Eporatio
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
27-09-2023
Summary of Product characteristics
(SPC)
27-09-2023
Public Assessment Report
(PAR)
16-12-2009
Active ingredient:
epoetin theta
Available from:
Ratiopharm GmbH
ATC code:
B03XA01
INN (International Name):
epoetin theta
Therapeutic group:
Other antianemic preparations
Therapeutic area:
Kidney Failure, Chronic; Anemia; Cancer
Therapeutic indications:
Treatment of symptomatic anaemia associated with chronic renal failure in adult patients.Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Product summary:
Revision: 13
Authorization status:
Authorised
Authorization date:
2009-10-29
Patient Information leaflet
54
B. PACKAGE LEAFLET
55
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPORATIO 1,000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
EPORATIO 2,000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
EPORATIO 3,000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
EPORATIO 4,000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
EPORATIO 5,000 IU/0.5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
EPORATIO 10,000 IU/1 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
EPORATIO 20,000 IU/1 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
EPORATIO 30,000 IU/1 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
epoetin theta
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 Eporatio is and what it is used for
2.
What you need to know before you use Eporatio
3.
How to use Eporatio
4.
Possible side effects
5.
How to store Eporatio
6.
Contents of the pack and other information
7.
Information for injecting yourself
1.
WHAT EPORATIO IS AND WHAT IT IS USED FOR
WHAT EPORATIO IS
Eporatio contains the active substance epoetin theta, which is almost
identical to erythropoietin, a
natural hormone produced by your body. Epoetin theta is a protein
produced by biotechnology. It
works in exactly the same way as erythropoietin. Erythropoietin is
produced in your kidneys and
stimulates your bone marrow to produce red blood cells. Red blood
cells are very important for
distributing oxygen within your body.
WHAT EPORATIO IS USED FOR
Eporatio is used for the treatment of anaemia accompanied by sympt
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Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe
Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe
Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe
Eporatio 4,000 IU/0.5 ml solution for injection in pre-filled syringe
Eporatio 5,000 IU/0.5 ml solution for injection in pre-filled syringe
Eporatio 10,000 IU/1 ml solution for injection in pre-filled syringe
Eporatio 20,000 IU/1 ml solution for injection in pre-filled syringe
Eporatio 30,000 IU/1 ml solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe
One pre-filled syringe contains 1,000 international units (IU) (8.3
µg) epoetin theta in 0.5 ml solution
for injection corresponding to 2,000 IU (16.7 µg) epoetin theta per
ml.
Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe
One pre-filled syringe contains 2,000 international units (IU) (16.7
µg) epoetin theta in 0.5 ml solution
for injection corresponding to 4,000 IU (33.3 µg) epoetin theta per
ml.
Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe
One pre-filled syringe contains 3,000 international units (IU) (25
µg) epoetin theta in 0.5 ml solution
for injection corresponding to 6,000 IU (50 µg) epoetin theta per ml.
Eporatio 4,000 IU/0.5 ml solution for injection in pre-filled syringe
One pre-filled syringe contains 4,000 international units (IU) (33.3
µg) epoetin theta in 0.5 ml solution
for injection corresponding to 8,000 IU (66.7 µg) epoetin theta per
ml.
Eporatio 5,000 IU/0.5 ml solution for injection in pre-filled syringe
One pre-filled syringe contains 5,000 international units (IU) (41.7
µg) epoetin theta in 0.5 ml solution
for injection corresponding to 10,000 IU (83.3 µg) epoetin theta per
ml.
Eporatio 10,000 IU/1 ml solution for injection in pre-filled syringe
One pre-filled syringe contains 10,000 international
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