Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
perflutren
GE Healthcare AS
V08DA01
perflutren
Contrast media
Echocardiography
This medicinal product is for diagnostic use only.Optison is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left-ventricular-endocardial-border delineation with resulting improvement in wall-motion visualisation.Optison should only be used in patients where the study without contrast enhancement is inconclusive.
Revision: 19
Authorised
1998-05-17
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET: INFORMATION FOR THE USER OPTISON 0.19 MG/ML DISPERSION FOR INJECTION Perflutren-containing microspheres 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. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What OPTISON is and what it is used for 2. What you need to know before you use OPTISON 3. How to use OPTISON 4. Possible side effects 5. How to store OPTISON 6. Contents of the pack and other information 1. WHAT OPTISON IS AND WHAT IT IS USED FOR OPTISON is an ultrasound contrast agent that helps to obtain clearer pictures (scan) of the heart during an echocardiography (a procedure where an image of the heart is obtained by using ultrasound). OPTISON improves the visualization of the inner cardiac walls in patients where the walls are difficult to see. OPTISON contains microspheres (tiny gas bubbles) that after injection travel through the veins to the heart and fill the left heart chambers, allowing the doctor to visualise and asses the function of the heart. This medicine is for diagnostic use only. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OPTISON DO NOT USE OPTISON - if you are allergic (hypersensitive) to perflutren or any of the other ingredients of OPTISON (listed in section 6). - i f you have severe pulmonary hypertension (systolic pulmonary artery pressure > 90 mm Hg). WARNINGS AND PRECAUTIONS Talk to your doctor before using OPTISON - if you have any known allergies - if you have a severe heart, lung, kidney or liver disease. The experience of OPTISON in severely ill patients is limited - if you have an artificial valve in your heart - if you have acute severe inflammation or sepsis - if you have a known blood clotting problem Your heart activity and rhythm will be monitored wh Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT OPTISON 0.19 mg/ml dispersion for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION OPTISON consists of perflutren-containing microspheres of heat treated human albumin, suspended in human albumin solution, 1%. Concentration: Perflutren-containing microspheres, 5-8 x 10 8 /ml with a mean diameter range of 2.5 - 4.5 µm. The approximate amount of perflutren gas in each ml of OPTISON is 0.19 mg. Excipient with known effect Each ml contains 0.15 mmol (3.45 mg) of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Dispersion for injection. Clear solution with white microsphere layer on top. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. OPTISON is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left ventricular endocardial border delineation with resulting improvement in wall motion visualisation. OPTISON should only be used in patients where the study without contrast enhancement is inconclusive. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION OPTISON should only be administered by physicians experienced in the field of diagnostic ultrasound imaging. Before administering OPTISON, please see section 6.6 for instructions for use/handling. This medicinal product is intended for left ventricular opacification after intravenous administration. Ultrasound imaging must be performed during injection of OPTISON as optimal contrast effect is obtained immediately after administration. Posology The recommended dose is 0.5 ml - 3.0 ml per patient. A dose of 3.0 ml is usually sufficient, but some 3 patients may need higher doses. The total dose should not exceed 8.7 ml per patient. The duration of the useful imaging time is 2.5 - 4.5 minutes for a dose of 0.5 - 3.0 ml. OPTISON could be repeatedly administered, however, the clinical experience Lesen Sie das vollständige Dokument