Retacrit

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

epoetin zeta

Available from:

Pfizer Europe MA EEIG

ATC code:

B03XA01

INN (International Name):

epoetin zeta

Therapeutic group:

Other antianemic preparations

Therapeutic area:

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

Therapeutic indications:

Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:treatment 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).Retacrit 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 (four or more units of blood for females or five or more units for males).Retacrit 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 expected moderate blood loss (900 to 1800 ml).

Product summary:

Revision: 31

Authorization status:

Authorised

Authorization date:

2007-12-18

Patient Information leaflet

91
B. PACKAGE LEAFLET
92
PACKAGE LEAFLET: INFORMATION FOR THE USER
RETACRIT 1 000 IU/0.3 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RETACRIT 2 000 IU/0.6 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RETACRIT 3 000 IU/0.9 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RETACRIT 4 000 IU/0.4 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RETACRIT 5 000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RETACRIT 6 000 IU/0.6 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RETACRIT 8 000 IU/0.8 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RETACRIT 10 000 IU/1 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RETACRIT 20 000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
RETACRIT 30 000 IU/0.75 ML SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
RETACRIT 40 000 IU/1 MLSOLUTION 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 Retacrit is and what it is used for
2.
What you need to know before you use Retacrit
3.
How to use Retacrit
4.
Possible side effects
5.
How to store Retacrit
6.
Contents of the pack and other information
1.
WHAT RETACRIT IS AND WHAT IT IS USED FOR
Retacrit 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.
•
RETACRIT IS USED TO TREAT SYMPTOMATIC ANAEMIA CA

Summary of Product characteristics

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