País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
EPOPROSTENOL
Actelion Registration Ltd
B01AC09
EPOPROSTENOL
0.5 Milligram
Pdr for Soln for Infusion
Product subject to prescription which may not be renewed (A)
epoprostenol
Authorised
2016-09-16
1 PACKAGE LEAFLET: INFORMATION FOR THE USER VELETRI 0.5 MG, POWDER FOR SOLUTION FOR INFUSION VELETRI 1.5 MG, POWDER FOR SOLUTION FOR INFUSION Epoprostenol 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 or 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What VELETRI is and what it is used for 2. What you need to know before you take VELETRI 3. How to take VELETRI 4. Possible side effects 5. How to store VELETRI 6. Contents of the pack and other information 1. WHAT VELETRI IS AND WHAT IT IS USED FOR VELETRI contains the active substance epoprostenol, which belongs to a group of medicines called prostaglandin, which stops blood from clotting and widens the blood vessels. VELETRI is used to treat a lung condition called ‘pulmonary arterial hypertension’. This is where the pressure is high in the blood vessels in the lungs. VELETRI widens the blood vessels to lower the blood pressure in the lungs. VELETRI is used to prevent blood clotting during kidney dialysis when heparin cannot be used. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VELETRI DO NOT USE VELETRI IF YOU ARE ALLERGIC to VELETRI or any of the other ingredients of this medicine (listed in section 6). if you have HEART FAILURE. if you start to develop a build-up of fluid in your lungs causing breathlessness after starting this treatment. If you think any of these apply to you, DON’T TAKE VELETRI until you have checked with your doctor. WARNINGS AND PRECAUTIONS Talk to your doctor before using VELETRI. VELETRI contains sodium (less than 1 mmol sodium (23 mg) per dos Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Veletri 0.5 Milligram Powder for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 0.531 mg epoprostenol sodium equivalent to 0.5 mg epoprostenol One mL of reconstituted solution contains 0.1 mg epoprostenol (as epoprostenol sodium) (0.5 mg epoprostenol in 5 mL of solvent). Excipient(s) with known effect: sodium, (0.03 mg for 0.5 mg/vial) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for infusion White to off-white powder For the pH of the diluted solution see section 4.4 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VELETRI is indicated for: Pulmonary Arterial Hypertension VELETRI is indicated for the treatment of pulmonary arterial hypertension (PAH) (idiopathic or heritable PAH and PAH associated with connective tissue diseases) in patients with WHO Functional Class III–IV symptoms to improve exercise capacity (see section 5.1). Renal Dialysis VELETRI is indicated for use in haemodialysis in emergency situations when use of heparin carries a high risk of causing or exacerbating bleeding or when heparin is otherwise contraindicated (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Pulmonary Arterial Hypertension VELETRI is only indicated for continuous infusion by intravenous route. Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension. _Short-term (acute) dose ranging:_ This procedure should be conducted in a hospital with adequate resuscitation equipment. A short-term dose-ranging procedure administered via either a peripheral or central venous line is required to determine the long-term infusion rate. The infusion is initiated at 2 ng/kg/min and increased by increments of 2 ng/kg/min every 15 min or longer until maximum haemodynamic benefit or dose - limiting pharmacological effects are elicited. If the initial infusion rate of 2 ng/kg/min is not tolerated, a lower Llegiu el document complet