Abseamed

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

epoetin alfa

Saatavilla:

Medice Arzneimittel Pütter GmbH Co. KG

ATC-koodi:

B03XA01

INN (Kansainvälinen yleisnimi):

epoetin alfa

Terapeuttinen ryhmä:

Antianemic preparations

Terapeuttinen alue:

Anemia; Kidney Failure, Chronic; Cancer

Käyttöaiheet:

Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis.Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre existing anaemia at the start of chemotherapy).Abseamed can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (haemoglobin (Hb) 10-13 g/dl [6.2-8.1 mmol/l], no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).Abseamed can be used to reduce exposure to allogeneic blood transfusions in adult non iron deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. Use should be restricted to patients with moderate anaemia (e.g. Hb 10-13 g/dl) who do not have an autologous predonation programme available and with an expected blood loss of 900 to 1800 ml.

Tuoteyhteenveto:

Revision: 22

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2007-08-27

Pakkausseloste

75
B. PACKAGE LEAFLET
76
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ABSEAMED 1,000 IU/0.5 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
ABSEAMED 2,000 IU/1 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
ABSEAMED 3,000 IU/0.3 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
ABSEAMED 4,000 IU/0.4 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
ABSEAMED 5,000 IU/0.5 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
ABSEAMED 6,000 IU/0.6 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
ABSEAMED 7,000 IU/0.7 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
ABSEAMED 8,000 IU/0.8 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
ABSEAMED 9,000 IU/0.9 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
ABSEAMED 10,000 IU/1 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
ABSEAMED 20,000 IU/0.5 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
ABSEAMED 30,000 IU/0.75 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
ABSEAMED 40,000 IU/1 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
Epoetin alfa
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Abseamed is and what it is used for
2.
What you need to know before you use Abseamed
3.
How to use Abseamed
4.
Possible side effects
5.
How to store Abseamed
6.
Contents of the pack and other information
1.
WHAT ABSEAMED IS AND WHAT IT IS USED FOR
Abseamed contains the active substance epoetin alfa, a protein that
stimulates the bone marrow to
produce more red blood cells which carry haemoglobin (a substance that
transports oxygen). Epoe

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Abseamed 1,000 IU/0.5 mL solution for injection in a pre-filled
syringe
Abseamed 2,000 IU/1 mL solution for injection in a pre-filled syringe
Abseamed 3,000 IU/0.3 mL solution for injection in a pre-filled
syringe
Abseamed 4,000 IU/0.4 mL solution for injection in a pre-filled
syringe
Abseamed 5,000 IU/0.5 mL solution for injection in a pre-filled
syringe
Abseamed 6,000 IU/0.6 mL solution for injection in a pre-filled
syringe
Abseamed 7,000 IU/0.7 mL solution for injection in a pre-filled
syringe
Abseamed 8,000 IU/0.8 mL solution for injection in a pre-filled
syringe
Abseamed 9,000 IU/0.9 mL solution for injection in a pre-filled
syringe
Abseamed 10,000 IU/1 mL solution for injection in a pre-filled syringe
Abseamed 20,000 IU/0.5 mL solution for injection in a pre-filled
syringe
Abseamed 30,000 IU/0.75 mL solution for injection in a pre-filled
syringe
Abseamed 40,000 IU/1 mL solution for injection in a pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Abseamed 1,000 IU/0.5 mL solution for injection in a pre-filled
syringe
Each mL of solution contains 2,000 IU of epoetin alfa
*
corresponding to 16.8 micrograms per mL
A pre-filled syringe of 0.5 mL contains 1,000 international units (IU)
corresponding to 8.4 micrograms
epoetin alfa. *
Abseamed 2,000 IU/1 mL solution for injection in a pre-filled syringe
Each mL of solution contains 2,000 IU of epoetin alfa
*
corresponding to 16.8 micrograms per mL
A pre-filled syringe of 1 mL contains 2,000 international units (IU)
corresponding to 16.8 micrograms
epoetin alfa. *
Abseamed 3,000 IU/0.3 mL solution for injection in a pre-filled
syringe
Each mL of solution contains 10,000 IU of epoetin alfa
*
corresponding to 84.0 micrograms per mL
A pre-filled syringe of 0.3 mL contains 3,000 international units (IU)
corresponding
to 25.2 micrograms epoetin alfa. *
Abseamed 4,000 IU/0.4 mL solution for injection in a pre-filled
syringe
Each mL of solution contains 10,000 IU of epoetin alfa
*