Država: Evropska unija
Jezik: angleščina
Source: EMA (European Medicines Agency)
betaine
SERB SA
A16AA06
betaine anhydrous
Other alimentary tract and metabolism products,
Homocystinuria
Amversio is indicated as adjunctive treatment of homocystinuria, involving deficiencies or defects in:• cystathionine beta-synthase (CBS),• 5,10 methylene tetrahydrofolate reductase (MTHFR),• cobalamin cofactor metabolism (cbl).
Authorised
2022-05-05
16 B. PACKAGE LEAFLET 17 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AMVERSIO 1 G ORAL POWDER betaine anhydrous READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Amversio is and what it is used for 2. What you need to know before you take Amversio 3. How to take Amversio 4. Possible side effects 5. How to store Amversio 6. Contents of the pack and other information 1. WHAT AMVERSIO IS AND WHAT IT IS USED FOR Amversio contains betaine anhydrous which is intended to be an adjunctive treatment of homocystinuria, an inherited (genetic) disease where the amino acid methionine cannot be broken down completely by the body. Methionine is present in regular food protein (such as meat, fish, milk, cheese, eggs). It is converted into homocysteine which is then normally converted into cysteine during digestion. Homocystinuria is a disease caused by the accumulation of homocysteine which is not converted to cysteine and is characterised by formation of clots in the veins, bone weakness, and skeletal and crystalline lens abnormalities. The use of Amversio together with other treatments such as vitamin B6, vitamin B12, folate and a specific diet aims to reduce the elevated homocysteine levels in your body. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMVERSIO _ _ DO NOT TAKE AMVERSIO - if you are allergic to betaine anhydrous. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Amversio. - If you notice side effects like headaches, vomiting or a change in your vision and you are of the homocyst Preberite celoten dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Amversio 1 g oral powder 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of powder contains 1 g of betaine anhydrous. 3. PHARMACEUTICAL FORM Oral powder. White crystalline free flowing powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amversio is indicated as adjunctive treatment of homocystinuria, involving deficiencies or defects in: • cystathionine beta-synthase (CBS), • 5,10-methylene-tetrahydrofolate reductase (MTHFR), • cobalamin cofactor metabolism (cbl). Amversio should be used as supplement to other therapies such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a specific diet. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Amversio treatment should be supervised by a physician experienced in the treatment of patients with homocystinuria. Posology _ _ _Children and adults _ The recommended total daily dose is 100 mg/kg/day given in 2 doses daily. However, the dose should be individually titrated according to plasma levels of homocysteine and methionine. In some patients doses above 200 mg/kg/day were needed to reach therapeutic goals. Caution should be exercised with up-titrating doses for patients with CBS deficiency due to the risk for hypermethioninaemia. Methionine levels should be closely monitored in these patients. _ _ _Special populations _ _Hepatic or renal impairment _ Experience with betaine anhydrous therapy in patients with renal insufficiency or non-alcoholic hepatic steatosis has demonstrated no need to adapt the dose regimen of Amversio. _Therapeutic monitoring _ The aim of treatment is to keep plasma levels of total homocysteine below 15 μmol/L or as low as possible. The steady-state response usually occurs within a month. Method of administration Oral use 3 The bottle should be lightly shaken before opening. Three measuring spoons are provided which dispense either 100 mg, 150 mg or 1 g of betaine anhydrous. It is recommended that a heaped measuring spoon is removed from the bottl Preberite celoten dokument