Country: Malta
Language: English
Source: Medicines Authority
MEGLUMINE AMIDOTRIZOATE; SODIUM AMIDOTRIZOATE
Bayer PLC
V08AA01
MEGLUMINE AMIDOTRIZOATE; SODIUM AMIDOTRIZOATE
GASTROENTERAL SOLUTION
MEGLUMINE AMIDOTRIZOATE 660 mg/ml; SODIUM AMIDOTRIZOATE 100 mg/ml
POM
CONTRAST MEDIA
Authorised
2007-07-25
PACKAGING TECHNOLOGY BERLIN SGSMZ page 1 Bayer AG client: 138 material-no.: 85989170 PZ: 2793A-3 code-no.: 47 name: LF GASTROGRAFIN GB country: GB colors: BLACK version: 18.07.2017/01 Restricted Document dimension: 311 X 457 MM READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. R Keep this leaflet. You may need to read it again. R If you have any further questions, ask your doctor giving you Gastrografin (the radiologist) or the X-ray department staff R If you get any side effects, talk to your doctor or the X-ray department staff/radiologist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Gastrografin is and what it is used for 2. What you need to know before you are given Gastrografin 3. How you will be given Gastrografin 4. Possible side effects 5. How to store Gastrografin 6. Content of the pack and other information 1. WHAT GASTROGRAFIN IS AND WHAT IT IS USED FOR Gastrografin is a contrast medium (a dye) which contains iodine. It is used to clearly show on X-rays the area of your body that your doctor wants to investigate. This will be your gullet (oesophagus), stomach or intestines (gastrointestinal tract). It may also be used to treat an intestinal obstruction in newborn babies (meconium ileus). 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. Gastrografin 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. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GASTROGRAFIN DO NOT USE GASTROGRAFIN: R if you are allergic to sodium amidotrizoate, meglumine amidotrizoate, iodine or iodine-containin Read the complete document
013_0 Page 1 of 8 1.3.1 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Gastrografin gastroenteral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains: 100 mg sodium amidotrizoate (sodium diatrizoate) and 660 mg meglumine amidotrizoate (meglumine diatrizoate). Excipients with known effect: disodium edetate, sodium hydroxide, saccharin sodium For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastroenteral solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use by oral or rectal administration only. Gastrografin is a contrast medium for the radiological examination of the gastrointestinal tract (also in combination with barium sulphate). Gastrografin may be of particular value in the following instances: 1. Suspected partial or complete stenosis. 2. Acute haemorrhage. 3. Threatening perforation (peptic ulcer, diverticulum). 4. Other acute conditions which are likely to require surgery. 5. After resection of the stomach or intestine (danger of perforation or leak). 6. Megacolon. 7. Visualisation of a foreign body or tumour before endoscopy. 8. Visualisation of a gastrointestinal fistula. 9. Before Endoscopy Further indications: 013_0 Page 2 of 8 1.3.1 2 Early diagnosis of a radiologically undetectable perforation or anastomotic defect in the oesophagus. The treatment of uncomplicated meconium ileus. Computerised tomography in the abdominal region. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage for oral use The dosage is dependent on the type of examination and the age of the patient. _Adults and children of 10 years of age or over_: Visualisation of the stomach: 60 ml Follow-through examination of the gastrointestinal tract: a maximum of 100 ml Computerised tomography (CT) 0.5 - 1.5 litres of approximately 3% Gastrografin solution (30 ml Gastrografin/1 litre of water). _Older and cachectic patients_: Dilution with an equal volume of water is recommended. _Children_ Children (up to 10 y Read the complete document