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seetõttu ei soovitata ravimi subkutaanset manustamist kroonilise neerupudulikkusega patsientidele.
therefore, the sc route is not recommended for patients with ckd
Ultimo aggiornamento 2012-04-11
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koolitusjuhendis peab sisalduma alljärgnev oluline teave. • alfaepoetiini sisaldavate ravimite kasutamine võib põhjustada immunogeensust, mis viib harvadel juhtudel isoleeritud erütrotsütaarse aplaasiani. • teiste epoetiinravimitega suureneb ravimi subkutaansel manustamisel immunogeensusoht kroonilise neerupuudulikkuse korral. • puuduvad piisavad andmed abseamedi kohta, et teada ükskõik millise suurenenud immunogeensusohu ulatust ravimi subkutaansel kasutamisel. • seetõttu ei soovitata ravimi subkutaanset manustamist kroonilise neerupudulikkusega patsientidele. • tõhususe puudumist või muid immunogeensuse sümptomeid tuleb uurida. • müügiloa hoidjat tuleb teavitada igast oletatavast isoleeritud erütrotsütaarse aplaasia või immunogeensuse tekkimise juhust.
the educational leaflet shall contain the following key elements: • that the use of epoetin alfa products can cause immunogenicity which in rare cases may lead to pure red cell aplasia (prca) • that with other epoetin products, the risk of immunogenicity in chronic kidney disease (ckd) is increased with the subcutaneous (sc) route. • there is insufficient data on abseamed to know the size of any increased immunogenicity risk with subcutaneous use • therefore, the sc route is not recommended for patients with ckd • the loss of efficacy or other symptoms of the development of immunogenicity should be investigated • any suspected case of pure red cell aplasia or development of immunogenicity should be reported to the mah
Ultimo aggiornamento 2011-10-23
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