Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Selexipag
Janssen Cilag International NV
B01AC27
selexipag
Antithrombotic agents
Hypertension, Pulmonary
Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II–III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.,
Revision: 13
Authorised
2016-05-12
33 B. PACKAGE LEAFLET 34 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT UPTRAVI 200 MICROGRAM FILM-COATED TABLETS UPTRAVI 400 MICROGRAM FILM-COATED TABLETS UPTRAVI 600 MICROGRAM FILM-COATED TABLETS UPTRAVI 800 MICROGRAM FILM-COATED TABLETS UPTRAVI 1,000 MICROGRAM FILM-COATED TABLETS UPTRAVI 1,200 MICROGRAM FILM-COATED TABLETS UPTRAVI 1,400 MICROGRAM FILM-COATED TABLETS UPTRAVI 1,600 MICROGRAM FILM-COATED TABLETS selexipag READ ALL OF THIS LEAFLET CAREFULLY BEFORE 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, ask your doctor or nurse. - 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 have any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet (see section 4). WHAT IS IN THIS LEAFLET 1. What Uptravi is and what it is used for 2. What you need to know before you take Uptravi 3. How to take Uptravi 4. Possible side effects 5. How to store Uptravi 6. Contents of the package and other information 1. WHAT UPTRAVI IS AND WHAT IT IS USED FOR Uptravi is a medicine that contains the active substance selexipag. It acts on blood vessels in a similar way to the natural substance prostacyclin, making them relax and widen. Uptravi is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients insufficiently controlled with other types of medicines for PAH known as endothelin receptor antagonists and phosphodiesterase type 5 inhibitors. Uptravi can be used on its own if the patient is not a candidate for these medicines. PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries). In people with PAH, these arteries narrow, so the heart has to work harder to pump blood through them. This may cause people to feel tired, dizzy, short of breath, or experience other sy Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Uptravi 200 microgram film-coated tablets Uptravi 400 microgram film-coated tablets Uptravi 600 microgram film-coated tablets Uptravi 800 microgram film-coated tablets Uptravi 1,000 microgram film-coated tablets Uptravi 1,200 microgram film-coated tablets Uptravi 1,400 microgram film-coated tablets Uptravi 1,600 microgram film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Uptravi 200 microgram film-coated tablets Each film-coated tablet contains 200 micrograms of selexipag. Uptravi 400 microgram film-coated tablets Each film-coated tablet contains 400 micrograms of selexipag. Uptravi 600 microgram film-coated tablets Each film-coated tablet contains 600 micrograms of selexipag. Uptravi 800 microgram film-coated tablets Each film-coated tablet contains 800 micrograms of selexipag. Uptravi 1,000 microgram film-coated tablets Each film-coated tablet contains 1,000 micrograms of selexipag. Uptravi 1,200 microgram film-coated tablets Each film-coated tablet contains 1,200 micrograms of selexipag. Uptravi 1,400 microgram film-coated tablets Each film-coated tablet contains 1,400 micrograms of selexipag. Uptravi 1,600 microgram film-coated tablets Each film-coated tablet contains 1,600 micrograms of selexipag. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Uptravi 200 microgram film-coated tablets Round, 7.3 mm diameter, light-yellow, film-coated tablets,with “2” debossed on one side. Uptravi 400 microgram film-coated tablets 3 Round, 7.3 mm diameter, red, film-coated tablets with “4” debossed on one side. Uptravi 600 microgram film-coated tablets Round, 7.3 mm diameter, light-violet, film-coated tablets with “6” debossed on one side. Uptravi 800 microgram film-coated tablets Round, 7.3 mm diameter, green, film-coated tablets with “8” debossed on one side. Uptravi 1,000 microgram film-coated tablets Round, 7.3 mm diameter, orange, film-coated tablets with “10” debo Pročitajte cijeli dokument