Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
darbepoetin alfa
Dompé Biotec S.p.A.
B03XA02
darbepoetin alfa
Antianemic preparations
Kidney Failure, Chronic; Anemia; Cancer
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients.Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Revision: 19
Withdrawn
2001-06-08
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Nespo 10 micrograms solution for injection in a pre-filled syringe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 ml (25 µg/ml). Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1). For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) in a pre-filled syringe. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients. Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nespo treatment should be initiated by physicians experienced in the above mentioned indications. Nespo is supplied ready for use in a pre-filled syringe. The instructions for use, handling and disposal are given in section 6.6. _TREATMENT OF SYMPTOMATIC ANAEMIA IN ADULT AND PAEDIATRIC CHRONIC RENAL FAILURE PATIENTS _ Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician’s evaluation of the individual patient’s clinical course and condition is necessary. Nespo should be administered either subcutaneously or intravenously in order to increase haemoglobin to not greater than 12 g/dl (7.5 mmol/l). Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid the puncture of peripheral veins. Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed. Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dl (6.2 mmol/l) to 12 g/dl (7.5 mmol/l). A sustained haemoglobin level of greater than 12 g/dl (7.5 mmol/l Прочетете целия документ
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Nespo 10 micrograms solution for injection in a pre-filled syringe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 ml (25 µg/ml). Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1). For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) in a pre-filled syringe. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients. Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nespo treatment should be initiated by physicians experienced in the above mentioned indications. Nespo is supplied ready for use in a pre-filled syringe. The instructions for use, handling and disposal are given in section 6.6. _TREATMENT OF SYMPTOMATIC ANAEMIA IN ADULT AND PAEDIATRIC CHRONIC RENAL FAILURE PATIENTS _ Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician’s evaluation of the individual patient’s clinical course and condition is necessary. Nespo should be administered either subcutaneously or intravenously in order to increase haemoglobin to not greater than 12 g/dl (7.5 mmol/l). Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid the puncture of peripheral veins. Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed. Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dl (6.2 mmol/l) to 12 g/dl (7.5 mmol/l). A sustained haemoglobin level of greater than 12 g/dl (7.5 mmol/l Прочетете целия документ