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Studie von Grifols zeigt, dass eine höhere Dosis von PROLASTIN-C den Alpha1-PI-Spiegel in Patienten mit AAT-Mangel in den normalen Bereich anhebt
Date:5/22/2013

ugmentationstherapie mit einem Alpha-1-Proteinasehemmer (Alpha-1-PI) bei Lungenerkrankungen und dem Verlauf von Emphysemen bei Alpha-1-Antitrypsinmangel wurde noch nicht in randomisierten, kontrollierten klinischen Studien nachgewiesen. PROLASTIN-C ist nicht als Therapie für Lungenerkrankungen in Patienten vorgesehen, bei denen kein schwerer Alpha-1-PI-Mangel festgestellt wurde.

PROLASTIN-C kann Spuren von IgA enthalten. Bei Patienten, bei denen das Vorhandensein IgA-Antikörpern festgestellt wurde, die bei selektivem oder schwerem IgA-Mangel vorhanden sein können, besteht ein größeres Risiko für potenziell schwere Überempfindlichkeits- und anaphylaktische Reaktionen. PROLASTIN-C ist bei Patienten mit IgA-Antikörpern kontraindiziert.

Die meisten arzneimittelbedingten Nebenwirkungen bei den klinischen Studien waren bei ≥1 % der Probanden Frösteln, Unwohlsein, Kopfschmerz, Ausschlag, Hitzewallung und Pruritus. Die schwerste, bei der klinischen Studie von PROLASTIN-C beobachtete Komplikation war ein Ausschlag im Bauchbereich und an den Extremitäten bei einem Probanden.

PROLASTIN-C wird aus menschlichem Plasma hergestellt. Bei Produkten aus menschlichem Plasma kann das Risiko einer Übertragung von Infektionserregern bestehen, z.B. Viren und, zumindest theoretisch, des Erregers der Creutzfeldt-Jakob-Krankheit (CJD).

Die vollständigen Informationen zur Verschreibung finden Sie auf http://www.talecris-pi.info/inserts/PROLASTIN-C.pdf

Sie werden ersucht, negative Nebenwirkungen von rezeptpflichtigen Medikamenten bei der FDA zu melden. Besuchen Sie hierzu www.fda.gov/medwatch oder wenden Sie sich telefonisch an 1-800-FDA-1088.


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