PELGRAZ 6 mg Инъекционный Раствор

Содержание инструкции

1. Pelgraz 6 mg injectable solution in pre-filled syringe
   1. What is Pelgraz and what is it 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. Package contents and other information
2. Pelgraz 6 mg injectable solution in pre-filled injector
   1. What is Pelgraz and what is it used for
   2. What you need to know before you use Pelgraz
   3. How to use Pelgraz
   4. Before the injection
   5. Injection
   6. Disposal
   7. Possible side effects
   8. How to store Pelgraz
   9. Contents of the pack and other information

Pelgraz 6 mg injectable solution in pre-filled syringe

pegfilgrastim

Read this leaflet carefully before using this medicine as 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, 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 is Pelgraz and what is it used for

Pelgraz contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced using a
biotechnological technique in a bacterial cell called Escherichia coli. It belongs to a
group of proteins called 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 can 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 very
sensitive to the effects of chemotherapy; this can cause a decrease in the number of these cells
present 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 greater risk of contracting
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 to help the body 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 other ingredients 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, swelling of the face (anaphylaxis), redness and flushing, skin rash and itchy skin areas.
• you have an allergy to latex. The needle cover of the pre-filled syringe contains a latex derivative that may cause serious allergic reactions.
• you have cough, fever and difficulty breathing. This may be a sign of Acute Respiratory Distress Syndrome (ARDS).
• you have one or more of the following side effects:
• swelling or bloating, which may be associated with reduced fluid passage, difficulty breathing, abdominal swelling and a feeling of fullness and a general feeling of fatigue. These could be symptoms of a condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels in the body. See section 4.
• you have pain in the upper left side of your abdomen or pain in the tip of your shoulder. These could be signs of a problem with the spleen (splenomegaly).
• you have recently had a severe lung infection (pneumonia), fluid in the lungs (pulmonary edema), inflammation of the lungs (interstitial lung disease) or an abnormality found on an X-ray (pulmonary infiltrate).
• 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 want to monitor you closely.
• you have sickle cell anemia. Your doctor may want 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 have 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 that carries blood from the heart to the rest of the body), this has been reported rarely in cancer patients and healthy people. Symptoms include fever, abdominal pain, malaise, back pain and increased markers of inflammation (e.g., C-reactive protein and white blood cell count). See a doctor if you notice these symptoms. The doctor will regularly check your blood and urine, as Pelgraz can damage the tiny filters inside 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 talk to your doctor about the risks of developing a blood cancer. If you have or may have a
blood cancer, you should not use Pelgraz unless directed to do so by your doctor.

Loss of response to pegfilgrastim
If you have a decrease in response or failure to maintain response to treatment
with pegfilgrastim, your doctor will investigate the reasons, 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
Tell 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
tested in pregnant women. It is important to tell your doctor if:

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

If you find yourself to be pregnant during treatment with Pelgraz, tell your doctor.
Unless your doctor tells you otherwise, you should stop breastfeeding if you use Pelgraz.

Driving and using machines
Pelgraz does not alter or negligibly alters the ability to drive and operate
machines.

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, that is to say essentially
“sodium-free”.

3. How to use Pelgraz

Pelgraz is indicated in adults aged 18 years or older.
Always take Pelgraz exactly as your doctor has instructed. If you have any doubts, consult your doctor or
pharmacist. The usual dose is a subcutaneous injection (injection under the skin) of 6 mg with 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 compromise its activity.

How to give yourself a Pelgraz injection
Your doctor may believe that it is best for you to give yourself the Pelgraz injection. Your doctor or
nurse will show you how to give yourself a Pelgraz injection. Do not attempt to inject the medicine yourself
before being specifically trained by your doctor or nurse.
Instructions on how to give yourself a Pelgraz injection are provided below, however, proper treatment of the condition requires close and ongoing collaboration with your doctor.
If you have any doubts or questions about self-injection, contact your doctor or nurse.

How to perform a Pelgraz self-injection?
You will need to inject yourself into the tissue under the skin, which is called a subcutaneous
injection.

Requiredmaterial
To perform the subcutaneous injection, you will need:

• a pre-filled syringe of Pelgraz
• cotton ball soaked in alcohol

What do I have to do before giving myself a subcutaneous injection of Pelgraz?

• 1. Remove the pre-filled syringe from the refrigerator.
• 2. Do not remove the protective cap from the needle until you are ready to give the injection.
• 3. Check the expiration date on the label of the pre-filled syringe (Exp.). Do not use it if the expiration date (the last day of the month indicated) has passed or 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 and colorless liquid. Do not use it if particles are present.
• 5. For a more comfortable injection, leave the pre-filled syringe out of the refrigerator for half an hour so that it reaches 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 hot water).
• 6. Wash your hands thoroughly.
• 7. Find a comfortable, well-lit surface and keep everything you need (pre-filled syringe and cotton ball soaked in alcohol) within reach.

How do I prepare the Pelgraz injection?
Before giving yourself a Pelgraz injection, you must perform the following operations:

Do not use a pre-filled syringe if it has fallen onto a hard surface.
Step 1: Integrity check of the system
Make sure the system is intact/not damaged. Do not use the product if damage is noticed
(breakage of the syringe or needle protection) or if components are lost and if the needle protection
is in the safety position before use, as shown in Figure 9, because this indicates that the
system is already in operation. In general, the product should not be used if it does not comply with
Figure 1. In this case, dispose of the product in a biological risk container.

Image 1.

Step 2: Removing the needle cap

• 1. Remove the protective cap as shown in Figure 2. Hold the needle protection body in one hand with the needle tip facing away from the operator and without touching the plunger rod. With the other hand, pull off the needle cap. After removal, discard the needle cap in a biological risk container.
• 2. You may notice a small air bubble in the pre-filled syringe. You do not need to remove the air bubble before the injection. Injecting the solution with the air bubble is harmless.
• 3. You can now use the pre-filled syringe.

Figure 2

Where should I give myself the injection?
The most suitable places to give yourself the injection are:

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

Figure 3

If another person is giving you the injection, you can also use the back of your arms (see
Figure 4).

Figure 4

It is recommended to change the injection site each time to avoid the risk of soreness at the
site.

How do I give myself the injection?
Disinfect the skin at the injection site with a cotton ball soaked in alcohol and lift
the skin between your thumb and index finger without pinching it (see Figure 5).

Figure 5

Step 3: Needle insertion

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

Figure 6

Figure 7

Prefilled syringe with safety device for the needle

• Penetrate the needle into the skin as shown by the nurse or doctor
• Gently pull the plunger to check that you have not punctured a blood vessel. If blood is present in the syringe, remove the needle and penetrate it into another point.
• Inject the dose indicated by the doctor following the instructions below:

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

Figure 8

Step 5: Needle tip protection
The safety system is activated when the plunger rod is fully depressed:

• Hold the syringe firmly and slowly lift your thumb off the head of the plunger;
• The plunger rod moves upwards with the thumb and the spring retracts the needle from the site, into the needle safety protection (see figure 9).

Figure 9

Remember
If you have problems, do not hesitate to consult your doctor or nurse for help and advice.

Disposal of used syringes
Dispose of the syringes as suggested 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 your Pelgraz injection
If you self-inject and have forgotten your Pelgraz dose, you should contact your doctor to
determine when to give the next injection.

If you stop your Pelgraz injection
Your doctor will tell 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 contact your doctor or pharmacist.

4. Possible side effects

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

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

These could be symptoms of an uncommon condition (may affect up to 1 in

• 100) called "Capillary Leak Syndrome", which causes blood to leak from small blood vessels inside the body and requires urgent medical attention.

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

• bone pain. Your doctor will tell you 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 changes may occur in the blood, but these will be detected during routine blood tests. White blood cell levels may increase for a short period of time. Platelet levels may decrease causing bruising.

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

• allergic-type reactions, including redness and flushing, skin rash (reddening of the skin) and skin swellings with itching.
• severe allergic reactions including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).
• enlargement of the spleen.
• rupture of the spleen. Some cases of spleen rupture have been fatal. It is important that you contact your doctor immediately if you feel pain in the upper left side of your abdomen or left shoulder as this may indicate problems with the spleen.
• breathing problems. If you have cough, fever and difficulty breathing contact your doctor.
• cases of Sweet syndrome (purple, raised and painful lesions on the limbs and sometimes on the face and neck, associated with fever) have been reported, but other factors may have contributed.
• cutaneous vasculitis (inflammation of the blood vessels in the skin).
• damage to the tiny filters inside the kidneys (glomerulonephritis).
• redness at the injection site
• abnormal blood values (lactate dehydrogenase, uric acid and alkaline phosphatase)
• abnormal liver blood values (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 that carries blood from the heart to the rest of the body), see section 2.
• bleeding from the lung (pulmonary haemorrhage).
• Stevens Johnson syndrome, which can manifest with reddish patches or round spots, often with central blisters, located on the trunk, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes and which 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 attention. See also section 2.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through 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 which is stated on the pack 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 can be stored at room temperature (not exceeding 25°C ± 2°C) once only and for a
maximum period of 15 days. Pelgraz left at room temperature for more than 15 days must be
discarded. If you have any questions regarding storage, ask 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 effectiveness of Pelgraz.
Keep the pre-filled syringe in the packaging to protect the medicine from light.
Do not use this medicine if you notice that it is cloudy or if you see particles.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pelgraz contains

• The active ingredient 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).

Description of Pelgraz and package contents
Pelgraz is a clear, colorless injectable solution in a pre-filled syringe with a needle. Each syringe
pre-filled contains 0.6 mL of solution.
Pelgraz is available in a pack of 1 pre-filled syringe, with automatic needle protection in
a single blister with a cotton wool pad soaked in alcohol.

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,
Netherlands
For further information on this medicinal product, please refer to 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.
Tel: +34 93 301 00 64

IT
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 medicine is available on the website of the European Medicines
Agency http://www.ema.europa.eu
_________________________________________________________________________________

The following information is intended exclusively for healthcare professionals:
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 affect the stability of Pelgraz. DO NOT use if exposure is greater than 24 hours
or repeated.
In order to optimize the traceability of granulocyte colony-stimulating factors, it is necessary to
clearly record the name (Pelgraz) and batch number of the administered syringe in the patient's file.
Use of the pre-filled syringe with safety device for the needle
The needle safety device covers the needle after injection and prevents the operator from injury. The
device does not interfere with the normal use of the syringe. Press the plunger rod and push firmlyat the end of the injection to ensure complete emptying of the syringe. Hold firmly
the skin until the injection is complete. Hold the syringe firmly and slowly lift your thumb
from the plunger head. The plunger rod moves upwards with the thumb and the spring retracts the needle
from the site, into the needle protection.

Do not use a pre-filled syringe if it has fallen onto a hard surface.
Disposal
Dispose of any unused medicine or waste material in accordance with local requirements.

Pelgraz 6 mg injectable solution in pre-filled injector

pegfilgrastim

Read this leaflet carefully before you use this medicine as 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 others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 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 is Pelgraz and what is it used for

Pelgraz contains the active ingredient pegfilgrastim. Pegfilgrastim is a protein produced with a
biotechnological technique in a bacterial cell 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 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 can 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 very
sensitive to the effects of chemotherapy; this can cause a decrease in the number of these cells
present 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 greater risk of contracting
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 to help the body fight infections.

2. What you need to know before you use Pelgraz

Do not use Pelgraz

• if you are allergic to pegfilgrastim, to filgrastim or to 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, swelling of the face (anaphylaxis), redness and flushing, skin rash and itchy areas of skin.
• you have an allergy to latex. The needle cover of the pre-filled syringe contains a latex derivative that may cause serious allergic reactions.
• you have cough, fever and difficulty breathing. This may be a sign of Acute Respiratory Distress Syndrome (ARDS).
• you have one or more of the following side effects:
• swelling or bloating, which may be associated with reduced fluid passage, difficulty breathing, abdominal swelling and a feeling of fullness and a general feeling of tiredness. These may be symptoms of a condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels in the body. See section 4.
• you have pain in the upper left side of your abdomen or pain at the tip of your shoulder. These may be signs of a problem with the spleen (splenomegaly).
• you have recently had a severe lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease) or an abnormality found on an X-ray (pulmonary infiltrate).
• you know you have abnormal blood cell counts (e.g. increased white blood cells or anaemia) or a decrease in platelet levels, which reduces the body's ability to clot (thrombocytopenia). Your doctor may want to monitor you closely.
• you have sickle cell anaemia. Your doctor may want 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 leukaemia (AML). Symptoms may include fatigue, fever and easy bruising or bleeding
• you suddenly have 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 may be signs of a severe allergic reaction.
• you have symptoms of inflammation of the aorta (a large blood vessel that carries blood from the heart to the rest of the body), this has been reported rarely in cancer patients and healthy people. Symptoms 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 notice these symptoms.

The doctor will regularly check your blood and urine because Pelgraz can damage the tiny
filters inside 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 talk to your doctor about the risks of developing a blood cancer. If you have or may have a
blood cancer, you should not use Pelgraz unless directed to do so by your doctor.

Loss of response to pegfilgrastim
If you have a decrease in response or failure to maintain the response to treatment
with pegfilgrastim, the doctor will investigate the reasons, including the possibility that you have developed
antibodies that neutralise 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
Tell 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
tested 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 find out that you are pregnant during treatment with Pelgraz, tell your doctor.
Unless your doctor tells you otherwise, you should stop breastfeeding if you are using Pelgraz.

Driving and using machines
Pelgraz does not alter or negligibly alters the ability to drive vehicles or use
machines.

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 in adults aged 18 years or older.
Always take Pelgraz exactly as your doctor has instructed. If you have any doubts, ask your doctor or
pharmacist. The usual dose is a subcutaneous injection (injection under the skin) of 6 mg with
a pre-filled injector, 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 compromise its activity.

How to self-inject Pelgraz
Your doctor may consider it best for you to self-inject Pelgraz. Your doctor or
nurse will show you how to self-inject Pelgraz. Do not attempt to inject the medicine yourself
before being specifically trained by your doctor or nurse.
Instructions on how to self-inject Pelgraz are provided below, however, proper management of the
condition requires close and ongoing collaboration with your doctor.
If you have any doubts or questions about self-injection, contact your doctor or nurse.

How to perform a Pelgraz self-injection?
You will need to inject into the tissue under the skin, which is known as a subcutaneous
injection.

Requiredmaterials
To perform the subcutaneous injection, you will need:

• a pre-filled Pelgraz injector
• alcohol-soaked cotton ball

What should I do before giving myself a subcutaneous injection of Pelgraz?

• 1. Remove the pre-filled injector from the refrigerator.
• 2. Check the expiration date on the injector label (Exp.). Do not use it if the expiration date (the last day of the month indicated) has passed or if the injector 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 and colorless liquid. Do not use it if particles are present.
• 4. For a more comfortable injection, leave the pre-filled injector out of the refrigerator for half an hour to reach room temperature or hold it gently in your hand for a few minutes. Do not heat Pelgraz in any other way (e.g., do not heat it in a microwave or in hot water).
• 5. Wash your hands thoroughly.
• 6. Find a comfortable, well-lit surface and have everything you need (pre-filled injector and alcohol-soaked cotton ball) within reach.

How do I prepare the Pelgraz injection?
Before giving yourself a Pelgraz injection, you must perform the following operations:

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

Preparation

• Wash your hands with soap and warm running water.

• Choose the injection site (abdomen or thigh for self-administration, with the additional possibility of the back of the arm for administration by a healthcare professional or caregiver)

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

1. Before the injection

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

• Remove the cap on 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 to the ground after removing the cap.
• Proceed with the injection within 5 minutes of removing the cap on the bottom.

2. Injection

• Position the injector directly on the skin (at approximately 90 degrees).

• Push the plunger down. The medicine comes out while you push. Proceed at the speed you feel 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 will 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 pre-filled injector of Pelgraz: throw the injector into a suitable sharps container. Regulations vary depending on the region. Check with your doctor or pharmacist for instructions on correct disposal. Do not throw the injector into normal household waste.

Remember
If you have 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 your Pelgraz injection
If you self-inject and have forgotten your dose of Pelgraz, you should contact your doctor to
determine when to administer the next injection.

If you stop your Pelgraz injection
Your doctor will tell 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, consult your doctor or pharmacist.

4. Possible side effects

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

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

These could be symptoms of an uncommon condition (may affect up to 1 in

• 100) called "Capillary Leak Syndrome", which causes blood to leak from small blood vessels inside the body and requires urgent medical attention.

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

• bone pain. Your doctor will tell you 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 changes may occur in the blood, but these will be detected during routine blood tests. White blood cell levels may rise for a short period of time. Platelet levels may decrease causing bruising.

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

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

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

• inflammation of the aorta (the large blood vessel that carries blood from the heart to the rest of the body), see section 2.
• bleeding from the lung (pulmonary hemorrhage).
• Stevens Johnson syndrome, which can manifest with reddish patches or round spots, often with central blisters, located on the trunk, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes and which 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 attention. See also section 2.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through 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 which is stated on the pack and on the label
of the pre-filled 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 can be stored at room temperature (not above 25°C ± 2°C) once only and for a
maximum period of 15 days. Pelgraz left at room temperature for more than 15 days must be
discarded. If you have any questions regarding storage, ask your doctor, nurse or pharmacist.
Do not freeze this medicine. Accidental exposure to freezing temperatures once only for
less than 24 hours does not compromise the effectiveness of Pelgraz.
Keep the pre-filled syringe in the packaging to protect the medicine from light.
Do not use this medicine if you notice that it is cloudy or if you see particles.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pelgraz contains

• The active ingredient 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).

Description of Pelgraz and contents of the pack
Pelgraz is a clear, colourless injectable solution in a pre-filled syringe fitted with a needle. Each
pre-filled syringe contains 0.6 mL of solution.
Pelgraz is available in a pack of 1 syringe in a unique cardboard pack with an alcohol-soaked
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,
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.
Tel: +34 93 301 00 64

IT
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 medicine is available on the European Medicines Agency website http://www.ema.europa.eu
_________________________________________________________________________________

The following information is intended for healthcare professionals only:
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, once for less than
24 hours, does not affect the stability of Pelgraz. DO NOT use if the exposure is greater than 24 hours
or repeated.
In order to optimise the traceability of granulocyte colony-stimulating factors, it is necessary to
clearly record the name (Pelgraz) and batch number of the administered pre-filled syringe
in the patient’s file.
Disposal
Dispose of any unused medicine or waste material in accordance with local requirements.