L'ANSM a mis en évidence la persist

L'ANSM a mis en évidence la persistance d’une utilisation hors du cadre restrictif de l’autorisation de mise sur le marché (AMM) de la nitrofurantoïne, de l’ordre de 60 % des prescriptions. Elle souhaite donc renforcer l’information concernant le bon usage de cet antibiotique dont les indications avaient déjà été restreintes en 2012 du fait d’effets indésirables pulmonaires et hépatiques graves rapportés. Il est ainsi rappelé que la nitrofurantoïne est réservée au traitement des infections urinaires sous quatre conditions : en traitement curatif et non prophylactique, pour des infections documentées, uniquement chez la femme et non chez l’homme, et pour une durée brève (5-7 jours).

Kết quả (Anh) 1:

The MSNA highlighted the persistence of use outside the restrictive framework of the authorization for placing on the market (AMM) of nitrofurantoin, of the order of 60% of the prescriptions. She wishes so to enhance information about the proper use of this antibiotic indications had already been restricted in 2012 as a result of adverse lung and serious liver reported. It is thus recalled that nitrofurantoin is reserved for the treatment of urinary infections under four conditions: no prophylactic and curative treatment, for infections only documented in women, not men, and for a brief period (5-7 days).

Kết quả (Anh) 2:

The ANSM highlighted the persistence of use outside the restrictive framework of the marketing authorization (MA) of nitrofurantoin, around 60% of prescriptions. It therefore wishes to strengthen the information concerning the proper use of this antibiotic which indications had already been restricted in 2012 due to adverse pulmonary and reported serious liver effects. It is well noted that nitrofurantoin is reserved for the treatment of urinary tract infections under four conditions: in curative and not preventive for the documented infections, only in women and not in men, and for a short period (5-7 days).