[Italiano-Español] RETIRO DEL MERCADO DE LOTES DEL PRODUCTO "NUTRIFLEX OMEGA SPECIAL"

ritiro dal mercato dei lotti di prodotto "Nutriflex Omega speciale"
Martedì 3 dicembre 2019
ANMAT Informa operatori sanitari che la società B Braun Medical SA ha avviato un richiamo volontario del mercato dei 9 lotti di specialità medica "Nutriflex Omega speciali / glucosio, lipidi, amminoacidi, elettroliti. Iniettabili Emulsione 1250 ml e 1875 ml. Confezione contenente 5 unità (sacche flessibili poliammide / polipropilene tre telecamere). certificato No. 57106".
I lotti interessati dal provvedimento sono:
Omega Nutriflex speciale 1250 ml: • 182.148.051 con scadenza 04/2020.
Omega Nutriflex speciale 1875 ml: • 174,938,051, con scadenza 11 / 2019. • 180.638.052 con scadenza 01/2020 • 180.858.051 con scadenza 01/2020 • 181.038.051 con scadenza 02/2020 • 181.558.051, con scadenza 03 / 2020 • 181.928.052 con scadenza 04/2020 • 182.448.051 con scadenza 05/2020 • 190.638.052 con scadenza 01/2021.
Il prodotto è adatto per l'alimentazione di acidi grassi essenziali energia e, tra omega-3 e 6 acidi grassi, aminoacidi, elettroliti e fluido nella nutrizione parenterale di pazienti in stati di catabolismo moderata grave quando la nutrizione orale o enterale è impossibile, insufficiente o controindicata.
La misura è stata presa dopo rilevato che alcune singoli sacchetti prodotto può subire una deviazione dalla specifica di pH, colore e / o la qualità dell'emulsione.
Questa Amministrazione sta conducendo il monitoraggio nazionale il ritiro del mercato e raccomanda professionisti a non utilizzare il lotto unità relative e dettagliate.
Retiro del mercado de lotes del producto "Nutriflex Omega Special"
martes 03 de diciembre de 2019
La ANMAT informa a los profesionales de la salud que la firma B Braun Medical S. A. ha iniciado el retiro voluntario del mercado de 9 lotes de la especialidad medicinal "Nutriflex Omega Special/ Glucosa, lípidos, aminoácidos, electrolitos. Emulsión inyectable por 1250 ml y 1875 ml. Envase conteniendo 5 unidades (bolsas flexibles de poliamida/ polipropileno de 3 cámaras). Certificado N° 57106".
Los lotes afectados por la medida son los siguientes:
Nutriflex Omega Special por 1250 ml:• 182148051, con vencimiento 04/ 2020.
Nutriflex Omega Special por 1875 ml:• 174938051, con vencimiento 11/ 2019. • 180638052, con vencimiento 01/ 2020. • 180858051, con vencimiento 01/ 2020. • 181038051, con vencimiento 02/ 2020. • 181558051, con vencimiento 03/ 2020. • 181928052, con vencimiento 04/ 2020. • 182448051, con vencimiento 05/ 2020. • 190638052, con vencimiento 01/ 2021.
El producto se encuentra indicado para el suministro de energía y ácidos grasos esenciales, incluyendo los ácidos grasos omega 3 y 6, aminoácidos, electrolitos y líquidos en la nutrición parenteral de los pacientes en estados de catabolismo moderado a grave, cuando la nutrición oral o enteral es imposible, insuficiente o está contraindicada.
La medida fue adoptada luego de que detectara que algunas bolsas individuales del producto podrían sufrir una desviación de la especificación en los valores de pH, coloración y/ o calidad de la emulsión.
Esta Administración Nacional se encuentra realizando el seguimiento del retiro del mercado y recomienda a los profesionales que se abstengan de utilizar las unidades correspondientes los lotes detallados.

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