Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Barium sulfate
Bracco Imaging spa
V08BA; V08BA01
Barium sulfate
98.45%w/w percent weight/weight
Powder for oral suspension
Product subject to Restricted Prescription (C)
Barium sulfate containing X-ray contrast media; barium sulfate with suspending agents
Marketed
1992-11-03
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 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. • If you get any side effects, talk to your doctor, or other healthcare professionals helping you with your X-ray examination. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Maxibar is and what it is used for 2. What you need to know before you use Maxibar 3. How to use Maxibar 4. Possible side effects 5. How to store Maxibar 6. Contents of the pack and other 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. WHAT YOU NEED TO KNOW BEFORE YOU USE MAXIBAR DO NOT USE MAXIBAR IF YOU: • are allergic to barium sulfate or any of the other ingredients of this medicine (see section 6) • know that you have a hole in your bowel or stomach (gastrointestinal perforation) • know that you have an abnormal passage connecting your esophagus (tracheo-esophageal 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 of the bowel called necrotising enterocolitis • have a severe intestinal paralysis • are a baby and have problems swallowing • have recently had Baca dokumen lengkap
Health Products Regulatory Authority 03 April 2019 CRN008PXS Page 1 of 8 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; andSodium 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. 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 t of the gastrointestinal tract – known or suspected tracheo-esophageal fistula – gastrointestinal haemorrhage – gastrointestinal ischaem Baca dokumen lengkap