• Обучителна листовка • Кратка характеристика на продукта (КХП), и листовка и данни върху опаковката.
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 Renal Failure (CRF) is increased with the subcutaneous route. • There is insufficient data on Retacrit to know the size of any increased immunogenicity risk with subcutaneous use • Therefore, the sc route is not recommended for patients with CRF • 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