AIFA: Antibatterico con istamina. Richiesto il ritiro dalle farmacie

17 2017

AIFA: Antibatterico con istamina. Richiesto il ritiro dalle farmacie

Troppa #istamina nell'antibatterico, la Società Pfizer lo ritira dalle farmacie.
La Società Pfizer, ha comunicato di aver iniziato una procedura di ritiro dalle farmacie di alcuni lotti della specialità medicinale GENTOMIL

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AIFA: La decisione di ritiro comunicata dall'AIFA, evidenzia Giovanni D'Agata, presidente dello “Sportello dei Diritti”, si è reso necessario a seguito di elevati livelli di istamina presenti nella sostanza attiva della gentamicina solfato, prodotta dalla ditta Fujian-Fukang in Cina, usata nel processo produttivo del medicinale Gentomil. Nello specifico, si tratta delle confezioni di GENTOMIL*IM IV 10F 80MG 2ML - AIC 029314059: Lotto Scadenza 5155 Luglio 2020, 5174 Ottobre 2020, 5187 Novembre 2020 e 6021 Febbraio 2021.

Il medicinale GENTOMIL è utilizzato nel trattamento delle infezioni da germi sensibili alla gentamicina: Forme pleuro-polmonari: bronchiti, broncopolmoniti, polmonite franca-lobare, pleuriti, empiemi. Infezioni urinarie acute e croniche: cistiti, pieliti, cistopieliti, pielonefriti, calcolosi infette (del bacinetto, dell’uretere, della vescica), uretriti, prostatiti, vescicoliti. Stati settici: batteriemie, setticemie, setticopiemie, sepsi neonatali. Infezioni del sistema nervoso: meningiti, meningoencefaliti, ecc. Infezioni chirurgiche: ascessi, flemmoni, osteomieliti, infezioni traumatiche. Infezioni otorinolaringoiatriche: otiti medie purulente, sinusiti, mastoiditi, tonsilliti, faringotonsilliti. Infezioni #ostetrico-ginecologiche: aborto settico, metriti, parametriti, salpingiti, salpingo- ovariti, pelviperitoniti, mastiti, ecc. Ustioni: infezioni insorte nelle gravi ustioni e nei trapianti cutanei, eventualmente in associazione alla forma topica. Le confezioni dei succitati lotti presenti in farmacia dovranno essere immagazzinate in apposita area sicura e quindi predisposte per lo smaltimento. La Società Pfizer comunicherà a breve le istruzioni sulla gestione di ritiro/distruzione e relativi indennizzi.

Source by Sportello_dei_diritti

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