https://www.researchgate.net/publication/
viernes, 8 de marzo de 2024
(Stanford Medicine) Muy últil. Acceso gratuito a la Guía de antimicrobianos de la Universidad de Stanford.
EMA. Nota de seguridad. Reacciones adversas DAPAGLIFLOZINA.
Se incorpora a las Infecciones genitales casos que conducen a intervención por fimosis y circuncisión.
New product information wording – Extracts from PRAC
recommendations on signals
Adopted at the 23-26 October 2023 PRAC
The product information wording in this document is extracted from the document entitled ‘PRAC
recommendations on signals’ which contains the whole text of the PRAC recommendations for product
information update, as well as some general guidance on the handling of signals. It can be found here
(in English only).
New text to be added to the product information is underlined. Current text to be deleted is struck
through.
1. Dapagliflozin; dapagliflozin, metformin; dapagliflozin,
saxagliptin – Acquired phimosis and phimosis (EPITT no
19935)
For dapagliflozin monoproducts
Summary of product characteristics
4.8 – Undesirable effects
Description of selected adverse reactions
Vulvovaginitis, balanitis and related genital infections
[New paragraph to be added at the end of this section]
<...>
Cases of phimosis/acquired phimosis have been reported concurrent with genital infections and in some cases, circumcision was required



