Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium amidotrizoate; Meglumine amidotrizoate
Bayer Plc
Sodium amidotrizoate; Meglumine amidotrizoate
40mg/1ml ; 260mg/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5016703000976
V015_0 1 of 12 Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes. If you have any doubts or queries about your medication, please contact your doctor or pharmacist. PACKAGE LEAFLET: INFORMATION FOR THE PATIENT UROGRAFIN® SODIUM AMIDOTRIZOATE (SODIUM DIATRIZOATE) AND MEGLUMINE AMIDOTRIZOATE (MEGLUMINE DIATRIZOATE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 the doctor giving you Urografin (the radiologist) or the X-ray department staff. - If you get any side effects, talk to your doctor or the X-ray department staff/radiologist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Urografin is and what it is used for 2. What you need to know before you are given Urografin 3. How you will be given Urografin 4. Possible side effects 5. How to store Urografin 6. Contents of the pack and other information 1. WHAT UROGRAFIN IS AND WHAT IT IS USED FOR Urografin is an injectable contrast medium (a dye) which contains iodine. It is used to clearly show on X-rays the area of your body that your doctor wants to investigate. X-rays, like radio waves, can pass through objects and can be focused to make a picture. When you have an X-ray, the beam of rays goes through your body where it is absorbed to differing degrees by different tissues such as bones, muscles and organs. When the rays come out on the other side they make a pattern of light and shade on a film. Urografin helps to make this pattern clearer. The film is then examined by a specialist who will make a diagnosis. This medicine is for diagnostic use only. V015_0 2 of 12 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN UROGRAFIN DO NO Прочитайте повний документ
OBJECT 1 UROGRAFIN 150 Summary of Product Characteristics Updated 09-Oct-2017 | Bayer plc 1. Name of the medicinal product Urografin® 150 2. Qualitative and quantitative composition 1ml contains 40mg sodium amidotrizoate (sodium diatrizoate) and 260mg meglumine amidotrizoate (meglumine diatrizoate). Excipient with known effect Sodium calcium edetate For the full list of excipients, see section 6.1. 3. Pharmaceutical form Aqueous solution for injection 4. Clinical particulars 4.1 Therapeutic indications X-ray contrast medium for the delineation of the vascular and renal systems. 4.2 Posology and method of administration 1. Adults only The table below shows the medium the licence holder suggests for each investigation. This medium may be used at the discretion of the radiologist for other established permutations of medium and examination which, for the sake of simplicity, have been omitted from the table. Examination Dose regimen Drip-infusion urography 2-4 ml/kg body wt up to 250 ml Retrograde urography 5-10 ml Cystography Up to 500 ml (Other indications include: high dose urography, pelvic venography, venacavography, arthrography, selective visceral angiography, limb venography, jugular venography, vesiculography, sialography, sinusography, amniography, lymphangiography, intramuscular urography, operative cholangiography,percutaneous cholangiography, fistulography, oesophageal and anal atresia). _Urografin medium is not suitable for myelography_ 2. Children and neonates _Drip-infusion urography:_ Dosage of Urografin 150 should not exceed 4 ml/kg body weight. • General Information The patient should be recumbent during the administration of Urografin and kept under close observation for at least 30 minutes (see Special warnings and special precautions for use), Experience shows that contrast medium is tolerated better if it is warmed to body temperature. 4.3 Contraindications Proven or suspected hypersensitivity to iodine-containing contrast media, uncontrolled thyrotoxicosis and decompensated cardiac insuffic Прочитайте повний документ