Basic Information
Sibnayal
Regulatory Information
EMEA/H/C/005407
April 30, 2021
December 10, 2020
3
May 16, 2025
Company Information
France
262 rue du Faubourg Saint Honoré 75008 Paris
Advicenne SA
Active Substances Detail
Potassium citrate monohydratedPotassium hydrogen carbonate
Potassium citrate monohydrated
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Sibnayal is indicated for the treatment of distal renal tubular acidosis (dRTA) in adults, adolescents and children aged one year and older.
Overview Summary
Sibnayal is a medicine used to treat patients from the age of one year with distal renal tubular acidosis (dRTA), a disease in which the kidneys do not remove acid through the urine well enough. This results in a build-up of acid in the blood, which leads to a range of symptoms including hearing and growth problems, vomiting, kidney stones and lack of alertness. The disease also causes levels of potassium in the blood to fall, which can lead to muscle weakness and paralysis. Sibnayal contains the active substances potassium citrate and potassium hydrogen carbonate.