Silapo

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

epoetin zeta

Saadav alates:

Stada Arzneimittel AG

ATC kood:

B03XA01

INN (Rahvusvaheline Nimetus):

epoetin zeta

Terapeutiline rühm:

Antianemic preparations

Terapeutiline ala:

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

Näidustused:

Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patientsTreatment of anaemia associated with chronic renal failure in adult and paediatric 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).Silapo 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 (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).Silapo is indicated for non-iron deficient adults prior to major elective orthopaedic surgery having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions. Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1 800 ml).Silapo can be used to increase haemoglobin concentration in symptomatic anaemia (haemoglobin concentration of ≤10 g/dl) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (

Toote kokkuvõte:

Revision: 17

Volitamisolek:

Authorised

Loa andmise kuupäev:

2007-12-18

Infovoldik

66
B. PACKAGE LEAFLET
67
PACKAGE LEAFLET: INFORMATION FOR THE USER
SILAPO 1 000 IU/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
SILAPO 2 000 IU/0.6 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
SILAPO 3 000 IU/0.9 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
SILAPO 4 000 IU/0.4 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
SILAPO 5 000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
SILAPO 6 000 IU/0.6 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
SILAPO 8 000 IU/0.8 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
SILAPO 10 000 IU/1 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
SILAPO 20 000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
SILAPO 30 000 IU/0.75 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
SILAPO 40 000 IU/1 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
epoetin zeta
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 Silapo is and what it is used for
2.
What you need to know before you use Silapo
3.
How to use Silapo
4.
Possible side effects
5.
How to store Silapo
6.
Contents of the pack and other information
1.
WHAT SILAPO IS AND WHAT IT IS USED FOR
Silapo contains the active substance epoetin zeta – a protein, that
stimulates the bone marrow to
produce more red blood cells, which carry haemoglobin (a substance
that transports oxygen). Epoetin
zeta is a copy of the human protein erythropoietin
(ee-rith-roe-po-eh-tin) and acts in the same way.

SILAPO IS USED TO TREAT SYMPTOMATIC ANAEMIA CAUSED BY KIDNEY DISEASE

in ch

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe
Silapo 2 000 IU/0.6 mL solution for injection in pre-filled syringe
Silapo 3 000 IU/0.9 mL solution for injection in pre-filled syringe
Silapo 4 000 IU/0.4 mL solution for injection in pre-filled syringe
Silapo 5 000 IU/0.5 mL solution for injection in pre-filled syringe
Silapo 6 000 IU/0.6 mL solution for injection in pre-filled syringe
Silapo 8 000 IU/0.8 mL solution for injection in pre-filled syringe
Silapo 10 000 IU/1 mL solution for injection in pre-filled syringe
Silapo 20 000 IU/0.5 mL solution for injection in pre-filled syringe
Silapo 30 000 IU/0.75 mL solution for injection in pre-filled syringe
Silapo 40 000 IU/1 mL solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe
1 pre-filled syringe with 0.3 mL solution for injection contains 1 000
international units (IU) epoetin
zeta* (recombinant human erythropoietin). The solution contains 3 333
IU epoetin zeta per mL.
_Excipient with known effect_
Each pre-filled syringe contains 0.15 mg phenylalanine.
Silapo 2 000 IU/0.6 mL solution for injection in pre-filled syringe
1 pre-filled syringe with 0.6 mL solution for injection contains 2 000
international units (IU) epoetin
zeta* (recombinant human erythropoietin). The solution contains 3 333
IU epoetin zeta per mL.
_Excipient with known effect_
Each pre-filled syringe contains 0.30 mg phenylalanine.
Silapo 3 000 IU/0.9 mL solution for injection in pre-filled syringe
1 pre-filled syringe with 0.9 mL solution for injection contains 3 000
international units (IU) epoetin
zeta* (recombinant human erythropoietin). The solution contains 3 333
IU epoetin zeta per mL.
_Excipient with known effect_
Each pre-filled syringe contains 0.45 mg phenylalanine.
Silapo 4 000 IU/0.4 mL solution for injection in pre-filled syringe
1 pre-filled syringe with 0.4 mL solution for injec