NeoRecormon

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
NeoRecormon 500 IU solution for injection in pre-filled syringe 
NeoRecormon 2000 IU solution for injection in pre-filled syringe 
NeoRecormon  3000 IU solution for injection in pre-filled syringe 
NeoRecormon  4000 IU solution for injection in pre-filled syringe 
NeoRecormon  5000 IU solution for injection in pre-filled syringe 
NeoRecormon  6000 IU solution for injection in pre-filled syringe 
NeoRecormon  10,000 IU solution for injection in pre-filled syringe 
NeoRecormon  20,000 IU solution for injection in pre-filled syringe 
NeoRecormon  30,000 IU solution for injection in pre-filled syringe 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
NeoRecormon 500 IU solution for injection in pre-filled syringe 
 
One pre-filled syringe with 0.3 ml solution for injection contains 500 international units (IU) 
corresponding to 4.15 micrograms epoetin beta* (recombinant human erythropoietin). 
One ml solution for injection contains 1667 IU epoetin beta. 
 
NeoRecormon 2000 IU solution for injection in pre-filled syringe 
 
One pre-filled syringe with 0.3 ml solution for injection contains 2000 international units (IU) 
corresponding to 16.6 micrograms epoetin beta* (recombinant human erythropoietin). 
One ml solution for injection contains 6667 IU epoetin beta. 
 
NeoRecormon 3000 IU solution for injection in pre-filled syringe 
 
One pre-filled syringe with 0.3 ml solution for injection contains 3000 international units (IU) 
corresponding to 24.9 micrograms epoetin beta* (recombinant human erythropoietin). 
One ml solution for injection contains 10,000 IU epoetin beta. 
 
NeoRecormon 4000 IU solution for injection in pre-filled syringe 
 
One pre-filled syringe with 0.3 ml solution for injection contains 4000 international units (IU) 
corresponding to 33.2 micrograms epoetin beta* (recombinant human erythropoietin). 
One ml solution for injection contains 13,333 IU epoetin beta. 
 
NeoRecormon 5000 IU solution for injection in pre-filled syringe 
 
One pre-filled syringe with 0.3 ml solution for injection contains 5000 international units (IU) 
corresponding to 41.5 micrograms epoetin beta* (recombinant human erythropoietin). 
One ml solution for injection contains 16,667 IU epoetin beta. 
 
NeoRecormon 6000 IU solution for injection in pre-filled syringe 
 
One pre-filled syringe with 0.3 ml solution for injection contains 6000 international units (IU) 
corresponding to 49.8 micrograms epoetin beta* (recombinant human erythropoietin). 
One ml solution for injection contains 20,000 IU epoetin beta. 
 
NeoRecormon 10,000 IU solution for injection in pre-filled syringe 
 
One pre-filled syringe with 0.6 ml solution for injection contains 10,000 international units (IU) 
corresponding to 83 micrograms epoetin beta* (recombinant human erythropoietin). 
One ml solution for injection contains 16,667 IU epoetin beta. 
 



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NeoRecormon 20,000 IU solution for injection in pre-filled syringe 
 
One pre-filled syringe with 0.6 ml solution for injection contains 20,000 international units (IU) 
corresponding to 166 micrograms epoetin beta* (recombinant human erythropoietin). 
One ml solution for injection contains 33,333 IU epoetin beta. 
 
NeoRecormon 30,000 IU solution for injection in pre-filled syringe 
 
One pre-filled syringe with 0.6 ml solution for injection contains 30,000 international units (IU) 
corresponding to 250 micrograms epoetin beta* (recombinant human erythropoietin). 
One ml solution for injection contains 50,000 IU epoetin beta. 
 
* produced in Chinese Hamster Ovary cells (CHO) by recombinant DNA technology 
 
Excipient(s) with known effect 
 
Phenylalanine (up to 0.3 mg/syringe) 
Sodium (less than 1 mmol/syringe) 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection. 
Colourless, clear to slightly opalescent solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
NeoRecormon is indicated for: 
- Treatment of symptomatic anaemia associated with chronic renal failure in adult and paediatric 

patients. 
- Prevention of anaemia of prematurity in infants with a birth weight of 750 to 1500 g and a 

gestational age of less than 34 weeks. 
- Treatment of symptomatic anaemia in adult patients with non-myeloid malignancies receiving 

chemotherapy. 
- Increasing the yield of autologous blood from patients in a pre-donation programme. 
 Its use in this indication must be balanced against the reported increased risk of thromboembolic 

events. Treatment should only be given to patients with moderate anaemia (Hb 10 - 13 g/dl 
[6.21 - 8.07 mmol/l], no iron deficiency) if blood conserving procedures are not available or 
insufficient when the scheduled major elective surgery requires a large volume of blood (4 or 
more units of blood for females or 5 or more units for males). See section 5.1 

 
4.2 Posology and method of administration 
 
Therapy with NeoRecormon should be initiated by physicians experienced in the above-mentioned 
indications. As anaphylactoid reactions were observed in isolated cases, it is recommended that the 
first dose be administered under medical supervision. 
 
Posology 
 
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients 
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. 



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NeoRecormon should be administered either subcutaneously or intravenously in order to increase 
haemoglobin to not greater than 12 g/dl (7.5 mmol/l). Subcutaneous use is preferable in patients who 
are not receiving haemodialysis to avoid puncture of peripheral veins. In case of intravenous 
administration, the solution should be injected over approx. 2 minutes, e.g. in haemodialysis patients 
via the arteriovenous fistula at the end of dialysis. 
 
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 
(6.2 mmol/l) to 12 g/dl (7.5 mmol/l). A sustained haemoglobin level of greater than 12 g/dl 
(7.5 mmol/l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin 
values exceeding 12 g/dl (7.5 mmol/l) are observed are described below. 
 
A rise in haemoglobin of greater than 2 g/dl (1.25 mmol/l) over a four-week period should be avoided. 
If it occurs, appropriate dose adjustment should be made as provided. If the rate of rise in haemoglobin 
is greater than 2 g/dl (1.25 mmol/l) in one month or if the haemoglobin level is increasing and 
approaching 12 g/dl (7.45 mmol/l), the dose is to be reduced by approximately 25%. If the 
haemoglobin level continues to increase, therapy should be interrupted until the hemoglobin level 
begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the 
previously administered dose. 
 
Patients should be monitored closely to ensure that the lowest approved effective dose of 
NeoRecormon is used to provide adequate control of the symptoms of anaemia whilst maintaining a 
haemoglobin concentration below to 12 g/dl (7.45 mmol/l). 
 
Caution should be exercised with escalation of NeoRecormon doses in patients with chronic renal 
failure. In patients with a poor haemoglobin response to NeoRecormon, alternative explanations for 
the poor response should be considered (see sections 4.4 and 5.1). 
 
In the presence of hypertension or existing cardiovascular, cerebrovascular, or peripheral vascular 
diseases, the weekly increase in Hb and the target Hb should be determined individually taking into 
account the clinical picture. 
 
Treatment with NeoRecormon is divided into two stages. 
 
1. Correction phase 
 
- Subcutaneous administration: 
 The initial dosage is 3 x 20 IU/kg body weight per week. The dosage may be increased every 4 

weeks by 3 x 20 IU/kg and week if the increase of Hb is not adequate (< 0.25 g/dl per week). 
 The weekly dose can also be divided into daily doses. 
- Intravenous administration: 
 The initial dosage is 3 x 40 IU/kg per week. The dosage may be raised after 4 weeks to 80 IU/kg 

- three times per week - and by further increments of 20 IU/kg if needed, three times per week, 
at monthly intervals. 

For both routes of administration, the maximum dose should not exceed 720 IU/kg per week. 
 
 
2. Maintenance phase 
 
To maintain an Hb of between 10 and 12 g/dl, the dosage is initially reduced to half of the previously 
administered amount. Subsequently, the dose is adjusted at intervals of one or two weeks individually 
for the patient (maintenance dose). 
 
In the case of subcutaneous administration, the weekly dose can be given as one injection per week or 
in divided doses three or seven times per week. Patients who are stable on a once weekly dosing 



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regimen may be switched to once every two weeks administration. In this case, dose increases may be 
necessary. 
 
Results of clinical studies in children have shown that, on average, the younger the patients, the higher 
the NeoRecormon doses required. Nevertheless, the recommended dosing schedule should be 
followed as the individual response cannot be predicted. 
 
Treatment with NeoRecormon is normally a long-term therapy. It can, however, be interrupted, if 
necessary, at any time. Data on the once weekly dosing schedule are based on clinical studies with a 
treatment duration of 24 weeks. 
 
Prevention of anaemia of prematurity 
The solution is administered subcutaneously at a dose of 3 x 250 IU/kg b.w. per week. Premature 
infants who have already been transfused by the start of treatment with NeoRecormon are not likely to 
benefit as much as untransfused infants. The recommended treatment duration is 6 weeks. 
 
Treatment of symptomatic chemotherapy-induced anaemia in cancer patients 
NeoRecormon should be administered by the subcutaneous route to patients with anaemia (e.g. 
haemoglobin concentration ≤ 10g/dl (6.2 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. 
 
The weekly dose can be given as one injection per week or in divided doses 3 to 7 times per week. 
 
The recommended initial dose is 30,000 IU per week (corresponding to approximately 450 IU/kg body 
weight per week, based on an average weighted patient). 
 
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 
(6.2 mmol/l) to 12 g/dl (7.5 mmol/l). A sustained haemoglobin level of greater than 12 g/dl 
(7.5 mmol/l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin 
values exceeding 12 g/dl (7.5 mmol/l) are observed are described below. 
 
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 should be considered. If, after 8 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. 
 
The therapy should be continued for up to 4 weeks after the end of chemotherapy. 
 
The maximum dose should not exceed 60,000 IU per week. 
 
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced 
by 25 to 50% in order to maintain haemoglobin at that level. Appropriate dose titration should be 
considered. 
 
If the haemoglobin exceeds 12 g/dl (7.5 mmol/l), the dose should be reduced by approximately 25 to 
50%. Treatment with NeoRecormon should be temporarily discontinued if haemoglobin levels exceed 
13 g/dl (8.1 mmol/l). Therapy should be reinitiated at approximately 25% lower than the previous dose 
after haemoglobin levels fall to 12 g/dl (7.5 mmol/l) or below. 
 
If the rise in haemoglobin is greater than 2 g/dl (1.3 mmol/l) in 4 weeks, the dose should be reduced by 
25 to 50%. 
 



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Patients should be monitored closely to ensure that the lowest approved dose of NeoRecormon is used 
to provide adequate control of the symptoms of anaemia. 
 
Treatment for increasing the amount of autologous blood 
The solution is administered intravenously over approx. 2 minutes or subcutaneously. 
NeoRecormon is administered twice weekly over 4 weeks. On those occasions where the patient’s 
PCV allows blood donation, i.e. PCV ≥ 33%, NeoRecormon is administered at the end of blood 
donation. 
During the entire treatment period, a PCV of 48% should not be exceeded. 
 
The dosage must be determined by the surgical team individually for each patient as a function of the 
required amount of pre-donated blood and the endogenous red cell reserve: 
1. The required amount of pre-donated blood depends on the anticipated blood loss, use of blood 

conserving procedures and the physical condition of the patient. 
 This amount should be that quantity which is expected to be sufficient to avoid homologous 

blood transfusions. 
 The required amount of pre-donated blood is expressed in units whereby one unit in the 

nomogram is equivalent to 180 ml red cells. 
2. The ability to donate blood depends predominantly on the patient’s blood volume and baseline 

PCV. Both variables determine the endogenous red cell reserve, which can be calculated 
according to the following formula. 

 
 Endogenous red cell reserve = blood volume [ml] x (PCV - 33) ÷ 100 
 Women: blood volume [ml] = 41 [ml/kg] x body weight [kg] + 1200 [ml] 
 Men: blood volume [ml] = 44 [ml/kg] x body weight [kg] + 1600 [ml] 
 (body weight ≥ 45 kg) 
 
The indication for treatment with NeoRecormon and, if given, the single dose, should be determined 
from the required amount of pre-donated blood and the endogenous red cell reserve according to the 
following graphs. 
 
 Female patients Male patients 
Required amount of pre-donated blood Required amount of pre-donated blood 
[units] [units] 

 
 
Endogenous red cell reserve [ml] Endogenous red cell reserve [ml] 
 
The single dose thus determined is administered twice weekly over 4 weeks. The maximum dose 
should not exceed 1600 IU/kg body weight per week for intravenous or 1200 IU/kg per week for 
subcutaneous administration. 



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Method of administration 
 
The NeoRecormon pre-filled syringe is ready for use. Only solutions which are clear or slightly 
opalescent, colourless and practically free of visible particles may be injected. 
NeoRecormon in pre-filled syringe is a sterile but unpreserved product. Under no circumstances 
should more than one dose be administered per syringe; the medicinal product is for single use only. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or any of the excipients listed in section 6.1. 
 
Poorly controlled hypertension. 
 
In the indication “increasing the yield of autologous blood”: myocardial infarction or stroke in the 
month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as 
history of venous thromboembolic disease. 
 
4.4 Special warnings and precautions for use 
 
Traceability 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
NeoRecormon should be used with caution in the presence of refractory anaemia with excess blasts in 
transformation, epilepsy, thrombocytosis, and chronic liver failure. Folic acid and vitamin B12 
deficiencies should be ruled out as they reduce the effectiveness of NeoRecormon. 
 
Caution should be exercised with escalation of NeoRecormon 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). 
 
In order to ensure effective erythropoiesis, iron status should be evaluated for all patients prior to and 
during treatment, and supplementary iron therapy may be necessary and conducted in accordance with 
therapeutic guidelines. 
 
Severe aluminium overload due to treatment of renal failure may compromise the effectiveness of 
NeoRecormon. 
 
The indication for treatment with NeoRecormon of nephrosclerotic patients not yet undergoing 
dialysis should be defined individually, as a possible acceleration of progression of renal failure 
cannot be ruled out with certainty. 
 
Pure red cell aplasia (PRCA) 
 
PRCA caused by neutralising anti-erythropoietin antibodies has been reported in association with 
erythropoietin therapy, including NeoRecormon. These antibodies have been shown to cross-react 
with all erythropoietic proteins, and patients suspected or confirmed to have neutralising antibodies to 
erythropoietin should not be switched to NeoRecormon (see section 4.8). 
 
PRCA in patients with Hepatitis C 
 
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 



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interferon and ribavirin, when epoetins are used concomitantly. Epoetins are not approved in the 
management of anaemia associated with hepatitis C. 
 
Blood pressure monitoring 
 
An increase in blood pressure or aggravation of existing hypertension, especially in cases of rapid 
PCV increase can occur. These increases in blood pressure can be treated with medicinal products. If 
blood pressure rises cannot be controlled by drug therapy, a transient interruption of NeoRecormon 
therapy is recommended. Particularly at the beginning of therapy, regular monitoring of the blood 
pressure is recommended, including between dialyses. Hypertensive crisis with encephalopathy-like 
symptoms may occur and require the immediate attention of a physician and intensive medical care. 
Particular attention should be paid to sudden stabbing migraine-like headaches as a possible warning 
sign. 
 
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 4.8). 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, 
NeoRecormon should be withdrawn immediately and an alternative treatement considered. If the 
patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of 
NeoRecormon, treatment with ESA must not be restarted in this patient at any time. 
 
Chronic renal failure 
 
In chronic renal failure patients, there may be a moderate dose-dependent rise in the platelet count 
within the normal range during treatment with NeoRecormon, especially after intravenous 
administration. This regresses during the course of continued therapy. It is recommended that the 
platelet count be monitored regularly during the first 8 weeks of therapy. 
 
Haemoglobin concentration 
 
In patients with chronic renal failure, 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 or cerebrovascular events including stroke 
was observed when erythropoiesis stimulating agents (ESAs) were administered to target a 
haemoglobin of greater than 12 g/dl (7.5 mmol/l).  
 
Controlled clinical trials have not shown significant benefits attributable to the administration of 
epoetins when haemoglobin concentration is increased beyond the level necessary to control 
symptoms of anaemia and to avoid blood transfusion. 
 
In premature infants there may be a slight rise in platelet counts, particularly up to day 12 - 14 of life, 
therefore platelets should be monitored regularly. 
 
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 tumours. 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 NeoRecormon and other erythropoiesis-stimulating agents (ESAs) 
have shown: 
- shortened time to tumour progression in patients with advanced head and neck cancer receiving 

radiation therapy when administered to target a haemoglobin of greater than 14 g/dl 
(8.7 mmol/l), 



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- 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 of 12-14 g/dl (7.5-8.7 mmol/l), 

- increased risk of death when administered to target a haemoglobin of 12 g/dl (7.5 mmol/l) in 
patients with active malignant disease receiving neither chemotherapy nor radiation therapy. 
ESAs 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) 
 
There may be an increase in blood pressure which can be treated with drugs. It is therefore 
recommended to monitor blood pressure, in particular in the initial treatment phase in cancer patients. 
 
Platelet counts and haemoglobin level should also be monitored at regular intervals in cancer patients. 
 
In patients in an autologous blood pre-donation programme there may be an increase in platelet count, 
mostly within the normal range. Therefore, it is recommended that the platelet count be determined at 
least once a week in these patients. If there is an increase in platelets of more than 150 x 109/l or if 
platelets rise above the normal range, treatment with NeoRecormon should be discontinued. 
 
In preterm infants, a potential risk of erythropoietin to cause retinopathy could not be excluded, 
therefore caution should be exercised and the decision to treat a preterm infant should be balanced 
against the potential benefit and risk of this treatment and available alternative options. 
 
In chronic renal failure patients, an increase in heparin dose during haemodialysis is frequently 
required during the course of therapy with NeoRecormon as a result of the increased packed cell 
volume. Occlusion of the dialysis system is possible if heparinisation is not optimum. 
 
Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, 
should be considered in chronic renal failure patients at risk of shunt thrombosis. 
 
Serum potassium and phosphate levels should be monitored regularly during therapy with 
NeoRecormon. Potassium elevation has been reported in a few uraemic patients receiving 
NeoRecormon, though causality has not been established. If an elevated or rising potassium level is 
observed, then consideration should be given to ceasing administration of NeoRecormon until the 
level has been corrected. 
 
For use of NeoRecormon in an autologous pre-donation programme, the official guidelines on 
principles of blood donation must be considered, in particular: 
- only patients with a PCV ≥ 33% (haemoglobin ≥ 11 g/dl [6.83 mmol/l]) should donate; 
- special care should be taken with patients below 50 kg weight; 
- the single volume drawn should not exceed approx. 12% of the patient’s estimated blood 

volume. 
Treatment should be reserved for patients in whom it is considered of particular importance to avoid 
homologous blood transfusion taking into consideration the risk/benefit assessment for homologous 
transfusions. 
 
Misuse  
 
Misuse by healthy persons may lead to an excessive increase in packed cell volume. This may be 
associated with life-threatening complications of the cardiovascular system. 
 



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Excipients 
 
NeoRecormon in pre-filled syringe contains up to 0.3 mg phenylalanine/syringe as an excipient. 
Therefore, this should be taken into consideration in patients affected with severe forms of 
phenylketonuria. 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i.e. essentially 
“sodium-free”. 
 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
The clinical results obtained so far do not indicate any interaction of NeoRecormon with other 
medicinal products. 
Animal experiments revealed that epoetin beta does not increase the myelotoxicity of cytostatic 
medicinal products like etoposide, cisplatin, cyclophosphamide, and fluorouracil. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 

 
For epoetin beta no clinical data on exposed pregnancies are available.  
Caution should be exercised when prescribing to pregnant women. 
 
Breast-feeding 
 
It is unknown whether epoetin beta is excreted in human milk. A decision on whether to 
continue/discontinue breast-feeding or to continue/discontinue therapy with epoetin beta should be 
made taking into account the benefit of breast-feeding to the child and the benefit of epoetin beta 
therapy to the woman. 
 
Fertility 
 
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, 
embryonal/foetal development, parturition or postnatal development (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
NeoRecormon has no influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
Based on results from clinical trials including 1725 patients, approximately 8% of patients treated with 
NeoRecormon are expected to experience adverse reactions.  
 
Anaemic patients with chronic renal failure 
The most frequent adverse reaction during treatment with NeoRecormon is an increase in blood 
pressure or aggravation of existing hypertension, especially in cases of rapid PCV increase (see 
section 4.4). Hypertensive crisis with encephalopathy-like symptoms (e.g. headaches and confused 
state, sensorimotor disorders - such as speech disturbance or impaired gait - up to tonoclonic seizures) 
may also occur in individual patients with otherwise normal or low blood pressure (see section 4.4).  
 
Shunt thromboses may occur, especially in patients who have a tendency to hypotension or whose 
arteriovenous fistulae exhibit complications (e.g. stenoses, aneurisms), see section 4.4. In most cases, a 
fall in serum ferritin values simultaneous with a rise in packed cell volume is observed (see section 



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4.4). In addition, transient increases in serum potassium and phosphate levels have been observed in 
isolated cases (see section 4.4).  
 
In isolated cases, neutralising anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA) 
associated with NeoRecormon therapy has been reported. In case anti-erythropoietin 
antibody-mediated PRCA is diagnosed, therapy with NeoRecormon must be discontinued and patients 
should not be switched to another erythropoietic protein (see section 4.4). 
Adverse reactions are listed in Table 1 below. 
 
Patients with cancer 
Epoetin beta treatment-related headache and hypertension which can be treated with drugs are 
common (see section 4.4).  
 
In some patients, a fall in serum iron parameters is observed (see section 4.4).  
 
Clinical studies have shown a higher frequency of thromboembolic events in cancer patients treated 
with NeoRecormon compared to untreated controls or placebo. In patients treated with NeoRecormon, 
this incidence is 7% compared to 4% in controls; this is not associated with any increase in 
thromboembolic mortality compared with controls. 
Adverse reactions are listed in Table 2 below. 
 
Patients in an autologous blood pre-donation programme 
Patients in an autologous blood pre-donation programme have been reported to show a slightly higher 
frequency of thromboembolic events. However, a causal relationship with treatment with 
NeoRecormon could not be established. 
 
In placebo-controlled trials, temporary iron deficiency was more pronounced in patients treated with 
NeoRecormon than in controls (see section 4.4). 
Adverse reactions are listed in Table 3 below. 
 
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) 
 
Tabulated list of adverse reactions  
 
Adverse reactions are listed according to MedDRA system organ class and frequency category. 
Frequency categories are defined using 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). 
 
Table 1: Adverse reactions attributed to the treatment with NeoRecormon in controlled clinical 
trials in CKD patients 
System organ class Adverse reaction  Frequency  
Vascular disorders Hypertension  

Hypertensive crisis 
Common  
Uncommon  

Nervous system disorders Headache Common  
Blood and lymphatic 
system disorders 

Shunt thrombosis 
Thrombocytosis 

Rare  
Very rare  

 



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Table 2: Adverse reactions attributed to the treatment with NeoRecormon in controlled clinical 
trials in cancer patients 
System organ class Adverse reaction  Frequency  
Vascular disorders Hypertension Common  
Blood and lymphatic 
system disorders 

Thromboembolic event Common  

Nervous system disorders Headache Common  
 
Table 3: Adverse reactions attributed to the treatment with NeoRecormon in controlled clinical 
trials in patients in an autologous blood pre-donation programme 
System organ class Adverse reaction  Frequency 
Nervous system disorders Headache Common  

 
Premature infants 
A fall in serum ferritin values is very common (see section 4.4). 
 
Description of selected adverse reactions 
 
Rarely, epoetin beta treatment-related skin reactions such as rash, pruritus, urticaria or injection site 
reactions may occur. In very rare cases, epoetin beta treatment-related anaphylactoid reactions have 
been reported. However, in controlled clinical studies no increased incidence of hypersensitivity 
reactions was found. 
 
In very rare cases, particularly when starting treatment, epoetin beta treatment-related flu-like 
symptoms such as fever, chills, headaches, pain in the limbs, malaise and/or bone pain have been 
reported. These reactions were mild or moderate in nature and subsided after a couple of hours or 
days. 
 
Data from a controlled clinical trial with epoetin alfa or darbepoetin alfa, reported an incidence of 
stroke as common. 
 
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 NeoRecormon is very wide. Even at very high serum levels no symptoms of 
poisoning have been observed. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: antianemic, ATC code: B03XA01 
 
Mechanism of action  
 
Erythropoietin is a glycoprotein that stimulates the formation of erythrocytes from its committed 
progenitors. It acts as a mitosis stimulating factor and differentiation hormone. 
Epoetin beta, the active substance of NeoRecormon, is identical in its amino acid and carbohydrate 
composition to erythropoietin that has been isolated from the urine of anaemic patients. 
 

https://www.ema.europa.eu/documents/template-form/appendix-v-adverse-drug-reaction-reporting-details_en.doc


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The biological efficacy of epoetin beta has been demonstrated after intravenous and subcutaneous 
administration in various animal models in vivo (normal and uraemic rats, polycythaemic mice, dogs). 
After administration of epoetin beta, the number of erythrocytes, the Hb values and reticulocyte counts 
increase as well as the 59Fe-incorporation rate. 
 
An increased 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in 
vitro (mouse spleen cell culture) after incubation with epoetin beta. 
Investigations in cell cultures of human bone marrow cells showed that epoetin beta stimulates 
erythropoiesis specifically and does not affect leucopoiesis. Cytotoxic actions of epoetin beta on bone 
marrow or on human skin cells were not detected. 
 
After single dose administration of epoetin beta no effects on behaviour or locomotor activity of mice 
and circulatory or respiratory function of dogs were observed. 
 
Clinical efficacy and safety 
 
In a randomised, double-blind, placebo-controlled study of 4,038 chronic renal failure patients not on 
dialysis with type 2 diabetes and haemoglobin levels ≤ 11 g/dl, patients received either treatment with 
darbepoetin alfa to target haemoglobin levels of 13 g/dl or placebo (see section 4.4). The study did not 
meet either primary objective of demonstrating a reduction in risk for all-cause mortality, 
cardiovascular morbidity, or end-stage renal disease (ESRD). Analysis of the individual components 
of the composite endpoints showed the following HR (95% CI): death 1.05 (0.92, 1.21), stroke 1.92 
(1.38, 2.68), congestive heart failure (CHF) 0.89 (0.74, 1.08), myocardial infarction (MI) 0.96 (0.75, 
1.23), hospitalisation for myocardial ischaemia 0.84 (0.55, 1.27), ESRD 1.02 (0.87, 1.18). 
 
Pooled post-hoc analyses of clinical studies with ESAs have been performed in CRF patients (on 
dialysis, not on dialysis, with or without diabetes). A tendency towards increased risk estimates for 
all-cause mortality, cardiovascular and cerebrovascular events associated with higher cumulative ESA 
doses independent of the diabetes or dialysis status was observed (see sections 4.2 and 4.4). 
 
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 2833 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. 
 
An individual patient data based meta-analysis, which included data from all 12 controlled clinical 
studies in anaemic cancer patients conducted with NeoRecormon (n=2301), showed an overall hazard 
ratio point estimate for survival of 1.13 in favour of controls (95% CI 0.87, 1.46). In patients with 
baseline haemoglobin ≤ 10 g/dl (n=899), the hazard ratio point estimate for survival was 0.98 (95% CI 
0.68 to 1.40). An increased relative risk for thromboembolic events was observed in the overall 
population (RR 1.62, 95% CI: 1.13, 2.31). 
 
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 



14 

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). 
 
In very rare cases, neutralising anti-erythropoietin antibodies with or without pure red cell aplasia 
(PRCA) occurred during rHuEPO therapy. 
 
5.2 Pharmacokinetic properties 
 
Pharmacokinetic investigations in healthy volunteers and uraemic patients show that the half-life of 
intravenously administered epoetin beta is between 4 and 12 hours and that the distribution volume 
corresponds to one to two times the plasma volume. Analogous results have been found in animal 
experiments in uraemic and normal rats. 
 
After subcutaneous administration of epoetin beta to uraemic patients, the protracted absorption results 
in a serum concentration plateau, whereby the maximum concentration is reached after an average of 
12 - 28 hours. The terminal half-life is higher than after intravenous administration, with an average of 
13 - 28 hours. 
 
Bioavailability of epoetin beta after subcutaneous administration is between 23 and 42% as compared 
with intravenous administration. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction.  
A carcinogenicity study with homologous erythropoietin in mice did not reveal any signs of 
proliferative or tumourigenic potential. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Urea, 
Sodium chloride, 
Polysorbate 20, 
Sodium dihydrogen phosphate dihydrate, 
Disodium phosphate dodecahydrate,  
Calcium chloride dihydrate,  
Glycine,  
L-Leucine,  
L-Isoleucine,  
L-Threonine,  
L-Glutamic acid,  
L-Phenylalanine, 
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 
 
2 years. 



15 

 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C – 8°C). 
 
Keep the pre-filled syringe in the outer carton, in order to protect from light. 
 
For the purpose of ambulatory use, the patient may remove the medicinal product from the refrigerator 
and store it at room temperature (not above 25°C) for one single period of up to 3 days. 
 
6.5 Nature and contents of container 
 
Pre-filled syringe (Type I glass) with a tip cap and a plunger stopper (teflonised rubber).  
 
NeoRecormon 500 IU, NeoRecormon 2000 IU, NeoRecormon 3000 IU, NeoRecormon 4000 IU, 
NeoRecormon 5000 IU and NeoRecormon 6000 IU solution for injection in pre-filled syringe 
 
Each pre-filled syringe contains 0.3 ml solution. 
 
NeoRecormon 10,000 IU, NeoRecormon 20,000 IU and NeoRecormon 30,000 IU solution for 
injection in pre-filled syringe 
 
Each pre-filled syringe contains 0.6 ml solution. 
 
NeoRecormon is provided in the following pack-sizes: 
 
NeoRecormon 500 IU solution for injection in pre-filled syringe 
 
1 pre-filled syringe with 1 needle (30G1/2) or 6 pre-filled syringes with 6 needles (30G1/2). 
 
NeoRecormon 2000 IU, NeoRecormon 3000 IU, NeoRecormon 4000 IU, NeoRecormon 5000 IU, 
NeoRecormon 6000 IU, NeoRecormon 10,000 IU and NeoRecormon 20,000 IU solution for injection 
in pre-filled syringe 
 
1 pre-filled syringe with 1 needle (27G1/2) or 6 pre-filled syringes with 6 needles (27G1/2). 
 
NeoRecormon 30,000 IU solution for injection in pre-filled syringe 
 
1 pre-filled syringe with 1 needle (27G1/2) or 4 pre-filled syringes with 4 needles (27G1/2). 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
First wash your hands! 
1. Remove one syringe from the pack and check that the solution is clear, colourless and 

practically free from visible particles. Remove the cap from the syringe. 
2. Remove one needle from the pack, fix it on the syringe and remove the protective cap from the 

needle. 
3. Expel air from the syringe and needle by holding the syringe vertically and gently pressing the 

plunger upwards. Keep pressing the plunger until the amount of NeoRecormon in the syringe is 
as prescribed. 

4. Clean the skin at the site of injection using an alcohol wipe. Form a skin fold by pinching the 
skin between thumb and forefinger. Hold the syringe barrel near to the needle and insert the 
needle into the skin fold with a quick, firm action. Inject the NeoRecormon solution. Withdraw 
the needle quickly and apply pressure over the injection site with a dry, sterile pad. 

 



16 

This medicinal product is for single use only. Any unused product or waste material should be 
disposed of in accordance with local requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
EU/1/97/031/ 025-026 
EU/1/97/031/029-030 
EU/1/97/031/031-032 
EU/1/97/031/033-034 
EU/1/97/031/035-036 
EU/1/97/031/037-038 
EU/1/97/031/041-042  
EU/1/97/031/043-044  
EU/1/97/031/045-046 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 16 July 1997 
Date of latest renewal: 16 July 2007 
 
 
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. 

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


17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 
SUBSTANCE(S) AND MANUFACTURER(S) 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  



18 

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

 
Name and address of the manufacturer(s) of the biological active substance(s) 
 
Roche Diagnostics GmbH 
Nonnenwald 2 
D-82377 Penzberg 
Germany 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Roche Pharma AG 
Emil-Barell-Strasse 1 
D-79639 Grenzach-Wyhlen 
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 REQUIREMENT OF THE MARKETING 

AUTHORISATION  
 
• Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs 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 marketing authorisation holder (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. 

 
.



19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



21 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 500 IU PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NeoRecormon 500 IU solution for injection in pre-filled syringe 
epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 pre-filled syringe contains 500 IU epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
1 syringe contains: Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, 
disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, 
L-Threonine, L-glutamic acid, L-Phenylalanine, and water for injections. 
Medicinal product contains phenylalanine and sodium, see leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
1 pre-filled syringe (0.3 ml) and 1 needle (30G1/2) 
6 pre-filled syringes (0.3 ml) and 6 needles (30G1/2) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous and 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. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Keep the pre-filled syringe in the outer carton, in order to protect from light 



22 

 
 
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 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/97/031/025 1 pre-filled syringe 
EU/1/97/031/026 6 pre-filled syringes 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
neorecormon 500 IU 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  



23 

 
 
 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABELS 500 IU pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
NeoRecormon 500 IU injection 
epoetin beta 
IV/SC use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.3 ml 
 
 
6. OTHER 
 



24 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 2000 IU pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NeoRecormon 2000 IU solution for injection in pre-filled syringe 
epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 pre-filled syringe contains 2000 IU epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
1 syringe contains: Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, 
disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, 
L-Threonine, L-glutamic acid, L-Phenylalanine, and water for injections. 
Medicinal product contains phenylalanine and sodium, see leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
1 pre-filled syringe (0.3 ml) and 1 needle (27G1/2) 
6 pre-filled syringes (0.3 ml) and 6 needles (27G1/2) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use.  
Subcutaneous and 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. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Keep the pre-filled syringe in the outer carton, in order to protect from light 



25 

 
 
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 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/97/031/029 1 pre-filled syringe 
EU/1/97/031/030 6 pre-filled syringes 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
neorecormon 2000 IU 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN 



26 

 
 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABELS 2000 IU pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
NeoRecormon 2000 IU injection 
epoetin beta 
IV/SC use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.3 ml 
 
 
6. OTHER 
 



27 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 3000 IU pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NeoRecormon 3000 IU solution for injection in pre-filled syringe 
epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 pre-filled syringe contains 3000 IU epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
1 syringe contains: Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, 
disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, 
L-Threonine, L-glutamic acid, L-Phenylalanine, and water for injections. 
Medicinal product contains phenylalanine and sodium, see leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
1 pre-filled syringe (0.3 ml) and 1 needle (27G1/2) 
6 pre-filled syringes (0.3 ml) and 6 needles (27G1/2) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous and 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. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Keep the pre-filled syringe in the outer carton, in order to protect from light 



28 

 
 
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 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/97/031/031 1 pre-filled syringe 
EU/1/97/031/032 6 pre-filled syringes 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
neorecormon 3000 IU 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN  



29 

 
 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABELS 3000 IU pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
NeoRecormon 3000 IU injection 
epoetin beta 
IV/SC use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.3 ml 
 
 
6. OTHER 
 



30 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 4000 IU pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NeoRecormon 4000 IU solution for injection in pre-filled syringe 
epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 pre-filled syringe contains 4000 IU epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
1 syringe contains: Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, 
disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, 
L-Threonine, L-glutamic acid, L-Phenylalanine, and water for injections. 
Medicinal product contains phenylalanine and sodium, see leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
1 pre-filled syringe (0.3 ml) and 1 needle (27G1/2) 
6 pre-filled syringes (0.3 ml) and 6 needles (27G1/2) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous and 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. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Keep the pre-filled syringe in the outer carton, in order to protect from light 



31 

 
 
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 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/97/031/041 1 pre-filled syringe 
EU/1/97/031/042 6 pre-filled syringes 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
neorecormon 4000 IU 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  



32 

 
 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABELS 4000 IU pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
NeoRecormon 4000 IU injection 
epoetin beta 
IV/SC use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.3 ml 
 
 
6. OTHER 
 



33 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 5000 IU pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NeoRecormon 5000 IU solution for injection in pre-filled syringe 
epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 pre-filled syringe contains 5000 IU epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
1 syringe contains: Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, 
disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, 
L-Threonine, L-glutamic acid, L-Phenylalanine, and water for injections. 
Medicinal product contains phenylalanine and sodium, see leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
1 pre-filled syringe (0.3 ml) and 1 needle (27G1/2) 
6 pre-filled syringes (0.3 ml) and 6 needles (27G1/2) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous and 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. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Keep the pre-filled syringe in the outer carton, in order to protect from light 



34 

 
 
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 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/97/031/033 1 pre-filled syringe 
EU/1/97/031/034 6 pre-filled syringes 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
neorecormon 5000 IU 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  



35 

 
 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABELS 5000 IU pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
NeoRecormon 5000 IU injection 
epoetin beta 
IV/SC use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.3 ml 
 
 
6. OTHER 
 



36 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 6000 IU pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NeoRecormon 6000 IU solution for injection in pre-filled syringe 
epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 pre-filled syringe contains 6000 IU epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
1 syringe contains: Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, 
disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, 
L-Threonine, L-glutamic acid, L-Phenylalanine, and water for injections. 
Medicinal product contains phenylalanine and sodium, see leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
1 pre-filled syringe (0.3 ml) and 1 needle (27G1/2) 
6 pre-filled syringes (0.3 ml) and 6 needles (27G1/2) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous and 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. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Keep the pre-filled syringe in the outer carton, in order to protect from light 



37 

 
 
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 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/97/031/043 1 pre-filled syringe 
EU/1/97/031/044 6 pre-filled syringes 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
neorecormon 6000 IU 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  



38 

 
 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABELS 6000 IU pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
NeoRecormon 6000 IU injection 
epoetin beta 
IV/SC use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.3 ml 
 
 
6. OTHER 
 



39 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 10,000 IU pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NeoRecormon 10,000 IU solution for injection in pre-filled syringe 
epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 pre-filled syringe contains 10,000 IU epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
1 syringe contains: Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, 
disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, 
L-Threonine, L-glutamic acid, L-Phenylalanine, and water for injections. 
Medicinal product contains phenylalanine and sodium, see leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
1 pre-filled syringe (0.6 ml) and 1 needle (27G1/2) 
6 pre-filled syringes (0.6 ml) and 6 needles (27G1/2) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous and 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. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Keep the pre-filled syringe in the outer carton, in order to protect from light 



40 

 
 
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 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/97/031/035 1 pre-filled syringe 
EU/1/97/031/036 6 pre-filled syringes 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
neorecormon 10.000 IU 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  



41 

 
 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABELS 10,000 IU pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
NeoRecormon 10,000 IU injection 
epoetin beta 
IV/SC use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.6 ml 
 
 
6. OTHER 
 



42 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 20,000 IU pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NeoRecormon 20,000 IU solution for injection in pre-filled syringe 
epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 pre-filled syringe contains 20,000 IU epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
1 syringe contains: Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, 
disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, 
L-Threonine, L-glutamic acid, L-Phenylalanine, and water for injections. 
Medicinal product contains phenylalanine and sodium, see leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
1 pre-filled syringe (0.6 ml) and 1 needle (27G1/2) 
6 pre-filled syringes (0.6 ml) and 6 needles (27G1/2) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous and 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. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Keep the pre-filled syringe in the outer carton, in order to protect from light 



43 

 
 
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 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/97/031/037 1 pre-filled syringe 
EU/1/97/031/038 6 pre-filled syringes 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
neorecormon 20.000 IU 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  



44 

 
 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABELS 20,000 IU pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
NeoRecormon 20,000 IU injection 
epoetin beta 
IV/SC use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.6 ml 
 
 
6. OTHER 
 



45 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 30,000 IU pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
NeoRecormon 30,000 IU solution for injection in pre-filled syringe 
epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 pre-filled syringe contains 30,000 IU epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
1 syringe contains: Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, 
disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, 
L-Threonine, L-glutamic acid, L-Phenylalanine, and water for injections. 
Medicinal product contains phenylalanine and sodium, see leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
1 pre-filled syringe (0.6 ml) and 1 needle (27G1/2) 
4 pre-filled syringes (0.6 ml) and 4 needles (27G1/2) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous and 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. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Keep the pre-filled syringe in the outer carton, in order to protect from light 



46 

 
 
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 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/97/031/045 1 pre-filled syringe 
EU/1/97/031/046 4 pre-filled syringes 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
neorecormon 30.000 IU 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  



47 

 
 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABELS 30,000 IU pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
NeoRecormon 30,000 IU injection 
epoetin beta 
IV/SC use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.6 ml 
 
 
6. OTHER 
 



48 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



49 

 
Package leaflet: Information for the user 

 
NeoRecormon 500 IU 

NeoRecormon 2000 IU 
NeoRecormon 3000 IU 
NeoRecormon 4000 IU 
NeoRecormon 5000 IU 
NeoRecormon 6000 IU 

NeoRecormon 10,000 IU 
NeoRecormon 20,000 IU 
NeoRecormon 30,000 IU 

solution for injection in pre-filled syringe 
epoetin beta 

 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor or pharmacist. 
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs or illness are the same as yours. 
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What NeoRecormon is and what it is used for 
2. What you need to know before you use NeoRecormon 
3. How to use NeoRecormon 
4. Possible side effects 
5. How to store NeoRecormon 
6. Content of the pack and other information 
 
 
1. What NeoRecormon is and what it is used for 
 
NeoRecormon is a clear, colourless solution for injection under the skin (subcutaneously) or into a 
vein (intravenously). It contains a hormone called epoetin beta, which stimulates the production of red 
blood cells. Epoetin beta is produced by a specialised genetic technology and works in exactly the 
same way as the natural hormone erythropoietin. 
You must talk to your doctor if you do not feel better or if you feel worse. 
 
NeoRecormon is indicated for: 
 
• Treating symptomatic anaemia caused by chronic kidney disease (renal anaemia) in patients 

on dialysis, or not yet on dialysis. 
• Preventing anaemia in premature infants (weighing 750 to 1500 g and born at less than 

34 weeks). 
• Treating anaemia with related symptoms in adult cancer patients receiving chemotherapy 
• Treating people donating their own blood before surgery. The injections of epoetin beta will 

increase the amount of blood that can be taken from your body before surgery and given back 
during or after the operation (this is an autologous transfusion). 

 
 



50 

2. What you need to know before you use NeoRecormon 
 
Do not use NeoRecormon 
• if you are allergic to epoetin beta or any of the other ingredients of this medicine (listed in 

section 6) 
• if you have blood pressure problems that cannot be controlled  
• if you are donating your own blood before surgery, and: 

• you had a heart attack or stroke in the month before your treatment 
• you have unstable angina pectoris – new or increasing chest pain 
• you are at risk of blood clots in the veins (deep venous thrombosis) – for example, if you 

have had clots before. 
If any of these apply to you, or might apply, tell your doctor at once. 
 
Warnings and precautions 
Talk to your doctor before using  NeoRecormon 
• if your baby needs treatment with NeoRecormon, your baby will be carefully monitored 

for any potential effects on the eye 
• if your anaemia does not improve with epoetin treatment 
• if you are low in certain B vitamins (folic acid or vitamin B12) 
• if you have very high levels of aluminium in your blood 
• if your blood platelet count is high 
• if you have chronic liver disease 
• if you have epilepsy 
• if you have developed anti-erythropoietin antibodies and pure red cell aplasia (reduced or 

stopped production of red blood cells) during prior exposure to any erythropoietic substance. In 
this case you should not be switched to NeoRecormon. 

 
Take special care with other products that stimulate red blood cell production:  
NeoRecormon is one of a group of products that stimulate the production of red blood cells like the 
human protein erythropoietin does. Your doctor will always record the exact product you are using. 
 
Serious skin reaction 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-likes 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 taking NeoRecormon and 
contact your doctor or seek medical attention immediately. 
 
Special Warning: 
During treatment with NeoRecormon 
 
If you are a patient with chronic kidney disease, and particularly if you do not respond properly to 
NeoRecormon, your doctor will check your dose of NeoRecormon because repeatedly increasing your 
dose of NeoRecormon 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. 
 
If you are a cancer patient, you should be aware that NeoRecormon 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. 
 



51 

If you are a nephrosclerotic patient and you are not on dialysis, your doctor will decide whether 
treatment is right for you. This is because one cannot rule out a possible acceleration of progression of 
kidney disease with absolute certainty. 
 
Your doctor may do regular blood tests to check:  
• your potassium levels. If you have high or rising potassium levels your doctor may reconsider 

your treatment  
• your blood platelet count. The number of platelets can rise slightly to moderately during epoetin 

treatment, and this can cause changes in blood clotting. 
 
If you are a kidney patient under haemodialysis, your doctor may adjust your dose of heparin. This 
should avoid a blockage in the tubing of the dialysis system. 
 
If you are a kidney patient under haemodialysis and at risk of shunt thrombosis, blood clots 
(thromboses) may form in your shunt (vessel used for connection to the dialysis system). Your doctor 
might prescribe acetylsalicylic acid or modify the shunt.  
 
If you are donating your own blood before surgery, your doctor will need to: 
• check that you are capable of giving blood, especially if you weigh less than 50 kg 
• check that you have a sufficient level of red blood cells (haemoglobin of at least 11 g/dL) 
• make sure that only 12% of your blood will be donated at once. 
 
Do not misuse NeoRecormon: 
Misuse of NeoRecormon by healthy people may lead to an increase in blood cells and consequently 
thicken the blood. This can in turn lead to life-threatening complications of the heart or blood vessels. 
 
Other medicines and NeoRecormon 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines, including medicines obtained without a prescription.  
 
Pregnancy, breast-feeding and fertility  
There is not much experience with NeoRecormon in pregnant women or women who are 
breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. 
NeoRecormon has not shown evidence of impaired fertility in animals. The potential risk for humans 
is unknown. 
 
Driving and using machines 
No effects on ability to drive or use machines have been observed. 
 
NeoRecormon contains phenylalanine and sodium 
This medicine contains phenylalanine. May be harmful for people with phenylketonuria.    
If you have phenylketonuria, talk to your doctor about your treatment with NeoRecormon. 
 
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’. 
 
 
3. How to use NeoRecormon 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if 
you are not sure. 
  
Your doctor will use the lowest effective dose to control the symptoms of your anaemia. 
  
If you do not respond adequately to NeoRecormon, your doctor will check your dose and will inform 
you if you need to change doses. 
  
Treatment must be started under the supervision of your doctor. 



52 

Further injections are given by your doctor or, after you have been trained, you can inject 
NeoRecormon yourself (see instructions at the end of this leaflet.) 
  
NeoRecormon can be injected under the skin in the abdomen, arm or thigh, or into a vein. Your doctor 
will decide which is best for you. 
  
Your doctor will carry out regular blood tests to monitor how your anaemia is responding to treatment 
by measuring your haemoglobin level. 
 
NeoRecormon dosing 
The dose of NeoRecormon depends on your disease condition, the way the injection is given (under 
the skin or into a vein) and your body weight. Your doctor will work out the right dose for you. Your 
doctor will use the lowest effective dose to control the symptoms of your anaemia. 
 
If you do not respond adequately to NeoRecormon, your doctor will check your dose and will inform 
you if you need to change doses of NeoRecormon. 
 
• Symptomatic anaemia caused by chronic kidney disease 
 
Your injections are given under the skin or into a vein. If the solution is given into your vein it 
should be injected over about 2 minutes, e.g. people on haemodialysis will receive the injection via the 
arteriovenous fistula at the end of dialysis. 
People who are not on haemodialysis will usually have injections under the skin.  
 
Treatment with NeoRecormon is divided into two stages: 
 
a) Correcting the anaemia 
The initial dose for injections under the skin is 20 IU per injection for every 1 kg of your body 
weight, given three times per week. 
After 4 weeks, the doctor will do tests and, if the treatment response is not sufficient, your dose may 
be raised to 40 IU/kg per injection, given three times per week. The doctor may continue to increase 
your dose at monthly intervals if necessary. 
The weekly dose can also be divided into daily doses. 
The initial dose for injections into veins is 40 IU per injection for every 1 kg of your body weight, 
given three times per week. 
After 4 weeks, the doctor will do tests and, if the treatment response is not sufficient, your dose may 
be raised to 80 IU/kg per injection, given three times per week. The doctor may continue to increase 
your dose at monthly intervals if necessary. 
For both types of injection, the maximum dose should not exceed 720 IU for every 1 kg of your body 
weight per week. 
 
b) Maintaining sufficient red blood cell levels 
The maintenance dose: Once your red blood cells reach an acceptable level, the dose is reduced to 
half the dose used to correct the anaemia. The weekly dose can be given once per week or divided into 
three or seven doses per week. If your red blood cell level is stable on a once weekly dosing regimen, 
your dose may be switched to once every two weeks administration. In this case dose increases may be 
necessary. 
Every one or two weeks, the doctor may adjust your dose to find your individual maintenance dose. 
Children will start by following the same guidelines. In trials, children usually needed higher doses of 
NeoRecormon (the younger the child, the higher the dose). 
Treatment with NeoRecormon is normally a long-term therapy. However, it can be interrupted at any 
time, if necessary. 
 



53 

• Anaemia in premature infants 
 
Injections are given under the skin. 
 
The initial dose is 250 IU per injection for every 1 kg the infant weighs, three times a week. 
 
Premature infants who have been transfused before the start of treatment with NeoRecormon are not 
likely to benefit as much as untransfused infants. 
 
The recommended treatment duration is 6 weeks. 
 
• Adults with symptomatic anaemia receiving chemotherapy for cancer  
 
Injections are given under the skin. 
 
Your doctor may initiate treatment with NeoRecormon if your haemoglobin level is 10 g/dL or less. 
After initiation of therapy, your doctor will maintain your haemoglobin level between 10 and 12 g/dL. 
 
The initial weekly dose is 30,000 IU. This may be given as one injection per week, or in divided 
doses as 3 to 7 injections per week. Your doctor will take regular blood samples. He or she may 
raise or lower your dose or interrupt your treatment according to the test results. The haemoglobin 
values should not exceed a value of 12 g/dL. 
 
The therapy should be continued for up to 4 weeks after the end of chemotherapy. 
 
The maximum dose should not exceed 60,000 IU per week. 
 
• People donating their own blood before surgery 
 
Injections are given into a vein over 2 minutes, or under the skin. 
 
The dose of NeoRecormon depends on your condition, red blood cell levels and how much blood will 
be donated before surgery. 
 
The dose worked out by your doctor will be given twice per week for 4 weeks. When you donate 
blood, NeoRecormon will be given to you at the end of a donation session. 
 
The maximum dose should not exceed 
• for injections into veins: 1600 IU for every 1 kg of your body weight per week 
• for injections under the skin: 1200 IU for every 1 kg of your body weight per week. 
 
If you inject too much NeoRecormon 
Do not increase the dose your doctor has given you. If you think you have injected more 
NeoRecormon 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 NeoRecormon 
If you have missed an injection, or injected too little, talk to your doctor.  
 
Do not take a double dose to make up for any forgotten doses. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 



54 

4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
Side effects which can affect any patient 

• Most people (very common may affect more than 1 in 10 people) get lower levels of iron 
in their blood. Almost all patients have to be treated with iron supplements during their 
NeoRecormon therapy. 

• Rarely (may affect up to 1 in 1,000 people), allergies or skin reactions, such as rash or 
hives, itching or reactions around the injection site have occurred.  

• Very rarely (may affect up to 1 in 10,000 people) a severe form of allergic reaction has 
occurred, especially just after an injection. It needs to be treated at once. If you get unusual 
wheezing or difficulty breathing; swollen tongue, face or throat, or swelling around the 
injection site; if you feel light-headed or faint or if you collapse, call your doctor at once. 

• Very rarely (may affect up to 1 in 10,000 people) people experienced flu-like symptoms, 
especially when they just started treatment. These include fever, chills, headaches, pain in 
the limbs, bone pain and/or feeling generally unwell. These reactions were usually mild to 
moderate and went away within a few hours or days. 

• 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 NeoRecormon if you develop these symptoms and contact your doctor or seek 
medical attention immediately. See also section 2.  

 
Additional side effects in people with chronic kidney disease (renal anaemia) 

• Increase in blood pressure, worsening of existing high blood pressure and headaches are 
the most common side effects (very common may affect more than 1 in 10 people). Your 
doctor will regularly check your blood pressure, particularly at the beginning of therapy. Your 
doctor may treat the high blood pressure with drugs or temporarily interrupt your 
NeoRecormon therapy. 

• Call a doctor at once if you get headaches, especially sudden, stabbing, migraine-like 
headaches, confusion, speech disturbance, unsteady walking, fits or convulsions. These 
may be signs of severely elevated blood pressure (hypertensive crisis), even if your blood 
pressure is usually normal or low. It needs to be treated at once. 

• If you have low blood pressure or shunt complications, you may be at risk of shunt 
thrombosis (a blood clot in the vessel used for connection to the dialysis system).  

• Very rarely (may affect up to 1 in 10,000 people), patients have had rising levels of 
potassium or phosphates in the blood. This can be treated by your doctor.  

• Pure red cell aplasia (PRCA) caused by neutralising antibodies has been observed 
during erythropoietin therapy, including in isolated cases during therapy with 
NeoRecormon. PRCA means that the body stopped or reduced the production of red blood 
cells. This causes severe anaemia, symptoms of which would include unusual tiredness and a 
lack of energy. If your body produces neutralising antibodies, your doctor will discontinue 
therapy with NeoRecormon, and determine the best course of action to treat your anaemia. 

 
Additional side effects in adults receiving chemotherapy for cancer 

• Increase in blood pressure and headaches may occasionally occur. Your doctor may treat 
the high blood pressure with drugs. 

• An increase in the occurrence of blood clots has been observed. 
 
Additional side effects in people donating their own blood before surgery 

• A slight increase in the occurrence of blood clots has been observed. 
 



55 

Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. 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 NeoRecormon 
 
• Keep this medicine out of the sight and reach of children. 
• Do not use NeoRecormon after the expiry date which is stated on the carton and label. 
• Store in a refrigerator (2°C – 8°C). 
• The syringe can be removed from the refrigerator and left at room temperature for a single 

period of maximum 3 days (but not above 25°C). 
• Keep the pre-filled syringe in the outer carton, in order to protect from light. 
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist 

how to dispose of medicines no longer required. These measures will help protect the 
environment. 

 
 
6. Contents of the pack and other information 
 
What NeoRecormon contains 
 
• The active substance is epoetin beta. One pre-filled syringe contains either 500, 2000, 3000, 

4000, 5000, 6000, 10,000, 20,000 or 30,000 IU (international units) epoetin beta in 0.3 ml or 
0.6 ml solution. 

• The other ingredients are: 
urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, disodium 
phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, 
L-Threonine, L-Glutamic acid, and L-Phenylalanine and water for injections. 

 
What NeoRecormon looks like and contents of the pack 
 
NeoRecormon is a solution in a pre-filled syringe for injection 
The solution is colourless, clear to slightly opalescent. 
 
NeoRecormon 500 IU, 2000 IU, 3000 IU, 4000 IU, 5000 IU and 6000 IU: Each pre-filled syringe 
contains 0.3 ml solution. 
NeoRecormon 10,000 IU, 20,000 IU and 30,000 IU: Each pre-filled syringe contains 0.6 ml solution. 
 
NeoRecormon is provided in the following pack-sizes: 
 
NeoRecormon 500 IU 
1 pre-filled syringe with 1 needle (30G1/2) or 
6 pre-filled syringes with 6 needles (30G1/2). 
 
NeoRecormon 2000 IU, 3000 IU, 4000 IU, 5000 IU, 6000 IU, 10,000 IU and 20,000 IU 
1 pre-filled syringe with 1 needle (27G1/2) or 
6 pre-filled syringes with 6 needles (27G1/2). 
 
NeoRecormon 30,000 IU 
1 pre-filled syringe with 1 needle (27G1/2) or 
4 pre-filled syringes with 4 needles (27G1/2). 
 
Not all pack sizes may be marketed. 
 

https://www.ema.europa.eu/documents/template-form/appendix-v-adverse-drug-reaction-reporting-details_en.doc


56 

Marketing Authorisation Holder 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
Manufacturer 
Roche Pharma AG 
Emil-Barell-Strasse 1 
D-79639 Grenzach-Wyhlen 
Germany  
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 
België/Belgique/Belgien 
N.V. Roche S.A. 
Tél/Tel: +32 (0) 2 525 82 11 
 

Lietuva 
UAB “Roche Lietuva” 
Tel: +370 5 2546799 
 

България 
Рош България ЕООД 
Тел: +359 2 818 44 44 
 

Luxembourg/Luxemburg 
(Voir/siehe Belgique/Belgien) 
 

Česká republika 
Roche s. r. o. 
Tel: +420 - 2 20382111 

Magyarország 
Roche (Magyarország) Kft. 
Tel: +36 - 23 446 800 
 

Danmark 
Roche a/s 
Tlf: +45 - 36 39 99 99 
 

Malta 
(See Ireland) 
 

Deutschland 
Roche Pharma AG 
Tel: +49 (0) 7624 140 
 

Nederland 
Roche Nederland B.V. 
Tel: +31 (0) 348 438050 
 

Eesti 
Roche Eesti OÜ 
Tel: + 372 - 6 177 380 
 

Norge 
Roche Norge AS 
Tlf: +47 - 22 78 90 00 
 

Ελλάδα 
Roche (Hellas) A.E.  
Τηλ: +30 210 61 66 100 
 

Österreich 
Roche Austria GmbH 
Tel: +43 (0) 1 27739 
 

España 
Roche Farma S.A. 
Tel: +34 - 91 324 81 00 
 

Polska 
Roche Polska Sp.z o.o. 
Tel: +48 - 22 345 18 88 
 

France 
Roche 
Tél: +33 (0) 1 47 61 40 00 
 

Portugal 
Roche Farmacêutica Química, Lda 
Tel: +351 - 21 425 70 00 
 

Hrvatska 
Roche d.o.o 
Tel: +385 1 4722 333 
 

România 
Roche România S.R.L. 
Tel: +40 21 206 47 01 
 



57 

Ireland 
Roche Products (Ireland) Ltd. 
Tel: +353 (0) 1 469 0700 
 

Slovenija 
Roche farmacevtska družba d.o.o. 
Tel: +386 - 1 360 26 00 
 

Ísland  
Roche a/s 
c/o Icepharma hf 
Sími: +354 540 8000 
 

Slovenská republika  
Roche Slovensko, s.r.o. 
Tel: +421 - 2 52638201 
 

Italia 
Roche S.p.A. 
Tel: +39 - 039 2471 

Suomi/Finland 
Roche Oy  
Puh/Tel: +358 (0) 10 554 500 
 

Kύπρος  
Γ.Α.Σταμάτης & Σια Λτδ. 
Τηλ: +357 - 22 76 62 76 
 

Sverige 
Roche AB 
Tel: +46 (0) 8 726 1200 
 

Latvija 
Roche Latvija SIA 
Tel: +371 - 6 7039831 
 

United Kingdom 
Roche Products Ltd. 
Tel: +44 (0) 1707 366000 
 

 
This leaflet was last revised in <{MM/YYYY}> <{month YYYY}> 
 

Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 

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


58 

NeoRecormon pre-filled syringe 
Instructions for Use 

 
The following instructions explain how to give an injection of NeoRecormon. Be sure that you read, 
understand and follow the Instructions for Use as well as the package leaflet before injecting 
NeoRecormon. Your healthcare provider will show you how to prepare and inject NeoRecormon 
properly before you use it for the first time. Do not inject yourself unless you have received training. 
Consult your healthcare provider if you require further information. 
NeoRecormon can be administered through 2 manners, your doctor will decide which way is right for 
you: 
• Intravenous administration (into the vein or vein port), only to be performed by healthcare 

professionals. 
•  Subcutaneous administration (under the skin). 
 
Before you begin 

•  Do not take the needle cap off until you are ready to inject NeoRecormon. 
•  Do not try to take the syringe apart at any time. 
•  Do not reuse the same syringe. 
•  Do not use if the syringe has been dropped or damaged. 
•  Do not leave the syringe unattended. 
•  Keep the syringe and needle and the puncture-resistant or sharps disposal container out of reach 

of children. 
•  Contact your healthcare professional if you have any questions. 

 
Storage Instructions 

•  Keep your unused syringe(s) in the original carton and store in a refrigerator at 2˚C to 8˚C. 
•  Keep your syringe out of direct sunlight. 
•  Do not freeze. 
•  Do not use if the syringe has been frozen. 
•  Always keep the syringe dry. 

 
Supplies needed to give your injection  
Included in the carton: 

• NeoRecormon pre-filled syringe(s). 
 

          



59 

•  Injection needle(s) (27G or 30G) (depending on the prescribed strengths of the medicine) with 
safety shield (used for priming, setting the dose and injecting the medicine). 

 
Note: Each carton contains either 1 syringe/1 needle, 4 syringes/4 needles or 6 syringes/6 needles. 

•  Instructions for Use and a package leaflet. 
 
Not included in the box: 

•  1 alcohol swab. 
•  1 dry sterile pad. 
•  1 puncture-resistant container or sharps container for safe disposal of rubber cap, needle cap and 

used syringe. 
 
Preparing for injection  
 

1 Find a well-lighted, clean, flat, working surface. 
•  Take the carton with the syringe(s) and needle(s) out of the refrigerator 

 
2 Check the carton has not been damaged and check the expiration date on the carton has not 

passed. 
•  Do not use if the expiration date has passed, if the syringe is dropped or damaged, or if the 

carton appears to be tampered with. In this case, proceed to step 19 and contact your healthcare 
provider. 

 
3 Take one syringe out of the carton and one needle from the needle box. Be careful when taking 

out the syringe. Make sure you always hold the syringe as shown in the picture below. 
•  Do not flip the carton upside down to remove the syringe. 
•  Do not handle the syringe by holding the plunger or needle cap. 

Remark: If you have a multipack, put the carton with the remaining syringe(s) and needle(s) back into 
the refrigerator 

 
 

4 Inspect the syringe and needle closely 
•  Check the syringe and needle for any damage. Do not use the syringe if you have dropped the 

syringe or if any part of the syringe appears to be damaged. 



60 

•  Check the expiration date on the syringe and the needle. Do not use the syringe or the needle if 
the expiration date has passed. 

•  Check the liquid in the syringe. The liquid should be clear and colourless. Do not use the 
syringe if the liquid is cloudy, discoloured, or has particles. 

 
5 Place the syringe on a clean, flat surface. 

•  Set aside the syringe for 30 minutes so it can warm up on its own to room temperature. Leave 
the needle cap on while it warms up. 

•  Do not speed up the warming process in any way, and do not put the syringe in a microwave or 
in warm water. 

Remark: If the syringe does not reach room temperature, this could cause the injection to feel 
uncomfortable and make it hard to push the plunger. 

 
6 Attach the needle to the syringe. 

•  Remove the needle from its blister. 
•  Pull the rubber cap off the end of the syringe (A). 
•  Dispose of the rubber cap in a puncture-resistant or sharps disposal container immediately. 
•  Do not touch the tip of the syringe. 
•  Do not push or pull the plunger. 
•  Hold the syringe by the barrel and push the needle onto the syringe (B). 
•  Gently twist until it is fully attached (C) 

A)  



61 

 

B)  

C)    
 

7 Place the syringe on a clean, flat surface until ready for use. 
 

8 Wash your hands with soap and water. 
 
9 Choose an injection site: 

•  The recommended injection sites are the top of your thigh or the lower part of your abdomen 
below the belly button. Do not inject within the 5 cm (2 inches) area directly around your belly 
button. 

•  Choose a different injection site for each new injection. 
•  Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact. 
•  Do not inject into vein or into a muscle 

 
 



62 

10 Wipe the injection site with an alcohol swab and let it air dry for 10 seconds. 
•  Do not fan or blow on the cleaned area. 
•  Do not touch the injection site again before giving the injection. 

 
 
Administering the subcutaneous injection  
 

11 Move the safety shield away from the needle towards the syringe barrel. 

 
 

12 Hold the syringe and needle tightly at the hub and carefully pull the injection needle cap away 
from the syringe. Use the syringe within 5 minutes of removing the cap; otherwise, the needle 
may clog. 
•  Do not hold the plunger while you remove the needle cap. 
•  Do not touch the needle after removing the needle cap. 
•  Do not re-cap the needle. 

Throw away the needle cap in a sharps disposal container immediately. 

 
 



63 

13 Hold the syringe with the needle pointing up. Remove the larger air bubbles by gently tapping the 
syringe barrel with your fingers until the air bubbles rise to the top of the syringe. Then, slowly 
push the plunger up to push the air bubbles out of the syringe. 

 
 

14 Adjust to your prescribed dose by slowly pushing the plunger. 
 

   
 

15 Pinch the selected injection site and fully insert the needle at a 45° to 90° angle with a quick, firm 
action. 
•  Do not touch the plunger while inserting the needle into the skin 
•  Do not insert the needle through clothing. 

Once the needle is inserted, release the pinch and hold the syringe tightly in place. 

 
 



64 

16 Slowly inject your prescribed dose by gently pushing the plunger all the way down 
•  Remove the needle and syringe from the injection site at the same angle as inserted. 

 
 
After the injection  
 

17 There may be a little bleeding at the injection site. You can press a dry sterile pad over the 
injection site. Do not rub the injection site. 
•  If needed, you may cover the injection site with a small bandage. 
•  In case of skin contact with medicine, wash the area that touched the medicine with water. 

 
18 Move the safety shield forward 90°, away from the syringe barrel (A). 

Holding the syringe with one hand, press the safety shield down against a flat surface with a firm, 
quick motion until you hear a “click” (B). 

•  If you do not hear a click, look to see that the needle is fully covered by the safety shield. 
•  Keep your fingers behind the safety shield and away from the needle at all times. 

A)  

B)            
 



65 

19 Put your used syringe in a sharps disposal container right away after use. 
•  Do not try to remove the used injection needle from the used syringe. 
•  Do not recap the injection needle. 
•  Do not throw away (dispose of) the syringe in your household trash. 

Important: Always keep the sharps disposal container out of the reach of children. 
 



66 

<-------------------------------------------------------------------------------------------------------------------------- 
---> 
Instructions for Use intended for healthcare professional only 
 
The following Instructions for Use explain how to give an intravenous injection of NeoRecormon. Be 
sure that you read, understand and follow the Instructions for Use as well as the package leaflet before 
injecting NeoRecormon.  
 
Administering the intravenous injection 
Preparing for injection: follow steps 1 to 8 
 

9 Select a vein. Change vein with each injection to prevent soreness in one spot. 
 • Do not inject into a red or swollen area. 
 • Do not inject into a muscle. 
Clean the skin above the vein with an alcohol swab and let dry. 
 • Do not fan or blow on the cleaned area. 
 • Do not touch the injection site again before giving the injection. 
10  Prepare the syringe and needle: follow steps 11 to 14 
15  Insert the needle into the vein.  
 • Do not hold or push on the plunger while inserting needle. 
16 Slowly inject the prescribed dose by gently pushing the plunger all the way down. Remove the 
needle and syringe from the injection site at the same angle as inserted. 
 

After the injection: follow steps 17 to 19 
 
Administering the intravenous injection via injection port  
Preparing for injection: follow steps 1 to 8. 
 

9 Clean the skin above the injection port with an alcohol swab and let dry. 
Clean the injection port as instructed by the provider. 
 • Do not fan or blow on the cleaned area. 
 • Do not touch the injection site again before giving the injection. 
10 Prepare the syringe and needle: follow steps 11 to 14. 
15 Insert the needle into the injection port (follow the instruction of the injection port provider) 
 • Do not hold or push on the plunger while inserting needle. 
16  Slowly inject the prescribed dose by gently pushing the plunger all the way down. 
Remove the needle and syringe from the injection port at the same angle as inserted. 

 
After the injection: follow steps 17 to 19. 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENT 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