ZIEXTENZO 6 mg Roztwór Do Wstrzykiwań

Treść ulotki

1. Ziextenzo 6 mg injectable solution in pre-filled syringe
   1. What is Ziextenzo and what is it used for
   2. What you need to know before using Ziextenzo
   3. How to use Ziextenzo
   4. Possible side effects
   5. How to store Ziextenzo
   6. Content of the pack and other information

Ziextenzo 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 for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could 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 Ziextenzo is and what it is used for
• 2. What you need to know before you use Ziextenzo
• 3. How to use Ziextenzo
• 4. Possible side effects
• 5. How to store Ziextenzo
• 6. Contents of the pack and other information

1. What is Ziextenzo and what is it used for

Ziextenzo contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced with 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.
Ziextenzo 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 very 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 greater risk of
contracting an infection.
Your doctor has prescribed Ziextenzo to stimulate the bone marrow (the part of the bones that produces
blood cells) to produce more white blood cells to help the body fight infections.

2. What you need to know before using Ziextenzo

Do not use Ziextenzo

• 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 Ziextenzo:

• if you have an allergic reaction including weakness, low blood pressure, difficulty breathing, swelling of the face (anaphylaxis), flushing and redness, skin rash and itchy skin areas.
• if you have cough, fever and difficulty breathing. This may be a sign of Acute Respiratory Distress Syndrome (ARDS).
• if 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 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.
• if you have pain in the upper left side of your abdomen or pain at the tip of your shoulder. These could be signs of a problem with the spleen (splenomegaly).
• if 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).
• if 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 blood's ability to clot (thrombocytopenia). Your doctor may want to monitor you closely.
• if you have sickle cell anemia. Your doctor may want to monitor you closely.
• if you have breast or lung cancer, Ziextenzo 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.
• if you suddenly have signs of allergy such as skin rash, hives or itching on the skin, 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.
• if you have symptoms of inflammation of the aorta (the large blood vessel that carries blood from the heart to the rest of the body), which has been reported rarely in cancer patients and healthy donors. Symptoms may include fever, abdominal pain, malaise, back pain and increased markers of inflammation. Tell your doctor if you experience such symptoms.

The doctor will regularly check your blood and urine because pegfilgrastim can damage the
tiny filters inside your kidneys (glomerulonephritis).
Severe skin reactions (Stevens-Johnson syndrome) have been observed with the use of Ziextenzo. If
you notice any of the symptoms described in section 4, stop using Ziextenzo and seek
immediate medical attention.
Talk to your doctor about the risks of developing a blood cancer. If you develop or are likely to
develop a blood cancer, you should not use Ziextenzo unless directed 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.

Other medicines and Ziextenzo
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. Pegfilgrastim has not
been studied in pregnant women. It is important that you tell your doctor if:

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

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

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

Ziextenzo contains sorbitol (E420) and sodium
This medicine contains 30 mg of sorbitol per pre-filled syringe 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 Ziextenzo

Ziextenzo is indicated in adults aged 18 years or older.
Use Ziextenzo following the doctor's instructions exactly. If you have any doubts, consult your doctor or
pharmacist. The usual dose is a subcutaneous injection (injection under the skin) of 6 mg which must
be administered using a prefilled syringe at least 24 hours after the last dose of
chemotherapy at the end of each chemotherapy cycle.

How to self-inject Ziextenzo
Your doctor may consider that it is best for you to self-inject Ziextenzo. Your doctor or
nurse will show you how to self-inject Ziextenzo. Do not attempt to self-inject unless you have been
explained how to do it.
of Ziextenzo by yourself.
Do not shake Ziextenzo vigorously as this may compromise its activity.

If you use more Ziextenzo than you should
If you use more Ziextenzo than you should, you must contact your doctor, pharmacist or nurse.

If you forget to inject Ziextenzo
If you self-inject and have forgotten your dose of Ziextenzo, you should contact your doctor to
determine when to administer the next injection.
If you have any questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Inform 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 people) 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.
• some changes may occur in the blood, but these will be detected during routine blood tests. White blood cell counts may increase for a short period of time. Platelet counts 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 itchy skin swelling.
• severe allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, facial swelling).
• enlargement of the spleen.
• splenic rupture. Some cases of splenic 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 your left shoulder as this may indicate problems with the spleen.
• breathing problems. If you have a 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 to these.
• cutaneous vasculitis (inflammation of the blood vessels in the skin).
• damage to the tiny filters inside the kidneys (glomerulonephritis).
• redness at the injection site.
• 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 lungs (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 Ziextenzo 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 listed in Annex V. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Ziextenzo

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./EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C).
You can take Ziextenzo out of the refrigerator and keep it at room temperature (not exceeding 35 °C) for no more than
120 hours. Once the syringe has been removed from the refrigerator and has reached room temperature (not
exceeding 35 °C) it must be used within 120 hours or discarded.
Do not freeze. Ziextenzo can be used if it has been accidentally frozen once for less than
24 hours.
Keep the container in the outer 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. Content of the pack and other information

What Ziextenzo 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 glacial acetic acid, sorbitol (E420), polysorbate 20, sodium hydroxide and water for injections. See section 2 “Ziextenzo contains sorbitol (E420) and sodium”.

Description of the appearance of Ziextenzo and contents of the pack
Ziextenzo is a clear, colorless to slightly yellowish injectable solution (injection) in a
pre-filled syringe (6 mg/0.6 mL).
Each pack contains 1 glass pre-filled syringe with a rubber plunger stopper (bromobutyl rubber, latex-free), a plunger rod, a 29 gauge stainless steel
needle attached and a needle cap (thermoplastic elastomer, latex-free). The syringes are supplied with
an automatic needle protection device.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestr. 10
6250 Kundl
Austria

Manufacturer
Sandoz GmbH
Biochemiestr. 10
6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestrasse 10
6336 Langkampfen
Austria
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Sandoz nv/sa
Tél/Tel: +32 2 722 97 97

Lietuva
Sandoz Pharmaceuticals d.d filialas
Tel: +370 5 2636 037

България
Сандоз България КЧТ
Тел.: +359 2 970 47 47

Luxembourg/Luxemburg
Sandoz nv/sa
Tél/Tel: +32 2 722 97 97

Česká republika
Sandoz s.r.o.
Tel: +420 225 775 111

Magyarország
Sandoz Hungária Kft.
Tel.: +36 1 430 2890

Danmark/Norge/Ísland/Sverige
Sandoz A/S
Tlf: +45 63 95 10 00

Malta
Sandoz Pharmaceuticals d.d.
Tel: +35699644126

Deutschland
Hexal AG
Tel: +49 8024 908 0

Nederland
Sandoz B.V.
Tel: +31 36 52 41 600

Eesti
Sandoz d.d. Eesti filiaal
Tel: +372 665 2400

Österreich
Sandoz GmbH
Tel: +43 5338 2000

Ελλάδα
SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε.
Τηλ: +30 216 600 5000

Polska
Sandoz Polska Sp. z o.o.
Tel.: +48 22 209 70 00

España
Sandoz Farmacéutica, S.A.
Tel: +34 900 456 856

Portugal
Sandoz Farmacêutica Lda.
Tel: +351 21 000 86 00

France
Sandoz SAS
Tél: +33 1 49 64 48 00

România
Sandoz Pharmaceuticals SRL
Tel: +40 21 407 51 60

Slovenija
Sandoz farmacevtska družba d.d.
Tel: +386 1 580 29 02

Hrvatska
Sandoz d.o.o.
Tel: +385 1 23 53 111

Ireland
Rowex Ltd.
Tel: + 353 27 50077

Slovenská republika
Sandoz d.d. - organizačná zložka
Tel: +421 2 48 20 0600

Italia
Sandoz S.p.A.
Tel: +39 02 96541

Suomi/Finland
Sandoz A/S
Puh/Tel: +358 10 6133 400

Κύπρος
Sandoz Pharmaceuticals d.d.
Τηλ: +357 22 69 0690

United Kingdom (Northern Ireland)
Sandoz GmbH
Tel: +43 5338 2000

Latvija
Sandoz d.d. Latvia filiāle
Tel: +371 67 892 006

Altre fonti d’informazioni
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu .
This leaflet is available in all European Union/European Economic Area languages on the
website of the European Medicines Agency.

Instructions for use of Ziextenzo pre-filled syringe with needle protection
To help avoid possible infections and to ensure correct use of the medicinal product, it is important
that you follow these instructions.
Read ALL the instructions before giving yourself the injection. It is important that you do not try to give
yourself the injection if you have not been shown how to do so by your doctor, nurse or pharmacist. The
pack contains the pre-filled syringe individually sealed in a plastic blister.

Ziextenzo pre-filled syringe with needle protection

After the medicinal product has been injected, the needle protection device will activate to cover
the needle. The needle protection serves to protect healthcare professionals, caregivers and patients from
accidental needle stick injuries after the injection.

What else you need for the injection:

• Alcohol swab.
• Cotton ball or gauze.
• Sharps container for disposal of sharps.

Important safety information
Caution: Keep the pre-filled syringe out of the sight and reach of children.

• 1. Do not open the pack until you are ready to use the pre-filled syringe.
• 2. Do not use the pre-filled syringe if the blister seal is broken, as use may not be safe.
• 3. Do not use the pre-filled syringe if there is liquid in the blister. Do not use the pre-filled syringe if the needle cap is missing or not firmly attached. In all these cases, return the entire product pack to the pharmacy.
• 4. Never leave the pre-filled syringe unattended where it could be tampered with by others.
• 5. Do not shake the pre-filled syringe.
• 6. Be careful not to touch the wings of the needle protection device before use. If you touch them, the needle protection device may be activated too early.
• 7. Do not remove the needle cap until just before giving yourself the injection.
• 8. The pre-filled syringe cannot be reused. Dispose of the syringe immediately after use in a sharps container.
• 9. Do not use the syringe if it has fallen onto a hard surface or has fallen after the needle cap has been removed.

Storage of Ziextenzo pre-filled syringe

• 1. Store the pre-filled syringe in the blister pack in the carton to protect the medicinal product from light.
• 2. Store in a refrigerator at a temperature between 2 °C and 8 °C. Do not freeze.
• 3. Before use, remove the pre-filled syringe from the refrigerator and allow Ziextenzo to reach room temperature (up to a maximum of 35 °C) for about 15-30 minutes.
• 4. Do not usethe pre-filled syringe after the expiry date which is stated on the carton or the syringe label. If the syringe is expired, return the entire pack to the pharmacy.

The injection site

The injection site is the point on the body where you will use the
pre-filled syringe.

• The recommended site is the front of the thighs. You can also use the lower abdomen, but notthe area within 5 centimetres around the navel.
• Choose a different site each time you give an injection.
• Do not inject into areas where the skin is sensitive, bruised, red, scaly or hardened. Avoid injecting into areas with scars or stretch marks.

If someone else is giving you the injection, you can also use the
outer upper arm.

Preparation of Ziextenzo pre-filled syringe ready for use

• 1. Remove the pack containing the blister-packed pre-filled syringe from the refrigerator and leave it closedfor about 15-30 minutes until it has reached room temperature.
• 2. When you are ready to use the pre-filled syringe, open the blister and wash your hands thoroughly with soap and water.
• 3. Clean the injection site with an alcohol swab.
• 4. Remove the pre-filled syringe from the blister, holding it by the centre as shown below. Do not grip the plunger. Do not grip the needle cap.

• 5. Check that the transparent plastic protection of the needle is above the glass syringe barrel. If the transparent needle protection covers the needle cap (as shown below), the syringe needle protection device has been activated. DO NOT use this syringe and take a new one. The figure below shows a syringe ready for use.

ACTIVATED device - DO NOT USE

In this configuration, the protection
device is ACTIVATED - DO NOT USE the
pre-filled syringe
READY TO USE device

In this configuration, the protection
device is NOT activated and the
pre-filled syringe is ready for use

• 6. Examine the pre-filled syringe. The liquid should be clear, ranging in colour from transparent to slightly yellowish. A small air bubble may be visible in the liquid. This is normal. Do not usethe pre-filled syringe if you notice particles and/or a change in colour.
• 7. Do not usethe syringe if it is broken or activated. Return Ziextenzo pre-filled syringe and the pack to the pharmacy.

How to use Ziextenzo pre-filled syringe
1

Carefully remove the needle cap by pulling it
straight off. Dispose of the needle cap. You may
see a drop of liquid at the end of the needle.
This is normal.

Pinch up the skin at the injection site and insert the
needle as shown. Push the needle in completely to
ensure that all of the medicinal product is delivered.

Holding the pre-filled syringe as shown,
slowly push the plunger all the way inuntil
the plunger head is completely between the wings
of the needle protection device.
Keep the plunger fully depressed while holding the
syringe in place for 5 seconds.

Keep the plunger fullydepressed
while carefully withdrawing the needle from the
injection site by pulling it straight out, then release
the skin.

Slowly release the plunger and let the
syringe needle protection device automatically
cover the exposed needle.
There may be a small amount of blood at the
injection site. You can press a cotton ball or
gauze onto the injection site, holding it for 10
seconds. Do not rub the injection site. If
necessary, you can cover the injection site with a
plaster.

For healthcare professionals only
The trade name of the product administered
must be clearly recorded in the patient's record.
Remove and retain the syringe label.
Turn the plunger to move the label into a
position where it can be removed.

Instructions for disposal
Dispose of the used syringe in a sharps container
(a closable, puncture-resistant container).

Do not dispose of medicines via wastewater or
household waste. Ask your doctor or pharmacist
how to dispose of medicines you no longer use.
This will help protect the environment.
Unused medicines and waste materials from such
medicines should be disposed of in accordance with
local regulations.