Country: European Union
Language: English
Source: EMA (European Medicines Agency)
cholic acid
Retrophin Europe Ltd
A05AA03
cholic acid
Bile and liver therapy
Metabolism, Inborn Errors
Cholic Acid FGK is indicated for the treatment of inborn errors of primary bile acid synthesis, in infants from one month of age for continuous lifelong treatment through adulthood, encompassing the following single enzyme defects:sterol 27-hydroxylase (presenting as cerebrotendinous xanthomatosis, CTX) deficiency;2- (or alpha-) methylacyl-CoA racemase (AMACR) deficiency;cholesterol 7 alpha-hydroxylase (CYP7A1) deficiency.
Revision: 14
Withdrawn
2015-11-20
Medicinal product no longer authorised 35 B. PACKAGE LEAFLET Medicinal product no longer authorised 36 PACKAGE LEAFLET: INFORMATION FOR THE USER KOLBAM 50 MG HARD CAPSULES KOLBAM 250 MG HARD CAPSULES cholic 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Kolbam is and what it is used for 2. What you need to know before you use Kolbam 3. How to use Kolbam 4. Possible side effects 5. How to store Kolbam 6. Contents of the pack and other information 1. WHAT KOLBAM IS AND WHAT IT IS USED FOR Kolbam contains a substance called cholic acid. In the body cholic acid is naturally produced in the liver and is part of the bile, a fluid that helps digestion and absorbs fat and vitamins from the food. Cholic acid also promotes normal growth of children. Patients with certain types of conditions known as inborn errors of bile synthesis cannot produce cholic acid and bile normally, which leads to the production and build-up of abnormal substances that are potentially damaging to the liver. Kolbam is used to treat these ‘inborn errors of bile acid synthesis’. By replacing the missing cholic acid it stimulates the production of normal bile and helps prevent the build-up of the abnormal substances in the liver. In growing infants, treatment with cholic acid helps wit Read the complete document
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 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 Kolbam 50 mg hard capsules. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 50 mg of cholic acid. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. 50 mg capsule: Size number 2 capsule with a Swedish orange cap (black imprint “ASK001”) and body (black imprint “50mg”). The capsules contain a white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kolbam is indicated for the treatment of inborn errors in primary bile acid synthesis due to Sterol 27- hydroxylase (presenting as cerebrotendinous xanthomatosis, CTX) deficiency, 2- (or α -) methylacyl- CoA racemase (AMACR) deficiency or Cholesterol 7 α -hydroxylase (CYP7A1) deficiency 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, including paediatricians, experienced in the management of the specific deficiencies. Posology The recommended dosage for cholic acid in the treatment of inborn errors of primary bile acid synthesis is 10-15 mg/kg per day, either as a single daily dose or in divided doses, for both adult and paediatric patients. The dose should be subsequently titrated to the desired effect but should not exceed a maximum of 15 mg/kg/day. Where the dose calculated is not a multiple of 50, the nearest dose below the maximum of 15 mg/kg/day should be selected, provided that is sufficient to suppress urinary bile acids. If not, the next higher dose should be selected. Patients should be monitored initially every 3 months during the first year then 6 mo Read the complete document