Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Barium sulfate
Bracco Imaging spa
V08BA; V08BA01
Barium sulfate
96.5 percent weight/weight
Powder for rectal suspension
Product subject to Restricted Prescription (C)
Barium sulfate containing X-ray contrast media; barium sulfate with suspending agents
Marketed
1992-10-13
POLIBAR 96.5 % W/W POWDER FOR RECTAL SUSPENSION barium sulfate PACKAGE LEAFLET: INFORMATION FOR THE USER POLIBAR 96.5 % W/W POWDER FOR RECTAL SUSPENSION barium sulfate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU HAVE 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See Section 4. IN THIS LEAFLET: 1. What Polibar is and what it is used for 2. What you need to know before you have Polibar 3. How Polibar will be given to you 4. Possible side effects 5. How to store Polibar 6. Contents of the pack and other information 1. WHAT POLIBAR IS AND WHAT IT IS USED FOR Polibar 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. Polibar will be given to you as an enema (into your back passage). 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 HAVE POLIBAR DO NOT HAVE POLIBAR 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 (gastrointestinal perforation) • know that you have an abnormal passage connecting your stomach with your bowel (gastrointestinal fistula) • suffer from bleeding in your bowel • suffer from insufficient blood supply (ischaemia) of the bowel wall • have an enlarged bowel - a condition called megacolon or toxic megacolon • have a severe inflamed condition of the bowel called necrotising enterocolitis • suffer from poor movement of your bowel - a condition called colonic Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Polibar 96.5 % w/w powder for rectal suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Barium sulfate 96.5 % w/w For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for rectal suspension (enema). White powder, free from grittiness, intended for suspension in water. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Polibar is for use as a radiopaque agent during X-ray visualisation of the gastrointestinal tract. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Polibar is for rectal (enema) administration. The powder must be reconstituted prior to administration (see section 6.6). The administered dose of Polibar 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 of the gastrointestinal tract H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Soma hati kamili