Sibnayal
potassium citrate / potassium hydrogen carbonate
Table of contents
Overview
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.
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Sibnayal : EPAR - Medicine overview (PDF/120.89 KB)
First published: 03/05/2021 -
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Sibnayal : EPAR - Risk-management-plan summary (PDF/93.77 KB)
First published: 03/05/2021
Authorisation details
Product details | |
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Name |
Sibnayal
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Agency product number |
EMEA/H/C/005407
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Active substance |
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International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Acidosis, Renal Tubular
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Anatomical therapeutic chemical (ATC) code |
A12BA30
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Publication details | |
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Marketing-authorisation holder |
Advicenne S.A.
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Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
30/04/2021
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Contact address |
262 rue du Faubourg Saint Honoré |
Product information
27/06/2023 Sibnayal - EMEA/H/C/005407 - IB/0009
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Mineral supplements
Therapeutic indication
Sibnayal is indicated for the treatment of distal renal tubular acidosis (dRTA) in adults, adolescents and children aged one year and older.