Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
BARIUM SULFATE
Bracco UK Limited
BARIUM SULFATE
98.45%w/w %w/w
Powder for Oral Suspension
Product subject to Restricted Prescription (C)
Authorised
0000-00-00
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER MAXIBAR 98.45 % W/W POWDER FOR ORAL SUSPENSION Barium sulfate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or other healthcare professionals helping you with your X-ray examination. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, radiographer or nurse helping you with your X-ray examination. IN THIS LEAFLET: 1. What Maxibar is and what it is used for 2. Before you use Maxibar 3. How to use Maxibar 4. Possible side effects 5. How to store Maxibar 6. Further information 1. WHAT MAXIBAR IS AND WHAT IT IS USED FOR Maxibar 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. Maxibar 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. BEFORE YOU USE MAXIBAR DO NOT USE MAXIBAR IF YOU • are allergic (hypersensitive) to barium sulfate or any of the other ingredients of Maxibar (see section 6) • know that you have a hole or blockage in your bowel or stomach (gastrointestinal perforation or obstruction) • 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 Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Maxibar 98.45% w/w powder for oral suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Barium sulfate 98.45% w/w Excipient(s) with known effect: Sorbitol 2 g per 340 g dose; and. Sodium 259 mg per 340 g dose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral suspension. A white to off-white bulky powder for oral suspension with a slightly sweet fruit taste, intended for suspension in water. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. 'Maxibar' is 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Maxibar is recommended for oral administration. The powder must be reconstituted prior to administration (see section 6.6). The administered dose of Maxibar will depend on the patient in question and the section of the gastrointestinal tract to be viewed. ADULTS: Instructions for reconstitution are shown in section 6.6 but the actual administered dose should be determined, from experience, by the radiologist. ELDERLY: The dosage should be determined, from experience, by the radiologist. There are no special dosage recommendations. CHILDREN: The dosage will be dependent on the size, age, health state and anatomic region to be imaged of the child. Individual requirements should be determined, from experience, by the radiologist. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 09/09/2014_ _CRN 2143200_ _page number: 1_ 4.3 CONTRAINDICATIONS _Im Baca dokumen lengkapnya