Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Chenodeoxycholic acid
Leadiant GmbH
A05AA01
chenodeoxycholic acid
Bile and liver therapy
Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors
Chenodeoxycholic acid is indicated for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (CTX)) in infants, children and adolescents aged 1 month to 18 years and adults.
Revision: 6
Authorised
2017-04-10
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET: INFORMATION FOR THE USER CHENODEOXYCHOLIC ACID LEADIANT 250 MG HARD CAPSULES chenodeoxycholic acid This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Chenodeoxycholic acid Leadiant is and what it is used for 2. What you need to know before you take Chenodeoxycholic acid Leadiant 3. How to take Chenodeoxycholic acid Leadiant 4. Possible side effects 5. How to store Chenodeoxycholic acid Leadiant 6. Contents of the pack and other information 1. WHAT CHENODEOXYCHOLIC ACID LEADIANT IS AND WHAT IT IS USED FOR Chenodeoxycholic acid Leadiant capsules contain a substance called chenodeoxycholic acid. This substance is normally produced by the liver from cholesterol. It is a part of the bile, a fluid which helps in the digestion of fat and vitamins from food. Patients with a rare condition known as cerebrotendinous xanthomatosis (CTX) cannot produce chenodeoxycholic acid and this causes a build-up of fatty deposits in various areas of the body. This can cause damage to the affected areas. Chenodeoxycholic acid Leadiant capsules treats CTX by replacing the chenodeoxycholic acid, which prevents the build-up of the fatty deposits. Chenodeoxycholic acid Leadiant capsules can be used from the age of one month and patients with CTX will require tre Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Chenodeoxycholic acid Leadiant 250 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 250 mg of chenodeoxycholic acid. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule Size 0 capsule, 21.7 mm in length with a yellow body and orange cap, containing a white, compressed powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Chenodeoxycholic acid is indicated for the treatment of inborn errors of primary bile acid synthesis due to sterol 27-hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (CTX)) in infants, children and adolescents aged 1 month to 18 years and adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment must be initiated and monitored by physicians experienced in the management of CTX or inborn errors of primary bile acid synthesis. During the initiation of therapy and dose adjustment, serum cholestanol levels and/or urine bile alcohols should be monitored every 3 months till metabolic control and then annually. The lowest dose of chenodeoxycholic acid that effectively reduces the serum cholestanol and/or urine bile alcohols levels to within the normal range should be chosen. Liver function should also be monitored. Concurrent elevation of liver enzymes above normal levels may indicate overdose. After the initiation period, cholestanol, urine bile alcohols and liver function should be determined annually, at a minimum, and the dose adjusted accordingly (see section 4.4). Additional or more frequent investigations may need to be undertaken to monitor therapy during periods of fast growth, concomitant disease and pregnancy (see section 4.6). In case of persistent lack of therap Pročitajte cijeli dokument