Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
CHENODEOXYCHOLIC ACID
MBI PHARMA LTD., ISRAEL
A05AA01
HARD CAPSULE
CHENODEOXYCHOLIC ACID 250 MG
PER OS
Required
PHARMALOOP S.L, SPAIN
CHENODEOXYCHOLIC ACID
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.
2022-09-30
1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 Dispensing this medicine requires a doctor’s prescription Chenodeoxycholic acid Leadiant Hard capsules ACTIVE INGREDIENT: Each capsule contains 250 mg chenodeoxycholic acid. For a list of inactive ingredients and allergens see section 6: 'Additional information'. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have further questions, ask your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? This medicine is intended for treating inborn problems producing primary bile acids because the enzyme sterol 27 hydroxylase is missing (an illness called cerebrotendinous xanthomatosis [CTX]. This medicine is intended for treating infants from one month old, children and adolescents up to 18 years old, and adults. THERAPEUTIC GROUP: digestive tract and metabolism - bile treatments - bile acid medication. ABOUT CHENODEOXYCHOLIC ACID Chenodeoxycholic acid Leadiant capsules contain a substance called chenodeoxycholic acid. Normally, this substance is made from cholesterol in the liver. It is a component of bile, a fluid which helps in the digestion of fat and vitamins from food. People with a rare condition known as cerebrotendinous xanthomatosis (CTX) cannot produce chenodeoxycholic acid and this causes a buildup of fatty deposits in various areas of the body. These deposits can cause damage to the affected areas. Chenodeoxycholic acid Leadiant capsules can be used from the age of one month and patients with CTX will require treatment for the rest of their lives. 2. BEFORE USING THIS MEDICINE DO NOT TAKE THIS MEDICINE IF: − you are sensitive (allergic) to chenodeoxycholic acid or to any of the other ingredients that this medicine contains (listed in Section 6). SPECIAL WARNINGS Olvassa el a teljes dokumentumot
1 1. NAME OF THE MEDICINAL PRODUCT Chenodeoxycholic acid Leadiant 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 Leadiant 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 therapeutic response to chenodeoxycholic acid monotherapy, other treatment options should be considered. Posology _Adults _ The starting dose in adults is 750 mg/day, in three divided doses provided that it is sufficient to normalise serum cholestanol and/or urine bile alcohols. The daily dose can be subsequently inc Olvassa el a teljes dokumentumot