Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Iloprost trometamol
Schering Health Care Ltd
Iloprost trometamol
10microgram/1ml
Nebuliser liquid
Inhalation
No Controlled Drug Status
Valid as a prescribable product
BNF:
v017_0 Page 1 of 12 Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes. If you have any doubts or queries about your medication, please contact your doctor or pharmacist. 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. v017_0 Page 2 of 12 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 Soma hati kamili
VENTAVIS 10 MICROGRAM/ML NEBULISER SOLUTION Summary of Product Characteristics Updated 14-Aug-2017 | Bayer plc 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. 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 dos Soma hati kamili