Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: SERB S.A., Avenue Louise 480, 1050 Brussels, Belgium
Amversio is indicated as adjunctive treatment of homocystinuria, involving deficiencies or defects in:
Amversio should be used as supplement to other therapies such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a specific diet.
Amversio treatment should be supervised by a physician experienced in the treatment of patients with homocystinuria.
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.
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.
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.
Oral use.
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 bottle and a flat surface e.g. base of a knife is drawn across the top of the measure. This will give the following doses: the green measuring spoon dispenses 100 mg, the blue measuring spoon dispenses 150 mg and the purple measuring spoon dispenses 1 g of betaine anhydrous.
The powder should be mixed with water, juice, milk, formula or food until completely dissolved and ingested immediately after mixing.
No case of overdose has been reported.
Unopened bottle: 3 years.
After the first opening: 3 months.
Store in the original package.
Keep the bottle tightly closed in order to protect from moisture.
This medicinal product does not require any special temperature storage conditions.
White opaque HDPE bottle with a child resistant polypropylene cap with an induction seal liner.
Each pack contains 1 bottle with 180 g of powder and three measuring spoons.
The green measuring spoon dispenses 100 mg.
The blue measuring spoon dispenses 150 mg.
The purple measuring spoon dispenses 1 g.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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