Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium amidotrizoate; Meglumine amidotrizoate
Bayer Plc
Sodium amidotrizoate; Meglumine amidotrizoate
100mg/1ml ; 660mg/1ml
Oral solution
Rectal; Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 18030000; GTIN: 5016703008323
013_0 Page 1 of 5 Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes. If you have any doubts or queries about your medication, please contact your doctor or pharmacist. _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER GASTROGRAFIN® GASTROENTERAL SOLUTION SODIUM AMIDOTRIZOATE AND MEGLUMINE AMIDOTRIZOATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 giving you Gastrografin (the radiologist) or the X-ray department staff - 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. Contents 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 Baca dokumen lengkapnya
OBJECT 1 GASTROGRAFIN Summary of Product Characteristics Updated 10-Oct-2017 | Bayer plc 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: • 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 Baca dokumen lengkapnya