Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Meglumine; Sodium hydroxide ; Sodium amidotrizoate
Bayer Limited
V08AA01
Meglumine; Sodium hydroxide ; Sodium amidotrizoate
30 percent weight/volume
Solution for infusion
Product subject to Restricted Prescription (C)
diatrizoic acid
Marketed
1988-04-01
BP22036_REC30610 PACKAGE LEAFLET: INFORMATION FOR THE USER UROGRAFIN ® 30% W/V SOLUTION FOR INFUSION Sodium amidotrizoate Meglumine amidotrizoate Read all of this leaflet carefully before you are given this medicine • 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or the X- ray department staff/radiologist. IN THIS LEAFLET: 1. WHAT UROGRAFIN IS AND WHAT IT IS USED FOR 2. BEFORE YOU ARE GIVEN UROGRAFIN 3. HOW YOU WILL BE GIVEN UROGRAFIN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE UROGRAFIN 6. FURTHER 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 show the urinary tract clearly on X-rays. 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. 2. BEFORE YOU ARE GIVEN UROGRAFIN DO NOT USE UROGRAFIN IF: • you are, or suspect you are, allergic (hypersensitive) to iodine or iodine- containing contrast media or any of the other ingredients of Urografin ( see section 6: Further Information) • you have an overactive thyroid gland which is not being fully treated (manifest hyperthyroidism). • you have heart failure. Urografin must not be given into the space around the spinal cord because severe adverse reactions are possible. TAKE SPECIAL CARE WITH UROGRAFIN You must tell the X-ray department staff if you have any of the following: Прочитајте комплетан документ
Health Products Regulatory Authority 21 November 2022 CRN00D8K3 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Urografin 30 %w/v Solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of Urografin 30% for infusion contains 0.04 g sodium amidotrizoate and 0.26 g meglumine amidotrizoate (sodium diatrizoate and meglumine diatrizoate) in aqueous solution, containing the equivalent of 146 mg of Iodine in combined form per ml. Excipients: Contains 1.45mg (0.063mmol) sodium per ml (Each 250ml bottle contains 362.5mg sodium). For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for infusion. A clear, colourless to faintly yellow, odourless, sterile aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Infusion urography. UROGRAFIN IS NOT TO BE USED FOR MYELOGRAPHY, VENTRICULOGRAPHY OR CISTERNOGRAPHY, SINCE IT IS LIKELY TO PROVOKE NEUROTOXIC SYMPTOMS IN THESE EXAMINATIONS. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION GENERAL INFORMATION o Dietary suggestions In the case of abdominal angiography and urography, the diagnostic yield is increased if the bowels are emptied of faecal matter and gas. On the two days prior to the examination patients should therefore avoid flatulent food, in particular peas, beans and lentils, salads, fruit, dark and fresh bread and all kinds of uncooked vegetables. On the day before the examination, patients should refrain from eating after 6 p. m. Moreover, it can be appropriate to administer a laxative in the evening. In newborns, infants and young children, however, prolonged fasting and the administration of a laxative before the examination are contraindicated. o Hydration Adequate hydration must be assured before and after contrast medium administration. This applies especially to patients with multiple myeloma, diabetes mellitus with nephropathy, polyuria, oliguria, hyperuricaemia, as well as to newborns, infants, small children and elderly patients. Disorders of water and electrolyte balance must be corr Прочитајте комплетан документ