Pelgraz

Patient Information Leaflet

Pelgraz 6 mg solution for injection in pre-filled syringe

pegfilgrastim
Please read all of this leaflet carefully before you use this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as yours, because it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Pelgraz is and what it is used for
2. What you need to know before using 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 using biotechnology in a bacterial cell called Escherichia coli.
It belongs to a group of proteins known as cytokines and is very similar to a natural protein (granulocyte colony-stimulating factor) produced by our body.
Pelgraz is used to reduce the duration of neutropenia (low number of white blood cells) and the occurrence of febrile neutropenia (low number of white blood cells with fever) that may be caused by cytotoxic chemotherapy (medicines that destroy rapidly growing cells). White blood cells are important because they help the body fight infections. These cells are highly sensitive to the effects of chemotherapy; this can cause a decrease in the number of these cells in the body. If the number of white blood cells drops to a low level, there may not be enough left to fight bacteria, and you may be at increased risk of developing an infection.
Your doctor has prescribed Pelgraz to stimulate the bone marrow (the part of the bone that produces blood cells) to produce more white blood cells, helping your body to fight infections.

2. What you need to know before using Pelgraz

Do not use Pelgraz

• if you are allergic to pegfilgrastim, filgrastim, or any of the excipients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Pelgraz if:

• you have an allergic reaction including weakness, low blood pressure, difficulty breathing, facial swelling (anaphylaxis), redness and flushing, rash, or itchy skin areas.
• you are allergic to latex. The needle cap of the pre-filled syringe contains a latex derivative which may cause severe allergic reactions.
• you have cough, fever, and difficulty breathing. This may be a sign of Acute Respiratory Distress Syndrome (ARDS).
• you experience one or more of the following side effects:
  • swelling or bloating, which may be associated with reduced fluid passage, difficulty breathing, abdominal swelling, feeling of fullness, and a general feeling of fatigue. These could be symptoms of a condition called "Capillary Leak Syndrome" that causes leakage of blood from small vessels in the body. See section 4.
• you have pain in the upper left side of the abdomen or shoulder tip pain. These could be signs of a spleen problem (splenomegalia).
• you have recently had a severe lung infection (pneumonia), fluid in the lungs (pulmonary edema), lung inflammation (pulmonary interstitial disease), or an abnormal X-ray finding (pulmonary infiltration).
• you know you have abnormal blood cell counts (e.g. increased white blood cells or anemia) or a decrease in platelet levels, which reduces the body's ability to clot (thrombocytopenia). Your doctor may wish to monitor you closely.
• you have sickle cell anemia. Your doctor may wish to monitor you closely.
• if you have breast or lung cancer, Pelgraz in combination with chemotherapy and/or radiotherapy may increase the risk of a pre-leukemic blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms may include fatigue, fever, and easy bruising or bleeding.
• you suddenly develop signs of allergy such as skin rash, hives, or itching, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or difficulty breathing—these could be signs of a severe allergic reaction.
• you have symptoms of inflammation of the aorta (a large blood vessel carrying blood from the heart to the rest of the body), which has been rarely reported in cancer patients and healthy individuals. Symptoms may include fever, abdominal pain, malaise, back pain, and increased markers of inflammation (e.g., C-reactive protein and white blood cell count). Contact your doctor if you experience these symptoms. Your doctor will regularly check your blood and urine, as Pelgraz may damage the tiny filters in your kidneys (glomerulonephritis).

Severe skin reactions (Stevens-Johnson syndrome) have been observed with the use of Pelgraz. If you notice any of the symptoms described in section 4, stop using Pelgraz and seek immediate medical attention.
You should discuss with your doctor the risks of developing blood cancer. If you have or suspect you may have blood cancer, you must not use Pelgraz unless otherwise directed by your doctor.

Loss of response to pegfilgrastim
If you experience a decreased response or failure to maintain response to pegfilgrastim treatment, your doctor will investigate possible causes, including the possibility that you have developed antibodies that neutralize the activity of pegfilgrastim.

Children and adolescents
The safety and efficacy of Pelgraz in children have not been established. Consult your doctor or pharmacist before taking this medicine.

Other medicines and Pelgraz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. Pelgraz has not been studied in pregnant women. It is important that you inform your doctor if:

• you are pregnant;
• you suspect you may be pregnant; or
• you are planning to become pregnant.

If you become pregnant while being treated with Pelgraz, inform your doctor.
Unless otherwise advised by your doctor, you must stop breastfeeding while using Pelgraz.

Driving and using machines
Pelgraz does not affect or has negligible influence on the ability to drive or operate machinery.

Pelgraz contains sorbitol (E420) and sodium acetate
This medicine contains 30 mg of sorbitol per pre-filled syringe, equivalent to 50 mg/mL.
This medicine contains less than 1 mmol of sodium (23 mg) per 6 mg dose, i.e., essentially "sodium-free".

3. How to use Pelgraz

Pelgraz is indicated for adults aged 18 years and older.
Always take Pelgraz exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist. The usual dose is one subcutaneous injection (an injection under the skin) of 6 mg using a pre-filled syringe, which must be administered at least 24 hours after the last dose of chemotherapy at the end of each chemotherapy cycle.
Do not shake Pelgraz vigorously, as this may impair its activity.

How to self-administer the Pelgraz injection
Your doctor may consider it appropriate for you to self-inject Pelgraz. Your doctor or nurse will show you how to administer the injection. Do not attempt to inject the medicine yourself unless you have been specifically trained by your doctor or nurse.

Instructions on how to self-administer the Pelgraz injection are provided below; however, proper management of your condition requires close and continuous collaboration with your doctor.
If you have any questions or concerns about self-injection, consult your doctor or nurse.

How to perform a self-injection of Pelgraz?
You will need to administer the injection yourself into the tissue beneath the skin, known as a subcutaneous injection.

Materials required
To perform the subcutaneous injection, you will need:

• one pre-filled syringe of Pelgraz
• an alcohol swab

What should I do before administering a subcutaneous injection of Pelgraz?

1. Remove the pre-filled syringe from the refrigerator.
2. Do not remove the protective needle cap until you are ready to administer the injection.
3. Check the expiry date on the label of the pre-filled syringe (Exp.). Do not use if the expiry date (the last day of the month indicated) has passed, if the syringe has not been refrigerated for more than 15 days, or if it is expired.
4. Inspect the appearance of Pelgraz. It should be a clear, colourless liquid. Do not use if particles are present.
5. For a more comfortable injection, leave the pre-filled syringe at room temperature for half an hour to allow it to warm up, or hold it gently in your hand for a few minutes. Do not heat Pelgraz in any other way (for example, do not heat it in a microwave or in warm water).
6. Wash your hands thoroughly.
7. Find a comfortable, well-lit surface and have everything you need within reach (pre-filled syringe and alcohol swab).

How do I prepare the Pelgraz injection?
Before administering the Pelgraz injection, perform the following steps:
Do not use a pre-filled syringe if it has fallen on a hard surface.

Step 1: Check the integrity of the system
Ensure that the system is intact/undamaged. Do not use the product if any damage is visible (e.g., broken syringe or needle shield) or if components are missing, or if the needle shield is in the safety position before use, as shown in Figure 9, since this indicates that the system has already been activated. In general, do not use the product if it does not match Figure 1. In such cases, dispose of the product in a biological hazard container.

Image 1

Step 2: Remove the needle cap

1. Remove the protective cap as shown in Figure 2. Hold the needle shield body in one hand with the needle tip pointing away from the operator, without touching the plunger rod. With the other hand, pull off the needle cap. After removal, dispose of the needle cap in a biological hazard container.
2. You may notice a small air bubble in the pre-filled syringe. Do not remove the air bubble before injection. Injecting the solution with the air bubble is harmless.
3. The pre-filled syringe is now ready for use.

Figure 2

Where should I administer the injection?
The most suitable injection sites are:

• the upper thigh; and
• the abdomen, except the area around the navel (see Figure 3).

Figure 3

If someone else is administering the injection, the back of the upper arms may also be used (see Figure 4).
Figure 4

It is recommended to rotate the injection site each time to minimize the risk of local soreness.

How do I administer the injection?
Disinfect the skin at the injection site with an alcohol swab and gently pinch the skin between your thumb and index finger without compressing it (see Figure 5).
Figure 5

Step 3: Inserting the needle

• Gently pinch the skin at the injection site with one hand;
• With the other hand, insert the needle into the injection site without touching the plunger rod (at an angle of 45–90 degrees) (see Figures 6 and 7).

Figure 6

Figure 7

Pre-filled syringe with needle safety device

• Insert the needle into the skin as demonstrated by your nurse or doctor.
• Gently pull back on the plunger to check that you have not punctured a blood vessel. If blood appears in the syringe, withdraw the needle and insert it at another site.
• Administer the dose prescribed by your doctor, following the instructions below:

Step 4: Injection
Place your thumb on the plunger rod head. Press the plunger rod and push firmly at the end of the injection to ensure complete emptying of the syringe (see Figure 8). Hold the skin firmly until the injection is complete.
Figure 8

Step 5: Needle tip protection
The safety mechanism activates when the plunger rod is fully depressed:

• Keep the syringe steady and slowly lift your thumb from the plunger rod head;
• The plunger rod will move upward with your thumb, and the spring will retract the needle into the needle safety shield (see Figure 9).

Figure 9

Important reminders
If you experience any difficulties, do not hesitate to contact your doctor or nurse for help and advice.

Disposal of used syringes
Dispose of used syringes as instructed by your doctor, pharmacist, or nurse.

If you use more Pelgraz than you should
If you use more Pelgraz than prescribed, contact your doctor, pharmacist, or nurse.

If you forget to administer the Pelgraz injection
If you are self-injecting and have missed your dose of Pelgraz, contact your doctor to determine when to administer the next injection.

If you stop administering Pelgraz
Your doctor will advise you when to stop using this medicine. It is normal to undergo a series of Pelgraz treatments.

For further information on the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any one or a combination of the following side effects:

• swelling or puffiness, which may be associated with reduced urination, difficulty breathing, abdominal swelling and a feeling of fullness, and a general feeling of fatigue. These symptoms usually develop rapidly.

These could be symptoms of an uncommon condition (may affect up to 1 in 100 people) called "Capillary Leak Syndrome", which causes fluid to leak from small blood vessels into the body and requires urgent medical treatment.

Very common side effects (may affect more than 1 in 10 people):

• bone pain. Your doctor will advise you on what to take to relieve bone pain.
• nausea and headache.

Common side effects (may affect up to 1 in 10 people):

• pain at the injection site.
• general pain and joint and muscle aches.
• chest pain not caused by heart disease or heart attack.
• some blood changes may occur, but these will be detected during routine blood tests. White blood cell levels may rise temporarily. Platelet levels may decrease, leading to bruising.

Uncommon side effects (may affect up to 1 in 100 people):

• allergic-type reactions, including flushing and hot flushes, skin rash (reddening of the skin), and itchy skin swellings.
• severe allergic reactions including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, facial swelling).
• enlargement of the spleen.
• rupture of the spleen. Some cases of spleen rupture have been fatal. It is important to contact your doctor immediately if you feel pain in the upper left side of your abdomen or left shoulder, as this may indicate spleen problems.
• breathing problems. If you develop cough, fever, and difficulty breathing, contact your doctor.
• cases of Sweet’s syndrome (purple, raised, and painful skin lesions on the limbs and sometimes on the face and neck, associated with fever), although other factors may have contributed.
• cutaneous vasculitis (inflammation of the skin blood vessels).
• damage to the tiny filters in the kidneys (glomerulonephritis).
• redness at the injection site.
• abnormal blood test results (lactate dehydrogenase, uric acid, and alkaline phosphatase).
• abnormal liver blood test results (alanine aminotransferase and aspartate aminotransferase).
• coughing up blood (haemoptysis).
• blood disorders (myelodysplastic syndrome [MDS] or acute myeloid leukaemia [AML]).

Rare side effects (may affect up to 1 in 1,000 people):

• inflammation of the aorta (the large blood vessel carrying blood from the heart to the rest of the body), see section 2.
• bleeding from the lung (pulmonary haemorrhage).
• Stevens-Johnson syndrome, which may present as reddish patches or round spots, often with central blisters, located on the trunk, skin peeling, mouth ulcers, and sores in the throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms. If you develop these symptoms, stop using Pelgraz and contact your doctor or seek immediate medical help. See also section 2.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. 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 stated on the carton and on the label of the
syringe after "Exp". The expiry date refers to the last day of that month.
Store this medicine in a refrigerator (2°C – 8°C).
Pelgraz may be stored at room temperature (not above 25°C ± 2°C) only once and for a
maximum period of 15 days. Pelgraz left at room temperature for more than 15 days must be
discarded. For any doubts regarding storage, consult your doctor, nurse, or pharmacist.
Do not freeze this medicine. Accidental exposure to freezing temperatures once for less than
24 hours does not compromise the efficacy of Pegraz.
Keep the pre-filled syringe in its outer packaging to protect the medicine from light.
Do not use this medicine if you notice that it is cloudy or if particles are visible.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer used. This will help protect the environment.

6. Package contents 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 components are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections (see section 2).

Description of the appearance of Pelgraz and package contents
Pelgraz is a clear, colourless injectable solution in a pre-filled syringe with a needle. Each pre-filled
syringe contains 0.6 mL of solution.
Pelgraz is available in packs of 1 pre-filled syringe, with automatic needle protection, in a single blister
with an alcohol-impregnated swab.
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 Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
For further information on this medicinal product, please contact the local representative of the
Marketing Authorisation Holder.
AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IS / LT / LV / LX / MT / NL / NO
/ PT / PL / RO / SE / SI / SK / ES
Accord Healthcare S.L.U. IT
Tel: +34 93 301 00 64 Accord Healthcare Italia
Tel: +39 02 94323700
EL
Win Medica Pharmaceutical S.A.
Tel: +30 210 7488 821
Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu
_________________________________________________________________________________

The following information is intended for healthcare professionals only:

Pelgraz does not contain preservatives. The supplied syringes are for single use only to avoid any risk of
microbial contamination.
Do not freeze. Accidental exposure to freezing temperatures, once for less than
24 hours, does not impair the stability of Pelgraz. DO NOT use if exposure exceeds 24 hours
or is repeated.
To optimize traceability of granulocyte colony-stimulating factors, it is necessary
to clearly record the name (Pelgraz) and the batch number of the administered syringe in the
patient's medical record.
Use of the pre-filled syringe with needle safety device
The needle safety device covers the needle after injection and prevents the operator from needle-stick injury. The
device does not interfere with the normal use of the syringe. Press the plunger rod and push firmly
at the end of the injection to ensure complete emptying of the syringe. Hold the skin firmly until the injection is complete. Keep the syringe steady and slowly lift the thumb from the plunger head. The plunger rod moves upward with the thumb and the spring retracts the needle from the injection site into the needle shield.
Do not use a pre-filled syringe if it has fallen onto a hard surface.
Disposal
Dispose of any medicinal product or waste material in accordance with local requirements.

Package leaflet: information for the user

Pelgraz 6 mg solution for injection in a pre-filled syringe

pegfilgrastim
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Pelgraz is and what it is used for
2. What you need to know before using 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 using biotechnology in a bacterial cell called E. coli. It belongs to a group of proteins known as cytokines and is very similar to a natural protein (granulocyte colony-stimulating factor) produced by our 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 fever) that may be caused by cytotoxic chemotherapy (medicines that destroy rapidly growing cells). White blood cells are important because they help the body fight infections. These cells are highly sensitive to the effects of chemotherapy; this can cause a decrease in the number of these cells in the body. If the white blood cell count drops to a low level, there may not be enough cells left to fight bacteria, and you may be at increased risk of developing an infection.
Your doctor has prescribed Pelgraz to stimulate the bone marrow (the part of the bone responsible for producing blood cells) to produce more white blood cells, helping your body to fight infections.

2. What you need to know before using Pelgraz

Do not use Pelgraz

• if you are allergic to pegfilgrastim, filgrastim, or any of the excipients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Pelgraz if:

• you have an allergic reaction including weakness, low blood pressure, difficulty breathing, facial swelling (anaphylaxis), redness, flushing, rash, or itchy skin areas.
• you are allergic to latex. The needle cap of the pre-filled syringe contains a latex derivative which may cause severe allergic reactions.
• you have cough, fever, and difficulty breathing. This may be a sign of Acute Respiratory Distress Syndrome (ARDS).
• you experience one or more of the following side effects:
  • swelling or bloating, which may be associated with reduced fluid passage, difficulty breathing, abdominal swelling and fullness, and a general feeling of fatigue. These could be symptoms of a condition called "Capillary Leak Syndrome" that causes blood to leak from small vessels in the body. See section 4.
• you have pain in the upper left side of the abdomen or shoulder tip pain. These could be signs of a spleen problem (splenomegaly).
• you have recently had a severe lung infection (pneumonia), fluid in the lungs (pulmonary edema), lung inflammation (pulmonary interstitial disease), or an abnormal finding on X-ray (pulmonary infiltration).
• you know you have abnormal blood cell counts (e.g. elevated white blood cells or anemia) or decreased platelet levels, reducing your body's ability to clot (thrombocytopenia). Your doctor may wish to monitor you closely.
• you have sickle cell anemia. Your doctor may wish to monitor you closely.
• if you have breast or lung cancer, Pelgraz in combination with chemotherapy and/or radiotherapy may increase the risk of a pre-cancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms may include fatigue, fever, and easy bruising or bleeding.
• you suddenly develop signs of allergy such as rash, hives, or skin itching, swelling of the face, lips, tongue, or other body parts, shortness of breath, wheezing, or difficulty breathing—these could be signs of a severe allergic reaction.
• you have symptoms of inflammation of the aorta (a large blood vessel carrying blood from the heart to the rest of the body), which has been reported rarely in cancer patients and healthy individuals. Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., C-reactive protein and white blood cell count). Contact your doctor if you experience these symptoms.

Your doctor will regularly check your blood and urine, as Pelgraz may damage the tiny filters in your kidneys (glomerulonephritis).
Severe skin reactions (Stevens-Johnson syndrome) have been observed with the use of Pelgraz. If you notice any of the symptoms described in section 4, stop using Pelgraz and seek immediate medical attention.
You should discuss with your doctor the risks of developing blood cancer. If you have or may have blood cancer, you must not use Pelgraz unless instructed otherwise by your doctor.

Loss of response to pegfilgrastim
If you experience a reduced response or failure to maintain response to treatment with pegfilgrastim, your doctor will investigate possible reasons, including the possibility that you have developed neutralizing antibodies against pegfilgrastim.

Children and adolescents
The safety and efficacy of Pelgraz in children have not been established. Consult your doctor or pharmacist before taking this medicine.

Other medicines and Pelgraz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. Pelgraz has not been studied in pregnant women. It is important that you inform your doctor if:

• you are pregnant;
• you suspect you may be pregnant; or
• you are planning to become pregnant.

If you become pregnant while being treated with Pelgraz, inform your doctor.
Unless your doctor advises otherwise, you must stop breastfeeding while using Pelgraz.

Driving and using machines
Pelgraz does not affect or has a negligible effect on the ability to drive or operate machinery.

Pelgraz contains sorbitol (E420) and sodium
This medicine contains 30 mg of sorbitol per pre-filled injector, equivalent to 50 mg/mL.
This medicine contains less than 1 mmol (23 mg) of sodium per 6 mg dose, i.e., essentially “sodium-free”.

3. How to use Pelgraz

Pelgraz is indicated for adults aged 18 years and older.
Always take Pelgraz exactly as directed by your doctor. If you have any doubts, consult your doctor or
pharmacist. The usual dose is one 6 mg subcutaneous injection (injection under the skin) administered via a pre-filled syringe, which must be given at least 24 hours after the last dose of
chemotherapy at the end of each chemotherapy cycle.
Do not shake Pelgraz vigorously, as this may impair its activity.

How to self-administer a Pelgraz injection
Your doctor may consider it appropriate for you to self-inject Pelgraz. Your doctor or
nurse will show you how to administer the Pelgraz injection. Do not attempt to inject the medicine yourself
until you have been specifically trained by your doctor or nurse.

Instructions on how to self-administer a Pelgraz injection are provided below; however, proper management of your condition requires close and continuous collaboration with your doctor.
If you have any questions or concerns about self-injection, consult your doctor or nurse.

How to perform a Pelgraz self-injection?
You will need to administer the injection yourself into the tissue beneath the skin, known as a subcutaneous injection.

Materials needed
To perform the subcutaneous injection, you will need:

• one pre-filled syringe of Pelgraz
• an alcohol swab

What should I do before administering a subcutaneous injection of Pelgraz?

1. Remove the pre-filled syringe from the refrigerator.
2. Check the expiry date on the label of the pre-filled syringe (Exp.). Do not use it if the expiry date (the last day of the month indicated) has passed, if the syringe has not been refrigerated for more than 15 days, or if it is expired.
3. Inspect the appearance of Pelgraz. It should be a clear, colourless liquid. Do not use it if particles are visible.
4. For a more comfortable injection, leave the pre-filled syringe outside the refrigerator for half an hour to allow it to reach room temperature, or hold it gently in your hand for a few minutes. Do not heat Pelgraz in any other way (for example, do not heat it in a microwave or in warm water).
5. Wash your hands thoroughly.
6. Find a comfortable, well-lit surface and have everything you need within reach (pre-filled syringe and alcohol swab).

How do I prepare the Pelgraz injection?
Before administering the Pelgraz injection, carry out the following steps:

• Choose a clean, well-lit place to administer the treatment.
• Check the expiry date on the packaging. Do not use the product if the expiry date has passed.
• Prepare an alcohol swab and a sharps container.

Preparation

• Wash your hands with soap and running warm water.

• Choose the injection site (abdomen or thigh for self-administration; additionally, the back of the upper arm may be used if administered by a healthcare professional or caregiver).

• Disinfect the injection site: use an alcohol swab to clean the area. Allow it to air dry.

1. Before injection

• Check the liquid in the viewing window. Make sure there are no changes in color, cloudiness, or large particles.

• Remove the cap at the bottom: twist and pull it off. Keep your hands away from the needle cover after removing the cap. Do not reinsert the cap. Dispose of it immediately. Do not inject the solution if the pre-filled injector falls on the ground after removing the cap.
• Proceed with the injection within 5 minutes after removing the bottom cap.

2. Injection

• Place the injector directly onto the skin (at approximately 90 degrees).

• Push the plunger down. The medication will be released as you push. Proceed at the speed you find most comfortable.
• Do not lift the injector during the injection.

• The injection is complete when the plunger has been pushed down as far as possible, you hear a click, and the orange body is no longer visible.

• Lift upwards: the yellow strip indicates that the needle cover is locked.

3. Disposal

• Dispose of the used Pelgraz pre-filled injector: place the injector in a dedicated sharps container. Regulations may vary depending on your region. Please check with your doctor or pharmacist for instructions on proper disposal. Do not throw the injector into regular household waste.

To remember
If you have any problems, do not hesitate to consult 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 perform the self-injection and have forgotten your dose of Pelgraz, you must contact your doctor to determine when to administer the next injection.
If you stop using Pelgraz
Your doctor will advise you when to stop using this medicine. It is normal to undergo a series of treatments with Pelgraz.
For further information on the use of this medicine, please consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor immediately if you experience any one or a combination of the following side effects:

• swelling or puffiness, which may be associated with less frequent urination, difficulty breathing, abdominal swelling and a feeling of fullness, and a general feeling of fatigue. These symptoms usually develop rapidly.

These could be symptoms of an uncommon condition (may affect up to 1 in 100 people) called "Capillary Leak Syndrome," which causes blood to leak out of small blood vessels into the body and requires urgent medical treatment.

Very common side effects (may affect more than 1 in 10 people):

• bone pain. Your doctor will advise you on what to take to relieve bone pain.
• nausea and headache.

Common side effects (may affect up to 1 in 10 people):

• pain at the injection site.
• general discomfort and joint and muscle pain.
• chest pain not caused by heart disease or heart attack.
• some changes may occur in the blood, but these will be detected during routine blood tests. White blood cell levels may temporarily increase. Platelet levels may decrease, leading to bruising.

Uncommon side effects (may affect up to 1 in 100 people):

• allergic-type reactions, including flushing and hot flushes, skin rash (reddening of the skin), and itchy skin swellings.
• severe allergic reactions including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, facial swelling).
• enlargement of the spleen.
• rupture of the spleen. Some cases of spleen rupture have been fatal. It is important to contact your doctor immediately if you feel pain in the upper left side of your abdomen or left shoulder, as this may indicate spleen problems.
• breathing problems. If you develop cough, fever, and difficulty breathing, contact your doctor.
• cases of Sweet's syndrome (painful, raised, purplish skin lesions on the limbs and sometimes on the face and neck, associated with fever) have been reported, although other factors may have contributed.
• cutaneous vasculitis (inflammation of the blood vessels in the skin).
• damage to the tiny filters within the kidneys (glomerulonephritis).
• redness at the injection site.
• abnormal blood test results (lactate dehydrogenase, uric acid, and alkaline phosphatase).
• abnormal liver blood test results (alanine aminotransferase and aspartate aminotransferase).
• coughing up blood (haemoptysis).
• blood disorders (myelodysplastic syndrome [MDS] or acute myeloid leukaemia [AML]).

Rare side effects (may affect up to 1 in 1,000 people):

• inflammation of the aorta (the large blood vessel carrying blood from the heart to the rest of the body), see section 2.
• bleeding from the lung (pulmonary haemorrhage).
• Stevens-Johnson syndrome, which may present as reddish patches or round spots, often with central blisters, located on the trunk, skin peeling, mouth ulcers, and sores in the throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms. If you develop these symptoms, stop using Pelgraz and contact your doctor or seek immediate medical assistance. See also section 2.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. 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 stated on the box and on the label of the pre-filled injector after Exp. The expiry date refers to the last day of that month.
Store this medicine in the refrigerator (2°C – 8°C).
Pelgraz may be stored at room temperature (not above 25°C ± 2°C) only once and for a maximum period of 15 days. Pelgraz left at room temperature for more than 15 days must be discarded. For any doubts regarding storage, consult your doctor, nurse, or pharmacist.
Do not freeze this medicine. Accidental exposure to freezing temperatures once for less than 24 hours will not compromise the efficacy of Pelgraz.
Keep the pre-filled injector in its packaging to protect the medicine from light.
Do not use this medicine if it appears cloudy or if particles are visible.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents 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 components are sodium acetate, sorbitol (E420), polysorbate 20, and water for injections (see section 2).

Description of the appearance of Pelgraz and contents of the pack
Pelgraz is a clear, colourless injectable solution in a pre-filled syringe with a needle attached. Each
pre-filled syringe contains 0.6 mL of solution.
Pelgraz is available in packs of 1 pre-filled syringe in a single carton pack with an alcohol swab.

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 Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IS / LT / LV / LX / MT / NL / NO / PT / PL / RO / SE / SI / SK / ES
Accord Healthcare S.L.U. IT
Tel: +34 93 301 00 64 Accord Healthcare Italia
Tel: +39 02 94323700

EL
Win Medica Pharmaceutical S.A.
Tel: +30 210 7488 821

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

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The following information is intended exclusively for healthcare professionals:

Pelgraz does not contain preservatives. The supplied pre-filled syringes are for single use only to avoid
any risk of microbial contamination.
Do not freeze. Accidental exposure to freezing temperatures for less than 24 hours, on a single occasion,
does not compromise the stability of Pelgraz. DO NOT use if exposure exceeds 24 hours or is repeated.
To optimize traceability of granulocyte colony-stimulating factors, it is necessary to clearly record
the name (Pelgraz) and the batch number of the administered pre-filled syringe in the patient's medical record.
Disposal
Dispose of any medicinal product or waste material in accordance with local requirements.