Fulphila

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fulphila 6 mg solution for injection in pre-filled syringe 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection. The 
concentration is 10 mg/mL based on protein only**.  
 
*Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with 
polyethylene glycol (PEG).  
** The concentration is 20 mg/mL if the PEG moiety is included. 
 
The potency of this product 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  
 
Excipient with known effect 
 
Each pre-filled syringe contains 30 mg sorbitol (E420). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection (injection).  
 
Clear, colourless solution for injection. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients 
treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia 
and myelodysplastic syndromes). 
 

4.2 Posology and method of administration 
 
Pegfilgrastim therapy should be initiated and supervised by physicians experienced in oncology and/or 
haematology.  
 
Posology 
 
One 6 mg dose (a single pre-filled syringe) of pegfilgrastim is recommended for each chemotherapy 
cycle, given at least 24 hours after cytotoxic chemotherapy.  
 



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Special populations 
 
Patients with renal impairment  

No dose change is recommended in patients with renal impairment, including those with end stage 
renal disease. 
 
Paediatric population  

The safety and efficacy of pegfilgrastim in children has not yet been established. Currently available 
data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.  
 
Method of administration  
 
Fulphila is injected subcutaneously. The injections should be given into the thigh, abdomen or upper 
arm.  
 
For instructions on handling of the medicinal product before administration, see section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Traceability 
 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
Patients with myeloid leukaemia or myelodysplastic syndromes 
 
Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for 
pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia (AML) (see section 5.1). 
However, the long-term effects of pegfilgrastim have not been established in AML; therefore, it 
should be used with caution in this patient population.  
 
Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects 
may be seen on some non-myeloid cells in vitro.  
 
The safety and efficacy of pegfilgrastim have not been investigated in patients with myelodysplastic 
syndrome, chronic myelogenous leukaemia, and in patients with secondary Acute Myeloid Leukaemia 
(AML); therefore, it should not be used in such patients. Particular care should be taken to distinguish 
the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia.  
 
The safety and efficacy of pegfilgrastim administration in de novo AML patients aged < 55 years with 
cytogenetics t(15;17) have not been established.  
 
General 
 
The safety and efficacy of pegfilgrastim have not been investigated in patients receiving high dose 
chemotherapy. This medicinal product should not be used to increase the dose of cytotoxic 
chemotherapy beyond established dose regimens.  
 
Pulmonary adverse events  
 
Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF 
administration. Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher 
risk (see section 4.8).  



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The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological 
signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil 
count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS). In such 
circumstances pegfilgrastim should be discontinued at the discretion of the physician and the 
appropriate treatment given (see section 4.8). 
 
Glomerulonephritis  
 
Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim. Generally, 
events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and 
pegfilgrastim. Urinalysis monitoring is recommended. 
 
Capillary leak syndrome  
 
Capillary leak syndrome has been reported after granulocyte-colony stimulating factor administration 
and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration. Patients 
who develop symptoms of capillary leak syndrome should be closely monitored and receive standard 
symptomatic treatment, which may include a need for intensive care (see section 4.8).  
 
Splenomegaly and splenic rupture  
 
Generally asymptomatic cases of splenomegaly and cases of splenic rupture, including some fatal 
cases, have been reported following administration of pegfilgrastim (see section 4.8). Therefore, 
spleen size should be carefully monitored (e.g. clinical examination, ultrasound). A diagnosis of 
splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip 
pain.  
 
Thrombocytopenia and anaemia  
 
Treatment with pegfilgrastim alone does not preclude thrombocytopenia and anaemia because full 
dose myelosuppressive chemotherapy is maintained on the prescribed schedule. Regular monitoring of 
platelet count and haematocrit is recommended. Special care should be taken when administering 
single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia.  
 
Sickle cell anaemia  
 
Sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell trait or 
sickle cell disease (see section 4.8). Therefore, physicians should use caution when prescribing 
pegfilgrastim in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical 
parameters and laboratory status and be attentive to the possible association of this medicinal product 
with splenic enlargement and vaso-occlusive crisis.  
 
Leukocytosis  
 
White blood cell (WBC) counts of 100 x 109/L or greater have been observed in less than 1 % of 
patients receiving pegfilgrastim. No adverse events directly attributable to this degree of leukocytosis 
have been reported. Such elevation in white blood cells is transient, typically seen 24 to 48 hours after 
administration and is consistent with the pharmacodynamic effects of this medicinal product. 
Consistent with the clinical effects and the potential for leukocytosis, a WBC count should be 
performed at regular intervals during therapy. If leukocyte counts exceed 50 x 109/l after the expected 
nadir, this medicinal product should be discontinued immediately.  
 
Hypersensitivity  
 
Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have 
been reported in patients treated with pegfilgrastim. Permanently discontinue pegfilgrastim in patients 



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with clinically significant hypersensitivity. Do not administer pegfilgrastim to patients with a history 
of hypersensitivity to pegfilgrastim or filgrastim. If a serious allergic reaction occurs, appropriate 
therapy should be administered, with close patient follow-up over several days. 
 
Stevens-Johnson syndrome 
 
Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in 
association with pegfilgrastim treatment. If the patient has developed SJS with the use of 
pegfilgrastim, treatment with pegfilgrastim must not be restarted in this patient at any time.  
 
Immunogenicity  
 
As with all therapeutic proteins, there is a potential for immunogenicity.  
Rates of generation of antibodies against pegfilgrastim is generally low. Binding antibodies 
do occur as expected with all biologics; however, they have not been associated with 
neutralising activity at present. 
 
Aortitis 
 
Aortitis has been reported after G-CSF administration in healthy subjects and in cancer patients. The 
symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory 
markers (e.g. C-reactive protein and white blood cell count). In most cases aortitis was diagnosed by 
CT scan and generally resolved after withdrawal of G-CSF. See also section 4.8. 
 
Other warnings 
 
The safety and efficacy of pegfilgrastim for the mobilisation of blood progenitor cells in patients or 
healthy donors has not been adequately evaluated. 
 
Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been 
associated with transient positive bone imaging findings. This should be considered when interpreting 
bone-imaging results.  
 
This medicinal product contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 
50 mg / mL. The additive effect of concomitantly administered products containing sorbitol (or 
fructose) and dietary intake of sorbitol (or fructose) should be taken into account. 
 
This medicinal product contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say 
essentially ‘sodium-free’.  
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ 
pegfilgrastim should be administered at least 24 hours after administration of cytotoxic chemotherapy. 
In clinical trials, pegfilgrastim has been safely administered 14 days before chemotherapy. 
Concomitant use of pegfilgrastim with any chemotherapy agent has not been evaluated in patients. In 
animal models concomitant administration of pegfilgrastim and 5-fluorouracil (5-FU) or other 
antimetabolites has been shown to potentiate myelosuppression.  
 
Possible interactions with other haematopoietic growth factors and cytokines have not been 
specifically investigated in clinical trials.  
 
The potential for interaction with lithium, which also promotes the release of neutrophils, has not been 
specifically investigated. There is no evidence that such an interaction would be harmful.  
 
The safety and efficacy of pegfilgrastim have not been evaluated in patients receiving chemotherapy 
associated with delayed myelosuppression e.g., nitrosoureas.  



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Specific interaction or metabolism studies have not been performed, however, clinical trials have not 
indicated an interaction of pegfilgrastim with any other medicinal products. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy  
 
There are no or limited amount of data from the use of pegfilgrastim in pregnant women. Studies in 
animals have shown reproductive toxicity (see section 5.3). Pegfilgrastim is not recommended during 
pregnancy and in women of childbearing potential not using contraception.  
 
Breast-feeding  
 
There is insufficient information on the excretion of pegfilgrastim / metabolites in human milk, a risk 
to the newborns/infants cannot be excluded. A decision must be made whether to discontinue 
breast-feeding or to discontinue/abstain from Fulphila therapy taking into account the benefit of 
breast-feeding for the child and the benefit of therapy for the woman.  
 
Fertility  
 
Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative 
weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body 
surface area) (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Pegfilgrastim has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile  
 
The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and 
musculoskeletal pain (common [≥ 1/100 to < 1/10]). Bone pain was generally of mild to moderate 
severity, transient and could be controlled in most patients with standard analgesics.  
 
Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythema, 
flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon 
[≥ 1/1,000 to < 1/100]). Serious allergic reactions, including anaphylaxis can occur in patients 
receiving pegfilgrastim (uncommon) (see section 4.4).  
 
Capillary Leak Syndrome, which can be life-threatening if treatment is delayed, has been reported as 
uncommon (≥ 1/1,000 to < 1/100) in cancer patients undergoing chemotherapy following 
administration of granulocyte colony-stimulating factors; see section 4.4 and section “Description of 
selected adverse reactions” below.  
 
Splenomegaly, generally asymptomatic, is uncommon.  
 
Splenic rupture including some fatal cases is uncommonly reported following administration of 
pegfilgrastim (see section 4.4).  
 
Uncommon pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema, 
pulmonary infiltrates and pulmonary fibrosis have been reported. Uncommonly, cases have resulted in 
respiratory failure or Acute Respiratory Distress Syndrome (ARDS), which may be fatal (see 
section 4.4).  
 



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Isolated cases of sickle cell crises have been reported in patients with sickle cell trait or sickle cell 
disease (uncommon in sickle cell patients) (see section 4.4).  
 



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Tabulated list of adverse reactions  
 
The data in the table below describe adverse reactions reported from clinical trials and spontaneous 
reporting. Within each frequency grouping, undesirable effects are presented in order of decreasing 
seriousness. 
 

MedDRA 
system organ 
class 

Adverse reactions 

 
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) 

Blood and 
lymphatic 
system 
disorders  

 Thrombocytopenia
1  

Leukocytosis1  

Sickle cell crisis2;  
Splenomegaly2;  
Splenic rupture2 

  

Immune system 
disorders    

Hypersensitivity 
reactions;  
Anaphylaxis  

  

Metabolism and 
nutrition 
disorders  

  Elevations in uric acid     

Nervous system 
disorders  

Headache1  
     

Vascular 
disorders    

Capillary leak 
syndrome1  Aortitis  

Respiratory, 
thoracic and 
mediastinal 
disorders  
 

  

Acute Respiratory 
Distress Syndrome2;  
Pulmonary adverse 
reactions (interstitial 
pneumonia, pulmonary 
oedema, pulmonary 
infiltrates and 
pulmonary fibrosis); 
Haemoptysis 

Pulmonary 
haemorrhage  

Gastrointestinal 
disorders  
 

Nausea1  
     

Skin and 
subcutaneous 
tissue disorders  
 

  

Sweet’s syndrome 
(acute febrile 
dermatosis)1,2;  
Cutaneous vasculitis1,2  

Stevens-
Johnson 
syndrome 

 

Musculoskeletal 
and connective 
tissue disorders  
 

Bone pain  

Musculoskeletal 
pain (myalgia, 
arthralgia, pain in 
extremity, back 
pain, 
musculo-skeletal 
pain, neck pain)  

   

Renal and 
urinary 
disorders  

  Glomerulonephritis2    

General 
disorders and 
administration 
site conditions  

 
Injection site pain1  
Non-cardiac chest 
pain  

Injection site 
reactions2    



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Investigations    

Elevations in lactate 
dehydrogenase and 
alkaline phosphatase1;  
Transient elevations in 
LFT's for ALT or 
AST1  

  

 
1 See section “Description of selected adverse reactions” below.  
2 This adverse reaction was identified through post-marketing surveillance but not observed in 
randomised, controlled clinical trials in adults. The frequency category was estimated from a statistical 
calculation based upon 1,576 patients receiving pegfilgrastim in nine randomised clinical trials. 
 
Description of selected adverse reactions  
 
Uncommon cases of Sweet’s syndrome have been reported, although in some cases underlying 
haematological malignancies may play a role.  
 
Uncommon events of cutaneous vasculitis have been reported in patients treated with pegfilgrastim. 
The mechanism of vasculitis in patients receiving pegfilgrastim is unknown.  
  
Injection site reactions, including injection site erythema (uncommon) as well as injection site pain 
(common) have occurred on initial or subsequent treatment with pegfilgrastim.  
 
Common cases of leukocytosis (White Blood Count [WBC] > 100 x 109/l) have been reported (see 
section 4.4).  
 
Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated 
clinical effects, were uncommon; reversible, mild to moderate elevations in lactate dehydrogenase, 
with no associated clinical effects, were uncommon in patients receiving pegfilgrastim following 
cytotoxic chemotherapy.  
 
Nausea and headaches were very commonly observed in patients receiving chemotherapy.  
 
Uncommon elevations in liver function tests (LFTs) for ALT (alanine aminotransferase) or AST 
(aspartate aminotransferase), have been observed in patients after receiving pegfilgrastim following 
cytotoxic chemotherapy. These elevations are transient and return to baseline.  
 
Common cases of thrombocytopenia have been reported.  
 
Cases of capillary leak syndrome have been reported in the post marketing setting with granulocyte 
colony-stimulating factor use. These have generally occurred in patients with advanced malignant 
diseases, sepsis, taking multiple chemotherapy medicinal products or undergoing apheresis (see 
section 4.4).  
 
Paediatric population  
 
The experience in children and adolescents is limited. A higher frequency of serious adverse reactions 
in younger children aged 0-5 years (92 %) has been observed compared to older children aged 6-11 
and 12-21 years respectively (80 % and 67 %) and adults. The most common adverse reaction reported 
was bone pain (see section 5.1 and 5.2).  
 
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. 



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4.9 Overdose 
 
Single doses of 300 mcg/kg have been administered subcutaneously to a limited number of healthy 
volunteers and patients with non-small cell lung cancer without serious adverse reactions. The adverse 
events were similar to those in subjects receiving lower doses of pegfilgrastim. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: immunostimulants, colony stimulating factor; ATC Code: L03AA13  
 
Fulphila is a biosimilar medicinal product. Detailed information is available on the website of the 
European Medicines Agency http://www.ema.europa.eu. 
 
Human granulocyte colony stimulating factor (G-CSF) is a glycoprotein, which regulates the 
production and release of neutrophils from the bone marrow. Pegfilgrastim is a covalent conjugate of 
recombinant human G-CSF (r-metHuG-CSF) with a single 20 kd polyethylene glycol (PEG) molecule.  
Pegfilgrastim is a sustained duration form of filgrastim due to decreased renal clearance. Pegfilgrastim 
and filgrastim have been shown to have identical modes of action, causing a marked increase in 
peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or 
lymphocytes. Similarly to filgrastim, neutrophils produced in response to pegfilgrastim show normal 
or enhanced function as demonstrated by tests of chemotactic and phagocytic function. As with other 
haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial 
cells. G-CSF can promote growth of myeloid cells, including malignant cells, in vitro and similar 
effects may be seen on some non-myeloid cells in vitro. 
 
In two randomised, double-blind, pivotal studies in patients with high risk stage II-IV breast cancer 
undergoing myelosuppressive chemotherapy consisting of doxorubicin and docetaxel, use of 
pegfilgrastim, as a single once per cycle dose, reduced the duration of neutropenia and the incidence of 
febrile neutropenia similarly to that observed with daily administrations of filgrastim (a median of 
11 daily administrations). In the absence of growth factor support, this regimen has been reported to 
result in a mean duration of grade 4 neutropenia of 5 to7 days, and a 30-40 % incidence of febrile 
neutropenia. In one study (n = 157), which used a 6 mg fixed dose of pegfilgrastim the mean duration 
of grade 4 neutropenia for the pegfilgrastim group was 1.8 days compared with 1.6 days in the 
filgrastim group (difference 0.23 days, 95 % CI -0.15, 0.63). Over the entire study, the rate of febrile 
neutropenia was 13 % of pegfilgrastim-treated patients compared with 20 % of filgrastim-treated 
patients (difference 7 %, 95 % CI of -19 %, 5 %). In a second study (n = 310), which used a 
weight-adjusted dose (100 mcg /kg), the mean duration of grade 4 neutropenia for the pegfilgrastim 
group was 1.7 days, compared with 1.8 days in the filgrastim group (difference 0.03 days, 95 % 
CI -0.36, 0.30). The overall rate of febrile neutropenia was 9 % of patients treated with pegfilgrastim 
and 18 % of patients treated with filgrastim (difference 9 %, 95 % CI of -16.8 %,-1.1 %). 
 
In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on 
the incidence of febrile neutropenia was evaluated following administration of a chemotherapy 
regimen associated with a febrile neutropenia rate of 10-20 % (docetaxel 100 mg/m² every 3 weeks for 
4 cycles). Nine hundred and twenty eight patients were randomised to receive either a single dose of 
pegfilgrastim or placebo approximately 24 hours (day 2) after chemotherapy in each cycle. The 
incidence of febrile neutropenia was lower for patients randomised to receive pegfilgrastim compared 
with placebo (1 % versus 17 %, p < 0.001). The incidence of hospitalisations and IV anti-infective use 
associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group 
compared with placebo (1 % versus 14 %, p < 0.001; and 2 % versus 10 %, p < 0.001).  
 
A small (n = 83), Phase II, randomised, double-blind study in patients receiving chemotherapy for de 
novo acute myeloid leukaemia compared pegfilgrastim (single dose of 6 mg) with filgrastim, 

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


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administered during induction chemotherapy. Median time to recovery from severe neutropenia was 
estimated as 22 days in both treatment groups. Long term outcome was not studied (see section 4.4).  
 
In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients 
receiving 100 mcg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and 
cyclophosphamide (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils 
< 0.5 x 109) was observed in younger children aged 0-5 years (8.9 days) compared to older children 
aged 6-11 years and 12-21 years (6 days and 3.7 days, respectively) and adults. Additionally a higher 
incidence of febrile neutropenia was observed in younger children aged 0-5 years (75 %) compared to 
older children aged 6-11 years and 12-21 years (70 % and 33 %, respectively) and adults (see sections 
4.8 and 5.2). 
 
5.2 Pharmacokinetic properties 
 
After a single subcutaneous dose of pegfilgrastim, the peak serum concentration of pegfilgrastim 
occurs at 16 to 120 hours after dosing and serum concentrations of pegfilgrastim are maintained 
during the period of neutropenia after myelosuppressive chemotherapy. The elimination of 
pegfilgrastim is non-linear with respect to dose; serum clearance of pegfilgrastim decreases with 
increasing dose. Pegfilgrastim appears to be mainly eliminated by neutrophil mediated clearance, 
which becomes saturated at higher doses. Consistent with a self-regulating clearance mechanism, the 
serum concentration of pegfilgrastim declines rapidly at the onset of neutrophil recovery (see 
figure 1).  
 
Figure 1. Profile of median pegfilgrastim serum concentration and Absolute Neutrophil Count 
(ANC) in chemotherapy treated patients after a single 6 mg injection 
 

 
 
Due to the neutrophil-mediated clearance mechanism, the pharmacokinetics of pegfilgrastim is not 
expected to be affected by renal or hepatic impairment. In an open label, single dose study (n = 31) 
various stages of renal impairment, including end-stage renal disease, had no impact on the 
pharmacokinetics of pegfilgrastim.  
 



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Elderly 
 
Limited data indicate that the pharmacokinetics of pegfilgrastim in elderly subjects (> 65 years) is 
similar to that in adults.  
 
Paediatric population  
 
The pharmacokinetics of pegfilgrastim were studied in 37 paediatric patients with sarcoma, who 
received 100 mcg/kg pegfilgrastim after the completion of VAdriaC/IE chemotherapy. The youngest 
age group (0-5 years) had a higher mean exposure to pegfilgrastim (Area Under Curve (AUC)) (± 
Standard Deviation) (47.9 ± 22.5 mcg·hr/mL) than older children aged 6-11 years and 12-21 years 
(22.0 ± 13.1 mcg·hr/mL and 29.3 ± 23.2 mcg·hr/mL, respectively) (see section 5.1). With the 
exception of the youngest age group (0-5 years), the mean AUC in paediatric subjects appeared similar 
to that for adult patients with high-risk stage II-IV breast cancer and receiving 100 mcg/kg 
pegfilgrastim after the completion of doxorubicin/docetaxel (see sections 4.8 and 5.1). 
 
5.3 Preclinical safety data 
 
Preclinical data from conventional studies of repeated dose toxicity revealed the expected 
pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, 
extramedullary haematopoiesis and splenic enlargement.  
 
There were no adverse effects observed in offspring from pregnant rats given pegfilgrastim 
subcutaneously, but in rabbits pegfilgrastim has been shown to cause embryo/foetal toxicity (embryo 
loss) at cumulative doses approximately 4 times the recommended human dose, which were not seen 
when pregnant rabbits were exposed to the recommended human dose. In rat studies, it was shown that 
pegfilgrastim may cross the placenta. Studies in rats indicated that reproductive performance, fertility, 
oestrous cycling, days between pairing and coitus, and intrauterine survival were unaffected by 
pegfilgrastim given subcutaneously. The relevance of these findings for humans is not known. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 

Sodium acetate*  
Sorbitol (E420) 
Polysorbate 20  
Water for injections  
*Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide. 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products, particularly with sodium 
chloride solutions. 
 
6.3 Shelf life 
 
3 years. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C – 8°C).  
 
Fulphila may be exposed to room temperature (not above 30°C) for a maximum single period of up to 
72 hours. Fulphila left at room temperature for more than 72 hours should be discarded. 
 



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Do not freeze. Accidental exposure to freezing temperatures for a single period of less than 24 hours 
does not adversely affect the stability of Fulphila.  
 
Keep the container in the outer carton in order to protect from light. 
 
6.5 Nature and contents of container  
 
Pre-filled syringe (Type I glass), with a fluorotec-coated bromobutyl rubber stopper and a stainless 
steel needle with or without an automatic needle guard.  
 
Pack size of one pre-filled syringe, in blistered packaging. 
 
6.6 Special precautions for disposal and other handling 
 
Before administration, Fulphila solution should be inspected visually for particulate matter. Only a 
solution that is clear and colourless should be injected.  
 
Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive.  
 
The pre-filled syringe should be allowed 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 
 
Mylan S.A.S. 
117 allée des Parcs 
69800 Saint-Priest 
France 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/18/1329/001 1 pre-filled syringe 
EU/1/18/1329/002 1 pre-filled syringe with needle guard 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 

Date of first authorisation: 20 November 2018 
 
 
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/


14 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE 

SUBSTANCE AND MANUFACTURERS 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 

 



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

Name and address of the manufacturers of the biological active substance 
 
Biocon Ltd. 
20th km Hosur Road 
Electronics City, Bangalore, Karnataka 
IN-560 100 
560 100 Bangalore 
India 
 
Biocon Biologics India Limited 
Special Economic Zone 
Plot No: 2, 3, 4 & 5, Phase – IV 
Bommasandra-Jigani Link Road,  
Bommasandra Post, 
Bengaluru – 560099, 
India 
 
Name and address of the manufacturer(s) responsible for batch release 
 
McDermott Laboratories t/a Mylan Dublin Biologics 
Newenham Court 
Northern Cross 
Malahide Road 
Dublin 17 
Ireland 

 
Mylan Germany GmbH 
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1 
Bad Homburg v. d. Hoehe 
Hessen, 61352,  
Germany 

 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 

 
 

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 (PSURs) 
 

The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal. 

 
 



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

 
• Risk management plan (RMP) 

 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing 
authorisation and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

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

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



17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



19 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fulphila 6 mg solution for injection in pre-filled syringe 
pegfilgrastim 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL solution for injection (10 mg/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium acetate, sorbitol (E420), polysorbate 20, water for injections. See leaflet for further 
information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
1 single use pre-filled syringe (0.6 mL).  
1 single use pre-filled syringe with automatic needle guard (0.6 mL). 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Important: read the package leaflet before handling the pre-filled syringe. 
For subcutaneous use.  
Avoid vigorous shaking. 
 
 
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 
 
 



20 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator.  
Do not freeze.  
Keep the container 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 
 
Mylan S.A.S. 
117 allée des Parcs 
69800 Saint-Priest 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/18/1329/001 1 pre-filled syringe 
EU/1/18/1329/002 1 pre-filled syringe with needle guard 
 
 
13. BATCH NUMBER 
 

Lot:  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Fulphila 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



21 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 



22 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER WITH SYRINGE  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 

Fulphila 6 mg solution for injection 
pegfilgrastim 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Mylan S.A.S. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Subcutaneous use 
 
Important: handle syringe as pictured 
 
 

  
 



23 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SYRINGE LABEL  
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Fulphila 6 mg injection 
pegfilgrastim 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.6 mL 
 
 
6. OTHER 
 
 
 



24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



25 

Package leaflet: Information for the user 
 

Fulphila 6 mg solution for injection in pre-filled syringe 
pegfilgrastim 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

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

side effects not listed in this leaflet. See section 4. 
 
 
What is in this leaflet 
1. What Fulphila is and what it is used for  
2. What you need to know before you use Fulphila 
3. How to use Fulphila  
4. Possible side effects  
5. How to store Fulphila 
6. Contents of the pack and other information 
 
 
1. What Fulphila is and what it is used for 
 
Fulphila contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by 
biotechnology in bacteria called E. coli. It belongs to a group of proteins called cytokines, and is very 
similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.  
 
Fulphila is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence 
of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of 
cytotoxic chemotherapy (medicines that destroy rapidly growing cells). White blood cells are 
important as they help your body fight infection. These cells are very sensitive to the effects of 
chemotherapy which can cause the number of these cells in your body to decrease. If white blood cells 
fall to a low level there may not be enough left in the body to fight bacteria and you may have an 
increased risk of infection.  
 
Your doctor has given you Fulphila to encourage your bone marrow (part of the bone which makes 
blood cells) to produce more white blood cells that help your body fight infection.  
 
Fulphila is for use in adults aged 18 and over. 
 
 
2. What you need to know before you use Fulphila 
 
Do not use Fulphila   
- if you are allergic to pegfilgrastim, filgrastim or any of the other ingredients of this medicine 

(listed in section 6).  
 



26 

Warnings and precautions  
Talk to your doctor, pharmacist or nurse before using Fulphila:  
- if you experience an allergic reaction including weakness, drop in blood pressure, difficulty 

breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the 
skin that itch. 

- experience a cough, fever and difficulty breathing. This can be a sign of Acute Respiratory 
Distress Syndrome (ARDS).  

- if you have any of the following or combination of the following side effects:  
• swelling or puffiness, which may be associated with passing water less frequently, 

difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling 
of tiredness.  

These could be symptoms of condition called “Capillary Leak Syndrome” which causes blood to leak 
from the small blood vessels into your body. See section 4.  
- if you get left upper abdominal pain or pain at the tip of your shoulder. This may be a sign of a 

problem with your spleen (splenomegaly).  
- if you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary 

oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung 
infiltration).  

- if you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) 
or decreased blood platelet counts, which reduces the ability of your blood to clot 
(thrombocytopenia). Your doctor may want to monitor you more closely.  

- if you have sickle cell anaemia. Your doctor may monitor your condition more closely.  
- if you have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the 

face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing, 
these could be signs of a severe allergic reaction.  

- Inflammation of the aorta (the large blood vessel which transports blood from the heart to the 
body) has been reported rarely in cancer patients and healthy donors. The symptoms can include 
fever, abdominal pain, malaise, back pain and increased inflammatory markers. Tell your doctor 
if you experience these symptoms. 

 
Your doctor will check your blood and urine regularly as Fulphila can harm the tiny filters inside your 
kidneys (glomerulonephritis).  
 
Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of pegfilgrastim. 
Stop using Fulphila and seek medical attention immediately if you notice any of the symptoms 
described in section 4. 
 
You should talk to your doctor about your risks of developing cancers of the blood. If you develop or 
are likely to develop cancers of the blood, you should not use Fulphila, unless instructed by your 
doctor.  
 
Loss of response to Fulphila   
If you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, 
your doctor will investigate the reasons why including whether you have developed antibodies which 
neutralise pegfilgrastim’s activity.  
 
Children and adolescents 
Fulphila is not recommended for use in children and adolescents due to insufficient data on safety and 
effectiveness. 
 
Other medicines and Fulphila   
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.  
 
Pregnancy and breast-feeding  
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine.  



27 

 
Fulphila has not been tested in pregnant women. Therefore, your doctor may decide that you 
should not use this medicine. 
 
If you become pregnant during Fulphila treatment, please inform your doctor.  
 
Unless your doctor directs you otherwise, you must stop breast-feeding if you use Fulphila.  
 
Driving and using machines  
Fulphila has no or negligible effect on the ability to drive or use machines.  
 
Fulphila contains sorbitol and sodium acetate  
This medicine contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg / mL.  
 
This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially 
‘sodium-free’.  
 
 
3. How to use Fulphila 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if 
you are not sure.  
 
The recommended dose is one 6 mg subcutaneous injection (injection under your skin) using a 
pre-filled syringe and it should be given at least 24 hours after your last dose of chemotherapy at the 
end of each chemotherapy cycle.  
 
Do not shake Fulphila vigorously as this may affect its activity.  
 
Injecting Fulphila yourself  
Your doctor may decide that it would be more convenient for you to inject Fulphila yourself. Your 
doctor or nurse will show you how to inject yourself. Do not try to inject yourself if you have not been 
trained.  
For further instructions on how to inject yourself with Fulphila, please read the instructions for use at 
the end of this leaflet.  
 
If you use more Fulphila than you should  
If you use more Fulphila than you should, contact your doctor, pharmacist or nurse.  
 
If you forget to inject Fulphila   
If you have forgotten a dose of Fulphila, you should contact your doctor to discuss when you should 
inject the next dose. 
  
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.  
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
Please tell your doctor immediately if you have any of the following or combination of the following 
side effects:  
 
- swelling or puffiness, which may be associated with passing water less frequently, difficulty 

breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. These 
symptoms generally develop in a rapid fashion.  
 



28 

These could be symptoms of an uncommon (may affect up to 1 in 100 people) condition called 
“Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body 
and needs urgent medical attention.  
 
Very common side effects (may affect more than 1 in 10 people)  
- bone pain. Your doctor will tell you what you can take to ease the bone pain.  
- nausea and headaches.  
 
Common side effects (may affect up to 1 in 10 people) 
- pain at the site of injection.  
- general aches and pains in the joints and muscles.  
- some changes may occur in your blood, but these will be detected by routine blood tests. Your 

white blood cell count may become high for a short period of time. Your platelet count may 
become low which might result in bruising.  

- chest pain. 
 
Uncommon side effects (may affect up to 1 in 100 people) 
- allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin 

that itch.  
- serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty 

breathing, swelling of the face).  
- sickle cell crises in patients with sickle cell anaemia. 
- increased spleen size.  
- spleen rupture. Some cases of splenic rupture were fatal. It is important that you contact your 

doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder 
pain since this may relate to a problem with your spleen.  

- breathing problems. If you have a cough, fever and difficulty breathing please tell your doctor.  
- Sweet’s syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face 

and neck with fever) has occurred but other factors may play a role.  
- cutaneous vasculitis (inflammation of the blood vessels in the skin).  
- damage to the tiny filters inside your kidneys (glomerulonephritis).  
- redness at the site of injection.  
- coughing up blood (haemoptysis). 
 
Rare side effects (may affect up to 1 in 1,000 people) 
- inflammation of the aorta (the large blood vessel which transports blood from the heart to the 

body), see section 2. 
- bleeding from the lung (pulmonary haemorrhage). 
- Stevens-Johnson syndrome, which can appear as reddish target-like 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 Fulphila if you develop these 
symptoms and contact your doctor or seek medical attention immediately. See also section 2. 

 
Reporting of side effects  
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine.  
 
 
5. How to store Fulphila 
 
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 carton, on the blister and on the 
syringe label after EXP. The expiry date refers to the last day of that month.  
 



29 

Store in a refrigerator (2°C – 8°C).  
 
Do not freeze. Fulphila may be used if it is accidentally frozen for a single period of less than 
24 hours.  
 
Keep the container in the outer carton in order to protect from light.   
 
You may take Fulphila out of the refrigerator and keep it at room temperature (not above 30°C) for no 
longer than 3 days. Once a syringe has been removed from the refrigerator and has reached room 
temperature (not above 30°C) it must either be used within 3 days or disposed of.  
 
Do not use this medicine if you notice it is cloudy or there are particles in it.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment.  
 
 
6. Contents of the pack and other information 
 
What Fulphila contains  
- The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 

0.6 mL of solution. 
- The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections. 

See section 2 “Fulphila contains sorbitol and sodium”. 
 
What Fulphila looks like and contents of the pack  
Fulphila is a clear, colourless solution for injection in a glass pre-filled syringe with an attached 
stainless steel needle and needle cap. The syringe is provided with a blister wrapping.  
Each pack contains 1 pre-filled syringe.  
 
Marketing Authorisation Holder 
Mylan S.A.S. 
117 allée des Parcs 
69800 Saint-Priest  
France 
 
Manufacturer 
McDermott Laboratories t/a Mylan Dublin Biologics 
Newenham Court, Northern Cross, Malahide Road 
17 Dublin 
Ireland 
 
Mylan Germany GmbH 
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1 
Bad Homburg v. d. Hoehe 
Hessen, 61352,  
Germany 
 
 



30 

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Mylan EPD bvba/sprl 
Tél/Tel: + 32 (0)2 658 61 00 
 

Lietuva 
Mylan Healthcare UAB 
Tel: +370 5 205 1288 
 

България 
Майлан ЕООД 
Тел: +359 2 44 55 400 
 

Luxembourg/Luxemburg 
Mylan EPD bvba/sprl 
Tel: + 32 (0)2 658 61 00 
(Belgique/Belgien) 
 

Česká republika 
Mylan Healthcare CZ s.r.o. 
Tel: + 420 222 004 400 
 

Magyarország 
Mylan EPD Kft 
Tel: + 36 1 465 2100 

Danmark 
Mylan Denmark ApS 
Tlf: + 45 28116932 
 

Malta 
V.J. Salomone Pharma Ltd 
Tel: + 356 21 22 01 74 
 

Deutschland 
Mylan Healthcare GmbH  
Tel: +49 800 0700 800 
 

Nederland 
Mylan Healthcare BV 
Tel: +31 (0)20 426 3300 

Eesti 
BGP Products Switzerland GmbH Eesti 
filiaal  
Tel: + 372 6363 052 
 

Norge 
Mylan Healthcare Norge AS 
Tel: + 47 66 75 33 00 
 

Ελλάδα  
BGP ΠΡΟΪΟΝΤΑ Μ.Ε.Π.Ε. 
Τηλ: +30 210 9891 777  
 

Österreich 
Mylan Österreich GmbH 
Tel: +43 1 86390 
 

España 
Mylan Pharmaceuticals, S.L. 
Tel: + 34 900 102 712 
 

Polska 
Mylan Healthcare Sp. z o.o. 
Tel: + 48 22 546 64 00 
 

France 
Mylan Medical SAS 
Tel: +33 1 56 64 10 70 
 

Portugal 
Mylan, Lda. 
Tel: + 351 21 412 72 56 
 

Hrvatska 
Mylan Hrvatska d.o.o.   
Tel: +385 1 23 50 599 

România 
BGP Products SRL 
Tel: + 40 372 579 000 
 

Ireland 
Mylan Ireland Limited 
Tel: +353 (0) 87 1694982  

Slovenija 
Mylan Healthcare d.o.o. 
Tel: + 386 1 236 31 80 
 



31 

Ísland 
Icepharma hf  
Tel: +354 540 8000  
 

Slovenská republika 
Mylan s.r.o. 
Tel: +421 2 32 199 100 

Italia 
Mylan Italia S.r.l. 
Tel: + 39 02 612 46921 
 

Suomi/Finland 
Mylan Finland OY 
Puh/Tel: + 358 20 720 9555 
 

Κύπρος 
Varnavas Hadjipanayis Ltd 
Τηλ: +357 2220 7700 
 

Sverige 
Mylan AB  
Tel: + 46 855 522 750 
 

Latvija 
Mylan Healthcare SIA  
Tel: +371 676 055 80 
 

United Kingdom 
Generics [UK] Ltd 
Tel: +44 1707 853000 

This leaflet was last revised in {MM/YYYY}. 
 
Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu  
------------------------------------------------------------------------------------------------------------------------ 

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


32 

Instructions for injecting with the Fulphila pre-filled syringe 
 
This section contains information on how to give yourself an injection of Fulphila. It is important that 
you do not try to give yourself the injection unless you have received training from your doctor, nurse 
or pharmacist. If you have questions about how to inject, please ask your doctor, nurse or pharmacist 
for assistance.  
 
How do you, or the person injecting you, use Fulphila pre-filled syringe?  
You will need to give yourself the injection into the tissue just under the skin. This is known as a 
subcutaneous injection.  
 
Equipment that you need  
To give yourself a subcutaneous injection you will need:  
- a pre-filled syringe of Fulphila; and  
- alcohol wipes or similar.  
 
What should I do before I give myself a subcutaneous injection of Fulphila?  
 
1. Remove the syringe from the refrigerator.  
 
2. Do not shake the pre-filled syringe.  
 
3. Do not remove the needle cap from the syringe until you are ready to inject.  
 
4. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed the 
last day of the month shown.  
 
5. Check the appearance of Fulphila. It must be a clear and colourless liquid. If there are particles in it, 
you must not use it.  
 
6. For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room 
temperature or hold the pre-filled syringe gently in your hand for a few minutes. Do not warm the 
syringe in any other way (for example, do not warm it in a microwave or in hot water).  
 
7. Wash your hands thoroughly.  
 
8. Find a comfortable, well-lit, clean surface and put all the equipment you need within reach. 
 
How do I prepare my Fulphila injection?  
 

 
 
 
 
 
 

 
 
 
2. You may notice a small air bubble in the pre-filled syringe. You do not have to remove the air 
bubble before injecting. Injecting the solution with the air bubble is harmless.  
 
3. You can now use the pre-filled syringe.  
 

Before you inject Fulphila you must do the following:  
 
1. Hold the syringe barrel and gently take the cap from the needle 
without twisting. Pull straight as shown in pictures 1 and 2. Do not 
touch the needle or push the plunger.  
 



33 

Where should I give my injection? 
 

 
 
The most suitable places to inject yourself are:  
• the top of your thighs; and  
• the abdomen, except for the area around the navel.  
 
If someone else is injecting you, they can also use the back of your 
arms. 
 
 
 
 

 
How do I give my injection?  
 
1. Clean your skin by using an alcohol wipe.  
 
2. Pinch (without squeezing) the skin using your thumb and forefinger. Insert the needle into the skin.  
 
3. Push the plunger down with a slow constant pressure. Push the plunger all the way down as far as it 
will go to inject all the liquid.  
 
4. After injecting the liquid, remove the needle and let go of your skin.  
 
5. If you notice a spot of blood at the injection site dab with a cotton ball or tissues. Do not rub the 
injection site. If needed, you may cover the injection site with a plaster.  
 
6. Do not use any Fulphila that is left in the syringe.  
 
Remember  
 
Only use each syringe for one injection. If you have any problems, please ask your doctor or nurse for 
help and advice.  
 
Disposing of used syringes 
  

• Do not put the cap back on used needles.  
• Keep used syringes out of the sight and reach of children. 
• The used syringe should be disposed of in accordance with local requirements. Ask your 

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

 



34 

Package leaflet: Information for the user 
 

Fulphila 6 mg solution for injection in pre-filled syringe 
pegfilgrastim 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

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

side effects not listed in this leaflet. See section 4. 
 
 
What is in this leaflet 
 
1. What Fulphila is and what it is used for  
2. What you need to know before you use Fulphila 
3. How to use Fulphila  
4. Possible side effects  
5. How to store Fulphila 
6. Contents of the pack and other information 
 
 
1. What Fulphila is and what it is used for 
 
Fulphila contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced by 
biotechnology in bacteria called E. coli. It belongs to a group of proteins called cytokines, and is very 
similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.  
 
Fulphila is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence 
of febrile neutropenia (low white blood cell count with a fever) which can be caused by the use of 
cytotoxic chemotherapy (medicines that destroy rapidly growing cells). White blood cells are 
important as they help your body fight infection. These cells are very sensitive to the effects of 
chemotherapy which can cause the number of these cells in your body to decrease. If white blood cells 
fall to a low level there may not be enough left in the body to fight bacteria and you may have an 
increased risk of infection.  
 
Your doctor has given you Fulphila to encourage your bone marrow (part of the bone which makes 
blood cells) to produce more white blood cells that help your body fight infection.  
 
Fulphila is for use in adults aged 18 and over. 
 
 
2. What you need to know before you use Fulphila 
 
Do not use Fulphila  
- if you are allergic to pegfilgrastim, filgrastim or any of the other ingredients of this medicine 

(listed in section 6).  
 



35 

Warnings and precautions  
Talk to your doctor, pharmacist or nurse before using Fulphila:  
- if you experience an allergic reaction including weakness, drop in blood pressure, difficulty 

breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and areas of the skin 
that itch. 

- experience a cough, fever and difficulty breathing. This can be a sign of Acute Respiratory 
Distress Syndrome (ARDS).  

- if you have any of the following or combination of the following side effects:  
• swelling or puffiness, which may be associated with passing water less frequently, 

difficulty breathing, abdominal swelling and feeling of fullness, and a general 
feeling of tiredness.  

These could be symptoms of condition called “Capillary Leak Syndrome” which causes blood to 
leak from the small blood vessels into your body. See section 4.  

- if you get left upper abdominal pain or pain at the tip of your shoulder. This may be a sign of a 
problem with your spleen (splenomegaly).  

- if you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary 
oedema), inflammation of the lungs (interstitial lung disease) or an abnormal chest x-ray (lung 
infiltration).  

- if you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) or 
decreased blood platelet counts, which reduces the ability of your blood to clot 
(thrombocytopenia). Your doctor may want to monitor you more closely.  

- if you have sickle cell anaemia. Your doctor may monitor your condition more closely.  
- if you have sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, 

lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing, these 
could be signs of a severe allergic reaction.  

- Inflammation of the aorta (the large blood vessel which transports blood from the heart to the 
body) has been reported rarely in cancer patients and healthy donors. The symptoms can include 
fever, abdominal pain, malaise, back pain and increased inflammatory markers. Tell your doctor 
if you experience these symptoms. 

 
Your doctor will check your blood and urine regularly as Fulphila can harm the tiny filters inside your 
kidneys (glomerulonephritis).  
 
Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of pegfilgrastim. 
Stop using Fulphila and seek medical attention immediately if you notice any of the symptoms 
described in section 4. 
 
You should talk to your doctor about your risks of developing cancers of the blood. If you develop or 
are likely to develop cancers of the blood, you should not use Fulphila, unless instructed by your 
doctor.  
 
Loss of response to Fulphila   
If you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, 
your doctor will investigate the reasons why including whether you have developed antibodies which 
neutralise pegfilgrastim’s activity.  
 
Children and adolescents 
Fulphila is not recommended for use in children and adolescents due to insufficient data on safety and 
effectiveness. 
 
Other medicines and Fulphila   
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.  
 
Pregnancy and breast--feeding  
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine.  



36 

 
Fulphila has not been tested in pregnant women. Therefore, your doctor may decide that you 
should not use this medicine. 
 
If you become pregnant during Fulphila treatment, please inform your doctor.  
Unless your doctor directs you otherwise, you must stop breast-feeding if you use Fulphila.  
 
Driving and using machines  
Fulphila has no or negligible effect on the ability to drive or use machines.  
 
Fulphila contains sorbitol and sodium acetate  
This medicine contains 30 mg sorbitol in each pre-filed syringe which is equivalent to 50 mg / mL.  
This medicine contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially 
‘sodium-free’. 
 
 
3. How to use Fulphila 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if 
you are not sure.  
 
The recommended dose is one 6 mg subcutaneous injection (injection under your skin) using a 
pre-filled syringe and it should be given at least 24 hours after your last dose of chemotherapy at the 
end of each chemotherapy cycle.  
 
Do not shake Fulphila vigorously as this may affect its activity.  
 
Injecting Fulphila yourself  
Your doctor may decide that it would be more convenient for you to inject Fulphila yourself. Your 
doctor or nurse will show you how to inject yourself. Do not try to inject yourself if you have not been 
trained.  
 
For further instructions on how to inject yourself with pegfilgrastim, please read the instructions for 
use at the end of this leaflet.  
 
If you use more Fulphila than you should  
If you use more Fulphila than you should contact your doctor, pharmacist or nurse.  
 
If you forget to inject Fulphila   
If you have forgotten a dose of Fulphila, you should contact your doctor to discuss when you should 
inject the next dose.  
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
  
Please tell your doctor immediately if you have any of the following or combination of the following 
side effects:  
 
- swelling or puffiness, which may be associated with passing water less frequently, difficulty 

breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness. These 
symptoms generally develop in a rapid fashion.  

 



37 

These could be symptoms of an uncommon (may affect up to 1 in 100 people) condition called 
“Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body 
and needs urgent medical attention.  
 
Very common side effects (may affect more than 1 in 10 people) 
- bone pain. Your doctor will tell you what you can take to ease the bone pain.  
- nausea and headaches.  
 
Common side effects (may affect up to 1 in 10 people) 
- pain at the site of injection.  
- general aches and pains in the joints and muscles.  
- some changes may occur in your blood, but these will be detected by routine blood tests. Your 

white blood cell count may become high for a short period of time. Your platelet count may 
become low which might result in bruising.  

- chest pain. 
 
Uncommon side effects (may affect up to 1 in 100 people) 
- allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin that 

itch.  
- serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty 

breathing, swelling of the face).  
- sickle cell crises in patients with sickle cell anaemia. 
- increased spleen size.  
- spleen rupture. Some cases of splenic rupture were fatal. It is important that you contact your 

doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder 
pain since this may relate to a problem with your spleen.  

- breathing problems. If you have a cough, fever and difficulty breathing please tell your doctor.  
- Sweet’s syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face 

and neck with fever) has occurred but other factors may play a role.  
- cutaneous vasculitis (inflammation of the blood vessels in the skin).  
- damage to the tiny filters inside your kidneys (glomerulonephritis).  
- redness at the site of injection.  
- coughing up blood (haemoptysis). 
 
Rare side effects (may affect up to 1 in 1,000 people) 
- inflammation of the aorta (the large blood vessel which transports blood from the heart to the 

body), see section 2. 
- bleeding from the lung (pulmonary haemorrhage). 
- Stevens-Johnson syndrome, which can appear as reddish target-like 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 Fulphila if you develop these symptoms 
and contact your doctor or seek medical attention immediately. See also section 2. 

 
Reporting of side effects  
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Fulphila 
 
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 carton, on the blister and on the 
syringe label after EXP. The expiry date refers to the last day of that month.  
 



38 

Store in a refrigerator (2°C – 8°C).  
 
Do not freeze. Fulphila may be used if it is accidentally frozen for a single period of less than 
24 hours.  
 
Keep the container in the outer carton in order to protect from light.   
 
You may take Fulphila out of the refrigerator and keep it at room temperature (not above 30°C) for no 
longer than 3 days. Once a syringe has been removed from the refrigerator and has reached room 
temperature (not above 30°C) it must either be used within 3 days or disposed of.  
 
Do not use this medicine if you notice it is cloudy or there are particles in it.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Fulphila contains  
- The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 

0.6 mL of solution. 
- The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections. 

See section 2 “Fulphila contains sorbitol and sodium”. 
 
What Fulphila looks like and contents of the pack  
Fulphila is a clear, colourless solution for injection in a glass pre-filled syringe with an attached 
stainless steel needle and needle cap. The syringe is provided with a blister wrapping, the syringe is 
provided with an automatic needle guard. 
Each pack contains 1 glass pre-filled syringe 
 
 
Marketing Authorisation Holder 
Mylan S.A.S. 
117 allée des Parcs 
69800 Saint-Priest  
France 
 
Manufacturer 
McDermott Laboratories t/a Mylan Dublin Biologics 
Newenham Court, Northern Cross, Malahide Road 
17 Dublin 
Ireland 
 
Mylan Germany GmbH 
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1 
Bad Homburg v. d. Hoehe 
Hessen, 61352,  
Germany 
 
 



39 

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Mylan EPD bvba/sprl 
Tél/Tel: + 32 (0)2 658 61 00 
 

Lietuva 
Mylan Healthcare UAB 
Tel: +370 5 205 1288 
 

България 
Майлан ЕООД 
Тел: +359 2 44 55 400 
 
 

Luxembourg/Luxemburg 
Mylan EPD bvba/sprl 
Tel: + 32 (0)2 658 61 00 
(Belgique/Belgien) 
 

Česká republika 
Mylan Healthcare CZ s.r.o. 
Tel: + 420 222 004 400 
 

Magyarország 
Mylan EPD Kft 
Tel: + 36 1 465 2100 

Danmark 
Mylan Denmark ApS 
Tlf: + 45 28116932 
 

Malta 
V.J. Salomone Pharma Ltd 
Tel: + 356 21 22 01 74 
 

Deutschland 
Mylan Healthcare GmbH  
Tel: +49 800 0700 800 
 

Nederland 
Mylan Healthcare BV 
Tel: +31 (0)20 426 3300 

Eesti 
BGP Products Switzerland GmbH Eesti 
filiaal  
Tel: + 372 6363 052 
 

Norge 
Mylan Healthcare Norge AS 
Tel: + 47 66 75 33 00 
 

Ελλάδα  
BGP ΠΡΟΪΟΝΤΑ Μ.Ε.Π.Ε. 
Τηλ: +30 210 9891 777  
 

Österreich 
Mylan Österreich GmbH 
Tel: +43 1 86390 
 

España 
Mylan Pharmaceuticals, S.L. 
Tel: + 34 900 102 712 
 

Polska 
Mylan Healthcare Sp. z o.o. 
Tel: + 48 22 546 64 00 
 

France 
Mylan Medical SAS 
Tel: +33 1 56 64 10 70 
 

Portugal 
Mylan, Lda. 
Tel: + 351 21 412 72 56 
 

Hrvatska 
Mylan Hrvatska d.o.o.   
Tel: +385 1 23 50 599 

România 
BGP Products SRL 
Tel: + 40 372 579 000 
 

Ireland 
Mylan Ireland Limited 
Tel: +353 (0) 87 1694982  

Slovenija 
Mylan Healthcare d.o.o. 
Tel: + 386 1 236 31 80 
 



40 

Ísland 
Icepharma hf  
Tel: +354 540 8000  
 

Slovenská republika 
Mylan s.r.o. 
Tel: +421 2 32 199 100 

Italia 
Mylan Italia S.r.l. 
Tel: + 39 02 612 46921 
 

Suomi/Finland 
Mylan Finland OY 
Puh/Tel: + 358 20 720 9555 
 

Κύπρος 
Varnavas Hadjipanayis Ltd 
Τηλ: +357 2220 7700 
 

Sverige 
Mylan AB  
Tel: + 46 855 522 750 
 

Latvija 
Mylan Healthcare SIA  
Tel: +371 676 055 80 
 

United Kingdom 
Generics [UK] Ltd 
Tel: +44 1707 853000 

This leaflet was last revised in {MM/YYYY}. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu  
 
------------------------------------------------------------------------------------------------------------------------ 

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


41 

 
Instructions for use: 

 
Guide to parts 

Before use 
 

After use 
 

 



42 

Important 
Before you use a Fulphila pre-filled syringe with automatic needle guard, read this important 
information:  
• It is important that you do not try to give yourself the injection unless you have received 

training from your doctor or healthcare provider. 

• Fulphila is given as an injection into the tissue just under the skin (subcutaneous injection). 

 Do not remove the grey needle cap from the pre-filled syringe until you are ready to inject.  
 Do not use the pre-filled syringe if it has been dropped on a hard surface. Use a new 

pre-filled syringe and call your doctor or healthcare provider.  
 Do not attempt to activate the pre-filled syringe prior to injection.  
 Do not attempt to remove the clear pre-filled syringe safety guard from the pre-filled 

syringe.  
 Do not attempt to remove the peelable label on the pre-filled syringe barrel before 

administering your injection.  
 

Call your doctor or healthcare provider if you have any questions.  
 

 
Step 1: Prepare 

A. Remove the pre-filled syringe tray from the package and gather the supplies needed for your 
injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container 
(not included).  

For a more comfortable injection, leave the pre-filled syringe at room temperature for about 
30 minutes before injecting. Wash your hands thoroughly with soap and water.  
 
On a clean, well-lit work surface, place the new pre-filled syringe and the other supplies.  
 Do not try to warm the syringe by using a heat source such as hot water or microwave.  
 Do not leave the pre-filled syringe exposed to direct sunlight.  
 Do not shake the pre-filled syringe.  
• Keep pre-filled syringes out of the sight and reach of children. 

 

 
B.  Open the tray, peeling away the cover. Grab the pre-filled syringe safety guard to remove 

the pre-filled syringe from the tray.  
 

 
 

For safety reasons:  
 Do not grasp the plunger.  
 Do not grasp the grey needle cap. 

 

 



43 

C.   
 

Inspect the medicine and pre-filled syringe. 
 
 
 
 
 
 
 
 

 Do not use the pre-filled syringe if:  
• The medicine is cloudy or there are particles in it. It must be a clear and colourless liquid.  
• Any part appears cracked or broken.  
• The grey needle cap is missing or not securely attached.  
• The expiry date printed on the label has passed the last day of the month shown.  

In all cases, call your doctor or healthcare provider.  
 

 
Step 2: Get ready  

A. Wash your hands thoroughly. Prepare and clean your injection site.  
 
 
 
 
 
 
 
 
 
 
 

You can use:  
• Upper part of your thigh  
• Belly, except for a 5 cm (2-inch) area right around your belly button.  
• Outer area of upper arm (only if someone else is giving you the injection). 

 
Clean the injection site with an alcohol wipe. Let your skin dry. 
 
 Do not touch the injection site before injecting.  

 Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into 
areas with scars or stretch marks. 

 

 
B  Carefully pull the grey needle cap straight out and away from your body.  
 

 



44 

C  Pinch your injection site to create a firm surface.  
 
 
 
 
 
 
 
 
 
 

 It is important to keep the skin pinched when injecting.  
 

Step 3: Inject 
A  Hold the pinch. INSERT the needle into skin.  
 
 
 
 
 
 
 
 
 
 
 

 Do not touch the cleaned area of the skin. 
 
B  PUSH the plunger with slow and constant pressure until you feel or hear a “snap”. Push all 

the way down through the snap.  
 
 
 
 
 
 
 
 
 
 
 
 

    It is important to push down through the “snap” to deliver your full dose. 
 



45 

C  RELEASE your thumb. Then LIFT the syringe off skin.  
 
 
 
 
 
 

After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection 
needle.  

 Do not put the grey needle cap back on used pre-filled syringes. 
 

 
Healthcare professionals only 

The trade name of the administered product should be clearly recorded in the patient file. 
 

Step 4: Finish  
A  Discard the used pre-filled syringe and other supplies in a sharps disposal container.  
 

 
Medicines should be disposed of in accordance with local requirements. Ask your pharmacist how 
to dispose of medicines no longer required. These measures will help to protect the environment.  
Keep the syringe and sharps disposal container out of sight and reach of children.  

 Do not reuse the pre-filled syringe.  
 Do not recycle pre-filled syringes or throw them into household waste.  

 

 
B   

 

Examine the injection site. 

If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. 
Apply a plaster if needed.  
 
 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS 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 LE