국가: 노르웨이
언어: 노르웨이어
출처: Statens legemiddelverk
Tauroselkolsyre
GE Healthcare Buchler GmbH & Co. KG
V09DX01
Tauroselkolsyre
370 kBq
Kapsel, hard
Boks av plast 1 stk
C
Markedsført
1999-09-20
SUMMARY OF PRODUCT CHARACTERISTICS FOR SEHCAT, CAPSULE 1. NAME OF THE MEDICINAL PRODUCT SeHCAT 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tauroselcholic ( 75 Se) acid is supplied as capsules of 370 kBq at the activity reference date. Each capsule contains less than 0.1mg of tauroselcholic acid. Selenium-75 has a physical half-life of approximately 118 days and decays by gamma emission with principal energies at 0.136 MeV and 0.265 MeV. Excipient(s) with known effect Sodium: 71.04 mg/capsule For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Tauroselcholic ( 75 Se) acid is used for the investigation of bile acid malabsorption and measurement of bile acid pool loss. It may be used in the assessment of ileal function, in the investigation of inflammatory bowel disease and chronic diarrhoea and in the study of entero-hepatic circulation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and elderly patients The normal dose for adults and the elderly is one capsule, administered orally. Paediatric population If the product is to be administered to children the same dosage as in adults is used (see section 4.4 and 11). There is no paediatric dosage form or clinical experience of the use of this product in children. A careful assessment of the risk/benefit ratio should be undertaken before use of this product in children, particularly since the use of a fixed dose result in an increased effective dose equivalent in children (see section 11). Hepatic impairment Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients. Method of administration To ensure smooth passage of the capsule into the stomach, it is recommended that 15 ml drinks of water are taken by the patient before, during and after swallowing the capsule. The patient should be in a sitting or standing position during administration. The instru 전체 문서 읽기