Eporatio

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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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 units (IU) (83.3 µg) epoetin theta in 1 ml solution 
for injection corresponding to 10,000 IU (83.3 µg) epoetin theta per ml. 
 
Eporatio 20,000 IU/1 ml solution for injection in pre-filled syringe 
One pre-filled syringe contains 20,000 international units (IU) (166.7 µg) epoetin theta in 1 ml 
solution for injection corresponding to 20,000 IU (166.7 µg) epoetin theta per ml. 
 
Eporatio 30,000 IU/1 ml solution for injection in pre-filled syringe 
One pre-filled syringe contains 30,000 international units (IU) (250 µg) epoetin theta in 1 ml solution 
for injection corresponding to 30,000 IU (250 µg) epoetin theta per ml. 
 
Epoetin theta (recombinant human erythropoietin) is produced in Chinese Hamster Ovary Cells 
(CHO-K1) by recombinant DNA technology. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection (injection). 
 



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The solution is clear and colourless. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 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. 
 
4.2 Posology and method of administration 
 
Epoetin theta treatment should be initiated by physicians experienced in the above-mentioned 
indications. 
 
Posology 
Symptomatic anaemia associated with chronic renal failure 
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a 
physician’s evaluation of the individual patient’s clinical course and condition is necessary. Epoetin 
theta should be administered either subcutaneously or intravenously in order to increase haemoglobin 
level to not greater than 12 g/dl (7.45 mmol/l). 
 
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and 
below the desired haemoglobin level may be observed. Haemoglobin variability should be addressed 
through dose management, with consideration for the haemoglobin target range of 10 g/dl 
(6.21 mmol/l) to 12 g/dl (7.45 mmol/l). A sustained haemoglobin level of greater than 12 g/dl 
(7.45 mmol/l) should be avoided; guidance for appropriate dose adjustment if haemoglobin values 
exceeding 12 g/dl (7.45 mmol/l) are observed are described below. 
 
A rise in haemoglobin of greater than 2 g/dl (1.24 mmol/l) over a four week period should be avoided. 
If the rise in haemoglobin is greater than 2 g/dl (1.24 mmol/l) in 4 weeks or the haemoglobin value 
exceeds 12 g/dl (7.45 mmol/l), the dose should be reduced by 25 to 50%. It is recommended that 
haemoglobin be monitored every two weeks until levels have stabilised and periodically thereafter. If 
the haemoglobin level continues to increase, therapy should be interrupted until the haemoglobin level 
begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the 
previously administered dose. 
 
In the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular 
diseases, the increase in haemoglobin and the target haemoglobin value should be determined 
individually taking into account the clinical picture. 
 
Treatment with epoetin theta is divided into two stages. 
 
Correction phase 
Subcutaneous administration: The initial posology is 20 IU/kg body weight 3 times per week. The 
dose may be increased after 4 weeks to 40 IU/kg, 3 times per week, if the increase in haemoglobin is 
not adequate (< 1 g/dl [0.62 mmol/l] within 4 weeks). Further increases of 25% of the previous dose 
may be made at monthly intervals until the individual target haemoglobin level is obtained. 
 
Intravenous administration: The initial posology is 40 IU/kg body weight 3 times per week. The dose 
may be increased after 4 weeks to 80 IU/kg, 3 times per week, and by further increases of 25% of the 
previous dose at monthly intervals, if needed. 
 
For both routes of administration, the maximum dose should not exceed 700 IU/kg body weight per 
week. 



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Maintenance phase 
The dose should be adjusted as necessary to maintain the individual target haemoglobin level between 
10 g/dl (6.21 mmol/l) to 12 g/dl (7.45 mmol/l), whereby a haemoglobin level of 12 g/dl (7.45 mmol/l) 
should not be exceeded. If a dose adjustment is required to maintain the desired haemoglobin level, it 
is recommended that the dose be adjusted by approximately 25%. 
 
Subcutaneous administration: The weekly dose can be given as one injection per week or three times 
per week. 
 
Intravenous administration: Patients who are stable on a three times weekly dosing regimen may be 
switched to twice-weekly administration. 
 
If the frequency of administration is changed, haemoglobin level should be monitored closely and 
dose adjustments may be necessary. 
 
The maximum dose should not exceed 700 IU/kg body weight per week. 
 
If epoetin theta is substituted for another epoetin, haemoglobin level should be monitored closely and 
the same route of administration should be used. 
 
Patients should be monitored closely to ensure that the lowest approved effective dose of epoetin theta 
is used to provide adequate control of the symptoms of anaemia whilst maintaining a haemoglobin 
concentration below or at 12 g/dl (7.45 mmol/l). 
 
Caution should be exercised with escalation of epoetin theta doses in patients with chronic renal 
failure. In patients with a poor haemoglobin response to epoetin theta, alternative explanations for the 
poor response should be considered (see sections 4.4 and 5.1). 
 
Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy 
Epoetin theta should be administered by the subcutaneous route to patients with anaemia (e.g. 
haemoglobin concentration ≤ 10 g/dl [6.21 mmol/l]). Anaemia symptoms and sequelae may vary with 
age, gender, and overall burden of disease; a physician’s evaluation of the individual patient’s clinical 
course and condition is necessary. 
 
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and 
below the desired haemoglobin level may be observed. Haemoglobin variability should be addressed 
through dose management, with consideration for the haemoglobin target range of 10 g/dl 
(6.21 mmol/l) to 12 g/dl (7.45 mmol/l). A sustained haemoglobin level of greater than 12 g/dl 
(7.45 mmol/l) should be avoided; guidance for appropriate dose adjustment if haemoglobin values 
exceeding 12 g/dl (7.45 mmol/l) are observed are described below. 
 
The recommended initial dose is 20,000 IU, independent of bodyweight, given once-weekly. If, after 
4 weeks of therapy, the haemoglobin value has increased by at least 1 g/dl (0.62 mmol/l), the current 
dose should be continued. If the haemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l) 
a doubling of the weekly dose to 40,000 IU should be considered. If, after an additional 4 weeks of 
therapy, the haemoglobin increase is still insufficient an increase of the weekly dose to 60,000 IU 
should be considered. 
 
The maximum dose should not exceed 60,000 IU per week. 
 
If, after 12 weeks of therapy, the haemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l), 
response is unlikely and treatment should be discontinued. 
 
If the rise in haemoglobin is greater than 2 g/dl (1.24 mmol/l) in 4 weeks or the haemoglobin level 
exceeds 12 g/dl (7.45 mmol/l), the dose should be reduced by 25 to 50%. Treatment with epoetin theta 



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should be temporarily discontinued if haemoglobin levels exceed 13 g/dl (8.07 mmol/l). Therapy 
should be reinitiated at approximately 25% lower than the previous dose after haemoglobin levels fall 
to 12 g/dl (7.45 mmol/l) or below. 
 
Therapy should be continued up to 4 weeks after the end of chemotherapy. 
 
Patients should be monitored closely to ensure that the lowest approved dose of epoetin theta is used 
to provide adequate control of the symptoms of anaemia. 
 
Special populations 
Paediatric population 
The safety and efficacy of Eporatio in children and adolescents aged up to 17 years have not yet been 
established. No data are available. 
 
Method of administration 
The solution can be administered subcutaneously or intravenously. Subcutaneous use is preferable in 
patients who are not undergoing haemodialysis, in order to avoid puncturing peripheral veins. If 
epoetin theta is substituted for another epoetin, the same route of administration should be used. In 
cancer patients with non-myeloid malignancies receiving chemotherapy epoetin theta should be 
administered by the subcutaneous route only. 
 
Subcutaneous injections should be given into the abdomen, arm or thigh. 
 
The injection sites should be rotated and the injection performed slowly to avoid discomfort at the site 
of injection. 
 
For instructions on handling of the medicinal product before administration, see section 6.6. 
 
4.3 Contraindications 
 
- Hypersensitivity to the active substance, other epoetins and derivatives or to any of the 

excipients listed in section 6.1. 
- Uncontrolled hypertension. 
 
4.4 Special warnings and precautions for use 
 
General 
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/l 
or with transferrin saturation below 20%. To ensure effective erythropoiesis, iron status has to be 
evaluated for all patients prior to and during treatment.  
 
Non-response to therapy with epoetin theta should prompt a search for causative factors. Deficiencies 
of iron, folic acid or vitamin B12 reduce the effectiveness of epoetins and should therefore be 
corrected. Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, 
aluminium intoxication, underlying haematological diseases or bone marrow fibrosis may also 
compromise the erythropoietic response. A reticulocyte count should be considered as part of the 
evaluation. 
 
Pure red cell aplasia (PRCA) 
If typical causes of non-response are excluded, and the patient has a sudden drop in haemoglobin 
associated with reticulocytopenia, an examination of anti-erythropoietin antibodies and the bone 
marrow for diagnosis of pure red cell aplasia should be considered. Discontinuation of treatment with 
epoetin theta should be taken into account. 
 
PRCA caused by neutralising anti-erythropoietin antibodies has been reported in association with 
erythropoietin therapy, including with epoetin theta. These antibodies have been shown to cross-react 



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with all epoetins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin 
should not be switched to epoetin theta (see section 4.8). 
 
In order to improve the traceability of epoetins, the name of the administered epoetin should be 
clearly recorded in the patient file. 
 
A paradoxical decrease in haemoglobin and development of severe anaemia associated with low 
reticulocyte counts should prompt to discontinue treatment with epoetin and perform 
anti-erythropoietin antibody testing. Cases have been reported in patients with hepatitis C treated with 
interferon and ribavirin, when epoetins are used concomitantly. Epoetins are not approved in the 
management of anaemia associated with hepatitis C. 
 
Hypertension 
Patients on epoetin theta therapy can experience an increase in blood pressure or aggravation of 
existing hypertension particularly during the initial treatment phase. 
 
Therefore, in patients treated with epoetin theta, special care should be taken to monitor closely and 
control blood pressure. Blood pressure should be controlled adequately before initiation and during 
therapy to avoid acute complications, such as hypertensive crisis with encephalopathy-like symptoms 
(e.g. headaches, confused state, speech disturbances, impaired gait) and related complications 
(seizures, stroke), which may also occur in individual patients with otherwise normal or low blood 
pressure. If these reactions occur, they require the immediate attention of a physician and intensive 
medical care. Particular attention should be paid to sudden sharp migraine-like headaches as a 
possible warning signal. 
 
Increases in blood pressure may require treatment with antihypertensive medicinal products or a dose 
increase of existing antihypertensive medicinal products. In addition, a reduction of the administered 
dose of epoetin theta needs to be considered. If blood pressure values remain high, temporary 
interruption of epoetin theta therapy may be required. Once hypertension has been controlled with 
more intensified therapy, epoetin theta therapy should be re-started at a reduced dose. 
 
Misuse 
Misuse of epoetin theta by healthy persons may lead to an excessive increase in haemoglobin and 
haematocrit. This may be associated with life-threatening cardiovascular complications. 
 
Severe cutaneous adverse reactions 
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic 
epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association 
with epoetin treatment. More severe cases have been observed with long-acting epoetins. 
 
At the time of prescription, patients should be advised of the signs and symptoms and monitored 
closely for skin reactions. If signs and symptoms suggestive of these reactions appear, epoetin theta 
should be withdrawn immediately and an alternative treatment considered. 
 
If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of 
epoetin theta, treatment with epoetin theta must not be restarted in this patient at any time. 
 
Special populations 
Due to limited experience, the efficacy and safety of epoetin theta could not be assessed in patients 
with impaired liver function or homozygous sickle cell anaemia. 
 
In clinical trials, patients over 75 years of age had a higher incidence of serious and severe adverse 
events irrespective of a causal relationship to treatment with epoetin theta. Furthermore, deaths were 
more frequent in this patient group compared to younger patients. 
 
Laboratory monitoring 



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It is recommended that haemoglobin measurement, a complete blood count and platelet count be 
performed regularly.  
 
Symptomatic anaemia associated with chronic renal failure 
The use of epoetin theta in nephrosclerotic patients not yet undergoing dialysis should be defined 
individually, as a possible accelerated progression of renal failure cannot be ruled out with certainty. 
 
During haemodialysis, patients treated with epoetin theta may require increased anticoagulation 
treatment to prevent clotting of the arterio-venous shunt. 
 
In patients with chronic renal failure, the maintenance haemoglobin concentration should not exceed 
the upper limit of the target haemoglobin concentration recommended in section 4.2. In clinical trials, 
an increased risk of death and serious cardiovascular events was observed when epoetins were 
administered to target a haemoglobin level in excess of 12 g/dl (7.45 mmol/l). Controlled clinical 
trials have not shown significant benefits attributable to the administration of epoetins when the 
haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia 
and to avoid blood transfusion. 
 
Caution should be exercised with escalation of epoetin theta doses in patients with chronic renal 
failure since high cumulative epoetin doses may be associated with an increased risk of mortality, 
serious cardiovascular and cerebrovascular events. In patients with a poor haemoglobin response to 
epoetins, alternative explanations for the poor response should be considered (see sections 4.2 and 
5.1). 
 
Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy 
Effect on tumour growth 
Epoetins are growth factors that primarily stimulate red blood cell production. Erythropoietin 
receptors may be expressed on the surface of a variety of tumour cells. As with all growth factors, 
there is a concern that epoetins could stimulate the growth of any type of malignancy (see section 
5.1). 
 
In several controlled studies, epoetins have not been shown to improve overall survival or decrease 
the risk of tumour progression in patients with anaemia associated with cancer. In controlled clinical 
studies, use of epoetins has shown: 
- shortened time to tumour progression in patients with advanced head and neck cancer receiving 

radiation therapy when administered to target a haemoglobin level in excess of 14 g/dl 
(8.69 mmol/l), 

- shortened overall survival and increased deaths attributed to disease progression at 4 months in 
patients with metastatic breast cancer receiving chemotherapy when administered to target a 
haemoglobin value of 12-14 g/dl (7.45-8.69 mmol/l), 

- increased risk of death when administered to target a haemoglobin value of 12 g/dl 
(7.45 mmol/l) in patients with active malignant disease receiving neither chemotherapy nor 
radiation therapy. 

Epoetins are not indicated for use in this patient population. 
 
In view of the above, in some clinical situations blood transfusion should be the preferred treatment 
for the management of anaemia in patients with cancer. The decision to administer recombinant 
erythropoietins should be based on a benefit-risk assessment with the participation of the individual 
patient, which should take into account the specific clinical context. Factors that should be considered 
in this assessment should include the type of tumour and its stage, the degree of anaemia, 
life-expectancy, the environment in which the patient is being treated, and patient preference (see 
section 5.1). 
 



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Excipients 
This medicinal product contains less than 1 mmol sodium (23 mg) per pre-filled syringe, i.e. 
essentially ‘sodium-free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of epoetin 
theta in pregnant women. Animal studies with other epoetins do not indicate direct harmful effects 
with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to 
avoid the use of Eporatio during pregnancy. 
 
Breast-feeding 
It is unknown whether epoetin theta/metabolites are excreted in human milk, but data in neonates 
show no absorption or pharmacological activity of erythropoietin when given together with breast 
milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from 
Eporatio therapy taking into account the benefit of breast-feeding for the child and the benefit of 
therapy for the woman. 
 
Fertility 
No data are available. 
 
4.7 Effects on ability to drive and use machines 
 
Epoetin theta has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
Approximately 9% of patients can be expected to experience an adverse reaction. The most frequent 
adverse reactions are hypertension, influenza-like illness and headache. 
 
Tabulated list of adverse reactions 
The safety of epoetin theta has been evaluated based on results from clinical studies including 
972 patients. 
 
Adverse reactions listed below in table 1 are classified according to System Organ Class. Frequency 
groupings are defined according to the following convention: 
Very common:  ≥ 1/10; 
Common:  ≥ 1/100 to < 1/10; 
Uncommon:  ≥ 1/1,000 to < 1/100; 
Rare:   ≥ 1/10,000 to < 1/1,000; 
Very rare:  < 1/10,000; 
Not known:  cannot be estimated from the available data. 
 



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Table 1: Adverse reactions 
System organ class Adverse reaction Frequency 

Symptomatic anaemia 
associated with 
chronic renal failure 

Symptomatic anaemia 
in cancer patients with 
non-myeloid 
malignancies receiving 
chemotherapy 

Blood and lymphatic 
system disorders 

Pure red cell aplasia 
(PRCA)* 

Not known — 

Immune system 
disorders 

Hypersensitivity 
reactions 

Not known 

Nervous system 
disorders 

Headache Common 

Vascular disorders Hypertension* Common 
Hypertensive crisis* Common — 
Shunt thrombosis* Common — 
Thromboembolic 
events 

— Not known 

Skin and subcutaneous 
tissue disorders 

Skin reactions* Common 

Musculoskeletal and 
connective tissue 
disorders 

Arthralgia — Common 

General disorders and 
administration site 
conditions 

Influenza-like illness* Common 

*See subsection “Description of selected adverse reactions” below 
 
Description of selected adverse reactions 
In patients with chronic renal failure, neutralising anti-erythropoietin antibody-mediated pure red cell 
aplasia (PRCA) associated with epoetin theta therapy has been reported in post marketing setting. If 
PRCA is diagnosed, therapy with epoetin theta must be discontinued and patients should not be 
switched to another recombinant epoetin (see section 4.4). 
 
One of the most frequent adverse reactions during treatment with epoetin theta is an increase in blood 
pressure or aggravation of existing hypertension particularly during the initial treatment phase. 
Hypertension occurs in chronic renal failure patients more often during the correction phase than 
during the maintenance phase. Hypertension can be treated with appropriate medicinal products (see 
section 4.4). 
 
Hypertensive crisis with encephalopathy-like symptoms (e.g. headaches, confused state, speech 
disturbances, impaired gait) and related complications (seizures, stroke) may also occur in individual 
patients with otherwise normal or low blood pressure (see section 4.4). 
 
Shunt thrombosis may occur, especially in patients who have a tendency to hypotension or whose 
arterio-venous fistulae exhibit complications (e.g. stenoses, aneurisms) (see section 4.4). 
 
Skin reactions such as rash, pruritus or injection site reactions may occur. 
 
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic 
epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association 
with epoetin treatment (see section 4.4). 
 
Symptoms of influenza-like illness such as fever, chills and asthenic conditions have been reported. 
 



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Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
The therapeutic margin of epoetin theta is very wide. In the case of overdose, polycythaemia can 
occur. In the event of polycythaemia, epoetin theta should be temporarily withheld. 
 
If severe polycythaemia occurs, conventional methods (phlebotomy) may be indicated to reduce the 
haemoglobin level. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Other antianemic preparations, ATC code: B03XA01 
 
Mechanism of action 
Human erythropoietin is an endogenous glycoprotein hormone that is the primary regulator of 
erythropoiesis through specific interaction with the erythropoietin receptor on the erythroid progenitor 
cells in the bone marrow. It acts as a mitosis-stimulating factor and differentiation hormone. The 
production of erythropoietin primarily occurs in and is regulated by the kidney in response to changes 
in tissue oxygenation. Production of endogenous erythropoietin is impaired in patients with chronic 
renal failure and the primary cause of their anaemia is erythropoietin deficiency. In patients with 
cancer receiving chemotherapy the aetiology of anaemia is multifactorial. In these patients, 
erythropoietin deficiency and a reduced response of erythroid progenitor cells to endogenous 
erythropoietin both contribute significantly towards their anaemia. 
 
Epoetin theta is identical in its amino acid sequence and similar in its carbohydrate composition 
(glycosylation) to endogenous human erythropoietin. 
 
Preclinical efficacy 
The biological efficacy of epoetin theta has been demonstrated after intravenous and subcutaneous 
administration in various animal models in vivo (mice, rats, dogs). After administration of epoetin 
theta, the number of erythrocytes, the haematocrit values and reticulocyte counts increase. 
 
Clinical efficacy and safety 
Symptomatic anaemia associated chronic renal failure 
Data from correction phase studies in 284 chronic renal failure patients show that the haemoglobin 
response rates (defined as haemoglobin levels above 11 g/dl at two consecutive measurements) in the 
epoetin theta group (88.4% and 89.4% in studies in patients on dialysis and not yet undergoing 
dialysis, respectively) were comparable to epoetin beta (86.2% and 81.0%, respectively). The median 
time to response was similar in the treatment groups with 56 days in haemodialysis patients and 
49 days in patients not yet undergoing dialysis. 
 
Two randomised controlled studies were conducted in 270 haemodialysis patients and 288 patients 
not yet undergoing dialysis, who were on stable treatment with epoetin beta. Patients were 
randomised to continue their current treatment or to be converted to epoetin theta (same dose as 
epoetin beta) in order to maintain their haemoglobin levels. During the evaluation period (weeks 15 to 
26), the mean and median level of haemoglobin in patients treated with epoetin theta was virtually 
identical to their baseline haemoglobin level. In these two studies, 180 haemodialysis patients and 
193 patients not undergoing dialysis were switched from maintenance phase treatment with epoetin 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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beta to treatment with epoetin theta for a period of six months showing stable haemoglobin values and 
a similar safety profile as epoetin beta. In the clinical studies, patients not yet undergoing dialysis 
(subcutaneous administration) discontinued the study more frequently than haemodialysis patients 
(intravenous administration) as they had to terminate the study when starting dialysis. 
 
In two long-term studies, the efficacy of epoetin theta was evaluated in 124 haemodialysis patients 
and 289 patients not yet undergoing dialysis. The haemoglobin levels remained within the desired 
target range and epoetin theta was well tolerated over a period of up to 15 months. 
 
In the clinical studies, pre-dialysis patients were treated once-weekly with epoetin theta, 174 patients 
in the maintenance phase study and 111 patients in the long-term study. 
 
Pooled post-hoc analyses of clinical studies of epoetins have been performed in chronic renal failure 
patients (on dialysis, not on dialysis, in diabetic and non-diabetic patients). A tendency towards 
increased risk estimates for all-cause mortality, cardiovascular and cerebrovascular events associated 
with higher cumulative epoetin doses independent of the diabetes or dialysis status was observed (see 
sections 4.2 and section 4.4). 
 
Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy 
409 cancer patients receiving chemotherapy were included in two prospective, randomised 
double-blind, placebo-controlled studies. The first study was conducted in 186 anaemic patients with 
non-myeloid malignancies (55% with haematological malignancies and 45% with solid tumours) 
receiving non-platinum chemotherapy. The second study was conducted in 223 patients with various 
solid tumours receiving platinum-containing chemotherapy. In both studies, treatment with epoetin 
theta resulted in a significant haemoglobin response (p < 0.001), defined as an increase in 
haemoglobin of ≥ 2 g/dl without transfusion, and a significant reduction in transfusion requirements 
(p < 0.05) in comparison to placebo. 
 
Effect on tumour growth 
Erythropoietin is a growth factor that primarily stimulates red cell production. Erythropoietin 
receptors may be expressed on the surface of a variety of tumour cells. 
 
Survival and tumour progression have been examined in five large controlled studies involving a total 
of 2,833 patients, of which four were double-blind placebo-controlled studies and one was an open-
label study. Two of the studies recruited patients who were being treated with chemotherapy. The 
target haemoglobin concentration in two studies was > 13 g/dl; in the remaining three studies it was 
12-14 g/dl. In the open-label study there was no difference in overall survival between patients treated 
with recombinant human erythropoietin and controls. In the four placebo-controlled studies the hazard 
ratios for overall survival ranged between 1.25 and 2.47 in favour of controls. These studies have 
shown a consistent unexplained statistically significant excess mortality in patients who have anaemia 
associated with various common cancers who received recombinant human erythropoietin compared 
to controls. Overall survival outcome in the trials could not be satisfactorily explained by differences 
in the incidence of thrombosis and related complications between those given recombinant human 
erythropoietin and those in the control group. 
 
Data from three placebo-controlled clinical studies in 586 anaemic cancer patients conducted with 
epoetin theta, showed no negative effect of epoetin theta on survival. During the studies, mortality 
was lower in the epoetin theta group (6.9%) compared to placebo (10.3%). 
 
A systematic review has also been performed involving more than 9,000 cancer patients participating 
in 57 clinical trials. Meta-analysis of overall survival data produced a hazard ratio point estimate of 
1.08 in favour of controls (95% CI: 0.99, 1.18; 42 trials and 8,167 patients). An increased relative risk 
of thromboembolic events (RR 1.67, 95% CI: 1.35, 2.06; 35 trials and 6,769 patients) was observed in 
patients treated with recombinant human erythropoietin. There is therefore consistent evidence to 
suggest that there may be significant harm to patients with cancer who are treated with recombinant 
human erythropoietin. The extent to which these outcomes might apply to the administration of 



12 

recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve 
haemoglobin concentrations less than 13 g/dl, is unclear because few patients with these 
characteristics were included in the data reviewed. 
 
A patient-level data analysis has also been performed on more than 13,900 cancer patients (chemo-, 
radio-, chemoradio- or no therapy) participating in 53 controlled clinical trials involving several 
epoetins. Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in 
favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for cancer patients receiving 
chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 
10,441 patients). Meta-analyses also indicate consistently a significantly increased relative risk of 
thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section 
4.4). 
 
5.2 Pharmacokinetic properties 
 
General 
The pharmacokinetics of epoetin theta have been examined in healthy volunteers, in patients with 
chronic renal failure and in cancer patients receiving chemotherapy. The pharmacokinetics of epoetin 
theta are independent of age or gender. 
 
Subcutaneous administration 
Following subcutaneous injection of 40 IU/kg body weight epoetin theta at three different sites (upper 
arm, abdomen, thigh) in healthy volunteers, similar plasma level profiles were observed. The extent of 
absorption (AUC) was slightly greater after injection in the abdomen in comparison to the other sites. 
The maximum concentration is reached after an average of 10 to 14 hours and the average terminal 
half-life ranges from approximately 22 to 41 hours. 
 
Average bioavailability of epoetin theta after subcutaneous administration is approximately 31% 
compared with intravenous administration. 
 
In pre-dialysis patients with chronic renal failure following subcutaneous injection of 40 IU/kg body 
weight, the protracted absorption results in a concentration plateau, whereby the maximum 
concentration is reached after an average of approximately 14 hours. The terminal half-life is higher 
than after intravenous administration, with an average of 25 hours after single dosing and 34 hours in 
steady state after repeated dosing three times weekly, without leading to an accumulation of epoetin 
theta. 
 
In cancer patients receiving chemotherapy, after repeated subcutaneous administration of 20,000 IU 
epoetin theta once-weekly, the terminal half-life is 29 hours after the first dose and 28 hours in steady 
state. No accumulation of epoetin theta was observed. 
 
Intravenous administration 
In patients with chronic renal failure undergoing haemodialysis, the elimination half-life of epoetin 
theta is 6 hours after single dosing and 4 hours in steady state after repeated intravenous 
administration of 40 IU/kg body weight epoetin theta three times weekly. No accumulation of epoetin 
theta was observed. Following intravenous administration, the volume of distribution approximates to 
total blood volume. 
 
5.3 Preclinical safety data 
 
Non-clinical data with epoetin theta reveal no special hazard for humans based on conventional 
studies of safety pharmacology and repeated dose toxicity. 
 
Non-clinical data with other epoetins reveal no special hazard for humans based on conventional 
studies of genotoxicity and toxicity to reproduction. 
 



13 

In reproductive toxicity studies performed with other epoetins, effects interpreted as being secondary 
to decreased maternal body weight were observed at doses sufficiently in excess to the recommended 
human dose. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium dihydrogen phosphate dihydrate 
Sodium chloride 
Polysorbate 20 
Trometamol 
Hydrochloric acid (6 M) (for pH adjustment) 
Water for injections 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other 
medicinal products. 
 
6.3 Shelf life 
 
Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe 
2 years 
 
Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe 
2 years 
 
Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe 
2 years 
 
Eporatio 4,000 IU/0.5 ml solution for injection in pre-filled syringe 
2 years 
 
Eporatio 5,000 IU/0.5 ml solution for injection in pre-filled syringe 
30 months 
 
Eporatio 10,000 IU/1 ml solution for injection in pre-filled syringe 
30 months 
 
Eporatio 20,000 IU/1 ml solution for injection in pre-filled syringe 
30 months 
 
Eporatio 30,000 IU/1 ml solution for injection in pre-filled syringe 
30 months 
 
For the purpose of ambulatory use, the patient may remove the product from the refrigerator and store 
it at a temperature not above 25 °C for a single period of up to 7 days without exceeding the expiry 
date. Once removed from the refrigerator, the medicinal product must be used within this period or 
disposed of. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2 °C – 8 °C). 
 



14 

Do not freeze. 
 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 
6.5 Nature and contents of container 
 
Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe 
0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger 
stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle 
(stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a 
safety device. 
 
Pack sizes of 6 pre-filled syringes; 6 pre-filled syringes with safety needle or 6 pre-filled syringes with 
safety device. 
 
Not all pack sizes may be marketed. 
 
Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe 
0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger 
stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle 
(stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a 
safety device. 
 
Pack sizes of 6 pre-filled syringes; 6 pre-filled syringes with safety needle or 6 pre-filled syringes with 
safety device. 
 
Not all pack sizes may be marketed. 
 
Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe 
0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger 
stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle 
(stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a 
safety device. 
 
Pack sizes of 6 pre-filled syringes; 6 pre-filled syringes with safety needle or 6 pre-filled syringes with 
safety device. 
 
Not all pack sizes may be marketed. 
 
Eporatio 4,000 IU/0.5 ml solution for injection in pre-filled syringe 
0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger 
stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle 
(stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a 
safety device. 
 
Pack sizes of 6 pre-filled syringes; 6 pre-filled syringes with safety needle or 6 pre-filled syringes with 
safety device. 
 
Not all pack sizes may be marketed. 
 
Eporatio 5,000 IU/0.5 ml solution for injection in pre-filled syringe 
0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger 
stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle 
(stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a 
safety device. 
 



15 

Pack sizes of 6 pre-filled syringes; 6 pre-filled syringes with safety needle or 6 pre-filled syringes with 
safety device. 
 
Not all pack sizes may be marketed. 
 
Eporatio 10,000 IU/1 ml solution for injection in pre-filled syringe 
1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger 
stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle 
(stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a 
safety device. 
 
Pack sizes of 1, 4 and 6 pre-filled syringes; 1, 4 and 6 pre-filled syringes with safety needle or 1, 4 and 
6 pre-filled syringes with safety device. 
 
Not all pack sizes may be marketed. 
 
Eporatio 20,000 IU/1 ml solution for injection in pre-filled syringe 
1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger 
stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle 
(stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a 
safety device. 
 
Pack sizes of 1, 4 and 6 pre-filled syringes; 1, 4 and 6 pre-filled syringes with safety needle or 1, 4 and 
6 pre-filled syringes with safety device. 
 
Not all pack sizes may be marketed. 
 
Eporatio 30,000 IU/1 ml solution for injection in pre-filled syringe 
1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger 
stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle 
(stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a 
safety device. 
 
Pack sizes of 1, 4 and 6 pre-filled syringes; 1, 4 and 6 pre-filled syringes with safety needle or 1, 4 and 
6 pre-filled syringes with safety device. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
The pre-filled syringes are for single use only.  
 
The solution should be visually inspected prior to use. Only clear, colourless solutions without 
particles should be used. The solution for injection should not be shaken. It should be allowed to 
reach a comfortable temperature (15 °C - 25 °C) for injection. 
 
For instructions on how to inject the medicinal product, see package leaflet. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 



16 

89079 Ulm 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe 
EU/1/09/573/001 
EU/1/09/573/002 
EU/1/09/573/029 
 
Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe 
EU/1/09/573/003 
EU/1/09/573/004 
EU/1/09/573/030 
 
Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe 
EU/1/09/573/005 
EU/1/09/573/006 
EU/1/09/573/031 
 
Eporatio 4,000 IU/0.5 ml solution for injection in pre-filled syringe 
EU/1/09/573/007 
EU/1/09/573/008 
EU/1/09/573/032 
 
Eporatio 5,000 IU/0.5 ml solution for injection in pre-filled syringe 
EU/1/09/573/009 
EU/1/09/573/010 
EU/1/09/573/033 
 
Eporatio 10,000 IU/1 ml solution for injection in pre-filled syringe 
EU/1/09/573/011 
EU/1/09/573/012 
EU/1/09/573/013 
EU/1/09/573/014 
EU/1/09/573/015 
EU/1/09/573/016 
EU/1/09/573/034 
EU/1/09/573/035 
EU/1/09/573/036 
 
Eporatio 20,000 IU/1 ml solution for injection in pre-filled syringe 
EU/1/09/573/017 
EU/1/09/573/018 
EU/1/09/573/019 
EU/1/09/573/020 
EU/1/09/573/021 
EU/1/09/573/022 
EU/1/09/573/037 
EU/1/09/573/038 
EU/1/09/573/039 
 
Eporatio 30,000 IU/1 ml solution for injection in pre-filled syringe 
EU/1/09/573/023 
EU/1/09/573/024 



17 

EU/1/09/573/025 
EU/1/09/573/026 
EU/1/09/573/027 
EU/1/09/573/028 
EU/1/09/573/040 
EU/1/09/573/041 
EU/1/09/573/042 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 29 October 2009. 
Date of latest renewal: 11 September 2014. 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/. 
 



18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 
SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR 
BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 



19 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer of the biological active substance 
 
Teva Biotech GmbH 
Dornierstraße 10 
89079 Ulm 
Germany 
 
Name and address of the manufacturer responsible for batch release 
 
Teva Biotech GmbH 
Dornierstraße 10 
89079 Ulm 
Germany 
 
Merckle GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
● Periodic safety update reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
● Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 

● At the request of the European Medicines Agency; 
● Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



21 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



22 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe 
 
Epoetin theta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 1,000 international units (IU) (8.3 micrograms) epoetin theta in 0.5 ml 
solution for injection corresponding to 2,000 IU (16.7 micrograms) epoetin theta per ml. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, 
hydrochloric acid (6 M) (for pH adjustment), water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
6 pre-filled syringes containing 0.5 ml. 
6 pre-filled syringes with safety needle containing 0.5 ml. 
6 pre-filled syringes with safety device containing 0.5 ml. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
For single use only. 
 
Please use as follows: 
Box for the prescribed posology 
 
Subcutaneous or intravenous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 



23 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
Can be stored at room temperature (not above 25 °C) for up to 7 days within the shelf life. 
 
End of 7 days period at room temperature: __/__/____ 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
 
Do not freeze. 
 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/573/001 6 pre-filled syringes 
EU/1/09/573/002 6 pre-filled syringes with safety device 
EU/1/09/573/029 6 pre-filled syringes with safety needle 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 



24 

16. INFORMATION IN BRAILLE 
 
Eporatio 1,000 IU/0.5 ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



25 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe 
 
Epoetin theta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 2,000 international units (IU) (16.7 micrograms) epoetin theta in 
0.5 ml solution for injection corresponding to 4,000 IU (33.3 micrograms) epoetin theta per ml. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, 
hydrochloric acid (6 M) (for pH adjustment), water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
6 pre-filled syringes containing 0.5 ml. 
6 pre-filled syringes with safety needle containing 0.5 ml. 
6 pre-filled syringes with safety device containing 0.5 ml. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
For single use only. 
 
Please use as follows: 
Box for the prescribed posology 
 
Subcutaneous or intravenous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 



26 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
Can be stored at room temperature (not above 25 °C) for up to 7 days within the shelf life. 
 
End of 7 days period at room temperature: __/__/____ 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
 
Do not freeze. 
 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/573/003 6 pre-filled syringes 
EU/1/09/573/004 6 pre-filled syringes with safety device 
EU/1/09/573/030 6 pre-filled syringes with safety needle 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 



27 

16. INFORMATION IN BRAILLE 
 
Eporatio 2,000 IU/0.5 ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



28 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe 
 
Epoetin theta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 3,000 international units (IU) (25 micrograms) epoetin theta in 0.5 ml 
solution for injection corresponding to 6,000 IU (50 micrograms) epoetin theta per ml. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, 
hydrochloric acid (6 M) (for pH adjustment), water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
6 pre-filled syringes containing 0.5 ml. 
6 pre-filled syringes with safety needle containing 0.5 ml. 
6 pre-filled syringes with safety device containing 0.5 ml. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
For single use only. 
 
Please use as follows: 
Box for the prescribed posology 
 
Subcutaneous or intravenous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 



29 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
Can be stored at room temperature (not above 25 °C) for up to 7 days within the shelf life. 
 
End of 7 days period at room temperature: __/__/____ 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
 
Do not freeze. 
 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/573/005 6 pre-filled syringes 
EU/1/09/573/006 6 pre-filled syringes with safety device 
EU/1/09/573/031 6 pre-filled syringes with safety needle 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 



30 

16. INFORMATION IN BRAILLE 
 
Eporatio 3,000 IU/0.5 ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



31 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Eporatio 4,000 IU/0.5 ml solution for injection in pre-filled syringe 
 
Epoetin theta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 4,000 international units (IU) (33.3 micrograms) epoetin theta in 
0.5 ml solution for injection corresponding to 8,000 IU (66.7 micrograms) epoetin theta per ml. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, 
hydrochloric acid (6 M) (for pH adjustment), water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
6 pre-filled syringes containing 0.5 ml. 
6 pre-filled syringes with safety needle containing 0.5 ml. 
6 pre-filled syringes with safety device containing 0.5 ml. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
For single use only. 
 
Please use as follows: 
Box for the prescribed dose 
 
Subcutaneous or intravenous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 



32 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
Can be stored at room temperature (not above 25 °C) for up to 7 days within the shelf life. 
 
End of 7 days period at room temperature: __/__/____ 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
 
Do not freeze. 
 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/573/007 6 pre-filled syringes 
EU/1/09/573/008 6 pre-filled syringes with safety device 
EU/1/09/573/032 6 pre-filled syringes with safety needle 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 



33 

16. INFORMATION IN BRAILLE 
 
Eporatio 4,000 IU/0.5 ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



34 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Eporatio 5,000 IU/0.5 ml solution for injection in pre-filled syringe 
 
Epoetin theta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 5,000 international units (IU) (41.7 micrograms) epoetin theta in 
0.5 ml solution for injection corresponding to 10,000 IU (83.3 micrograms) epoetin theta per ml. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, 
hydrochloric acid (6 M) (for pH adjustment), water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
6 pre-filled syringes containing 0.5 ml. 
6 pre-filled syringes with safety needle containing 0.5 ml. 
6 pre-filled syringes with safety device containing 0.5 ml. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
For single use only. 
 
Please use as follows: 
Box for the prescribed posology 
 
Subcutaneous or intravenous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 



35 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
Can be stored at room temperature (not above 25 °C) for up to 7 days within the shelf life. 
 
End of 7 days period at room temperature: __/__/____ 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
 
Do not freeze. 
 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/573/009 6 pre-filled syringes 
EU/1/09/573/010 6 pre-filled syringes with safety device 
EU/1/09/573/033 6 pre-filled syringes with safety needle 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 



36 

16. INFORMATION IN BRAILLE 
 
Eporatio 5,000 IU/0.5 ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



37 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Eporatio 10,000 IU/1 ml solution for injection in pre-filled syringe 
 
Epoetin theta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 10,000 international units (IU) (83.3 micrograms) epoetin theta in 1 ml 
solution for injection corresponding to 10,000 IU (83.3 micrograms) epoetin theta per ml. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, 
hydrochloric acid (6 M) (for pH adjustment), water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
1 pre-filled syringe containing 1 ml. 
1 pre-filled syringe with safety needle containing 1 ml. 
1 pre-filled syringe with safety device containing 1 ml. 
4 pre-filled syringes containing 1 ml. 
4 pre-filled syringes with safety needle containing 1 ml. 
4 pre-filled syringes with safety device containing 1 ml. 
6 pre-filled syringes containing 1 ml. 
6 pre-filled syringes with safety needle containing 1 ml. 
6 pre-filled syringes with safety device containing 1 ml. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
For single use only. 
 
Please use as follows: 
Box for the prescribed posology 
 
Subcutaneous or intravenous use 
 
 



38 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
Can be stored at room temperature (not above 25 °C) for up to 7 days within the shelf life. 
 
End of 7 days period at room temperature: __/__/____ 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
 
Do not freeze. 
 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/573/011 1 pre-filled syringe 
EU/1/09/573/012 1 pre-filled syringe with safety device 
EU/1/09/573/013 4 pre-filled syringes 
EU/1/09/573/014 4 pre-filled syringes with safety device 
EU/1/09/573/015 6 pre-filled syringes 
EU/1/09/573/016 6 pre-filled syringes with safety device 
EU/1/09/573/034 1 pre-filled syringe with safety needle 
EU/1/09/573/035 4 pre-filled syringes with safety needle 
EU/1/09/573/036 6 pre-filled syringes with safety needle 
 
 
13. BATCH NUMBER 



39 

 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Eporatio 10,000 IU/1 ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



40 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Eporatio 20,000 IU/1 ml solution for injection in pre-filled syringe 
 
Epoetin theta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 20,000 international units (IU) (166.7 micrograms) epoetin theta in 
1 ml solution for injection corresponding to 20,000 IU (166.7 micrograms) epoetin theta per ml. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, 
hydrochloric acid (6 M) (for pH adjustment), water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
1 pre-filled syringe containing 1 ml. 
1 pre-filled syringe with safety needle containing 1 ml. 
1 pre-filled syringe with safety device containing 1 ml. 
4 pre-filled syringes containing 1 ml. 
4 pre-filled syringes with safety needle containing 1 ml. 
4 pre-filled syringes with safety device containing 1 ml. 
6 pre-filled syringes containing 1 ml. 
6 pre-filled syringes with safety needle containing 1 ml. 
6 pre-filled syringes with safety device containing 1 ml. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
For single use only. 
 
Please use as follows: 
Box for the prescribed posology 
 
Subcutaneous or intravenous use 
 
 



41 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
Can be stored at room temperature (not above 25 °C) for up to 7 days within the shelf life. 
 
End of 7 days period at room temperature: __/__/____ 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
 
Do not freeze. 
 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/573/017 1 pre-filled syringe 
EU/1/09/573/018 1 pre-filled syringe with safety device 
EU/1/09/573/019 4 pre-filled syringes 
EU/1/09/573/020 4 pre-filled syringes with safety device 
EU/1/09/573/021 6 pre-filled syringes 
EU/1/09/573/022 6 pre-filled syringes with safety device 
EU/1/09/573/037 1 pre-filled syringe with safety needle 
EU/1/09/573/038 4 pre-filled syringes with safety needle 
EU/1/09/573/039 6 pre-filled syringes with safety needle 
 
 
13. BATCH NUMBER 



42 

 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Eporatio 20,000 IU/1 ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



43 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Eporatio 30,000 IU/1 ml solution for injection in pre-filled syringe 
 
Epoetin theta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 30,000 international units (IU) (250 micrograms) epoetin theta in 1 ml 
solution for injection corresponding to 30,000 IU (250 micrograms) epoetin theta per ml. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, 
hydrochloric acid (6 M) (for pH adjustment), water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
1 pre-filled syringe containing 1 ml. 
1 pre-filled syringe with safety needle containing 1 ml. 
1 pre-filled syringe with safety device containing 1 ml. 
4 pre-filled syringes containing 1 ml. 
4 pre-filled syringes with safety needle containing 1 ml. 
4 pre-filled syringes with safety device containing 1 ml. 
6 pre-filled syringes containing 1 ml. 
6 pre-filled syringes with safety needle containing 1 ml. 
6 pre-filled syringes with safety device containing 1 ml. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
For single use only. 
 
Please use as follows: 
Box for the prescribed posology 
 
Subcutaneous or intravenous use 
 
 



44 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
Can be stored at room temperature (not above 25 °C) for up to 7 days within the shelf life. 
 
End of 7 days period at room temperature: __/__/____ 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
 
Do not freeze. 
 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/09/573/023 1 pre-filled syringe 
EU/1/09/573/024 1 pre-filled syringe with safety device 
EU/1/09/573/025 4 pre-filled syringes 
EU/1/09/573/026 4 pre-filled syringes with safety device 
EU/1/09/573/027 6 pre-filled syringes 
EU/1/09/573/028 6 pre-filled syringes with safety device 
EU/1/09/573/040 1 pre-filled syringe with safety needle 
EU/1/09/573/041 4 pre-filled syringes with safety needle 
EU/1/09/573/042 6 pre-filled syringes with safety needle 
 
 
13. BATCH NUMBER 



45 

 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Eporatio 30,000 IU/1 ml 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



46 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Eporatio 1,000 IU/0.5 ml injection 
 
Epoetin theta 
 
SC IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 ml 
 
 
6. OTHER 
 
IU 
 
 



47 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Eporatio 2,000 IU/0.5 ml injection 
 
Epoetin theta 
 
SC IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 ml 
 
 
6. OTHER 
 
IU 
 
 



48 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Eporatio 3,000 IU/0.5 ml injection 
 
Epoetin theta 
 
SC IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 ml 
 
 
6. OTHER 
 
IU 
 
 



49 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Eporatio 4,000 IU/0.5 ml injection 
 
Epoetin theta 
 
SC IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 ml 
 
 
6. OTHER 
 
IU 
 
 



50 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Eporatio 5,000 IU/0.5 ml injection 
 
Epoetin theta 
 
SC IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 ml 
 
 
6. OTHER 
 
IU 
 
 



51 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Eporatio 10,000 IU/1 ml injection 
 
Epoetin theta 
 
SC IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 ml 
 
6. OTHER 
 
IU 
 
 



52 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Eporatio 20,000 IU/1 ml injection 
 
Epoetin theta 
 
SC IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 ml 
 
6. OTHER 
 
IU 
 
 



53 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Eporatio 30,000 IU/1 ml injection 
 
Epoetin theta 
 
SC IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 ml 
 
6. OTHER 
 
IU 
 
 



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 symptoms (for example fatigue, 
weakness and shortness of breath). Anaemia occurs when your blood does not contain enough red 
blood cells. Treatment for anaemia is given to adult patients with chronic renal failure or to adult 
patients with non-myeloid cancer (cancer not originating in the bone marrow) who at the same time 
are receiving chemotherapy (medicines to treat cancer). 
 
 
2. What you need to know before you use Eporatio 
 
Do NOT use Eporatio 
- if you are allergic to epoetin theta, another epoetin or any of the other ingredients of this 

medicine (listed in section 6); 



56 

- if you have high blood pressure that cannot be controlled. 
 
Warnings and precautions 
 
General 
This medicine may not be suitable for the following patients. Please speak with your doctor if you 
belong to one of these patient groups: 
- patients with liver problems, 
- patients with pathological changes in their red blood cells (homozygous sickle cell anaemia). 
 
Your blood pressure needs to be checked closely before and during treatment with this medicine. If 
your blood pressure rises, your doctor may give you medicines to reduce your blood pressure. If you 
are already taking a medicine to reduce your blood pressure, your doctor might increase the dose. It 
may also be necessary to reduce your dose of Eporatio or to stop the treatment with Eporatio for a 
short period of time. 
 
If you get headaches, especially sudden, stabbing, migraine-like headaches, confusion, speech 
disturbance, unsteady walking, fits or convulsions, tell your doctor immediately. These may be signs 
of severely elevated blood pressure, even if your blood pressure is usually normal or low. It needs to 
be treated at once. 
 
Your doctor will carry out regular blood tests in order to monitor various blood components and their 
levels. In addition, the iron level in your blood will be checked before and during treatment with this 
medicine. If your iron level is too low, your doctor may also prescribe you an iron preparation. 
 
If you feel tired and weak or experience breathlessness, you must consult your doctor. These 
symptoms could indicate that your treatment with this medicine is ineffective. Your doctor will check 
that you do not have other causes of anaemia and may perform blood tests or examine your bone 
marrow. 
 
Your healthcare professional will always record the exact product you are using. This can help to 
provide more information on the safety of medicines like this one. 
 
Healthy people should not use Eporatio. The use of this medicine by healthy people can excessively 
increase certain blood parameters and in so doing cause problems with the heart or blood vessels that 
can be life threatening. 
 
Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis 
(TEN) have been reported in association with epoetin treatment. SJS/TEN can appear initially as 
reddish target-like spots or circular patches often with central blisters on the trunk. Also, ulcers of 
mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are 
often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of 
the skin and life-threatening complications. If you develop a serious rash or another of these skin 
symptoms, stop using Eporatio and contact your doctor or seek medical attention immediately. 
 
Anaemia caused by chronic renal failure 
If you are a patient with chronic renal failure, your doctor will check that a particular blood parameter 
(haemoglobin) does not exceed a defined threshold. If this blood parameter becomes too high, heart or 
vascular problems might occur, increasing the risk of death. 
 
If you are a patient with chronic renal failure, and particularly if you do not respond properly to 
Eporatio, your doctor will check your dose of Eporatio because repeatedly increasing your dose of 
Eporatio if you are not responding to treatment may increase the risk of having a problem of the heart 
or the blood vessels and could increase risk of myocardial infarction, stroke and death. 
 



57 

If you have hardening of the blood vessels in your kidneys (nephrosclerosis) but do not need to 
undergo dialysis, your doctor will consider whether treatment is suitable for you. This is because one 
cannot rule out a possible acceleration of progression of kidney disease with absolute certainty. 
 
If you are on dialysis, medicines that prevent blood coagulation are used. If you are being treated with 
Eporatio, the dose of the anticoagulant medicine may have to be increased. Otherwise the increased 
number of red blood cells may cause blocking of the arterio-venous fistula (an artificial connection 
between an artery and a vein which is surgically prepared in dialysis patients). 
 
Anaemia in cancer patients 
If you are a cancer patient you should be aware that this medicine may act as a blood cell growth 
factor and in some circumstances may have a negative impact on your cancer. Depending on your 
individual situation a blood transfusion may be preferable. Please discuss this with your doctor. 
 
Children and adolescents 
Do not give this medicine to children and adolescents under 18 years of age because there are no data 
that show that this medicine is safe and works in this age group. 
 
Other medicines and Eporatio 
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Pregnancy and breast-feeding 
Eporatio has not been tested in pregnant women. It is important to tell your doctor if you are pregnant, 
think you may be pregnant or plan to get pregnant, as the doctor may decide that you should not use 
this medicine. 
 
It is unknown whether the active substance in this medicine passes over to the breast milk. Therefore, 
your doctor may decide that you should not use this medicine if you are breast-feeding. 
 
Driving and using machines 
This medicine does not affect your ability to drive and use machines. 
 
Eporatio contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, i.e. essentially 
‘sodium-free’. 
 
 
3. How to use Eporatio 
 
Your treatment with this medicine is being initiated by a doctor who is experienced in the 
above-mentioned indications. 
 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
The recommended dose is… 
The dose of Eporatio (expressed in International Units or IU) depends on your disease condition, your 
body weight and the way the injection is given (under the skin [subcutaneous injection] or into a vein 
[intravenous injection]). Your doctor will work out the right dose for you. 
 
Anaemia caused by chronic renal failure 
The injections are given under the skin or into a vein. Patients on haemodialysis will usually receive 
the injection at the end of dialysis via an arterio-venous fistula. Patients who do not have to undergo 
dialysis are usally given the injections under the skin. Your doctor will carry out blood tests regularly 
and adjust the dosage or suspend the treatment if necessary. The haemoglobin values in your blood 



58 

should not exceed a value of 12 g/dl (7.45 mmol/l). Your doctor will use the lowest effective dose to 
control the symptoms of your anaemia. If you do not respond adequately to Eporatio, your doctor will 
check your dose and will inform you if you need to change doses of Eporatio. 
 
Treatment with Eporatio is divided into two stages: 
a) Correcting the anaemia 
The initial dose for injections under the skin is 20 IU per kg of bodyweight, given 3 times per week. If 
necessary, your doctor will increase your dose at monthly intervals. 
 
The initial dose for injections into veins is 40 IU per kg of bodyweight, given 3 times per week. If 
necessary, your doctor will increase your dose at monthly intervals. 
 
b) Maintaining sufficient red blood cell levels 
Once an adequate number of red blood cells has been reached, the maintenance dose required to keep 
the number constant will be determined by your doctor. 
 
In the case of injections under the skin, the weekly dose can be given either as 1 injection per week or 
as 3 divided injections per week. 
 
In the case of injections into veins, your dosage may be switched to 2 injections weekly. 
 
If the frequency of administration is changed, dose adjustments may be necessary. 
 
Treatment with Eporatio is normally a long-term therapy. 
 
The maximum dose should not exceed 700 IU per kg of bodyweight per week. 
 
Anaemia in cancer patients 
Injections are given under the skin. The injection will be given once-weekly. The initial dose is 
20,000 IU. Your doctor will carry out blood tests regularly and adjust the dosage or suspend the 
treatment if necessary. The haemoglobin values in your blood should not exceed a value of 12 g/dl 
(7.45 mmol/l). You will usually receive Eporatio until 1 month after the end of chemotherapy. 
 
The maximum dose should not exceed 60,000 IU. 
 
How are the injections given? 
This medicine is given as an injection using a pre-filled syringe. The injection is given either into a 
vein (intravenous injection) or into the tissue just under the skin (subcutaneous injection). 
 
If you are receiving Eporatio as an injection under the skin, your doctor may suggest that you learn 
how to inject yourself this medicine. Your doctor or nurse will give you instructions on how to do 
this. Do not attempt to give this medicine to yourself without this training. Some of the information 
required for using the pre-filled syringe can be found at the end of this package leaflet (see section “7. 
Information for injecting yourself”). Proper treatment of your disease, however, requires close and 
constant co-operation with your doctor. 
 
Each pre-filled syringe is for single use only. 
 
If you use more Eporatio than you should 
Do not increase the dose your doctor has given you. If you think you have injected more Eporatio than 
you should, contact your doctor. It is unlikely to be serious. Even at very high blood levels, no 
symptoms of poisoning have been observed. 
 
If you forget to use Eporatio 
If you have missed an injection, or injected too little, talk to your doctor. Do not inject a double dose 
to make up for a forgotten dose. 



59 

 
If you stop using Eporatio 
Before you stop using this medicine, talk to your doctor. 
 
If you have any further questions on the use of this medicine , ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Serious side effects: 
- Severely elevated blood pressure: 

If you get headaches, especially sudden, stabbing, migraine-like headaches, confusion, speech 
disturbance, unsteady walking, fits or convulsions, tell your doctor immediately. These may be 
signs of severely elevated blood pressure (common in patients with chronic renal failure, may 
affect up to 1 in 10 people), even if your blood pressure is usually normal or low. It needs to be 
treated at once. 

- Allergic reactions: 
Allergic reactions such as skin rash, raised areas of the skin that itch and severe allergic 
reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face 
have been reported (not known, frequency cannot be estimated from the available data). If you 
think you are having this type of reaction, you must stop your Eporatio injection and get 
medical help immediately. 

- Serious skin rashes: 
Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have 
been reported in association with epoetin treatment. These can appear as reddish target-like 
macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of 
mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. 
Stop using Eporatio if you develop these symptoms and contact your doctor or seek medical 
attention immediately. See also section 2. 

 
You may experience the following additional side effects: 
 
Common (may affect up to 1 in 10 people) 
- Headache; 
- High blood pressure; 
- Flu-like symptoms, such as fever, chills, feeling of weakness, tiredness; 
- Skin reactions, such as rash, itching or reactions around the injection site. 
 
Common in patients with chronic renal failure (may affect up to 1 in 10 people) 
- Blood clot in the arterio-venous fistula in patients on dialysis. 
 
Common in cancer patients (may affect up to 1 in 10 people) 
- Joint pain. 
 
Not known in patients with chronic renal failure (frequency cannot be estimated from the available 
data) 
- Cases of a condition called pure red cell aplasia (PRCA) have been reported. PRCA means that 

the body has stopped or reduced the production of red blood cells which causes severe anaemia. 
If your doctor suspects or confirms that you have this condition, you must not be treated with 
Eporatio or another epoetin. 

 
Not known in cancer patients (frequency cannot be estimated from the available data) 
- Thromboembolic events, e.g. increase in blood clots. 
 



60 

Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Eporatio 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the outer carton and on the pre-filled 
syringe after EXP. The expiry date refers to the last day of that month. 
 
Store in a refrigerator (2 °C – 8 °C). 
 
Do not freeze. 
 
Keep the pre-filled syringe in the outer carton, in order to protect from light. 
 
You may remove Eporatio from the refrigerator and store it not above 25 °C for a single period of up 
to 7 days without exceeding the expiry date. Once you have removed your medicine from the 
refrigerator you must use it within this period or it must be discarded. 
 
Do not use this medicine if you notice it is cloudy or there are particles in it. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Eporatio contains 
- The active substance is epoetin theta. 

Eporatio 1,000 IU/0.5 ml: One pre-filled syringe contains 1,000 international units (IU) 
(8.3 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 
2,000 international units (IU) (16.7 micrograms) per ml. 
Eporatio 2,000 IU/0.5 ml: One pre-filled syringe contains 2,000 international units (IU) 
(16.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 
4,000 international units (IU) (33.3 micrograms) per ml. 
Eporatio 3,000 IU/0.5 ml: One pre-filled syringe contains 3,000 international units (IU) 
(25 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 
6,000 international units (IU) (50 micrograms) per ml. 
Eporatio 4,000 IU/0.5 ml: One pre-filled syringe contains 4,000 international units (IU) 
(33.3 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 
8,000 international units (IU) (66.7 micrograms) per ml. 
Eporatio 5,000 IU/0.5 ml: One pre-filled syringe contains 5,000 international units (IU) 
(41.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 
10,000 international units (IU) (83.3 micrograms) per ml.. 
Eporatio 10,000 IU/1 ml: One pre-filled syringe contains 10,000 international units (IU) 
(83.3 micrograms) epoetin theta in 1 ml solution for injection corresponding to 
10,000 international units (IU) (83.3 micrograms) per ml. 
Eporatio 20,000 IU/1 ml: One pre-filled syringe contains 20,000 international units (IU) 
(166.7 micrograms) epoetin theta in 1 ml solution for injection corresponding to 
20,000 international units (IU) (166.7 micrograms) per ml. 
Eporatio 30,000 IU/1 ml: One pre-filled syringe contains 30,000 international units (IU) 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


61 

(250 micrograms) epoetin theta in 1 ml solution for injection corresponding to 
30,000 international units (IU) (250 micrograms) per ml. 

- The other ingredients are sodium dihydrogen phosphate dihydrate, sodium chloride, 
polysorbate 20, trometamol, hydrochloric acid (6 M) (for pH adjustment) and water for 
injections. 

 
What Eporatio looks like and contents of the pack 
Eporatio is a clear and colourless solution for injection in pre-filled syringe along with an injection 
needle. 
 
Eporatio 1,000 IU/0.5 ml, Eporatio 2,000 IU/0.5 ml, Eporatio 3,000 IU/0.5 ml, Eporatio 
4,000 IU/0.5 ml and Eporatio 5,000 IU/0.5 ml: Each pre-filled syringe contains 0.5 ml of solution. 
Packs of 6 pre-filled syringes; 6 pre-filled syringes with safety needle or 6 pre-filled syringes with 
safety device. 
 
Eporatio 10,000 IU/1 ml, Eporatio 20,000 IU/1 ml and Eporatio 30,000 IU/1 ml: Each pre-filled 
syringe contains 1 ml of solution. Packs of 1, 4 and 6 pre-filled syringes; 1, 4 and 6 pre-filled syringes 
with safety needle or 1, 4 and 6 pre-filled syringes with safety device. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
ratiopharm GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
Manufacturer 
Teva Biotech GmbH 
Dornierstraße 10 
89079 Ulm 
Germany 
 
Merckle GmbH 
Graf-Arco-Straße 3 
89079 Ulm 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Teva Pharma Belgium N.V./S.A./AG 
Tél/Tel: +32 3 820 73 73 
 

Lietuva 
UAB "Sicor Biotech" 
Tel: +370 5 266 0203 
 

България 
Актавис ЕАД 
Teл: +359 2 489 95 85 
 

Luxembourg/Luxemburg 
ratiopharm GmbH, Allemagne/Deutschland 
Tél/Tel: +49 731 402 02 
 

Česká republika 
Teva Pharmaceuticals CR, s.r.o. 
Tel: +420 251 007 111 
 

Magyarország 
Teva Gyógyszergyár Zrt. 
Tel.: +36 1 288 64 00 
 

Danmark 
Teva Denmark A/S 
Tlf: +45 44 98 55 11 

Malta 
Teva Pharmaceuticals Ireland, L-Irlanda 
Tel: +353 51 321740 



62 

  
Deutschland 
ratiopharm GmbH 
Tel: +49 731 402 02 
 

Nederland 
Teva Nederland B.V. 
Tel: +31 800 0228 400 
 

Eesti 
UAB "Sicor Biotech" Eesti filiaal 
Tel: +372 661 0801 
 

Norge 
Teva Norway AS 
Tlf: +47 66 77 55 90 
 

Ελλάδα 
Teva Ελλάς Α.Ε. 
Τηλ: +30 210 72 79 099 
 

Österreich 
ratiopharm Arzneimittel Vertriebs-GmbH 
Tel: +43 1 97 007 
 

España 
Teva Pharma, S.L.U. 
Tel: +34 91 387 32 80 

Polska 
Teva Pharmaceuticals Polska Sp. z o.o. 
Tel.: +48 22 345 93 00 
 

France 
Teva Santé 
Tél: +33 1 55 91 78 00 
 

Portugal 
ratiopharm, Comércio e Indústria de Produtos 
Farmacêuticos, Lda 
Tel: +351 21 424 80 00 
 

Hrvatska 
Pliva Hrvatska d.o.o. 
Tel: +385 1 37 20 000 
 

România 
Teva Pharmaceuticals S.R.L 
Tel: +40 21 230 65 24 
 

Ireland 
Teva Pharmaceuticals Ireland 
Tel: +353 51 321740 
 

Slovenija 
Pliva Ljubljana d.o.o. 
Tel: +386 1 58 90 390 
 

Ísland 
ratiopharm Oy, Finnland 
Sími: +358 20 180 5900 
 

Slovenská republika 
TEVA Pharmaceuticals Slovakia s.r.o. 
Tel: +421 2 57 26 79 11 
 

Italia 
Teva Italia S.r.l. 
Tel: +39 02 89 17 98 1 
 

Suomi/Finland 
ratiopharm Oy 
Puh/Tel: +358 20 180 5900 
 

Κύπρος 
Teva Ελλάς Α.Ε., Ελλάδα 
Τηλ: +30 210 72 79 099 
 

Sverige 
Teva Sweden AB 
Tel: +46 42 12 11 00 
 

Latvija 
UAB "Sicor Biotech" filiāle Latvijā 
Tel: +371 673 23 666 
 

United Kingdom 
Teva UK Limited 
Tel: +44 1977 628500 
 

 
This leaflet was last approved in . 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
 

http://www.ema.europa.eu/


63 

7. Information for injecting yourself 
 
This section contains information on how to give yourself an injection of Eporatio under the skin. It is 
important that you do not try to give yourself the injection unless you have received special training 
from your doctor or nurse. If you are not sure about giving yourself the injection or you have any 
questions, please ask your doctor or nurse for help. 
 
How Eporatio is used 
You will need to give yourself the injection into the tissue just under the skin. This is known as a 
subcutaneous injection. 
 
Equipment that you need 
To give yourself an injection into the tissue under the skin you will need: 
- a pre-filled syringe of Eporatio, 
- an alcohol wipe, 
- a piece of gauze bandage or a sterile gauze swab, 
- a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can 

dispose of used syringes safely. 
 
What you should do before your injection 
1. Take one blister with a pre-filled syringe out of the refrigerator. 
2. Open the blister and take the pre-filled syringe and the needle container out of the blister. Do 

not pick up the pre-filled syringe by the plunger or tip cap. 
3. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed 

the last day of the month shown. 
4. Check the appearance of Eporatio. It must be a clear and colourless liquid. If there are particles 

in it or if it is cloudy, you must not use it. 
5. There is a cap at the end of the needle container. Break the labelled seal and remove the cap 

(see picture 1). 
6. Remove the tip cap from the pre-filled syringe (see picture 2). 
7. Attach the needle to the syringe (see picture 3). Do not remove the needle cover at this time. 
8. For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room 

temperature (not above 25 °C) or hold the pre-filled syringe gently in your hand for a few 
minutes. Do not warm Eporatio in any other way (for example, do not warm it in a microwave 
or in hot water). 

9. Do not remove the needle cover from the syringe until you are ready to inject. 
10. Find a comfortable, well-lit place. Put everything you need within easy reach (the Eporatio 

pre-filled syringe, an alcohol wipe, a piece of gauze bandage or a sterile gauze swab and the 
puncture-proof container). 

11. Wash your hands thoroughly. 
 

1 
 



64 

2 3 
 
How to prepare for your injection 
Before you give yourself an Eporatio injection, you must do the following: 
1. Hold the syringe and gently remove the cover from the needle without twisting. Pull straight as 

shown in picture 4. Do not touch the needle or push the plunger. 
2. You may notice small air bubbles in the pre-filled syringe. If there are air bubbles present, 

gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. With 
the syringe pointing upwards, expel all air from the syringe by pushing the plunger slowly 
upwards. 

3. The syringe has a scale on the syringe barrel. Push the plunger up to the number (IU) on the 
syringe that matches the dose of Eporatio that your doctor prescribed. 

4. Check again to make sure the correct dose of Eporatio is in the syringe. 
5. You can now use the pre-filled syringe. 
 

4 
 
Where your injection should be given 
The most suitable places to inject yourself are: 
- the top of your thighs, 
- the abdomen, except for the area around the navel (see grey areas in picture 5). 
 
If someone else is injecting you, they can also use the back and side of your upper arms (see grey 
areas in picture 6). 
 
It is better to change the injection site every day to avoid the risk of soreness at any one site. 
 



65 

5 6 
 
How you should inject yourself 
1. Disinfect the injection site on the skin by using an alcohol wipe and pinch the skin between 

your thumb and forefinger, without squeezing it (see picture 7). 
2. Put the needle fully into the skin as shown by your doctor or nurse. The angle between the 

syringe and skin should not be too narrow (at least 45°, see picture 8). 
3. Inject the liquid into the tissue slowly and evenly, always keeping your skin pinched. 
4. After injecting the liquid, remove the needle and let go of your skin. 
5. Press the injection site with a piece of gauze bandage or a sterile gauze swab for several 

seconds. 
6. Only use each syringe for one injection. Do not use any Eporatio that is left in the syringe. 
 

7 8 
 
Remember 
If you have any problems, please ask your doctor or nurse for help and advice. 
 
Disposing of used syringes 
- Do not put the cover back on used needles. 
- Put used syringes into the puncture-proof container and keep this container out of the sight and 

reach of children. 
- Dispose of the full puncture-proof container as instructed by your doctor, pharmacist or nurse. 
- Never put the syringes that you have used into your normal household rubbish bin. 
 
 
7. Information for injecting yourself 
 
This section contains information on how to give yourself an injection of Eporatio under the skin. It is 
important that you do not try to give yourself the injection unless you have received special training 
from your doctor or nurse. If you are not sure about giving yourself the injection or you have any 
questions, please ask your doctor or nurse for help. 
 
How Eporatio is used 
You will need to give yourself the injection into the tissue just under the skin. This is known as a 
subcutaneous injection. 



66 

 
Equipment that you need 
To give yourself an injection into the tissue under the skin you will need: 
- a pre-filled syringe of Eporatio, 
- an alcohol wipe, 
- a piece of gauze bandage or a sterile gauze swab, 
- a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can 

dispose of used syringes safely. 
 
What you should do before your injection 
1. Take one blister with a pre-filled syringe out of the refrigerator. 
2. Open the blister and take the pre-filled syringe and the needle bag out of the blister. Do not pick 

up the pre-filled syringe by the plunger or tip cap. 
3. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed 

the last day of the month shown. 
4. Check the appearance of Eporatio. It must be a clear and colourless liquid. If there are particles 

in it or if it is cloudy, you must not use it. 
5. There are flaps at the end of the needle bag. Open the needle bag at the flaps (see picture 1). 
6. Remove the tip cap from the pre-filled syringe (see picture 2). 
7. Attach the needle to the syringe (see picture 3). Do not remove the needle cover at this time. 
8. Move the safety shield away from the needle and toward the syringe barrel. The safety shield 

will remain in the position you set (see picture 4) 
9. For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room 

temperature (not above 25 °C) or hold the pre-filled syringe gently in your hand for a few 
minutes. Do not warm Eporatio in any other way (for example, do not warm it in a microwave 
or in hot water). 

10. Do not remove the needle cover from the syringe until you are ready to inject. 
11. Find a comfortable, well-lit place. Put everything you need within easy reach (the Eporatio 

pre-filled syringe, an alcohol wipe, a piece of gauze bandage or a sterile gauze swab and the 
puncture-proof container). 

12. Wash your hands thoroughly. 
 

1 2 
 

3 4 
 



67 

How to prepare for your injection 
Before you give yourself an Eporatio injection, you must do the following: 
1. Hold the syringe and gently remove the cover from the needle without twisting. Pull straight as 

shown in picture 5. Do not touch the needle or push the plunger. 
2. You may notice small air bubbles in the pre-filled syringe. If there are air bubbles present, 

gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. With 
the syringe pointing upwards, expel all air from the syringe by pushing the plunger slowly 
upwards. 

3. The syringe has a scale on the syringe barrel. Push the plunger up to the number (IU) on the 
syringe that matches the dose of Eporatio that your doctor prescribed. 

4. Check again to make sure the correct dose of Eporatio is in the syringe. 
5. You can now use the pre-filled syringe. 
 

5 
 
Where your injection should be given 
The most suitable places to inject yourself are: 
- the top of your thighs, 
- the abdomen, except for the area around the navel (see grey areas in picture 6). 
 
If someone else is injecting you, they can also use the back and side of your upper arms (see grey 
areas in picture 7). 
 
It is better to change the injection site every day to avoid the risk of soreness at any one site. 
 

6 7 
 
How you should inject yourself 
1. Disinfect the injection site on the skin by using an alcohol wipe and pinch the skin between 

your thumb and forefinger, without squeezing it (see picture 8). 
2. Put the needle fully into the skin as shown by your doctor or nurse. The angle between the 

syringe and skin should not be too narrow (at least 45°, see pictures 9 and 10). 
3. Inject the liquid into the tissue slowly and evenly, always keeping your skin pinched (see 

picture 11). 
4. After injecting the liquid, remove the needle and let go of your skin. 



68 

5. Press the injection site with a piece of gauze bandage or a sterile gauze swab for several 
seconds. 

6. Push the safety shield towards the needle (see picture 12). 
7. Position the safety shield approximately 45° against a flat surface (see picture 13). 
8. Press down the needle with a firm, quick motion until a distinct audible click is heard (see 

picture 14). 
9. Confirm visually that the needle is fully engaged in the safety shield under the lock (see 

picture 15). 
10. Only use each syringe for one injection. Do not use any Eporatio that is left in the syringe. 
 

8 9 
 

10 11 
 

12 13 
 



69 

14 15 
 
Remember 
If you have any problems, please ask your doctor or nurse for help and advice. 
 
Disposing of used syringes 
- Put used syringes into the puncture-proof container and keep this container out of the sight and 

reach of children. 
- Dispose of the full puncture-proof container as instructed by your doctor, pharmacist or nurse. 
- Never put the syringes that you have used into your normal household rubbish bin. 
 
 
7. Information for injecting yourself 
 
This section contains information on how to give yourself an injection of Eporatio under the skin. It is 
important that you do not try to give yourself the injection unless you have received special training 
from your doctor or nurse. If you are not sure about giving yourself the injection or you have any 
questions, please ask your doctor or nurse for help. 
 
How Eporatio is used 
You will need to give yourself the injection into the tissue just under the skin. This is known as a 
subcutaneous injection. 
 
Equipment that you need 
To give yourself an injection into the tissue under the skin you will need: 
- a pre-filled syringe of Eporatio, 
- an alcohol wipe, 
- a piece of gauze bandage or a sterile gauze swab. 
 
What you should do before your injection 
1. Take one blister with a pre-filled syringe out of the refrigerator. 
2. Open the blister and take the pre-filled syringe and the needle container out of the blister. Do 

not pick up the pre-filled syringe by the plunger or tip cap. 
3. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed 

the last day of the month shown. 
4. Check the appearance of Eporatio. It must be a clear and colourless liquid. If there are particles 

in it or if it is cloudy, you must not use it. 
5. There is a cap at the end of the needle container. Break the labelled seal and remove the cap 

(see picture 1). 
6. Remove the tip cap from the pre-filled syringe (see picture 2). 
7. Attach the needle to the syringe (see picture 3). Do not remove the needle cover at this time. 
8. For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room 

temperature (not above 25 °C) or hold the pre-filled syringe gently in your hand for a few 
minutes. Do not warm Eporatio in any other way (for example, do not warm it in a microwave 
or in hot water). 

9. Do not remove the needle cover from the syringe until you are ready to inject. 



70 

10. Find a comfortable, well-lit place. Put everything you need within easy reach (the Eporatio 
pre-filled syringe, an alcohol wipe and a piece of gauze bandage or a sterile gauze swab). 

11. Wash your hands thoroughly. 
 

1 
 

2 3 
 
How to prepare for your injection 
Before you give yourself an Eporatio injection, you must do the following: 
1. Hold the syringe and gently remove the cover from the needle without twisting. Pull straight as 

shown in picture 4. The needle is surrounded by a retractable needle shield. Do not touch the 
needle or needle shield or push the plunger (see picture 5). 

2. You may notice small air bubbles in the pre-filled syringe. If there are air bubbles present, 
gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. With 
the syringe pointing upwards, expel all air from the syringe by pushing the plunger slowly 
upwards. 

3. The syringe has a scale on the syringe barrel. Push the plunger up to the number (IU) on the 
syringe that matches the dose of Eporatio that your doctor prescribed. 

4. Check again to make sure the correct dose of Eporatio is in the syringe. 
5. You can now use the pre-filled syringe. 
 

4 5 
 
Where your injection should be given 



71 

The most suitable places to inject yourself are: 
- the top of your thighs, 
- the abdomen, except for the area around the navel (see grey areas in picture 6). 
 
If someone else is injecting you, they can also use the back and side of your upper arms (see grey 
areas in picture 7). 
 
It is better to change the injection site every day to avoid the risk of soreness at any one site. 
 

6 7 
 
How you should inject yourself 
1. Disinfect the injection site on the skin by using an alcohol wipe and pinch the skin between 

your thumb and forefinger, without squeezing it (see picture 8). 
2. Put the shielded needle without hesitation and in one continuous motion fully into the skin as 

shown by your doctor or nurse. The angle between the syringe and skin should not be too 
narrow (at least 45°, see picture 9). The needle shield will retract completely when you insert 
the needle into the skin (see picture 10). 

3. Inject the liquid into the tissue slowly and evenly, always keeping your skin pinched (see 
picture 11). 

4. After injecting the liquid, remove the needle and let go of your skin. The needle will be 
shielded and locked automatically so that you can not prick yourself (see picture 12). 

5. Press the injection site with a piece of gauze bandage or a sterile gauze swab for several 
seconds. 

6. Only use each syringe for one injection. Do not use any Eporatio that is left in the syringe. 
 

8 9 
 



72 

10 11 
 

12 
 
Remember 
If you have any problems, please ask your doctor or nurse for help and advice. 
 
Disposing of used syringes 
The safety device prevents needle stick injuries after use, so no special precautions for disposal are 
required. Dispose of syringes with a safety device as instructed by your doctor, pharmacist or nurse. 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET