Dynepo
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
13-03-2008
Produktets egenskaber
(SPC)
13-03-2008
Offentlige vurderingsrapport
(PAR)
13-03-2008
Aktiv bestanddel:
epoetin delta
Tilgængelig fra:
Shire Pharmaceutical Contracts Limited
ATC-kode:
B03XA
INN (International Name):
epoetin delta
Terapeutisk gruppe:
Antianemic preparations
Terapeutisk område:
Kidney Failure, Chronic; Anemia
Terapeutiske indikationer:
Dynepo is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult patients. It may be used in patients on dialysis and in patients not on dialysis.
Produkt oversigt:
Revision: 9
Autorisation status:
Withdrawn
Autorisation dato:
2002-03-18
Indlægsseddel
Medicinal product no longer authorised
102
B. PACKAGE LEAFLET
Medicinal product no longer authorised
103
PACKAGE LEAFLET – INFORMATION FOR THE USER
DYNEPO 1,000 IU/0.5 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
DYNEPO 2,000 IU/0.5ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
DYNEPO 3,000 IU/0.3ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
DYNEPO 4,000 IU/0.4ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
DYNEPO 5,000 IU/0.5 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
DYNEPO 6,000 IU/0.3 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
DYNEPO 8,000 IU/0.4 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
DYNEPO 10,000 IU/0.5ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
Epoetin delta
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Dynepo is and what it is used for
2.
Before you take Dynepo
3.
How to take Dynepo
4.
Possible side effects
5.
How to store Dynepo
6.
Further information
1.
WHAT DYNEPO IS AND WHAT IT IS USED FOR
Epoetin delta is a human erythropoietin made by a technology process
called gene-activation, which
uses a human cell line.
Epoetin delta is a hormone which stimulates the production of red
blood cells in the bone marrow. Red
blood cells are very important since they contain haemoglobin, a
protein which distributes oxygen in
your body.
Dynepo is used for treating the symptoms of anaemia (which include
tiredness, weakness and shortness of
breath) associated with chronic renal failure in adult patients
, Anaemia is a blood disorder characterised by
a decrease in red blood cells. Dynepo may be used in patients on
dialysis (a bl
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Produktets egenskaber
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Dynepo 1,000 IU/0.5 ml solution for injection in a pre-filled syringe.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Pre-filled syringe containing 1,000 IU per 0.5 ml dose (2,000 IU/ml)
of the active substance epoetin delta.
Epoetin delta is produced in human cells (HT-1080) by gene-activation
technology.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in a pre-filled syringe.
Clear, colourless and waterlike.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dynepo is indicated for the treatment of symptomatic anaemia
associated with chronic renal failure (CRF)
in adult patients. It may be used in patients on dialysis and in
patients not on dialysis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Dynepo should be initiated by physicians experienced in
the treatment of anaemia
associated with CRF..
The dosage of Dynepo must be adjusted individually to maintain the
level of haemoglobin within the
target range of 10 to 12g/dl.
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. Dynepo
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 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 12g/dL (7.5mmol/l). A sustained haemoglobin level of
greater than 12 g/dL
(7.5 mmol/l) should be avoided; guidance for appropriate dose
adjus
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