Pajjiż: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
CYSTEAMINE AS BITARTRATE
MEDISON PHARMA LTD
A16AA04
HARD CAPSULE
CYSTEAMINE AS BITARTRATE 50 MG
PER OS
Required
RECORDATI RARE DISEASES, FRANCE
MERCAPTAMINE
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.
2019-06-30
1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only CYSTAGON 50 MG, 150 MG HARD CAPSULES NAME AND QUANTITY OF ACTIVE INGREDIENT: CYSTAGON - Each hard capsule contains cysteamine (as cysteamine bitartrate) 50mg, 150mg _ _ * Inactive ingredients and allergens: see section 6 of this leaflet (‘Additional information’). READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult 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? Cystagon is intended for treating patients who have been diagnosed with nephropathic cystinosis. The medicine reduces the buildup of cystine in several types of cells (such as white blood cells, muscle and liver cells) in nephropathic cystinosis patients, and when treatment is started early, the medicine postpones development of kidney failure. THERAPEUTIC GROUP: medicines for treating metabolic diseases. 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 buildup causes kidney damage and excretion of excess amounts of glucose, proteins and electrolytes. Different organs are affected at different ages. 2. BEFORE USING THIS MEDICINE X DO NOT USE THIS MEDICINE IF: • you or your child are sensitive (allergic) to the active substance cysteamine bitartrate, penicillamine, or any of the other ingredients of Cystagon (see section 6 ‘Additional information’). • you are pregnant, particularly during the first trimester. • you are breastfeeding. 2 SPECIAL WARNINGS ABOUT USING THIS MEDICINE • When your or your chi Aqra d-dokument sħiħ
PHYSICIAN'S PRESCRIBING INFORMATION 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 cysteamine 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 when the medici Aqra d-dokument sħiħ