Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
carglumic acid, Quantity: 200 mg
Recordati Rare Diseases Australia Pty Ltd
carglumic acid
Tablet, dispersible
Excipient Ingredients: colloidal anhydrous silica; microcrystalline cellulose; sodium lauryl sulfate; croscarmellose sodium; hypromellose; sodium stearylfumarate
Oral
60 Tablets, 5 Tablets
(S4) Prescription Only Medicine
Carbaglu is indicated in treatment of,? Hyperammonaemia due to N-acetylglutamate synthase primary deficiency,? Hyperammonaemia due to Organic Acidaemias such as:,-Hyperammonaemia due to isovaleric acidaemia -Hyperammonaemia due to methylmalonic acidaemia -Hyperammonaemia due to propionic acidaemia
Visual Identification: A bar-shaped tablet, with 4 punches on one side ('c c c c'), size 18.0 x 6.0 mm, with 3 break-marks both sides; Container Type: Tube; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure
Registered
2015-02-12
Carbaglu AU CMI 2.00 1 CARBAGLU ® _Carglumic acid, 200 mg Dispersible Tablets _ Consumer Medicine Information WHAT IS IN THIS LEAFLET This leaflet answers some of the more common questions about Carbaglu. It does not contain all of 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 Carbaglu against the benefits he/she expects it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read this again. WHAT CARBAGLU IS USED FOR Carbaglu is used to eliminate excessive levels of ammonia, referred to as hyperammonaemia. The high levels of ammonia in the blood may be caused by the lack of a specific liver enzyme called N- acetyl glutamate synthase (NAGS) or due to isovaleric acidaemia, methylmalonic acidaemia or propionic acidaemia. High levels of ammonia in the blood are toxic for the brain and leads in severe cases, to reduced levels of consciousness and coma. Some people are born with inherited diseases that cause some of the body’s enzymes to be missing or defective. The deficiency of NAGS is a rare disorder and results in patients not being able to eliminate nitrogen waste from the body which builds up after eating protein. This disorder persists for life and therefore the need for this treatment is lifelong. Isovaleric acidaemia, methylmalonic acidaemia and propionic acidaemias are rare disorders that can inhibit NAGS and cause episodes of hyperammonaemia. The treatment of elevated ammonia in these disorders is required during these episodes. Carbaglu helps the body’s natural process to eliminate ammonia by triggering the enzymes required to convert this to urea. This is eliminated from the body in urine. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CARBAGLU HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor’s prescription. BEFORE YOUR DOCTOR GIVES Прочитайте повний документ
AUSTRALIAN PRODUCT INFORMATION - CARBAGLU ® (CARGLUMIC ACID) 1 NAME OF THE MEDICINE Carglumic acid 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Carglumic acid is a white crystalline powder, soluble in boiling water, slightly soluble in cold water, practically insoluble in organic solvents (cyclohexane, dichloromethane, ether). CARBAGLU contains 200 mg of carglumic acid as the active ingredient. For the list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM CARBAGLU is a dispersible tablet containing 200 mg of carglumic acid. The tablets are white and elongated and can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Carbaglu is indicated in treatment of • Hyperammonaemia due to N-acetylglutamate synthase primary deficiency • Hyperammonaemia due to Organic Acidaemias such as: o Hyperammonaemia due to isovaleric acidaemia o Hyperammonaemia due to methymalonic acidaemia o Hyperammonaemia due to propionic acidaemia 4.2 DOSE AND METHOD OF ADMINISTRATION CARBAGLU treatment should be initiated under the supervision of a physician experienced in the treatment of metabolic disorders. Any episode of acute symptomatic hyperammonaemia should be treated as a life-threatening emergency and may be started as early as the first day of life. Treatment of hyperammonaemia may require dialysis, preferably hemodialysis, to remove a large burden of ammonia. Uncontrolled hyperammonaemia can rapidly result in brain injury/damage or death, and prompt use of all therapies necessary to reduce plasma ammonia levels is essential. Plasma levels of ammonia and amino acids should be maintained within normal limits. Ongoing monitoring of neurological and cardiac status, laboratory tests (renal, hepatic, haematological) and clinical responses in patients receiving carglumic acid is crucial to assess patient response. CARBAGLU tablets should not be swallowed whole or crushed. Disperse CARBAGLU tablets in water immediately before use. CARBAGLU is for oral administration only. ADULT DOSAGE Th Прочитайте повний документ