Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
mercaptamine bitartrate
Recordati Rare Diseases
A16AA04
mercaptamine bitartrate
Other alimentary tract and metabolism products,
Cystinosis
Cystagon is indicated for the treatment of proven nephropathic cystinosis. Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure.
Revision: 17
Authorised
1997-06-23
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: INFORMATION FOR THE USER CYSTAGON 50 MG HARD CAPSULES CYSTAGON 150 MG HARD CAPSULES Cysteamine bitartrate (mercaptamine bitartrate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor or your pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What CYSTAGON is and what it is used for 2. Before you use CYSTAGON 3. How to use CYSTAGON 4. Possible side effects 5. How to store CYSTAGON 6. Further information 1. WHAT CYSTAGON IS AND WHAT IT IS USED FOR Cystinosis is a metabolic disease called ‘nephropathic cystinosis’ which is characterized by an abnormal accumulation of the amino acid cystine in various organs of the body such as the kidney, eye, muscle, pancreas, and brain. Cystine build up causes kidney damage and excretion of excess amounts of glucose, proteins and electrolytes. Different organs are affected at different ages. CYSTAGON is prescribed to manage this rare inherited disorder. CYSTAGON is a medicine that reacts with cystine to decrease its level within the cells. 2. BEFORE YOU USE CYSTAGON DO NOT USE CYSTAGON - if you -or your child- are allergic (hypersensitive) to cysteamine bitartrate or penicillamine or any of the other ingredients of Cystagon. - If you are pregnant, this is particularly relevant during the first trimester - if you are breast-feeding. TAKE SPECIAL CARE WITH CYSTAGON - When your or your child’s disorder has been confirmed by leucocyte cystine measurements, the therapy with CYSTAGON must be started as soon as possible. _ _ - A few cases of skin lesions on elbows like little hard lumps have been reported in children treated with high doses of different Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT CYSTAGON 50 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 50 mg of cysteamine (as mercaptamine bitartrate) . For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard Capsule White, opaque hard capsules with CYSTA 50 on the body and RECORDATI RARE DISEASES on the cap. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION CYSTAGON is indicated for the treatment of proven nephropathic cystinosis. Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION CYSTAGON treatment should be initiated under the supervision of a physician experienced in the treatment of cystinosis. The goal of therapy is to keep leucocyte cystine levels below 1 nmol hemicystine/mg protein. White blood cell (WBC) cystine levels should therefore be monitored to adjust the dose. The WBC levels should be measured 5 to 6 hours after dosing and should be checked frequently when initiating therapy (e.g. monthly) and every 3-4 months when on a stable dose. • _For children up to age 12 years,_ CYSTAGON dosing should be on the basis of body surface area (g/m 2 /day). The recommended dose is 1.30 g/m 2 /day of the free base divided four times daily. • _For patients over age 12_ _and over 50 kg weight,_ the recommended CYSTAGON dose is 2 g/day, divided four times daily. Starting doses should be 1/4 to 1/6 of the expected maintenance dose, increased gradually over 4- 6 weeks to avoid intolerance. The dose should be raised if there is adequate tolerance and the leucocyte cystine level remains >1 nmol hemicystine/mg protein. The maximum dose of CYSTAGON used in clinical trials was 1.95 g/m 2 /day. The use of doses higher than 1.95 g/m 2 /day is not recommended (see section 4.4). Digestive tolerance of cysteamine is improved Pročitajte cijeli dokument