Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Selexipag
JOHNSON & JOHNSON SDN. BHD.
Selexipag
60 Tablets
Excella GmbH & Co.KG
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ UPTRAVI® FILM-COATED TABLETS Selexipag (200mcg, 400mcg, 600mcg, 800mcg, 1000mcg, 1200mcg, 1400mcg, 1600mcg) 1 WHAT IS IN THIS LEAFLET 1. What UPTRAVI is used for 2. How UPTRAVI works 3. Before you use UPTRAVI 4. How to use UPTRAVI 5. While you are using it 6. Side effects 7. Storage and Disposal of UPTRAVI 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT UPTRAVI IS USED FOR UPTRAVI is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adults. It can be used on its own or with other medicines for PAH. 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 symptoms. Ask your doctor if you have any questions about why it has been prescribed for you. HOW UPTRAVI WORKS UPTRAVI contains the active substance selexipag. It is a medicine that acts on a receptor that is the target of a natural substance called "prostacyclin". UPTRAVI widens the pulmonary arteries and reduces their hardening. This makes it easier for the heart to pump blood through the pulmonary arteries. It relieves the symptoms of PAH and improves the course of the disease. BEFORE YOU USE UPTRAVI - _When you must not use it_ Do not take UPTRAVI if 1. You have ever had an allergic reaction to selexipag or any of the ingredients listed at the end of this leaflet. Please consult your doctor immediately if you experience any signs or symptoms of a serious allergic reaction: • Wheezing • Swelling of the lips/mouth/throat/face • Difficulty in breathing or tightness in the throat • Hives or rash • Fainting 2. You have severe liver problems (Child-Pugh Class C) 3. You have had a stroke within the last 3 months 4. You have severe coronary heart disease or unstable angin Olvassa el a teljes dokumentumot
1 PRODUCT INFORMATION UPTRAVI ® (SELEXIPAG) FILM-COATED TABLET 1 NAME OF THE MEDICINE UPTRAVI selexipag 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Selexipag is a pale yellow crystalline powder that is practically insoluble in water. In the solid state selexipag is very stable, is not hygroscopic, and is not light sensitive. Each round film-coated tablet contains 200 micrograms or multiples thereof (respectively 400, 600, 800, 1000, 1200, 1400, or 1600 micrograms) selexipag. The film-coated tablets are not light sensitive. Refer to Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM UPTRAVI 200 micrograms, light yellow, debossed with '2', round, film-coated tablet. UPTRAVI 400 micrograms, red, debossed with '4', round, film-coated tablet. UPTRAVI 600 micrograms, light violet, debossed with '6', round, film-coated tablet. UPTRAVI 800 micrograms, green, debossed with '8', round, film-coated tablet. UPTRAVI 1000 micrograms, orange, debossed with '10', round, film-coated tablet. UPTRAVI 1200 micrograms, dark violet, debossed with '12', round, film-coated tablet. UPTRAVI 1400 micrograms, dark yellow, debossed with '14', round, film-coated tablet UPTRAVI 1600 micrograms, brown, debossed with '16', round, film-coated tablet Refer to Section 6.5 NATURE AND CONTENTS OF CONTAINER. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS 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. 2 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. 4.2 D OSE AND METHOD OF ADMINISTRATION Treatment should only be initiated and monitored by a physician experien Olvassa el a teljes dokumentumot