COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Zengac» (18A05059)
Estratto determina n. 1112/2018 del 13 luglio 2018 Medicinale: ZENGAC. Titolare A.I.C.: Fisiopharma S.r.l. Classificazione ai fini della rimborsabilita' La nuova indicazione terapeutica del medicinale «Zengac»: «Somministrazione endovenosa. Vancomicina e' indicata per il trattamento delle seguenti infezioni in tutte le fasce di eta': infezioni complicate della pelle e dei tessuti molli;
infezioni delle ossa e delle articolazioni;
polmonite acquisita in comunita' (CAP);
polmonite acquisita in ospedale (HAP), inclusa la polmonite associata a ventilazione (VAP);
endocarditi infettive;
meningiti batteriche acute;
batteriemia che insorge in associazione, o si sospetta sia associata, ad una delle condizioni precedenti. Vancomicina e' anche indicata in tutte le fasce di eta' per la profilassi antibatterica perioperatoria in pazienti che sono ad alto rischio di sviluppare l'endocardite batterica quando sottoposti a interventi di chirurgia maggiore. Somministrazione orale. Vancomicina e' indicata in tutte le fasce di eta' per il trattamento delle infezioni da Clostridium difficile (CDI). Occorre prendere in considerazione le linee guida ufficiali sull'uso appropriato degli agenti antibatterici», e' rimborsata come segue: confezioni: «1000 mg polvere per soluzione per infusione e per uso orale» flacone da 1000 mg - A.I.C. n. 034634028 (in base 10). Classe di rimborsabilita': H. Prezzo ex factory (IVA esclusa): €
9,77. Prezzo al pubblico (IVA inclusa): €
16,12;
500 mg polvere per soluzione per infusione e per uso orale
10 flaconcini da 500 mg - A.I.C. n. 034634030 (in base 10). Classe di rimborsabilita': C. Validita' del contratto: ventiquattro mesi. Classificazione ai fini della fornitura La classificazione ai fini della fornitura del medicinale «Zengac» e' la seguente: per l'A.I.C. n. 034634028 il regime di fornitura e': medicinale soggetto a prescrizione medica limitativa, da rinnovare volta per volta, vendibile al...
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