Երկիր: Ավստրալիա
Լեզու: անգլերեն
Աղբյուրը: Department of Health (Therapeutic Goods Administration)
mercaptamine (cysteamine) bitartrate, Quantity: 441.72 mg (Equivalent: mercaptamine (cysteamine), Qty 150 mg)
Alphapharm Pty Ltd
Capsule, hard
Excipient Ingredients: microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; sodium lauryl sulfate; silicon dioxide; croscarmellose sodium; titanium dioxide; Gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid
Oral
500
(S4) Prescription Only Medicine
For the management of nephropathic cystinosis in children and adults.
Visual Identification: white opaque capsule printed with CYSTA 150 on the body and MYLAN on the cap; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
1997-08-05
CYSTAGON ® _Mercaptamine (cysteamine) (as bitartrate)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CYSTAGON. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking CYSTAGON against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CYSTAGON IS USED FOR CYSTAGON contains a medicine called mercaptamine (cysteamine) that is used to manage nephropathic cystinosis, in children and adults. Nephropathic cystinosis is a rare inherited disorder characterised by the build-up of cystine in organs such as kidneys. Cystine build up causes kidney damage and excretion of excess amounts of glucose, proteins and electrolytes. Cystinosis can be detected by measuring the amount of cystine in while blood cells and other body cells. The results of cystinosis are slow body growth, weak bones and progressive kidney failure. Mercaptamine works by reacting with cystine so that the cystine level in cells is decreased. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. CYSTAGON is only available with a doctor's prescription. BEFORE YOU TAKE CYSTAGON _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE CYSTAGON IF YOU HAVE AN ALLERGY TO: • any medicine containing mercaptamine, penicillamine • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If i Կարդացեք ամբողջական փաստաթուղթը
AUSTRALIAN PRODUCT INFORMATION CYSTAGON ® _mercaptamine (cysteamine) (as bitartrate) capsule _ 1 NAME OF THE MEDICINE Mercaptamine (cysteamine) bitartrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each CYSTAGON capsule contains either 50 mg or 150 mg of mercaptamine free base as mercaptamine bitartrate. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM CYSTAGON capsules for oral administration, contain mercaptamine bitartrate, a cystine depleting agent which lowers the cystine content of cells in patients with cystinosis, an inherited defect of lysosomal transport. CYSTAGON 50 mg are white, opaque capsules printed with CYSTA 50 on the body and MYLAN on the cap. CYSTAGON 150 mg are white, opaque capsules printed with CYSTAGON 150 on the body and MYLAN on the cap. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CYSTAGON is indicated for the management of nephropathic cystinosis in children and adults. 4.2 DOSE AND METHOD OF ADMINISTRATION The initial dose is 0.2 to 0.3 g/m 2 /day, given in four divided doses, increasing over 4 to 6 weeks to a maintenance dose of 1.3 g/m 2 /day given in four divided doses for children up to 12 years. The maintenance dose of 1.3 g/m 2 /day can be calculated from the following table which is based on weight and surface area. WEIGHT IN KG MG OF MERCAPTAMINE FREE BASE EVERY 6 HOURS 0 – 2 100 2.5 – 5 150 5 – 6.5 200 6.5 – 9 250 9 – 10.5 300 10.5 – 14.5 350 14.5 – 19 400 19 – 23 450 > 23 500 Patients over 12 years old and 50 kg body weight should receive 2 g/day in four divided doses. This dose should be reached after 4 to 6 weeks as stated above. If the patient cannot tolerate a specific dose, therapy should be stopped temporarily and restarted at a lower dose. Intact capsules should not be administered to children under the age of approximately 6 years due to the risk of aspiration. The contents of the capsules may be sprinkled over food for children of this age. CYSTAGON ® – PRODUCT INFORMATION 2 Leukocyte Cystine Concent Կարդացեք ամբողջական փաստաթուղթը