Mircera

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe 
MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe 
MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe 
MIRCERA 60 micrograms/0.3 ml solution for injection in pre-filled syringe 
MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe 
MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled syringe 
MIRCERA 120 micrograms/0.3 ml solution for injection in pre-filled syringe 
MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe 
MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe 
MIRCERA 250 micrograms/0.3 ml solution for injection in pre-filled syringe 
MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe 
One pre-filled syringe contains 30 micrograms of methoxy polyethylene glycol-epoetin beta* at a 
concentration of 100 micrograms/ml 
MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe 
One pre-filled syringe contains 40 micrograms of methoxy polyethylene glycol-epoetin beta* at a 
concentration of 133 micrograms/ml. 
MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe 
One pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta* at a 
concentration of 167 micrograms/ml. 
MIRCERA 60 micrograms/0.3 ml solution for injection in pre-filled syringe 
One pre-filled syringe contains 60 micrograms of methoxy polyethylene glycol-epoetin beta* at a 
concentration of 200 micrograms/ml. 
MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe 
One pre-filled syringe contains 75 micrograms of methoxy polyethylene glycol-epoetin beta* at a 
concentration of 250 micrograms/ml 
MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled syringe 
One pre-filled syringe contains 100 micrograms of methoxy polyethylene glycol-epoetin beta* at a 
concentration of 333 micrograms/ml. 
MIRCERA 120 micrograms/0.3 ml solution for injection in pre-filled syringe 
One pre-filled syringe contains 120 micrograms of methoxy polyethylene glycol-epoetin beta* at a 
concentration of 400 micrograms/ml. 
MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe 
One pre-filled syringe contains 150 micrograms of methoxy polyethylene glycol-epoetin beta* at a 
concentration of 500 micrograms/ml. 
MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe 
One pre-filled syringe contains 200 micrograms of methoxy polyethylene glycol-epoetin beta* at a 
concentration of 667 micgrograms/ml 
MIRCERA 250 micrograms/0.3 ml solution for injection in pre-filled syringe 
One pre-filled syringe contains 250 micrograms of methoxy polyethylene glycol-epoetin beta* at a 
concentration of 833 micrograms/ml. 
MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe 
One pre-filled syringe contains 360 micrograms of methoxy polyethylene glycol-epoetin beta*at a 
concentration of 600 micrograms/ml. 
 
The strength indicates the quantity of the protein moiety of the methoxy polyethylene glycol-epoetin 
beta molecule without consideration of the glycosylation.  
 
*Protein produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells and 
covalently conjugated to a linear methoxy-polyethylene glycol (PEG).  
 



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The potency of methoxy polyethene glycol-epoetin beta should not be compared to the potency of 
another pegylated or non-pegylated protein of the same therapeutic class. For more information, see 
section 5.1. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection in pre-filled syringe (injection).  
The solution is clear and colourless to slightly yellowish. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients 
(see section 5.1). 
 
4.2 Posology and method of administration. 
 
Treatment with MIRCERA has to be initiated under the supervision of a physician experienced in the 
management of patients with renal impairment. 
 
Posology 
 
Treatment of symptomatic anaemia in adult chronic kidney disease 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. 
MIRCERA should be administered either subcutaneously or intravenously in order to increase 
haemoglobin to not greater than 12 g/dl (7.45 mmol/l). Subcutaneous use is preferable in patients who 
are not receiving haemodialysis to avoid puncture of peripheral veins. 
 
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and 
below the desired haemoglobin level may be observed. Haemoglobin variability should be addressed 
through dose management, with consideration for the haemoglobin target range of 10 g/dl 
(6.21 mmol/l) to 12 g/dl (7.45 mmol/l). A sustained haemoglobin level of greater than 12 g/dl 
(7.45 mmol/l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin 
values exceeding 12 g/dl (7.45 mmol/l) are observed are described below. 
 
A rise in haemoglobin of greater than 2 g/dl (1.24 mmol/l) over a four-week period should be avoided. 
If it occurs, appropriate dose adjustment should be made as provided. 

Patients should be monitored closely to ensure that the lowest approved effective dose of MIRCERA 
is used to provide adequate control of the symptoms of anaemia whilst maintaining a haemoglobin 
concentration below or at 12 g/dl (7.45 mmol/l).  

Caution should be exercised with escalation of MIRCERA doses in patients with chronic renal failure. 
In patients with a poor haemoglobin response to MIRCERA, alternative explanations for the poor 
response should be considered (see section 4.4 and 5.1). 
 
It is recommended that haemoglobin is monitored every two weeks until stabilized and periodically 
thereafter. 
 



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Patients not currently treated with an erythropoiesis stimulating agent (ESA): 
In order to increase haemoglobin levels to greater than 10 g/dl (6.21 mmol/l), the recommended 
starting dose in patients not on dialysis is 1.2 microgram/kg body weight, administered once every 
month as a single subcutaneous injection. 
 
Alternatively, a starting dose of 0.6 microgram/kg bodyweight may be administered once every two 
weeks as a single intravenous or subcutaneous injection in patients on dialysis or not on dialysis. 
 
The dose may be increased by approximately 25% of the previous dose if the rate of rise in 
haemoglobin is less than 1.0 g/dl (0.621 mmol/l) over a month. Further increases of approximately 
25% may be made at monthly intervals until the individual target haemoglobin level is obtained. 
 
If the rate of rise in haemoglobin is greater than 2 g/dl (1.24 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 haemoglobin level begins to decrease, at which point therapy should be restarted at a dose 
approximately 25% below the previously administered dose. After dose interruption a haemoglobin 
decrease of approximately 0.35 g/dl (0.22 mmol/l) per week is expected. Dose adjustments should not 
be made more frequently than once a month. 
 
Patients treated once every two weeks whose haemoglobin concentration is above 10 g/dl 
(6.21 mmol/l) may receive MIRCERA administered once-monthly using the dose equal to twice the 
previous once-every-two-week dose. 
 
Patients currently treated with an ESA: 
Patients currently treated with an ESA can be switched to MIRCERA administered once a month as a 
single intravenous or subcutaneous injection. The starting dose of MIRCERA is based on the 
calculated previous weekly dose of darbepoetin alfa or epoetin at the time of substitution as described 
in Table 1. The first injection should start at the next scheduled dose of the previously administered 
darbepoetin alfa or epoetin. 
 
Table 1: MIRCERA starting doses 

Previous weekly 
darbepoetin alfa 
intravenous or 

subcutaneous dose 
(microgram/week) 

Previous weekly 
epoetin 

intravenous or 
subcutaneous 

dose (IU/week) 

Monthly MIRCERA 
intravenous or 

subcutaneous dose 
(microgram/once 

monthly)  
<40 <8000 120 

40-80 8000-16000 200 
>80 >16000 360 

 
If a dose adjustment is required to maintain the target haemoglobin concentration above 10 g/dl 
(6.21 mmol/l), the monthly dose may be increased by approximately 25%. 
 
If the rate of rise in haemoglobin is greater than 2 g/dl (1.24 mmol/l) over a 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 haemoglobin level begins to decrease, at which point therapy should be restarted at a dose 
approximately 25% below the previously administered dose. After dose interruption a haemoglobin 
decrease of approximately 0.35 g/dl (0.22 mmol/l) per week is expected. Dose adjustments should not 
be made more frequently than once a month. 
 
Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin 
monitoring and strict adherence to dose adjustment guidance are recommended in these patients. 



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Treatment interruption  
Treatment with MIRCERA is normally long-term. However, it can be interrupted at any time, if 
necessary. 
 
Missed dose 
If one dose of MIRCERA is missed, the missed dose is to be administered as soon as possible and 
administration of MIRCERA is to be restarted at the prescribed dosing frequency. 
 
Patients with hepatic impairment 
No adjustments of the starting dose nor of the dose modification rules are required in patients with 
hepatic impairment (see section 5.2). 
 
Elderly population 
In clinical studies 24% of patients treated with MIRCERA were aged 65 to 74 years, while 20% were 
aged 75 years and over. No dose adjustment is required in patients aged 65 years or older. 
 
Paediatric population 
MIRCERA is not recommended for use in children and adolescents below 18 years due to a lack of 
safety and efficacy data. 
 
Method of administration 
MIRCERA should be administered either subcutaneously or intravenously. It can be injected 
subcutaneously in the abdomen, arm or thigh. All three injection sites are equally suitable. For 
instructions on the administration of the medicinal product, see section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Uncontrolled hypertension. 
 
4.4 Special warnings and precautions for use 
 
The safety and efficacy of MIRCERA therapy in other indications, including anaemia in patients with 
cancer, has not been established. 

Caution should be exercised with escalation of MIRCERA 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 section 4.2 and 5.1). 
 
Supplementary iron therapy is recommended for all patients with serum ferritin values below 
100 microgram/l or with transferrin saturation below 20%. To ensure effective erythropoiesis, iron 
status has to be evaluated for all patients prior to and during treatment.  
 
Failure to respond to MIRCERA therapy should prompt for a search for causative factors. Deficiencies 
of iron, folic acid or vitamin B12 reduce the effectiveness of ESAs and should therefore be corrected. 
Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe 
aluminium toxicity, underlying haematologic diseases, or bone marrow fibrosis may also compromise 
the erythropoietic response. A reticulocyte count should be considered as part of the evaluation. If all 
the conditions mentioned are excluded and the patient has a sudden drop of haemoglobin associated 
with reticulocytopenia and anti-erythropoietin antibodies, examination of the bone marrow for the 
diagnosis of Pure Red Cell Aplasia (PRCA) should be considered. In case PRCA is diagnosed, therapy 
with MIRCERA must be discontinued and patients should not be switched to another ESA. 
 
Physicians may request the Marketing Authorisation Holder to test or re-test serum samples in a 
reference laboratory for cases of suspected or confirmed AEAB-mediated PRCA or unexplained loss 



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of effect under MIRCERA treatment (e.g. observed clinically by severe anaemia and low reticulocyte 
count). 
 
Pure Red Cell Aplasia caused by anti-erythropoietin antibodies has been reported in association with 
all ESAs, including MIRCERA. These antibodies have been shown to cross-react with all ESAs, and 
patients suspected or confirmed to have antibodies to erythropoietin should not be switched to 
MIRCERA (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 interferon and ribavirin, when epoetins are used concomitantly. Epoetins are not approved 
in the management of anaemia associated with hepatitis C. 
 
Blood pressure monitoring: As with other ESAs, blood pressure may rise during treatment with 
MIRCERA. Blood pressure should be adequately controlled in all patients before, at initiation of, and 
during treatment with MIRCERA. If high blood pressure is difficult to control by medical treatment or 
dietary measures, the dose must be reduced or administration discontinued (see section 4.2). 
 
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, 
Mircera should be withdrawn immediately and an alternative treatement considered.If the patient has 
developed a severe cutaneous skin reaction such as SJS orTEN due to the use of Mircera, treatment 
with ESA must not be restarted in this patient at any time. 
 
Haemoglobin concentration: In patients with chronic kidney disease, 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, serious cardiovascular events including 
thrombosis or cerebrovascular events including stroke was observed when ESAs were administered to 
target a haemoglobin of greater than 12 g/dl (7.5 mmol/l) (see section 4.8). 
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. 
 
The safety and efficacy of MIRCERA therapy has not been established in patients with 
haemoglobinopathies, seizures, bleeding or a recent history of bleeding requiring transfusions or with 
platelet levels greater than 500 x 109/l. Therefore, caution should be used in these patients. 
 
Effect on tumour growth: MIRCERA, like other ESAs, is a growth factor that primarily stimulates 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 ESAs could stimulate the growth of any type 
of malignancy. Two controlled clinical studies in which epoetins were administered to patients with 
various cancers including head and neck cancers, and breast cancer, have shown an unexplained 
excess mortality. 
 
Misuse of MIRCERA by healthy people may lead to an excessive increase in haemoglobin. This may 
be associated with life-threatening cardiovascular complications. 
 
Traceability of MIRCERA: In order to improve the traceability of ESAs, the trade name of the 
administered ESA should be clearly recorded (or stated) in the patient file. 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentialy sodium free. 
 



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4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed. There is no evidence that MIRCERA alters the 
metabolism of other medicinal products. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are no data from the use of MIRCERA in pregnant women.  
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryofoetal 
development, parturition or postnatal development but indicate a class-related reversible reduction in 
foetal weight (see section 5.3). Caution should be exercised when prescribing to pregnant women. 
 
Breast-feeding 
It is unknown whether MIRCERA is excreted in human breast milk. One animal study has shown 
excretion of methoxy polyethylene glycol-epoetin beta in maternal milk. A decision on whether to 
continue or discontinue breast-feeding or to continue or discontinue therapy with MIRCERA should 
be made taking into account the benefit of breast-feeding to the child and the benefit of MIRCERA 
therapy to the woman.  
 
Fertility 
Studies in animals have shown no evidence of impaired fertility (see section 5.3). The potential risk 
for humans is unknown. 
 
4.7 Effects on ability to drive and use machines 
 
MIRCERA has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
(a) Summary of the safety profile 
 
The safety data base from clinical trials comprised 3,042 CKD patients, including 1,939 patients 
treated with MIRCERA and 1,103 with another ESA. Approximately 6% of patients treated with 
MIRCERA are expected to experience adverse reactions. The most frequent reported adverse reaction 
was hypertension (common). 
 
(b) Tabulated list of adverse reactions 
Adverse reactions in Table 2 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). 
 



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Table 2:  Adverse reactions attributed to the treatment with MIRCERA in CKD patients . 
Adverse reactions observed only during post-marketing are marked (*). 
 
System organ class Frequency Adverse reaction 
Blood and lymphatic system 
disorders 

Uncommon Thrombocytopenia* 
Not known Pure red cell aplasia* 

Immune system disorders Rare Hypersensitivity Not known Anaphylactic reaction* 

Nervous system disorders Uncommon Headache Rare Hypertensive encephalopathy 

Vascular disorders 

Common Hypertension 
Rare Hot flush 
Uncommon Thrombosis*  
Rare Pulmonary embolism* 

Skin and subcutaneous 
disorders 

Rare Rash, maculopapular 

Not known Stevens-Johnson syndrome / toxic epidermal necrolysis* 
Injury, poisoning and 
procedural complications Uncommon Vascular access thrombosis 

 
(c) Description of selected adverse reactions 
Cases of thrombocytopenia have been reported from post-marketing setting. A slight decrease in 
platelet counts remaining within the normal range was observed in clinical studies. 
Platelet counts below 100 x 109/l were observed in 7% of patients treated with MIRCERA and 4% of 
patients treated with other ESAs during clinical development. In a post-authorisation safety study with 
long treatment exposure of up to 8.4 years, baseline platelet counts below 100 x 109/l was present in 
2.1% of patients in the MIRCERA group and 2.4% of patients in other ESAs group. During the study, 
platelet counts below 100 x 109/l were observed yearly in 1.5% to 3.0% of patients treated with 
MIRCERA and 1.6% to 2.5% of patients treated with other ESAs.’ 
 
Data from a controlled clinical trial with epoetin alfa or darbepoetin alfa reported an incidence of 
stroke as common. A post-authorisation safety study showed similar incidence rate of stroke between 
MIRCERA (6.3%) and reference ESAs groups (epoetin alfa, darbepoetin alfa and epoetin beta) (7%). 
 
As with other ESAs, cases of thrombosis, including pulmonary embolism, have been reported in the 
post-marketing setting (see section 4.4). 
 
Neutralising anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA) has been reported, 
frequency unknown. In case PRCA is diagnosed, therapy with MIRCERA must be discontinued, and 
patients should not be switched to another recombinant erythropoietic protein (see section 4.4). 
 
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 range of MIRCERA is wide. Individual responsiveness must be considered when 
treatment is initiated. Overdose can result in manifestations of an exaggerated pharmacodynamic 
effect, e.g. excessive erythropoiesis. In case of excessive haemoglobin levels, treatment with 
MIRCERA should be temporarily discontinued (see section 4.2). If clinically indicated, phlebotomy 
may be performed. 
 
 

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


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5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Other antianemic preparations, ATC code: B03XA03 
 
Mechanism of action 
MIRCERA stimulates erythropoiesis by interaction with the erythropoietin receptor on progenitor cells 
in the bone marrow. Methoxy polyethylene glycol-epoetin beta, the active substance of MIRCERA, is 
a continuous erythropoietin receptor activator that shows a different activity at the receptor level 
characterized by a slower association to and faster dissociation from the receptor, a reduced specific 
activity in vitro with an increased activity in vivo, as well as an increased half-life, in contrast to 
erythropoietin. The average molecular mass is approximately 60 kDa of which the protein moiety plus 
the carbohydrate part constitutes approximately 30 kDa. 
 
Pharmacodynamic effects 
As primary growth factor for erythroid development, the natural hormone erythropoietin is produced 
in the kidney and released into the bloodstream in response to hypoxia. In responding to hypoxia, the 
natural hormone erythropoietin interacts with erythroid progenitor cells to increase red cell production. 
 
Clinical efficacy and safety 
Data from correction studies with patients treated once every two weeks and once every four weeks 
show that the haemoglobin response rates in the MIRCERA group at the end of the correction period 
were high and comparable to comparators. The median time to response was 43 days in the MIRCERA 
arm and 29 days in the comparator arm, with increases of haemoglobin within the first 6 weeks of 
0.2 g/dl/week and 0.3 g/dl/week, respectively. 
 
Four randomized controlled studies were performed in dialysis patients currently treated with 
darbepoetin alfa or epoetin at the time of enrollment. Patients were randomized to stay on their 
treatment at the time of enrollment or to be switched to MIRCERA in order to maintain stable 
haemoglobin levels. At the evaluation period (week 29-36), the mean and median level of 
haemoglobin in patients treated with MIRCERA was virtually identical to their baseline haemoglobin 
level. 
 
In a randomised, double-blind, placebo-controlled study of 4,038 CRF 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 of ESAs have been performed in chronic renal failure 
patients (on dialysis, not on dialysis, in diabetic and non-diabetic patients). A tendency towards 
increased risk estimates for all-cause mortality, cardiovascular and cerebrovascular events associated 
with higher cumulative ESA doses independent of the diabetes or dialysis status was observed (see 
section 4.2 and section 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 2,833 patients, of which four were double-blind placebo-controlled studies and one was an open-
label study. Two of the studies recruited patients who were being treated with chemotherapy. The 
target haemoglobin concentration in two studies was >13 g/dl; in the remaining three studies it was 12-
14 g/dl. In the open-label study there was no difference in overall survival between patients treated 



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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. 
 
A patient-level data analysis has also been performed on more than 13,900 cancer patients (chemo-, 
radia-, chemoradia-, 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 the cancer patients 
receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 
10,441 patients). Meta-analyses also indicate consistently a significantly increased relative risk of 
thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section 
4.4). No patients treated with MIRCERA were included in this data analysis. 
MIRCERA is not approved for treatment of patients with chemotherapy induced anaemia (see section 
4.1 and 4.4.).  
 
5.2 Pharmacokinetic properties  
 
The pharmacokinetics of methoxy polyethylene glycol-epoetin beta were studied in healthy volunteers 
and in anaemic patients with CKD including patients on dialysis and not on dialysis. 
 
Following subcutaneous administration to CKD patients not on dialysis, the maximum serum 
concentrations of methoxy polyethylene glycol-epoetin beta were observed 95 hours (median value) 
after administration. The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after 
subcutaneous administration was 54%. The observed terminal elimination half-life was 142 hours in 
CKD patients not on dialysis. 
 
Following subcutaneous administration to CKD patients on dialysis, the maximum serum 
concentrations of methoxy polyethylene glycol-epoetin beta were observed 72 hours (median value) 
after administration. The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after 
subcutaneous administration was 62% and the observed terminal elimination half-life was 139 hours 
in CKD patients on dialysis.  
 
Following intravenous administration to CKD patients on dialysis, the total systemic clearance was 
0.494 ml/h per kg. The elimination half-life after intravenous administration of methoxy polyethylene 
glycol-epoetin beta is 134 hours. 
 
A comparison of serum concentrations of methoxy polyethylene glycol-epoetin beta measured before 
and after haemodialysis in 41 CKD patients showed that haemodialysis has no effect on the 
pharmacokinetics of this medicinal product. 
 
An analysis in 126 CKD patients showed no pharmacokinetic difference between patients on dialysis 
and patients not on dialysis. 
 
In a single dose study, after intravenous administration, the pharmacokinetics of methoxy polyethylene 
glycol-epoetin beta are similar in patients with severe hepatic impairment as compared to healthy 
subjects (see section 4.2). 
 
5.3 Preclinical safety data 
 
Non-clinical data show no special hazard for humans based on conventional studies of cardiovascular 
safety pharmacology, repeat dose toxicity and reproductive toxicity. 
The carcinogenic potential of methoxy polyethylene glycol-epoetin beta has not been evaluated in 
long-term animal studies. It did not induce a proliferative response in non-haematological tumor cell 



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lines in vitro. In a six-month rat toxicity study no tumorigenic or unexpected mitogenic responses were 
observed in non-haematological tissues. In addition, using a panel of human tissues, the in vitro 
binding of methoxy polyethylene glycol-epoetin beta was only observed in target cells (bone marrow 
progenitor cells). 
 
No significant placental transfer of methoxy polyethylene glycol-epoetin beta was observed in the rat, 
and studies in animals have not shown any harmful effect on pregnancy, embryofoetal development, 
parturition or postnatal development. There was however a class-related reversible reduction in foetal 
weight and a decrease in postnatal body-weight gain of offspring at the doses causing exaggerated 
pharmacodynamic effects in mothers. Physical, cognitive, or sexual developments in the offspring of 
mothers receiving methoxy polyethylene glycol-epoetin beta during gestation and lactation were not 
affected. When MIRCERA was administered subcutaneously to male and female rats prior to and 
during mating, reproductive performance, fertility, and sperm assessment parameters were not affected.  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium dihydrogen phosphate monohydrate  
Sodium sulphate  
Mannitol (E421) 
Methionine  
Poloxamer 188  
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 
 
3 years 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C – 8°C). 
Do not freeze. 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
The end-user may remove the medicinal product from refrigeration for storage at a room temperature 
not above 30°C for one single period of 1 month. Once removed from the refrigerator the medicinal 
product must be used within this period. 
 
6.5 Nature and contents of container 
 
Pre-filled syringe (type I glass) with laminated plunger stopper (bromobutyl rubber) and tip cap 
(bromobutyl rubber) and a needle 27G1/2. 
 
Prefilled syringes 30, 40, 50, 60, 75, 100, 120, 150, 200 and 250 micrograms contain 0.3 ml solution. 
Pre-filled syringe 360 micrograms contains 0.6 ml solution. 
 
Prefilled syringes 30, 50, 75 micrograms are available in pack size of 1 or 3 pre-filled syringe(s). 
 
Prefilled syringes 40, 60, 100, 120, 150, 200, 250 and 360 micrograms are available in pack size of 1 
pre-filled syringe.  
 



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Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
The pre-filled syringe is ready for use. The sterile pre-filled syringe does not contain any preservative 
and is to be used for a single injection only. Only one dose should be administered per syringe. Only 
solutions which are clear, colourless to slightly yellowish and free of visible particles must be injected. 
Do not shake. 
Allow the pre-filled syringe to reach room temperature before injecting.  
 
Any unused medicinal 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 NUMBER(S)  
EU/1/07/400/008 
EU/1/07/400/009 
 
EU/1/07/400/010 
EU/1/07/400/011 
EU/1/07/400/012 
EU/1/07/400/013 
EU/1/07/400/017 
EU/1/07/400/018 
EU/1/07/400/019 
EU/1/07/400/020 
EU/1/07/400/021 
EU/1/07/400/022 
EU/1/07/400/023 
EU/1/07/400/024 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 20 July 2007 
Date of latest renewal: 15 May 2012 
 
 
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/


13 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

 A. MANUFACTURER (S) OF THE BIOLOGICAL ACTIVE SUBSTANCE 
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  
 



14 

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

 
Name and address of the manufacturer of the biological active substance 
 
Roche Diagnostics GmbH 
Werk Penzberg 
Nonnenwald 2 
D-82377 Penzberg 
Germany 
 
Name and address of the manufacturer responsible for batch release for the pre-filled syringes 
 
Roche Pharma AG 
Emil-Barrell-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 REQUIREMENTS OF THE MARKETING 

AUTHORISATION  
 
• Periodic Safety Update Reports 
 
The marketing authorisation holder shall submit periodic safety update reports for this product in 
accordance with the requirements set out in the list of Union reference dates (EURD list) provided for 
under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

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

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

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

 
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the 
same time. 
 



15 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET



16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



17 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 50 micrograms pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe 
methoxy polyethylene glycol-epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
 One pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, 
poloxamer 188 and water for injections. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
Each pack contains a pre-filled syringe of 0.3 ml and a needle 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For subcutaneous or intravenous use 
Read the package leaflet before use 
Do not shake 
 
 
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  
Do not freeze 
Keep the pre-filled syringe in the outer carton in order to protect from light 



18 

 
 
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/1/07/400/008 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
mircera 50 mcg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 



19 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
50 micrograms PRE-FILLED SYRINGES LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
MIRCERA 50 mcg/0.3 ml injection 
methoxy polyethylene glycol-epoetin beta 
SC/IV 
 
 
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 
 
50 mcg/0.3 ml 
 
 
6. OTHER 
 



20 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 75 micrograms pre-filled syringe  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe 
methoxy polyethylene glycol-epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 75 micrograms of methoxy polyethylene glycol-epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, 
poloxamer 188 and water for injections. See leaflet for further details.  
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
Each pack contains a pre-filled syringe of 0.3 ml and a needle 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For subcutaneous or intravenous use 
Read the package leaflet before use 
Do not shake 
 
 
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  
Do not freeze 
Keep the pre-filled syringe in the outer carton in order to protect from light 



21 

 
 
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/1/07/400/009 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
mircera 75 mcg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 



22 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
75 micrograms PRE-FILLED SYRINGES LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
MIRCERA 75 mcg/0.3 ml injection 
methoxy polyethylene glycol-epoetin beta 
SC/IV 
 
 
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 
 
75 mcg/0.3 ml 
 
 
6. OTHER 
 



23 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 100 microgram pre-filled syringe  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled syringe 
methoxy polyethylene glycol-epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 100 micrograms of methoxy polyethylene glycol-epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, 
poloxamer 188 and water for injections. See leaflet for further details. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
Each pack contains a pre-filled syringe of 0.3 ml and a needle 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For subcutaneous or intravenous use 
Read the package leaflet before use 
Do not shake 
 
 
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  
Do not freeze 
Keep the pre-filled syringe in the outer carton in order to protect from light 



24 

 
 
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/1/07/400/010 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
mircera 100 mcg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 



25 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
100 micrograms PRE-FILLED SYRINGES LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
MIRCERA 100 mcg/0.3 ml injection 
methoxy polyethylene glycol-epoetin beta 
SC/IV 
 
 
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 
 
100 mcg/0.3 ml 
 
 
6. OTHER 
 



26 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 150 microgram pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe 
methoxy polyethylene glycol-epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 150 micrograms of methoxy polyethylene glycol-epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, 
poloxamer 188 and water for injections. See leaflet for further details. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
Each pack contains a pre-filled syringe of 0.3 ml and a needle 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For subcutaneous or intravenous use 
Read the package leaflet before use 
 
Do not shake 
 
 
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 
 
 



27 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Do not freeze 
Keep the pre-filled syringe in the outer carton in order to protect from light 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/07/400/011 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
mircera 150 mcg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



28 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
150 micrograms PRE-FILLED SYRINGES LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
MIRCERA 150 mcg/0.3 ml injection 
methoxy polyethylene glycol-epoetin beta 
SC/IV 
 
 
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 
 
150 mcg/0.3 ml 
 
 
6. OTHER 
 



29 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 200 micrograms pre-filled syringe  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe 
methoxy polyethylene glycol-epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 200 micrograms of methoxy polyethylene glycol-epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, 
poloxamer 188 and water for injections. See leaflet for further details. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
Each pack contains a pre-filled syringe of 0.3 ml and a needle 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For subcutaneous or intravenous use 
Read the package leaflet before use 
 
Do not shake 
 
 
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 
 
 



30 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Do not freeze 
Keep the pre-filled syringe in the outer carton in order to protect from light 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/07/400/012 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
mircera 200 mcg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



31 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
200 micrograms PRE-FILLED SYRINGES LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
MIRCERA 200 mcg/0.3 ml injection 
methoxy polyethylene glycol-epoetin beta 
SC/IV 
 
 
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 
 
200 mcg/0.3 ml 
 
 
6. OTHER 
 



32 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 250 microgram pre-filled syringe  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
MIRCERA 250 micrograms/0.3 ml solution for injection in pre-filled syringe 
methoxy polyethylene glycol-epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 250 micrograms of methoxy polyethylene glycol-epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, 
poloxamer 188 and water for injections. See leaflet for further details. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
Each pack contains a pre-filled syringe of 0.3 ml and a needle 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For subcutaneous or intravenous use 
Read the package leaflet before use 
 
Do not shake 
 
 
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 
 
 



33 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Do not freeze 
Keep the pre-filled syringe in the outer carton in order to protect from light 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/07/400/013 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
mircera 250 mcg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



34 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
250 micrograms PRE-FILLED SYRINGES LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
MIRCERA 250 mcg/0.3 ml injection 
methoxy polyethylene glycol-epoetin beta 
SC/IV 
 
 
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 
 
250 mcg/0.3 ml 
 
 
6. OTHER 
 



35 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 30 micrograms pre-filled syringe  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe 
methoxy polyethylene glycol-epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 30 micrograms of methoxy polyethylene glycol-epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, 
poloxamer 188 and water for injections. See leaflet for further details. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
Each pack contains a pre-filled syringe of 0.3 ml and a needle 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For subcutaneous or intravenous use 
Read the package leaflet before use 
 
Do not shake 
 
 
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 
 
 



36 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator  
Do not freeze 
Keep the pre-filled syringe in the outer carton in order to protect from light 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/07/400/017 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
mircera 30 mcg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



37 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
30 micrograms PRE-FILLED SYRINGES LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
MIRCERA 30 mcg/0.3 ml injection  
methoxy polyethylene glycol-epoetin beta 
SC/IV 
 
 
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 
 
30 mcg/0.3 ml 
 
 
6. OTHER 
 



38 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 40 micrograms pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe 
methoxy polyethylene glycol-epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 40 micrograms of methoxy polyethylene glycol-epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, 
poloxamer 188 and water for injections. See leaflet for further details. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
Each pack contains a pre-filled syringe of 0.3 ml and a needle 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For subcutaneous or intravenous use 
Read the package leaflet before use 
 
Do not shake 
 
 
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 
 
 



39 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator  
Do not freeze 
Keep the pre-filled syringe in the outer carton in order to protect from light 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/07/400/018 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
mircera 40 mcg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



40 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
40 micrograms PRE-FILLED SYRINGES LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
MIRCERA 40 mcg/0.3 ml injection 
methoxy polyethylene glycol-epoetin beta 
SC/IV 
 
 
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 
 
40 mcg/0.3 ml 
 
 
6. OTHER 
 



41 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 60 micrograms pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
MIRCERA 60 micrograms/0.3 ml solution for injection in pre-filled syringe 
methoxy polyethylene glycol-epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 60 micrograms of methoxy polyethylene glycol-epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, 
poloxamer 188 and water for injections. See leaflet for further details. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
Each pack contains a pre-filled syringe of 0.3 ml and a needle 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For subcutaneous or intravenous use 
Read the package leaflet before use 
 
Do not shake 
 
 
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 
 
 



42 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator  
Do not freeze 
Keep the pre-filled syringe in the outer carton in order to protect from light 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/07/400/019 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
mircera 60 mcg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



43 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
60 micrograms PRE-FILLED SYRINGES LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
MIRCERA 60 mcg/0.3 ml injection 
methoxy polyethylene glycol-epoetin beta 
SC/IV 
 
 
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 
 
60 mcg/0.3 ml 
 
 
6. OTHER 
 



44 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 120 micrograms pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
MIRCERA 120 micrograms/0.3 ml solution for injection in pre-filled syringe 
methoxy polyethylene glycol-epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 120 micrograms of methoxy polyethylene glycol-epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, 
poloxamer 188 and water for injections. See leaflet for further details. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
Each pack contains a pre-filled syringe of 0.3 ml and a needle 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For subcutaneous or intravenous use 
Read the package leaflet before use 
 
Do not shake 
 
 
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 
 
 



45 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator  
Do not freeze 
Keep the pre-filled syringe in the outer carton in order to protect from light 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/07/400/020 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
mircera 120 mcg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



46 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
120 micrograms PRE-FILLED SYRINGES LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
MIRCERA 120 mcg/0.3 ml injection 
methoxy polyethylene glycol-epoetin beta 
SC/IV 
 
 
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 
 
120 mcg/0.3 ml 
 
 
6. OTHER 
 



47 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 360 micrograms pre-filled syringe 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe 
methoxy polyethylene glycol-epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 360 micrograms of methoxy polyethylene glycol-epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, 
poloxamer 188 and water for injections. See leaflet for further details. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
Each pack contains a pre-filled syringe of 0.6 ml and a needle 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For subcutaneous or intravenous use 
Read the package leaflet before use 
 
Do not shake 
 
 
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 
 
 



48 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator  
Do not freeze 
Keep the pre-filled syringe in the outer carton in order to protect from light 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/07/400/021 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
mircera 360 mcg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



49 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
360 micrograms PRE-FILLED SYRINGES LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
MIRCERA 360 mcg/0.6 ml injection 
methoxy polyethylene glycol-epoetin beta 
SC/IV 
 
 
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 
 
360 mcg/0.6 ml 
 
 
6. OTHER 
 



50 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 50 micrograms – 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe 
methoxy polyethylene glycol-epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, 
poloxamer 188 and water for injections. See leaflet for further details. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
Each pack contains 3 pre-filled syringes of 0.3 ml and 3 needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For subcutaneous or intravenous use 
Read the package leaflet before use 
 
Do not shake 
 
 
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 
 
 



51 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator  
Do not freeze 
Keep the pre-filled syringe in the outer carton in order to protect from light 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/07/400/023 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
mircera 50 mcg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



52 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 75 micrograms   
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe 
methoxy polyethylene glycol-epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 75 micrograms of methoxy polyethylene glycol-epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, 
poloxamer 188 and water for injections. See leaflet for further details. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
. Each pack contains 3 pre-filled syringes of 0.3 ml and 3 needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For subcutaneous or intravenous use 
Read the package leaflet before use 
 
Do not shake 
 
 
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  
Do not freeze 
Keep the pre-filled syringe in the outer carton in order to protect from light 



53 

 
 
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/1/07/400/024 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
mircera 75 mcg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



54 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 30 micrograms   
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe 
methoxy polyethylene glycol-epoetin beta 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One pre-filled syringe contains 30 micrograms of methoxy polyethylene glycol-epoetin beta. 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, 
poloxamer 188 and water for injections. See leaflet for further details. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 Each pack contains 3 pre-filled syringes of 0.3 ml and 3 needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For subcutaneous or intravenous use 
Read the package leaflet before use 
 
Do not shake 
 
 
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 
 
 



55 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator  
Do not freeze 
Keep the pre-filled syringe in the outer carton in order to protect from light 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/07/400/022 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
mircera 30 mcg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN: 



56 

  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



57 

 
Package leaflet: Information for the user 

 
MIRCERA 

30 micrograms/0.3 ml solution for injection in pre-filled syringe 
40 micrograms/0.3 ml solution for injection in pre-filled syringe 
50 micrograms/0.3 ml solution for injection in pre-filled syringe 
60 micrograms/0.3 ml solution for injection in pre-filled syringe 
75 micrograms/0.3 ml solution for injection in pre-filled syringe 

100 micrograms/0.3 ml solution for injection in pre-filled syringe 
120 micrograms/0.3 ml solution for injection in pre-filled syringe 
150 micrograms/0.3 ml solution for injection in pre-filled syringe 
200 micrograms/0.3 ml solution for injection in pre-filled syringe 
250 micrograms/0.3 ml solution for injection in pre-filled syringe 
360 micrograms/0.6 ml solution for injection in pre-filled syringe 

 
methoxy polyethylene glycol-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 of illness are the same as yours. 
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed 

in this leaflet. 
 
What is in this leaflet: 
1. What MIRCERA is and what it is used for 
2. What you need to know before you use MIRCERA 
3. How to use MIRCERA 
4. Possible side effects 
5. How to store MIRCERA 
6. Contents of the pack and other information 
 
 
1. What MIRCERA is and what it is used for 
 
This medicine is prescribed to you because you have anaemia caused by your chronic kidney disease 
and associated whith typical symptoms, such as tiredness, weakness and shortness of breath. This 
means that you have too few red blood cells and your haemoglobin level is too low (your body’s 
tissues might not receive enough oxygen). 
 
MIRCERA is indicated to treat only the symptomatic anaemia caused by chronic kidney disease. Its 
use is limited to adult patients (aged 18 years or older). 
 
MIRCERA is a medicine produced by gene-technology. Like the natural hormone erythropoietin, 
MIRCERA increases the number of red blood cells and haemoglobin level in your blood. 
 
 
2. What you need to know before you use MIRCERA 
 
Do not use MIRCERA 
• if you are allergic to methoxy polyethylene glycol-epoetin beta or to any of the other ingredients 

of this medicine (listed in section 6) 
• if you have high blood pressure that cannot be controlled 
 



58 

Warnings and precautions 
The safety and efficacy of MIRCERA therapy in other indications, including anaemia in patients with 
cancer, has not been established. 
 
Before treatment with MIRCERA 
• A condition called Pure Red Cell Aplasia (PRCA, stopped or reduced production of red blood 

cells) due to anti-erythropoietin antibodies was observed in some patients treated with 
erythropoiesis stimulating agents (ESAs), including MIRCERA. 

• If your doctor suspects or confirms that you have these antibodies in your blood, you must not 
be treated with MIRCERA. 

• If you are a patient with hepatitis C and you receive interferon and ribavirin you should discuss  
this with your doctor because a combination of ESAs with interferon and ribavirin has lead to a 
loss of effect and development of PRCA, a severe form of anemia, in rare cases. ESAs are not 
approved in the management of anaemia associated with hepatitis C. 

• If you are a patient with chronic kidney disease and anemia treated with an ESA and are also 
a cancer patient you should be aware that ESAs, might have a negative impact on your 
condition. You should discuss options for anemia treatment with your doctor. 

• It is not known if MIRCERA has a different effect in patients with haemoglobinopathies 
(disorders associated with abnormal haemoglobin), past or present bleeding, seizures or with a 
high blood platelet count. If you have any of these conditions, your doctor will discuss it with 
you and must treat you with caution. 

• Healthy people should not use MIRCERA. Using it can lead to too high haemoglobin levels and 
cause problems with the heart or blood vessels that may be life-threatening. 

 
During treatment with MIRCERA 
• If you are a patient with chronic renal failure, and particularly if you do not respond properly to 

MIRCERA, your doctor will check your dose of MIRCERA because repeatedly increasing your 
dose of MIRCERA 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.  

• Your doctor may initiate treatment with MIRCERA if your haemoglobin level is 10 g/dl 
(6.21 mmol/l) or less. After initiation of therapy, your doctor will seek to maintain your 
haemoglobin level between 10 and 12 g/dl (7.45 mmol/l). 

• Your doctor will check the amount of iron in your blood before and during MIRCERA 
treatment. If the amount is too low your doctor may give you an additional iron supplement. 

• Your doctor will check your blood pressure before and during your MIRCERA treatment. If 
your blood pressure is high and cannot be controlled, either by appropriate medicines or a 
special diet, your doctor will interrupt your MIRCERA treatment or reduce the dose. 

• Your doctor will check that your haemoglobin does not exceed a certain level, as high 
haemoglobin could put you at risk of having a problem of the heart or the blood vessels and 
could increase risk of thrombosis, including pulmonary embolism, myocardial infarction, stroke 
and death.  

• Contact your doctor if you feel tired, weak or have shortness of breath, because this could mean 
that your MIRCERA treatment is not effective. Your doctor will check that you do not have 
other causes of anaemia and may perform blood tests or examine your bone marrow. If you 
have developed PRCA, your MIRCERA treatment will be discontinued. You will not receive 
another ESA and your doctor will treat you for this condition. 

 
Children and adolescents 
Treatment with MIRCERA is not recommended in children and adolescents, because it has not been 
studied in these patients. 
 
Take special care with other products that stimulate red blood cell production: MIRCERA is one 
of a group of products that stimulate the production of red blood cells like the human protein 
erythropoietin does. Your healthcare professional will always record the exact product you are using. 
 



59 

Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis 
(TEN) have been reported in association with epoetin treatment. 
SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters 
on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. 
These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may 
progress to widespread peeling of the skin and life-threatening complications. 
 
If you develop a serious rash or another of these skin symptoms stop taking Mircera and contact your 
doctor or seek medical attention immediately. 
 
Other medicines and MIRCERA 
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
No interaction studies have been performed. There is no evidence that MIRCERA interacts with other 
medicines. 
 
 MIRCERA with food and drink 
Food and drink do not affect MIRCERA. 
 
Pregnancy, breast-feeding and fertility 
Ask your doctor or pharmacist for advice before taking any medicine. 
MIRCERA has not been studied in pregnant or breast-feeding women. 
Tell your doctor if you are pregnant, think you are pregnant or intend to become pregnant. Your doctor 
will consider what is the best treatment for you during pregnancy. 
Tell your doctor if you are breast-feeding or intend to breast-feed. Your doctor will advise if you 
should stop or continue breast-feeding and stop or continue your treatment. 
MIRCERA has not shown evidence of impaired fertility in animals. The potential risk for humans is 
unknown. 
 
Driving and using machines 
MIRCERA does not affect your ability to drive and use machines.  
 
Important information about some of the ingredients of MIRCERA 
This medicine contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodium-free’. 
 
 
3. How to use MIRCERA 
 
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 MIRCERA, your doctor will check your dose and will inform you 
if you need to change doses of MIRCERA. 
 
Treatment with MIRCERA must be started under the supervision of a healthcare professional. 
Further injections can be given by a healthcare professional or, after you have been trained, you can 
inject MIRCERA yourself (see instructions at the end of this leaflet.) 
 
MIRCERA 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. 
 



60 

• If you are not currently treated with an ESA 
If you are not on dialysis, the recommended starting dose of MIRCERA is 1.2 micrograms for every 
kilogram of your body weight to be administered under the skin once every month as a single injection. 
Alternatively, your doctor may decide to administer a starting dose of MIRCERA of 0.6 micrograms 
for every kilogram of your body weight. The dose is to be administered once every two weeks as a 
single injection under the skin or into a vein. Once your anaemia is corrected your doctor may change 
your dosing to once a month administration. 
If you are on dialysis, the recommended starting dose is 0.6 micrograms for every kilogram of your 
body weight. The dose is to be administered once every two weeks as a single injection under the skin 
orinto a vein. Once your anaemia iscorrected your doctor may change your dosing to once a month 
administration. 

 
Your doctor may increase or decrease your dose or temporarily stop your treatment to adjust your 
haemoglobin level, as appropriate for you. Dose changes will not be made more often than once a 
month. 
 
• If you are currently being treated with another ESA 
Your doctor may replace your current medicine with MIRCERA. Your doctor will decide to treat you 
with MIRCERA administered as a single injection once a month. Your doctor will calculate your 
MIRCERA starting dose based on the last dose of your previous medicine. The first MIRCERA dose 
will be given on the planned injection day of your previous medicine. 
 
Your doctor may increase or decrease your dose or temporarily stop your treatment to adjust your 
haemoglobin to an appropriate level for you. Dose changes will not be made more often than once a 
month. 
 
If you use more MIRCERA than you should 
Please contact your doctor or pharmacist if you used too large a dose of MIRCERA as it may be 
necessary to perform some blood tests and interrupt your treatment. 
 
If you forget to use MIRCERA 
If you miss a dose of MIRCERA administer the missed dose as soon as you remember and talk to your 
doctor about when to use the next doses. 
 
If you stop using MIRCERA 
Treatment with MIRCERA is normally long-term. It can, however, be stopped on the advice of your 
doctor at any time. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects  
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
The frequency of possible side effects listed below:  
 
A common side effect (may affect up to 1 in 10 people) is hypertension (high blood pressure). 
 
Uncommon side effects (may affect up to 1 in 100 pleople) are: 
• headache 
• vascular access thrombosis (blood clots in your dialysis access). 
 thrombocytopenia 
 thrombosis  
 



61 

Rare side effects (may affect up to 1 in 1000 people) are: 
• hypertensive encephalopathy (very high blood pressure that can result in headache, especially 

sudden, stabbing, migraine-like headache, confusion, speech disturbances, fits or convulsions).  
• pulmonary embolism. 
• maculo-papular rash (red skin reaction that can include pimples or spots) 
• hot flush 
• hypersensitivity (allergic reaction that can cause unusual wheezing or difficulty in breathing; 

swollen tongue, face or throat, or swelling around the injection site, or make you feel light-
headed, faint or cause you to collapse).  

If you have these symptoms please contact your doctor immediately to receive treatment. 
 
During clinical studies patients had a slight decrease in their platelet blood counts. There have been  
reports of platelet counts below the normal range (thrombocytopenia) in the post-marketing setting. 
 
Hypersensitivity reactions, including cases of anaphylactic reaction and serious skin rashes including 
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis have been reported in association 
with epoetin treatement. 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 Mircera if you develop these symptoms and 
contact your doctor or seek medical attention immediately, see also section 2. 
 
As with other ESAs, cases of thrombosis, including pulmonary embolism, have been reported in the 
post-marketing setting. 
 
A condition called Pure Red Cell Aplasia (PRCA, stopped or reduced production of red blood cells) 
due to anti-erythropoietin antibodies was observed in some patients treated with ESAs, including 
MIRCERA. 
 
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 MIRCERA 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the outer carton and pre-filled syringe 
label after ‘EXP’. The expiry date refers to the last day of that month. 
 
Store in a refrigerator (2 °C – 8 °C). Do not freeze. 
Keep the pre-filled syringe in the outer carton in order to protect from light. 
You may remove your MIRCERA pre-filled syringe from the refrigerator and store it at a room 
temperature not above 30 °C for a single period of one month. During this period when you have 
stored MIRCERA at a room temperature not above 30 °C you may not put MIRCERA back in the 
refrigerator before use. Once you have removed your medicine from the refrigerator you must use it 
within this period of one month. 
 
Only solutions which are clear, colourless to slightly yellowish and free of visible particles must be 
injected. 
 
Do not throw away any medicines via wastewater or household waste. 
Ask your pharmacist how to throw away medicines you no longer use. These measures will help 
protect the environment. 

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


62 

 
 
6.  Contents of the pack and other information 
 
What MIRCERA contains 
 
• The active substance is methoxy polyethylene glycol-epoetin beta. One pre-filled syringe 

contains: 
  30, 40, 50, 60, 75, 100, 120, 150, 200 or 250  micrograms in 0.3 ml and 360 micrograms in 

0.6 ml.  
• The other ingredients are sodium dihydrogen phosphate monohydrate, sodium sulphate, 

mannitol (E421), methionine, poloxamer 188 and water for injections. 
 
What MIRCERA looks like and contents of the pack 
MIRCERA is a solution for injection in pre-filled syringe. 
The solution is clear, colourless to slightly yellowish and free of visible particles. 
 
MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 
27G1/2. Each pre-filled syringe contains 0.3 ml or 0.6 ml. MIRCERA is available, for all strengths, in 
pack sizes of 1 and also packsize of 3 for the strengths 30, 50, 75 micrograms/0.3ml.  Not all pack 
sizes may be marketed. 
 
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  
 
 
България 
Рош България ЕООД 
Тел: +359 2 818 44 44 
 
 

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



63 

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 
 

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

http://www.emea.europa.eu/


64 

 

  

MIRCERA pre-filled syringe  
Instructions For Use 

 
The following instructions explain how to use the MIRCERA pre-filled syringe to give 
yourself an injection.  
It is important to read and follow these instructions carefully so that you are able to use the 
pre-filled syringe correctly and safely. Do not attempt to administer an injection until you are 
sure that you understand how to use the pre-filled syringe.  
 
IMPORTANT INFORMATION 

• Only use MIRCERA pre-filled syringeif you have been prescribed with this 

• medication. 

• Read the packaging and ensure you have the dose prescribed by your healthcare 
professional. 

• Do not use the pre-filled syringe if syringe, or the plastic tray containing the syringe 
appears to be damaged. 

• Do not use the syringe if the contents are cloudy, hazy or contain particles. 

• Never attempt to take the syringe apart. 

• Never pull on or handle the syringe by its plunger. 

• Do not remove the needle shield until you are ready to perform an injection. 

• Do not swallow the medicine in the syringe. 

• Do not inject through clothing. 

• Never re-use a syringe. 

• Do not touch the release clips (see diagram below) as this may damage the syringe and 
make it unusable. 

STORAGE  

Keep the syringe  and the puncture-resistant/ sharps container out of the reach of children.  

Store the syringe in its original box until ready to use. 



65 

 

Always store the syringe in a refrigerator at a temperature of 2 - 8°C (35.6 - 46.4°F). Do not 
allow the medicine to freeze, and protect the medicine from light. Keep the syringe dry. 

 

MATERIALS Included in the pack: 

A pre-filled syringe of MIRCERA and a separate injection needle 

 

 

 

Not included in the pack: 

 

Cleansing alcohol swabs Sterile cotton ball or gauze Puncture-resistant 
container or sharps 
container for safe disposal 
of needle and used syringe 

 



66 

Assemble all of the supplies you will need for an injection on a clean, well-lit flat surface such 
as a table. 

 

 

HOW TO GIVE THE INJECTION 
Step 1: Allow the syringe to adjust to room temperature 

 

Remove the box containing the 
MIRCERA pre-filled syringe from 
the refrigerator. Keep the syringe in 
the box to protect it from light and 
allow it to reach room temperature 
for at least 30 minutes. 
 
• Not allowing the medicine to 

come to room temperature could 
result in an uncomfortable 
injection, and it may be difficult 
to depress the plunger.  

• Do not warm up the syringe in 
any other way. 

 

Remove the plastic tray of the 
MIRCERA pre-filled syringe from 
the box without peeling back the 
protective film. 

 

 

 

 

 

 

 



67 

Step 2: Clean your hands 

 
 

Disinfect your hands well with soap 
and warm water or hands sanitizer. 

Step 3: Unpack and visually inspect the pre-filled syringe 

 

Peel back the protective film from 
the plastic tray and remove the 
needle and the syringe, holding the 
syringe by the middle of the body 
without touching the release clips. 
 
• Only handle the syringe by the 

body, because any contact with 
the release clips could cause 
premature release of the safety 
device. 

 

 

Examine the syringe and check the 
expiration date on the syringe and 
box. This is important to ensure that 
the syringe and medicine are safe to 
use. 
 
Do NOT use the syringe if: 
• You have accidentally dropped 

the syringe. 



68 

  

• Any part of the syringe appears to 
be damaged. 

• The contents are cloudy, hazy or 
contain particles. 

• The expiration date has passed. 

 
 

Step 4. Attach the needle to the syringe 

 
 

Grasp the packaged needle firmly in 
both hands. Break the seal of the 
needle, using a twisting motion, and 
remove the needle cap as pictured.  
Immediately throw away the needle 
cap in the sharps/ puncture-resistant 
container or sharps container. 
• Do not remove the needle shield 

that protects the needle. 

 
 

 
 

Grasp the syringe and the rubber tip 
cap firmly and remove the rubber tip 
cap from the syringe (bend and pull). 
• Do not touch the release clips of 

the safety device. 

• Do not push the plunger. 

• Do not pull on the plunger. 

 

 

Attach the needle to the syringe by 
pushing it firmly onto the syringe. 
 



69 

Step5. Remove the needle shield and prepare for injection 

 

 
 
 

Hold the syringe firmly with one 
hand and pull off the needle shield 
with the other hand. Throw away the 
needle shield in the puncture-
resistant container or sharps 
container. 
• Do not touch the needle or let it 

touch any surface, as the needle 
may become contaminated and 
may cause injury and pain if 
touched. 

• You may see a drop of liquid at 
the end of the needle. This is 
normal. 

• Never reattach the needle shield 
after removal. 

 

 
 

To remove air bubbles from the pre-
filled syringe, hold the syringe with 
the needle pointing up.  
Tap the syringe gently to bring any 
bubbles to the top.  
 



70 

 

Push the plunger up slowly to the 
remove all air,, as shown to you by a 
healthcare professional. 

 
Step 6. Perform the injection  

There are two different ways (routes) to inject MIRCERA into your body.  Follow the 
recommendations of your healthcare professional about how you should inject MIRCERA.  
 

 

Subcutaneous route: 

If you are advised to inject MIRCERA under your skin, please administer your dose as 
described below. 
 

 
 

Choose one of the recommended 
injection sites as shown. 
You may inject MIRCERA into the 
upper arm, thigh or abdomen, except 
around the navel (belly button). 
 
• You should use a different 

injection site each time you 
administer an injection, at least 
three centimeters from the area 
you used for the previous 
injection.  

 

 



71 

• Do not inject areas that could be 
irritated by a belt or waistband. 
Do not inject into moles, scars, 
bruises, or areas where the skin is 
tender, red, hard or not intact.  

 

 
 

Clean the chosen injection site area 
using an alcohol pad to reduce the 
risk of infection; carefully follow the 
instructions of the alcohol pad. 
 
• Let the skin dry for 

approximately 10 seconds. 

• Be sure not to touch the cleaned 
area prior to the injection and do 
not fan or blow on the clean area. 

 

 
 
 
 
 

 

To be sure the needle can be inserted 
correctly under the skin, use your 
free hand to pinch a fold of loose skin 
at the clean injection site. Pinching 
the skin is important to ensure that 
you inject under the skin (into fatty 
tissue) but not any deeper (into 
muscle). Injection into muscle could 
result in an uncomfortable injection. 
 
 
Fully insert the needle into the skin 
in a quick, “dart-like” motion. Slowly 
push the plunger with the thumb 
while holding the syringe with the 
forefinger and the middle finger 
against the finger grips until all the 
medicine is injected. 
Do not move the needle while it is 
inserted in the skin 
 

  
 
 



72 

 

Do not release the plunger before the 
end of injection or before the plunger 
is completely depressed.  
Take the needle out of the skin 
WITHOUT releasing the plunger. 

 

 
 

 
Release the plunger, allowing the 
needle guard to protect the needle. 

 

 

 
Now, the tear-off label can be 
removed, if necessary. 

 
Place a sterile cotton ball or gauze over the injection site and press for several seconds. 
• Do not rub the injection site with dirty hand or cloth. 
• If needed, you may cover the injection site with a small bandage. 
Dispose of the syringe: 
• Throw away used syringes in a sharps/ puncture-resistant container. 
• Do not try to replace the needle shield on the needle. 
• Do not throw away used syringes or the sharps/ puncture-resistant container in 
household trash and do not recycle them. 
• Dispose of the full container as instructed by your healthcare provider or pharmacist. 
 
Intravenous route: 
 
If your healthcare professional has recommended injection of MIRCERA into a vein, you 
should follow the procedure described below.  
After preparation of the syringe as described in steps 1 to 5: 
 



73 

 

Wipe off the venous port of the 
hemodialysis as instructed by your 
healthcare provider  
 
 
 
 
 
 
 
 
 
 
 

 
 

Insert the needle of the pre-filled 
syringe into the cleaned venous 
port. 
 

  
 
 
 
 
 
 
 
 
 
 
 
 
 
 



74 

 

Push the plunger with the thumb 
while holding the syringe with the 
forefinger and the middle finger 
against the finger grips until all the 
medicine is injected. 
Remove the pre-filled syringe from 
the venous port WITHOUT 
releasing the plunger.  
 
Release the plunger, allowing the 
needle guard to protect the needle. 
Now, the tear-off label can be 
removed, if necessary. 
 

 
Dispose of the syringe  

Throw away used syringes in a puncture-resistant container. 
 
• Do not try to replace the shield on the needle. 

• Do not throw away used syringes or the puncture-resistant container in household trash 
and do not recycle them. 

• Dispose of the full container as instructed by your healthcare provider or pharmacist. 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE 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
	A. LABELLING
	B. PACKAGE LEAFLET