Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
IOVERSOL
Mallinckrodt UK Commercial Ltd
V08AB07
IOVERSOL
240 Micromol
Solution for Injection
Product subject to Restricted Prescription (C)
Watersoluble, nephrotropic, low osmolar X-ray contrast media
Authorised
2013-03-22
1 POM PA 1850/2/3 PACKAGE LEAFLET: INFORMATION FOR THE USER OPTIRAY TM 240 MG I/ML PFS, solution for injection Active substance: Iodine (as Ioversol) 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. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Optiray is and what it is used for 2. What you need to know before you use Optiray 3. How to use Optiray 4. Possible side effects 5. How to store Optiray 6. Contents of the pack and other information 1. WHAT OPTIRAY IS AND WHAT IT IS USED FOR This medicine is for diagnostic use only. Optiray is used in adults for several types of X-ray procedures including: • IMAGING OF VESSELS, both arteries and veins • KIDNEYS • CT SCANS Optiray is an X-ray contrast medium containing iodine. The iodine blocks the X-rays, allowing vessels and the inner organs supplied with blood to be seen. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OPTIRAY DO NOT USE OPTIRAY • if you are ALLERGIC to CONTRAST MEDIA substances containing iodine or to any of the other ingredients of this medicine (listed in section 6) • if you have an OVERACTIVE THYROID GLAND WARNINGS AND PRECAUTIONS Talk to your doctor before using Optiray if you have • or previously had an allergic reaction (symptoms of an allergic reaction can be difficulty breathing, collapse, swelling, nausea, vomiting, low blood pressure, skin symptoms) • asthma • heart failure • d Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Optiray 240 mg I/ml PFS Solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains 509 mg ioversol equivalent to 240 mg Iodine Osmolality: 500 mosmoles/kg Viscosity: 4.6 mPa · s (at 25°C) Viscosity: 3.0 mPa · s (at 37°C) Contains Iodine per ml: 240 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless to faint yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Optiray 240 PFS is a non-ionic X-ray contrast medium that is indicated in adults for use in cerebral arteriography, venography, intravenous urography and with the intra-arterial digital subtraction angiography (IA-DSA) to provide contrast enhancement and facilitate visualisation of the vascular system. Optiray 240 PFS is also indicated in adults for use in computed tomography (CT) of the head and body. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS_ Recommended dosage schedule: * Repeated as necessary _ELDERLY_ Dosage as for adults. Where poor demonstration is to be expected, the dosage can be increased to the maximum. _PAEDIATRIC POPULATION_ The safety and efficacy of Optiray 240 PFS in children have not been established. The medicinal product should therefore not be used in children aged up to 18 years, until further data becomes available. For cerebral, peripheral and visceral angiography and for intravenous urography Optiray 300 may be used in children. It is recommended that intravascularly administered iodinated contrast agents are warmed up to body temperature prior Procedure Dosage * Maximum Total Dose Cerebral Arteriography - Carotid or vertebral artery 2-12 ml 200 ml - Aortic arch 20-5 Pročitajte cijeli dokument