Nespo
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
29-01-2009
Fachinformation
(SPC)
29-01-2009
Öffentlichen Beurteilungsberichts
(PAR)
29-01-2009
Wirkstoff:
darbepoetin alfa
Verfügbar ab:
Dompé Biotec S.p.A.
ATC-Code:
B03XA02
INN (Internationale Bezeichnung):
darbepoetin alfa
Therapiegruppe:
Antianemic preparations
Therapiebereich:
Kidney Failure, Chronic; Anemia; Cancer
Anwendungsgebiete:
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.
Produktbesonderheiten:
Revision: 19
Berechtigungsstatus:
Withdrawn
Berechtigungsdatum:
2001-06-08
Gebrauchsinformation
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
Lesen Sie das vollständige Dokument
Fachinformation
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
Lesen Sie das vollständige Dokument
