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

Marktrücknahme von Chargen des Produkts „NuTRIflex Omega Special"
Dienstag 3. Dezember 2019
ANMAT informiert Fachleute des Gesundheitswesens, dass das Unternehmen B Braun Medical SA einen freiwilligen Rückruf des Marktes für 9 viele medizinische Spezialität „NuTRIflex Omega Special / Glukose, Lipide, Aminosäuren eingeleitet hat, Elektrolyte. Injizierbare Emulsion 1250 ml und 1875 ml. Paket mit 5 Einheiten (flexible Beutel Polyamid / Polypropylen drei Kameras). Certificate No. 57106".
Viele von der Maßnahme betroffen sind:
Omega NuTRIflex Spezial 1250 ml: • 182.148.051, Reifung 04/2020.
Omega NuTRIflex Sonder 1875 ml: • 174.938.051, Reifung 11/2019 • 180.638.052, Reifung 01/2020 • 180.858.051, Reifung 01/2020 • 181.038.051, Reifung 02/2020 • 181.558.051, Reifung 03 / 2020 • 181.928.052, 04/2020 • 182.448.051, Reifung 05/2020 • 190.638.052 Reifung, Reifung 01/2021.
Das Produkt ist geeignet für Energie und essentielle Fettsäuren liefern, einschließlich Omega-3- und 6-Fettsäuren, Aminosäuren, Elektrolyten und Flüssigkeit in der parenteralen Ernährung von Patienten in Staaten Katabolisierungsgeschwindigkeit mäßig ernst, wenn Ernährung orale oder enterale es ist unmöglich, unzureichend oder kontraindiziert.
Die Maßnahme wurde, nachdem festgestellt, dass einige genommen einzelnen Beutel Produkt eine Abweichung von der Spezifikation in pH leiden können, Farbe und / oder Qualität der Emulsion.
Diese Regierung führt Nationale den Rückzug der Marktbeobachtung und empfiehlt Profis Refrain aus dem entsprechenden Einheiten detailliert Charge verwendet wird.
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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