy has been shown in: • Primary (idiopathic and heritable) pulmonary arterial hypertension • Pulmonary arterial hypertension secondary to scleroderma without significant interstitial pulmonary disease • Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunts and Eisenmenger’s physiology • Some improvements have also been shown in patients with pulmonary arterial hypertension WHO functional class II (see section 5.1). Bosentan Ferrer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Pulmonary arterial hypertension Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension. _Adults _ In adult patients, Bosentan Ferrer treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily. The same recommendations apply to re-introduction of Bosentan Ferrer after treatment interruption (see section 4.4). _Paediatric population _ Paediatric pharmacokinetic data have shown that bosentan plasma concentrations in chi Perskaitykite visą dokumentą