Pelgraz

1 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



 

2 
 

 
 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 
 
Pelgraz 6 mg solution for injection in pre-filled syringe 
 
Pelgraz 6 mg solution for injection in pre-filled injector 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Pelgraz 6 mg solution for injection in pre-filled syringe 
 
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**. 
 
Pelgraz 6 mg solution for injection in pre-filled injector 
 
Each pre-filled injector 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 medicinal 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. 
 
Excipients with known effect  
Each pre-filled syringe or pre-filled injector contains 30 mg sorbitol (E420) (see section 4.4). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for 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 
 
Pelgraz therapy should be initiated and supervised by physicians experienced in oncology and/or 
haematology. 



 

3 
 

 
Posology 
 
One 6 mg dose (a single pre-filled syringe or pre-filled injector) of Pelgraz is recommended for each 
chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.  
 
Special populations 
 
Paediatric population 
 
The safety and efficacy of Pelgraz in children and adolescents 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. 
 
Patients with renal impairment 
 
No dose change is recommended in patients with renal impairment, including those with end-stage 
renal disease. 
 
Method of administration 
 
Pelgraz is for subcutaneous use.The injections should be given subcutaneously 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 trade name of the 
administered product should be clearly recorded. 
 
Acute myeloid leukaemia (AML) 
 
Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for 
pegfilgrastim to filgrastim in patients with de novo 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 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 AML. 
 
The safety and efficacy of pegfilgrastim administration in de novo AML patients aged < 55 years with 
cytogenetics t(15;17) have not been established. 
 



 

4 
 

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 reactions 
 
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). 
 
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 Adult 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 medicinal products 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 reactions directly attributable to this degree of 



 

5 
 

leukocytosis have been reported. Such elevation in WBCs 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 
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 filgrastim or pegfilgrastim 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 WBC count). In most cases aortitis was 
diagnosed by CT scan and generally resolved after withdrawal of filgrastim or pegfilgrastim. See also 
section 4.8. 
 
Mobilisation of PBPC 
The safety and efficacy of Pelgraz for the mobilisation of blood progenitor cells in patients or healthy 
donors has not been adequately evaluated. 
 
Other special precautions 
 
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. 
 
Excipients with known effect 
This medicinal product contains 50 mg sorbitol in each unit volume, which is equivalent to 30 mg per 
6 mg dose.  
 
Pelgraz  contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say essentially ‘sodium-
free’. 
 
All patients 
 
The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which 
may cause allergic reactions. 
 



 

6 
 

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 Pelgraz with any chemotherapeutic medicinal product 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 Pelgraz have not been evaluated in patients receiving chemotherapy 
associated with delayed myelosuppression e.g. nitrosoureas. 
 
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 pegfilgrastim 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, erythaema, 
flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon 



 

7 
 

[≥ 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 ARDS, which may be fatal (see section 4.4). 
 
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). 
 
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 

 Thrombocytopeni
a1 
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  



 

8 
 

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

) 

Respiratory, 
thoracic and 
mediastinal 
disorders 

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

Pulmonary 
haemorrha
ge 

 

Gastrointestin
al disorders 

Nausea1      

Skin and 
subcutaneous 
tissue 
disorders 

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

Stevens-
Johnson 
syndrome 

 

Musculoskelet
al and 
connective 
tissue 
disorders 

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

   

Renal and 
urinary 
disorders 

  Glomerulonephrit
is2 

  

General 
disorders and 
administrative 
site conditions 

 Injection site pain1 
Non-cardiac chest 
pain 
 

Injection site 
reactions2 

  

Investigations   Elevations in 
lactate 
dehydrogenase 
and alkaline 
phosphatase1; 
Transient 
elevations in 
LFTs 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. 
 



 

9 
 

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 erythaema (uncommon) as well as injection site pain 
(common events) have occurred on initial or subsequent treatment with pegfilgrastim. 
 
Common cases of leukocytosis (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 alanine aminotransferase (ALT) or aspartate 
aminotransferase (AST), 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 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. 
 
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 
reactions 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 

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


 

10 
 

 
Pelgraz 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 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 intravenous  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 AML compared pegfilgrastim (single dose of 6 mg) with filgrastim, 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). 



 

11 
 

 
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. 
 
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 (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). 
 



 

12 
 

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). 
 
Pelgraz may be exposed to room temperature (not above 25°C ± 2°C) for a maximum single period of 
up to 72 hours. Pelgraz left at room temperature for more than 72 hours should be discarded.  
 
Do not freeze. Accidental exposure to freezing temperatures for a single period of less than 24 hours 
does not adversely affect the stability of Pelgraz. 
 
Keep the container in the outer carton in order to protect from light. 
 
6.5 Nature and contents of container 
 
Pelgraz 6 mg solution for injection in pre-filled syringe 
 
Pre-filled syringe (type I glass) with a permanently attached stainless steel injection needle, with a 
needle safety guard.  
 
The needle cover of the pre-filled syringe contains dry natural rubber (see section 4.4).  
 



 

13 
 

Each pre-filled syringe contains 0.6 mL of solution for injection. Pack size of one pre-filled syringe 
with one alcohol swab, in a blistered packaging. 
 
Pelgraz 6 mg solution for injection in pre-filled injector 
 
Pre-filled injector containing a pre-filled syringe (type I glass) with a permanently attached stainless 
steel injection needle. The pre-filled syringe is externally equipped with the device for self-
administration (pre-filled injector). 
 
The needle cover of the pre-filled syringe contains dry natural rubber (see section 4.4).  
 
Each pre-filled syringe injector contains 0.6 mL of solution for injection. Pack size of one pre-filled 
injector with one alcohol swab, in a blistered packaging. 
 
6.6 Special precautions for disposal and other handling 
 
Pelgraz 6 mg solution for injection in pre-filled syringe 
 
Before use, Pelgraz 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. 
 
Allow the pre -filled syringe to reach room temperature before injecting. 
 
Using the pre filled syringe with a needle safety guard  
 
The needle safety guard covers the needle after injection to prevent needle stick injury. This does not 
affect normal operation of the syringe. The plunger should be slowly and evenly depressed until the 
entire dose has been given and the plunger cannot be depressed any further. While maintaining 
pressure on the plunger, the syringe should be removed from the injection site. The needle safety 
guard will cover the needle when releasing the plunger. 
 
Pelgraz 6 mg solution for injection in pre-filled injector 
 
Before use, Pelgraz 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. 
 
Allow the pre-filled injector to reach room temperature before injecting. 
 
Disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Accord Healthcare S.L.U.  
World Trade Center, Moll de Barcelona, s/n,  
Edifici Est 6ª planta,  
08039 Barcelona,  
Spain 
 
 



 

14 
 

8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/18/1313/001 
EU/1/18/1313/002 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 21st September 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 



 

15 
 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 

SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR 
BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 

SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 



 

16 
 

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

 
Name and address of the manufacturer of the biological active substance 
 
Intas Pharmaceuticals Limited 
Plot no 423 / P/A 
Sarkhej Bavla Highway 
Village Moraiya, Taluka Sanand, 
Ahmedabad – 382213  
Gujarat 
INDIA 
 
Name and address of the manufacturer responsible for batch release 
 
Accord Healthcare Limited  
Sage House, 319 Pinner Road  
North Harrow, Middlesex HA1 4HF  
United Kingdom 
 
Accord Healthcare Polska Sp.z o.o., 
ul. Lutomierska 50,95-200 Pabianice, Poland 
Accord Healthcare B.V. 
Winthontlaan 200, 3526 KV Utrecht, Netherlands 
 
 
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. 
 
 
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; 



 

17 
 

• 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. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



 

18 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



 

19 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON (PRE-FILLED SYRINGE) 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pelgraz 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 (10 mg/mL) solution for injection. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium acetate, sorbitol (E420), polysorbate 20, water for injections. Read the package 
leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
1 pre-filled syringe  + 1 alcohol swab 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Avoid vigorous shaking. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Keep the syringe in the outer carton in order to protect from light. 
 



 

20 
 

 
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 
 
Accord Healthcare S.L.U.  
World Trade Center, Moll de Barcelona, s/n,  
Edifici Est 6ª planta,  
08039 Barcelona,  
Spain 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/18/1313/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
pelgraz 6 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN:  



 

21 
 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL (PRE-FILLED SYRINGE) 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Pelgraz 6 mg solution for injection in pre-filled syringe 
pegfilgrastim 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
6 mg 
 
 
6. OTHER  
 
Accord 



 

22 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON (PRE-FILLED INJECTOR) 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pelgraz 6 mg solution for injection in pre-filled injector 
pegfilgrastim 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled injector contains 6 mg of pegfilgrastim in 0.6 mL (10 mg/mL) solution for injection. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: sodium acetate, sorbitol (E420), polysorbate 20, water for injections. Read the package 
leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
1 pre-filled injector + 1 alcohol swab 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Subcutaneous use. 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Avoid vigorous shaking. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Keep the pre-filled injector in the outer carton in order to protect from light. 
 



 

23 
 

 
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 
 
Accord Healthcare S.L.U.  
World Trade Center, Moll de Barcelona, s/n,  
Edifici Est 6ª planta,  
08039 Barcelona,  
Spain 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/18/1313/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
pelgraz 6 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN:  



 

24 
 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL (PRE-FILLED INJECTOR)  
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Pelgraz 6 mg solution for injection in pre-filled injector 
pegfilgrastim 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
6 mg 
 
 
6. OTHER  
 
Accord 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



 

25 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



 

26 
 

Package leaflet: Information for the user 
 

Pelgraz 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 symptoms 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 Pelgraz is and what it is used for 
2. What you need to know before you use Pelgraz 
3. How to use Pelgraz 
4. Possible side effects 
5. How to store Pelgraz 
6. Contents of the pack and other information 
 
 
1. What Pelgraz is and what it is used for 
 
Pelgraz 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. 
 
Pelgraz 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 Pelgraz 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. 
 
 
2. What you need to know before you use Pelgraz 
 
Do not use Pelgraz 
 
• if you are allergic to pegfilgrastim, filgrastim,  or any of the other ingredients of this medicine 

(listed in section 6). 
 



 

27 
 

Warnings and precautions 
 
Talk to your doctor, pharmacist or nurse before using Pelgraz 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. 
• have an allergy to latex. The needle cap on the pre-filled syringe contains a derivative of latex 

and may cause severe allergic reactions. 
• experience a cough, fever and difficulty breathing. This can be a sign of Acute Respiratory 

Distress Syndrome (ARDS). 
• 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. 

• 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). 

• 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). 

• 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. 

• have sickle cell anaemia. Your doctor may monitor your condition more closely. 
• 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. 

 
Your doctor will check your blood and urine regularly as Pelgraz can harm the tiny filters inside your 
kidneys (glomerulonephritis). 
 
Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Pelgraz . Stop 
using Pelgraz 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 Pelgraz, unless instructed by your 
doctor. 
 
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 (e.g. C-reactive protein and 
white blood cell count). Tell your doctor if you experience these symptoms. 
 
Loss of response to pegfilgrastim 
 
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 
 
The safety and efficacy of Pelgraz in children has not yet been established. Ask your doctor or 
pharmacist for advice before taking any medicine. 
 



 

28 
 

Other medicines and Pelgraz 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Pregnancy and breast-feeding 
 
Ask your doctor or pharmacist for advice before taking any medicine. Pelgraz has not been tested in 
pregnant women. It is important to tell your doctor if you: 
• are pregnant; 
• think you may be pregnant; or 
• are planning to have a baby. 
 
If you become pregnant during Pelgraz treatment, please inform your doctor.  
 
Unless your doctor directs you otherwise, you must stop breast-feeding if you use Pelgraz. 
 
Driving and using machines 
 
Pelgraz has no or negligible effect on the ability to drive or use machines. 
 
Pelgraz contains sorbitol (E420) and sodium acetate 
 
This medicinal product contains 50 mg sorbitol in each unit volume, which is equivalent to 30 mg per 
6 mg dose. 
 
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 Pelgraz 
 
Pelgraz is for use in adults aged 18 and over. 
 
Always take Pelgraz exactly as your doctor has told you. You should check with your doctor or 
pharmacist if you are unsure. The usual 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 Pelgraz vigorously as this may affect its activity. 
 
Injecting Pelgraz yourself 
 
Your doctor may decide that it would be more convenient for you to inject Pelgraz yourself. Your 
doctor or nurse will show you how to inject yourself. Do not try to inject yourself unless you have 
received special training from your doctor or nurse. 
 
The instructions how to inject yourself  
are given below, but proper treatment of your disease requires close and constant co-operation with 
your doctor. 
 
If you are not sure about giving yourself the injection or you have any questions, please ask your 
doctor or nurse for help. 
 
How do I inject Pelgraz myself? 
 



 

29 
 

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 Pelgraz;  
• alcohol swab.  
 
What should I do before I give myself a subcutaneous injection of Pelgraz? 
 
1. Take the pre-filled syringe out of the refrigerator.  
2. Do not remove the needle cover from the syringe until just before you are ready to inject. 
3. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed 

the last day of the month shown or if it has been kept outside of the refrigerator for more than 72 
hours or has otherwise expired.  

4. Check the appearance of Pelgraz. It must be a clear and colourless liquid. If there are particles in 
it, you must not use it.  

5. 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 
Pelgraz in any other way (for example, do not warm it in a microwave or in hot water).  

6. Wash your hands thoroughly.  
7. Find a comfortable, well-lit place and put everything you need where you can reach them (the 

pre-filled syringe and alcohol swab).  
 
How do I prepare my Pelgraz injection? 
 
Before you inject Pelgraz you must do the following:  
 
1.  Hold the syringe and gently take the cover from the needle without twisting. Pull straight as 

shown in pictures 1 and 2. Do not touch the needle or push the plunger.  
 

1 

 
 



 

30 
 

2 

 
  

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.  
 
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 (see picture 3).  
 

3 

 
 
If someone else is injecting you, they can also use the back of your arms (see picture 4) 
 



 

31 
 

4 

 
 
It is better to change the injection site every time to avoid the risk of soreness at any one site.  
 
How do I give my injection?  
 
a.  Disinfect the injection site by using an alcohol swab and pinch the skin between your thumb and 

forefinger, without squeezing it (see picture 5).  
 

5 

 
 
Pre-filled syringe with needle safety guard  
 
b.  Put the needle fully into the skin as shown by your nurse or doctor (see picture 6).  
c.  Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood 

in the syringe, remove the needle and re-insert it in another place.  
d.  Always keeping your skin pinched, depress the plunger slowly and evenly while grasping the 

finger flange until the entire dose has been given and the plunger cannot be depressed any 
further. Do not release the pressure on the plunger!  

e.  After injecting the liquid, while keeping the syringe at the same angle and maintaining pressure 
on the plunger, remove the needle and then let go of your skin. The protective sleeve will 
automatically cover the needle and an audible “click” will be heard to confirm shield activation 
(see picture 7). The needle guard will not activate unless the entire dose has been given.  

 



 

32 
 

6 

 

 
  

7 

 
 
Remember 
If you have any problems, please ask your doctor or nurse for help and advice.  
 
Disposing of used syringes  
 
Dispose of the syringe as instructed by your doctor, pharmacist or nurse. 
 
If you use more Pelgraz than you should 
 
If you use more Pelgraz than you should contact your doctor, pharmacist or nurse. 
 
If you forget to inject Pelgraz 
 
If you are injecting yourself and have forgotten your dose of Pelgraz, you should contact your doctor 
to discuss when you should inject the next dose. 
 



 

33 
 

If you stop using Pelgraz 
 
Your doctor will tell you when to stop using Pelgraz. It is quite normal to have a number of courses of 
treatment with Pelgraz. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, Pelgraz 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. 

 
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. 
• pain in the chest that is not caused by heart disease or a heart attack. 
• 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. 

 
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). 
• 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. 
• abnormal blood test results (lactate dehydrogenase, uric acid and alkaline phosphatase). 
• abnormal blood test results related to the liver (alanine aminotransferase and aspartate 

aminotransferase). 
• coughing up blood (haemoptysis) 
 
Rare side effects (may affect up to 1 in 1,000 people): 



 

34 
 

• 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 Pelgraz 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 Pelgraz 
 
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 and on the syringe label 
after EXP. The expiry date refers to the last day of that month. 
 
Store in a refrigerator (2°C – 8°C). 
 
Pelgraz may be exposed to room temperature (not above 25°C ± 2°C) for a maximum single period of 
up to 72 hours. Pelgraz left at room temperature for more than 72 hours should be discarded. For all 
questions about storage, ask your doctor, nurse or pharmacist. 
 
Do not freeze. Accidental exposure to freezing temperatures for a single period of less than 24 hours 
does not adversely affect the stability of Pelgraz. 
 
Keep the pre-filled syringe in the carton in order to protect from light. 
 
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 to protect the environment. 
 
 
6. Contents of the pack and other information  
 
What Pelgraz 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). 
 
What Pelgraz looks like and contents of the pack 
 
Pelgraz is a clear colourless solution for injection in a pre-filled syringe with an injection needle. Each 
pre-filled syringe contains 0.6 mL of solution.  
 
Pelgraz is available in packs containing 1 pre-filled syringe, with prefixed needle safety guard in 
individual blister pack and one alcohol swab. 
 

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


 

35 
 

Marketing Authorisation Holder and Manufacturer 
Marketing Authorisation Holder 
Accord Healthcare S.L.U.  
World Trade Center, Moll de Barcelona, s/n,  
Edifici Est 6ª planta,  
08039 Barcelona,  
Spain 
 
Manufacturer 
Accord Healthcare Limited  
Sage House, 319 Pinner Road  
North Harrow, Middlesex HA1 4HF  
United Kingdom 
 
Accord Healthcare Polska Sp.z o.o., 
ul. Lutomierska 50,95-200 Pabianice, Poland 
 
Accord Healthcare B.V. 
Winthontlaan 200, 3526 KV Utrecht, Netherlands 
 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
AT / BE / BG / CY / CZ / DE / DK / EE / EL / FI / FR / HR / HU / IS / LT / LV / LX/ MT / NL / NO / 
PT / PL / RO / SE / SI / SK / UK/ ES 
Accord Healthcare S.L.U. 
Tel: +34 93 301 00 64 

IT 
Accord Healthcare Limited  
Tel: +39 02 94323700 

 
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 
 
--------------------------------------------------------------------------------------------------------------------------- 
 
The following information is intended for medical or healthcare professionals only:  
 
Pelgraz does not contain any preservative. In view of the possible risk of microbial contamination, 
Pelgraz syringes are for single use only.  
 
Do not freeze. Accidental exposure to freezing temperatures for up to 24 hours does not affect the 
stability of Pelgraz. If exposure has been greater than 24 hours or frozen more than once, then Pelgraz 
should NOT be used. 

 
In order to improve traceability of granulocyte-colony stimulating factors, the medicine name 
(Pelgraz) and batch number of the administered syringe should be clearly recorded in the patient file. 
 
Using the pre-filled syringe with needle safety guard  
 
The needle safety guard covers the needle after injection to prevent needle stick injury. This does not 
affect normal operation of the syringe. Depress the plunger slowly and evenly until the entire dose has 
been given and the plunger cannot be depressed any further. While maintaining pressure on the 

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


 

36 
 

plunger, remove the syringe from the patient. The needle safety guard will cover the needle when 
releasing the plunger.  
 
Disposal  
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 



 

37 
 

Package leaflet: Information for the user 
 

Pelgraz 6 mg solution for injection in pre-filled injector 
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 symptoms 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 Pelgraz is and what it is used for 
2. What you need to know before you use Pelgraz 
3. How to use Pelgraz 
4. Possible side effects 
5. How to store Pelgraz 
6. Contents of the pack and other information 
 
 
1. What Pelgraz is and what it is used for 
 
Pelgraz 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. 
 
Pelgraz 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 Pelgraz 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. 
 
 
2. What you need to know before you use Pelgraz 
 
Do not use Pelgraz 
 
• if you are allergic to pegfilgrastim, filgrastim,  or any of the other ingredients of this medicine 

(listed in section 6). 
 



 

38 
 

Warnings and precautions 
 
Talk to your doctor, pharmacist or nurse before using Pelgraz 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. 
• have an allergy to latex. The needle cap on the pre-filled syringe contains a derivative of latex 

and may cause severe allergic reactions. 
• experience a cough, fever and difficulty breathing. This can be a sign of Acute Respiratory 

Distress Syndrome (ARDS). 
• 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. 

• 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). 

• 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). 

• 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. 

• have sickle cell anaemia. Your doctor may monitor your condition more closely. 
• 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. 

 
Your doctor will check your blood and urine regularly as Pelgraz can harm the tiny filters inside your 
kidneys (glomerulonephritis). 
 
Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Pelgraz . Stop 
using Pelgraz 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 Pelgraz, unless instructed by your 
doctor. 
 
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 (e.g. C-reactive protein and 
white blood cell count). Tell your doctor if you experience these symptoms. 
 
Loss of response to pegfilgrastim 
 
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 
 
The safety and efficacy of Pelgraz in children has not yet been established. Ask your doctor or 
pharmacist for advice before taking any medicine. 
 



 

39 
 

Other medicines and Pelgraz 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Pregnancy and breast-feeding 
 
Ask your doctor or pharmacist for advice before taking any medicine. Pelgraz has not been tested in 
pregnant women. It is important to tell your doctor if you: 
• are pregnant; 
• think you may be pregnant; or 
• are planning to have a baby. 
 
If you become pregnant during Pelgraz treatment, please inform your doctor.  
 
Unless your doctor directs you otherwise, you must stop breast-feeding if you use Pelgraz. 
 
Driving and using machines 
 
Pelgraz has no or negligible effect on the ability to drive or use machines. 
 
Pelgraz contains sorbitol (E420) and sodium acetate 
 
This medicinal product contains 50 mg sorbitol in each unit volume, which is equivalent to 30 mg per 
6 mg dose. 
 
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 Pelgraz 
 
Pelgraz is for use in adults aged 18 and over. 
 
Always take Pelgraz exactly as your doctor has told you. You should check with your doctor or 
pharmacist if you are unsure. The usual dose is one 6 mg subcutaneous injection (injection under your 
skin) using a pre-filled injector 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 Pelgraz vigorously as this may affect its activity. 
 
Injecting Pelgraz yourself 
 
Your doctor may decide that it would be more convenient for you to inject Pelgraz yourself. Your 
doctor or nurse will show you how to inject yourself. Do not try to inject yourself unless you have 
received special training from your doctor or nurse. 
 
The instructions how to inject yourself  
are given below, but proper treatment of your disease requires close and constant co-operation with 
your doctor. 
 
If you are not sure about giving yourself the injection or you have any questions, please ask your 
doctor or nurse for help. 
 
How do I inject Pelgraz myself? 
 



 

40 
 

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 injector of Pelgraz;  
• alcohol swab.  
 
What should I do before I give myself a subcutaneous injection of Pelgraz? 
 
1. Take the pre-filled injector out of the refrigerator.  
2. Check the expiry date on the pre-filled injector label (EXP). Do not use it if the date has passed 

the last day of the month shown or if it has been kept outside of the refrigerator for more than 72 
hours or has otherwise expired.  

3. Check the appearance of Pelgraz. It must be a clear and colourless liquid. If there are particles in 
it, you must not use it.  

4. For a more comfortable injection, let the pre-filled injector stand for 30 minutes to reach room 
temperature or hold the pre-filled injector gently in your hand for a few minutes. Do not warm 
Pelgraz in any other way (for example, do not warm it in a microwave or in hot water).  

5. Wash your hands thoroughly.  
6. Find a comfortable, well-lit place and put everything you need where you can reach them (the 

pre-filled injector and alcohol swab).  
 
How do I prepare my Pelgraz injection? 
 
Before you inject Pelgraz you must do the following:  
 

• Choose a clean, well-lit space to administer your medication. 
• Check expiration date on package. Do not use if expiration date has passed. 
• Gather an alcohol swab and a sharps container  

 
Preparation 
 

 

• Wash hands with soap under warm running water. 

 

• Choose injection site (Abdomen or thigh if a patient is injecting 
himself/herself, with the additional option of the back of the arm if 
a Healthcare Provider or caregiver is assisting them) 



 

41 
 

 

• Clean injection site: use an alcohol swab to wipe site clean. Allow 
to air dry. 

 
1. Pre-Injection 
 

 

• Inspect liquid in window. Check for any changes in colour, 
cloudiness or large particles. 

 

• Remove bottom cap: Twist and pull bottom cap to remove. Keep 
hands away from needle guard after cap is removed. Do not recap. 
Dispose of bottom cap immediately. Do not inject if you drop the 
pre-filled injector after removing cap. 

• Inject within 5 minutes of removing bottom cap. 

 
2. Injection 
 

 

• Place the injector straight onto your skin (about 90 degrees).  
 

 

• Push the handle straight down: The medicine will be injected as 
you push. Do this at a speed that is comfortable for you. 

• Do not lift the injector during injection. 



 

42 
 

 

• Injection is completed when the handle has been pushed down as 
far as possible, you hear a click and the orange body is no longer 
visible. 

 

• Lift straight up: The yellow band indicates that the needle guard 
is locked. 

 
3. Disposal 
 

 

• Dispose of the used Pelgraz pre-filled injector: Place injector in 
an approved sharps container. Regulations vary by region. Check 
with your doctor or pharmacist for proper disposal instructions. 
Do not dispose of injector in household trash. 

 
Remember 
If you have any problems, please ask your doctor or nurse for help and advice.  
 
If you use more Pelgraz than you should 
 
If you use more Pelgraz than you should contact your doctor, pharmacist or nurse. 
 
If you forget to inject Pelgraz 
 
If you are injecting yourself and have forgotten your dose of Pelgraz, you should contact your doctor 
to discuss when you should inject the next dose. 
 
If you stop using Pelgraz 
 
Your doctor will tell you when to stop using Pelgraz. It is quite normal to have a number of courses of 
treatment with Pelgraz. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, Pelgraz can cause side effects, although not everybody gets them. 
 



 

43 
 

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. 

 
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. 
• pain in the chest that is not caused by heart disease or a heart attack. 
• 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. 

 
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). 
• 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. 
• abnormal blood test results (lactate dehydrogenase, uric acid and alkaline phosphatase). 
• abnormal blood test results related to the liver (alanine aminotransferase and aspartate 

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

 



 

44 
 

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 Pelgraz 
 
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 and on the pre-filled 
injector label after EXP. The expiry date refers to the last day of that month. 
 
Store in a refrigerator (2°C – 8°C). 
 
Pelgraz may be exposed to room temperature (not above 25°C ± 2°C) for a maximum single period of 
up to 72 hours. Pelgraz left at room temperature for more than 72 hours should be discarded. For all 
questions about storage, ask your doctor, nurse or pharmacist. 
 
Do not freeze. Accidental exposure to freezing temperatures for a single period of less than 24 hours 
does not adversely affect the stability of Pelgraz. 
 
Keep the pre-filled injector in the carton in order to protect from light. 
 
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 to protect the environment. 
 
 
6. Contents of the pack and other information  
 
What Pelgraz contains 
 
- The active substance is pegfilgrastim. Each pre-filled injector 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). 
 
What Pelgraz looks like and contents of the pack 
 
Pelgraz is a clear colourless solution for injection in a pre-filled injector with an injection needle. Each 
pre-filled injector contains 0.6 mL of solution.  
 
Pelgraz is available in a pack containing 1 pre-filled injector in a monocarton and one alcohol swab. 
 
Marketing Authorisation Holder and Manufacturer 
Marketing Authorisation Holder 
Accord Healthcare S.L.U. 
World Trade Center, Moll de Barcelona, s/n 
Edifici Est 6a planta, 
08039 Barcelona, 
Spain 
 
 

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


 

45 
 

Manufacturer 
Accord Healthcare Limited  
Sage House, 319 Pinner Road  
North Harrow, Middlesex HA1 4HF  
United Kingdom 
 
Accord Healthcare Polska Sp.z o.o., 
ul. Lutomierska 50,95-200 Pabianice, Poland 
 
Accord Healthcare B.V. 
Winthontlaan 200, 3526 KV Utrecht, Netherlands 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
AT / BE / BG / CY / CZ / DE / DK / EE / EL / FI / FR / HR / HU / IS / LT / LV / LX/ MT / NL / NO / 
PT / PL / RO / SE / SI / SK / UK 
Accord Healthcare S.L.U. 
Tel: +34 93 301 00 64 

IT 
Accord Healthcare Limited  
Tel: +39 02 94323700 

 
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 
 
--------------------------------------------------------------------------------------------------------------------------- 
 
The following information is intended for medical or healthcare professionals only:  
 
Pelgraz does not contain any preservative. In view of the possible risk of microbial contamination, 
Pelgraz in pre-filled injector are for single use only.  
 
Do not freeze. Accidental exposure to freezing temperatures for up to 24 hours does not affect the 
stability of Pelgraz. If exposure has been greater than 24 hours or frozen more than once, then Pelgraz 
should NOT be used. 

 
In order to improve traceability of granulocyte-colony stimulating factors, the medicine name 
(Pelgraz) and batch number of the administered pre-filled injector should be clearly recorded in the 
patient file. 
 
Disposal  
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
 
 
 
 

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

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