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
Ennakkoilmoitus yrityskeskittymästä (Asia N:o COMP/M.#- Electra/Englefield/GSL) – Yksinkertaistettuun menettelyyn mahdollisesti soveltuva asiaEMEA0.3 EMEA0.3