Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
IOVERSOL
Mallinckrodt UK Commercial Ltd
V08AB07
IOVERSOL
300 Micromol
Solution for Inj/Inf
Product subject to Restricted Prescription (C)
Watersoluble, nephrotropic, low osmolar X-ray contrast media
Authorised
2013-03-22
1 POM PA 1850/2/4 PACKAGE LEAFLET: INFORMATION FOR THE USER OPTIRAY TM 300 MG I/ML, solution for injection or infusion 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 for several types of X-ray procedures including: • IMAGING OF VESSELS, both arteries and veins (in adults and children) • KIDNEYS (in adults and children) • CT SCANS (in adults) 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, Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Optiray 300 mg I/ml Solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains 636 mg ioversol equivalent to 300 mg Iodine Osmolality: 645 mosmoles/kg Viscosity: 8.2 mPa · s (at 25°C) Viscosity: 5.5 mPa · s (at 37°C) Contains Iodine per ml: 300 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection or infusion. Clear, colourless to faint yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Optiray 300 is a non-ionic X-ray contrast medium that is indicated in adults for use in cerebral, peripheral, visceral, and renal arteriography, venography, intravenous urography and in intraarterial and intravenous digital subtraction angiography (IA-DSA). Optiray 300 is also indicated in adults for use in computed tomography (CT) of the head and body. Optiray 300 may also be used in children for cerebral, peripheral and visceral arteriography and for intravenous urography. 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_ Procedure Dosage * Maximum Total Dose Cerebral Arteriography - Carotid or vertebral artery 2-12 ml 200 ml - Aortic arch 20-50 ml 200 ml Peripheral Arteriography 10-90 ml 250 ml Venography 50-100 ml 250 ml Visceral Arteriography 12-60 ml 250 ml Renal Arteriography 6-15 ml 250 ml Intravenous Urography 50-75 ml 150 ml Head Computed Tomography 50-150 ml 150 ml Body Computed Tomography 25-150 ml 150 ml Intraarterial Digital Subtraction Angiography 5-80 ml 250 ml Intravenous Digital Subtract Đọc toàn bộ tài liệu