NeoRecormon

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

epoetin beta

Saatavilla:

Roche Registration GmbH

ATC-koodi:

B03XA01

INN (Kansainvälinen yleisnimi):

epoetin beta

Terapeuttinen ryhmä:

Antianemic preparations

Terapeuttinen alue:

Kidney Failure, Chronic; Anemia; Cancer; Blood Transfusion, Autologous

Käyttöaiheet:

Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients;treatment of symptomatic anaemia in adult patients with non-myeloid malignancies receiving chemotherapy;increasing the yield of autologous blood from patients in a pre-donation programme. Its use in this indication must be balanced against the reported increased risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (Hb 10 - 13 g/dl [6.21 - 8.07 mmol/l], no iron deficiency) if blood conserving 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).

Tuoteyhteenveto:

Revision: 33

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

1997-07-16

Pakkausseloste

48
B. PACKAGE LEAFLET
49
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEORECORMON 500 IU
NEORECORMON 2000 IU
NEORECORMON 3000 IU
NEORECORMON 4000 IU
NEORECORMON 5000 IU
NEORECORMON 6000 IU
NEORECORMON 10,000 IU
NEORECORMON 20,000 IU
NEORECORMON 30,000 IU
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
epoetin beta
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 or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs or illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What NeoRecormon is and what it is used for
2.
What you need to know before you use NeoRecormon
3.
How to use NeoRecormon
4.
Possible side effects
5.
How to store NeoRecormon
6.
Content of the pack and other information
1.
WHAT NEORECORMON IS AND WHAT IT IS USED FOR
NeoRecormon is a clear, colourless solution for injection under the
skin
_(subcutaneously)_
or into a
vein
_(intravenously). _
It contains a hormone called
_epoetin beta_
, which stimulates the production of red
blood cells. Epoetin beta is produced by a specialised genetic
technology and works in exactly the
same way as the natural hormone erythropoietin.
You must talk to your doctor if you do not feel better or if you feel
worse.
NeoRecormon is indicated for:
•
TREATING SYMPTOMATIC ANAEMIA CAUSED BY CHRONIC KIDNEY DISEASE
(renal anaemia) in patients
on dialysis, or not yet on dialysis.
•
PREVENTING ANAEMIA IN PREMATURE INFANTS
(weighing 750 to 1500 g and born at less than
34 weeks).
•
TREATING ANAEMIA WITH RELATED SYMPTOMS IN ADULT CANCER PATIENTS
RECEIVING CHEMOTHERAPY
•
TREATING PEOPLE DONATING THEIR OWN BLOOD BEFORE SURGERY.
The injections of epoetin beta will
increas

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
NeoRecormon 500 IU solution for injection in pre-filled syringe
NeoRecormon 2000 IU solution for injection in pre-filled syringe
NeoRecormon 3000 IU solution for injection in pre-filled syringe
NeoRecormon 4000 IU solution for injection in pre-filled syringe
NeoRecormon 5000 IU solution for injection in pre-filled syringe
NeoRecormon 6000 IU solution for injection in pre-filled syringe
NeoRecormon 10,000 IU solution for injection in pre-filled syringe
NeoRecormon 20,000 IU solution for injection in pre-filled syringe
NeoRecormon 30,000 IU solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
NeoRecormon 500 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.3 ml solution for injection contains 500
international units (IU)
corresponding to 4.15 micrograms epoetin beta* (recombinant human
erythropoietin).
One ml solution for injection contains 1667 IU epoetin beta.
NeoRecormon 2000 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.3 ml solution for injection contains
2000 international units (IU)
corresponding to 16.6 micrograms epoetin beta* (recombinant human
erythropoietin).
One ml solution for injection contains 6667 IU epoetin beta.
NeoRecormon 3000 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.3 ml solution for injection contains
3000 international units (IU)
corresponding to 24.9 micrograms epoetin beta* (recombinant human
erythropoietin).
One ml solution for injection contains 10,000 IU epoetin beta.
NeoRecormon 4000 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.3 ml solution for injection contains
4000 international units (IU)
corresponding to 33.2 micrograms epoetin beta* (recombinant human
erythropoietin).
One ml solution for injection contains 13,333 IU epoetin beta.
NeoRecormon 5000 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.3 ml solution