Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
iloprost
Bayer AG
B01AC11
iloprost
Antithrombotic agents
Hypertension, Pulmonary
Treatment of patients with primary pulmonary hypertension, classified as New York Heart Association functional class III, to improve exercise capacity and symptoms.
Revision: 30
Authorised
2003-09-15
42 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: INFORMATION FOR THE USER VENTAVIS 10 MICROGRAM/ML NEBULISER SOLUTION iloprost READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist 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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ventavis is and what it is used for 2. What you need to know before you use Ventavis 3. How to use Ventavis 4. Possible side effects 5. How to store Ventavis 6. Contents of the pack and other information 1. WHAT VENTAVIS IS AND WHAT IT IS USED FOR WHAT VENTAVIS IS The active substance of Ventavis is iloprost. It imitates a natural substance in the body called prostacyclin. Ventavis inhibits unwanted blocking or narrowing of blood vessels and allows more blood to flow through the vessels. WHAT VENTAVIS IS USED FOR Ventavis is used to treat moderate cases of primary pulmonary hypertension (PPH) in adult patients. PPH is a category of pulmonary hypertension where the cause of the high blood pressure is not known. This is a condition where blood pressure is too high in the blood vessels between the heart and the lungs. Ventavis is used to improve exercise capacity (the ability to carry out physical activity) and symptoms. HOW VENTAVIS WORKS Breathing in the mist carries Ventavis to the lungs, where it can work most effectively in the artery between heart and lungs. Improved blood flow leads to a better supply of oxygen to the body and reduced strain on the heart. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VENTAVIS DO NOT USE VENTAVIS • IF YOU ARE ALLERGIC to iloprost or any of the other ingredients of this medicine (listed Lesen Sie das vollständige Dokument
1 _ _ _ _ _ _ _ _ _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ventavis 10 microgram/ml nebuliser solution Ventavis 20 microgram/ml nebuliser solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ventavis 10 microgram/ml nebuliser solution 1 ml solution contains 10 microgram iloprost (as iloprost trometamol). Each ampoule with 1 ml solution contains 10 microgram iloprost. Each ampoule with 2 ml solution contains 20 microgram iloprost. Ventavis 20 microgram/ml nebuliser solution 1 ml solution contains 20 microgram iloprost (as iloprost trometamol). Each ampoule with 1 ml solution contains 20 microgram iloprost. Excipient with known effect • Ventavis 10 microgram/ml: Each ml contains 0.81 mg ethanol 96% (equivalent to 0.75 mg ethanol) • Ventavis 20 microgram/ml: Each ml contains 1.62 mg ethanol 96% (equivalent to 1.50 mg ethanol). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nebuliser solution. Ventavis 10 microgram/ml nebuliser solution Clear, colourless solution. Ventavis 20 microgram/ml nebuliser solution Clear, colourless to slightly yellowish solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of adult patients with primary pulmonary hypertension, classified as NYHA functional class III, to improve exercise capacity and symptoms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DRUG PRODUCT SUITABLE INHALATION DEVICE (NEBULISER) TO BE USED Ventavis 10 microgram/ml Breelib I-Neb AAD Venta-Neb Ventavis 20 microgram/ml Breelib I-Neb AAD Ventavis should only be initiated and monitored by a physician experienced in the treatment of pulmonary hypertension. 3 Posology _Dose per inhalation session _ At initiation of Ventavis treatment the first inhaled dose should be 2.5 microgram iloprost as delivered at the mouthpiece of the nebuliser. If this dose is well tolerated, dosing should be increased to 5 microgram iloprost and maintained at that dose. In case of poor tolerability of the 5 microgram dose, the dose should be reduced to 2.5 micr Lesen Sie das vollständige Dokument