Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Perflutren-containing lipid microspheres
Lantheus MI UK Ltd
Perflutren-containing lipid microspheres
150microlitre/1ml
Solution for dispersion for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF:
PACKAGE LEAFLET: INFORMATION FOR THE USER LUMINITY 150 MICROLITRES/ML GAS AND SOLVENT FOR DISPERSION FOR INJECTION/INFUSION perflutren 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. - 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 Luminity is and what it is used for 2. What you need to know before you use Luminity 3. How to use Luminity 4. Possible side effects 5. How to store Luminity 6. Further information 1. WHAT LUMINITY IS AND WHAT IT IS USED FOR Luminity is an ultrasound contrast agent that contains microspheres (tiny bubbles) of perflutren gas as the active substance. Luminity is for diagnostic use only. It is a contrast agent (a medicine that helps to make internal body structures visible during imaging tests). Luminity is used in adults to obtain a clearer scan of the chambers of the heart, especially of the left ventricle, during echocardiography (a diagnostic test where an image of the heart is obtained using ultrasound). Luminity is used in patients with suspected or confirmed coronary artery disease (obstruction of the blood vessels supplying the heart muscle), when the image obtained with non-contrast echocardiography is not optimal. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LUMINITY _ _ DO NOT USE LUMINITY - if you are allergic to perflutren or any of the other ingredients of Luminity. (listed in section 6). If you have had an allergic reaction in the past with Luminity or any other ultrasound contrast agent tell your doctor. WARNINGS AND PRECAUTIONS Talk to your doctor before using Luminity - if you have been told you have a heart shunt - if you have severe heart or lung diseases or if you need mechanical help to breathe - if you have an artificial valve in your h Прочитайте повний документ
OBJECT 1 LUMINITY 150 MICROLITRES/ML GAS AND SOLVENT FOR DISPERSION FOR INJECTION/INFUSION Summary of Product Characteristics Updated 22-May-2018 | Lantheus MI UK Limited 1. Name of the medicinal product Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion 2. Qualitative and quantitative composition Each ml contains a maximum of 6.4 x 10 9 perflutren-containing lipid microspheres, with a mean diameter range of 1.1-2.5 micrometres (μm). The approximate amount of perflutren gas in each ml is 150 microlitres (μl). Excipient(s) with known effect Each ml contains 2.679 mg sodium For the full list of excipients, see section 6.1. 3. Pharmaceutical form Gas and solvent for dispersion for injection/infusion Colourless, uniformly clear to translucent liquid. 4. Clinical particulars 4.1 Therapeutic indications This medicinal product is for diagnostic use only. Luminity is an ultrasound contrast-enhancing agent for use in adult patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress. 4.2 Posology and method of administration Luminity should only be administered by trained physicians with technical expertise in performing and interpreting contrast echocardiograms, and appropriate resuscitation equipment should be available in case of cardiopulmonary or hypersensitivity reactions (see section 4.4). Posology _Bolus intravenous injection using non-linear contrast imaging technique at rest and stress:_ The recommended dose is multiple injections of 0.1 to 0.4 ml of dispersion, followed by a 3 to 5 ml bolus of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection to maintain optimal contrast enhancement. The total dose of perflutre Прочитайте повний документ