Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Barium sulfate
Bracco UK Ltd
Barium sulfate
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF:
E-Z-HD ® 98 % W/W POWDER FOR ORAL SUSPENSION barium sulfate PACKAGE LEAFLET: INFORMATION FOR THE USER E-Z-HD ® 98 % W/W POWDER FOR ORAL SUSPENSION barium sulfate 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, radiographer or nurse helping you with your X-ray examination. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, radiographer or nurse. This includes any possible side effects not listed in this leaflet. See section 4 IN THIS LEAFLET: 1. What E-Z-HD is and what it is used for 2. What you need to know before you use E-Z-HD 3. How to use E-Z-HD 4. Possible side effects 5. How to store E-Z-HD 6. Contents of the pack and other information 1. WHAT E-Z-HD IS AND WHAT IT IS USED FOR E-Z-HD belongs to a group of medicines called ‘contrast media’. It is used when you have an X-ray of your digestive system. It contains a chemical that helps the X-ray show up. This gives a clearer ‘picture’ of your digestive system on the X-ray. E-Z-HD will be given to you as a drink. This medicine is for diagnostic use only. It only helps to diagnose a problem. It cannot be used to treat any diseases. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE E-Z-HD DO NOT USE E-Z-HD IF YOU: • are allergic to barium sulfate or any of the other ingredients of E-Z-HD (listed in section 6) • know that you have a hole in your bowel or stomach (gastrointestinal perforation) • know that you have an abnormal passage connecting your stomach with your bowel (gastrointestinal fistula) • suffer from bleeding in your bowel or stomach • suffer from insufficient blood supply (ischaemia) of the bowel wall • have an enlarged bowel - a condition called megacolon or toxic megacolon • have an inflamed condition Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT E-Z-HD 98 % w/w powder for oral suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active Constituent: _ _ _ _ _ _ _ _ _ _ _ Barium sulfate 98.45 % w/w _Excipients include: _ Sorbitol (E420), 1.89 g per 340 g dose. Approximately 310 mg sodium per 340 g dose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral suspension. White powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. E-Z-HD is a high density suspension for use as a radiopaque agent during X-ray visualisation of the upper gastro-intestinal tract (oesophagus, stomach and duodenum). It is designed for optimal use in double contrast X-ray examinations. E-Z-HD is indicated in adults and children 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology E-Z-HD must be administered orally. The powder must be reconstituted prior to administration (see section 6.6). The administered dose of E-Z-HD will depend on the patient in question and the section of the gastrointestinal tract to be viewed. Method of administration ADULTS: The contents of one prefilled bottle (340 g) are dispersed in 65 mL of water to produce a 250 % w/v suspension which is swallowed by the patient after a suitable gas producing agent has been administered. CHILDREN: The dosage will be dependent on the size, age, health state and anatomical region to be imaged of the child. Individual requirements should be determined, from experience, by the radiologist. ELDERLY: There are no special dosage recommendations. The dosage should be determined, from experience, by the radiologist. 4.3 CONTRAINDICATIONS _Immune System Disorders _ Hypersensitivity to barium sulfate or to any of the excipients listed in section 6.1. _Gastrointestinal Disorders _ Patients with any of the following: – a known or suspected, perforation of the gastrointestinal tract – known or suspected trachea-esophageal fistula – gastrointestinal haemorrhage – gastrointes Lesen Sie das vollständige Dokument