CHOLEDIAM

The solution is administered intravenously, to patients fasting for 6 hours prior to examination. 1 mCi), other doses may be justifiable. 5 mCi) is necessary to obtain images of sufficient quality. The examination as sequential or functional scintigraphy may be started immediately after injection.

Cholecystokinins or a fatty meal may be used to contract the gall bladder.

Very rare cases of allergic type reactions may appear after administration of Mebrofenin. For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit. The activity administered must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the need to obtain the intended diagnostic result.

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. For diagnostic nuclear medicine investigations, the current evidence suggests that these adverse effects will occur with low frequency because of the low radiation dose incurred.

For most diagnostic investigations using a nuclear medicine procedure, the radiation dose delivered (EDE) is less than 20 mSv. Higher doses may be justified in some clinical circumstances. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

4. Special Warnings and Special Precautions for Use This radiopharmaceutical may be used and administered only by authorised persons. Radiopharmaceuticals intended for administration to patients should be prepared by the user in a manner which satisfies both radiological safety and pharmaceutical quality requirements.

The biliary tree may not be adequately visualised in the following circumstances : - Parenteral nutrition - Prolonged dieting - After a meal : the test should be performed with the patient fasted for six hours - Hepatocellular insufficiency - Hepatitis

3. Contra-Indications There are no specific contra-indications.