Ziextenzo 6 mg solucion inyectable en jeringa precargada

Package Insert: Information for the Patient

Ziextenzo 6 mg Pre-filled Syringe Injectable Solution

Pegfilgrastim

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section4.

Ziextenzo contains the active ingredient pegfilgrastim. Pegfilgrastim is a protein produced by biotechnology in the bacteriumE. coli. Pegfilgrastim 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 white blood cell count) and the incidence of febrile neutropenia (low white blood cell count and fever) that can be caused bycytotoxic chemotherapy (medicines that destroy rapidly dividing cells). White blood cells are important cells that contribute to fighting infections. These cells are sensitive to the effects of chemotherapy, which can cause their number to decrease. Ifthe white blood cell count is very low, there may not be enough to fight off bacteria, which implies a higher risk of contracting an infection.

Your doctor has prescribed Ziextenzo to stimulate your bone marrow (the part of the bone where blood cells are produced) to produce more white blood cells that will help you fight offinfections.

No use Ziextenzo

• if you are allergic to pegfilgrastim, filgrastim, or any of the other components of this medication (listed in section6).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Ziextenzo:

• if you experience an allergic reaction that includes weakness, decreased blood pressure, difficulty breathing, facial swelling (anaphylaxis), redness and flushing, skin rash, and itching in areas of the skin.
• if you experience cough, fever, and difficulty breathing. This may be a sign of acute respiratory distress syndrome (ARDS).
• if you experience any or a combination of the following adverse effects:

• swelling that may be associated with urinating less frequently, difficulty breathing, swelling, and a feeling of abdominal fullness and a general feeling offatigue.

These may be symptoms of a condition called "Capillary Leak Syndrome" that can cause blood to leak from a small blood vessel into other parts of your body. See section4.

• if you have pain in the upper left abdominal area or pain in the shoulder tip. This may be a sign of a spleen problem (splenomegaly).
• if you recently had a severe lung infection (pneumonia), fluid in the lungs (pulmonary edema), inflammation of the lungs (interstitial lung disease), or an abnormal chest X-ray result (pulmonary infiltration).
• if you are aware of any alteration in blood cell count (e.g., increased white blood cell count or anemia) or a decrease in platelet count, which can reduce the blood's ability to clot (thrombocytopenia). Your doctor may want to monitor you more closely.
• if you have sickle cell anemia. Your doctor may closely monitor your disease.
• if you are a cancer patient, the combined treatment of Ziextenzo with chemotherapy and/or radiation therapy may increase the risk of developing a pre-cancerous hematological condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms may include fatigue, fever, easy bruising, or bleeding.
• if you experience sudden signs of allergy, such as skin rash, itching, or urticaria, facial swelling, lip, tongue, or other body part swelling, shortness of breath, wheezing, or difficulty breathing, which may be signs of a severe allergic reaction.
• if you experience symptoms of aorta inflammation (the large blood vessel that carries blood from the heart to the rest of the body), which is rarely reported in cancer patients and healthy donors. Symptoms may include fever, abdominal pain, general discomfort, back pain, and increased inflammatory markers. Inform your doctor if you experience these symptoms.

Your doctor will perform regular blood and urine tests since pegfilgrastim may damage the small filters within the kidneys (glomerulonephritis).

Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of Ziextenzo. Stop using Ziextenzo and seek medical attention immediately if you observe any of the symptoms described in section4.

You should consult with your doctor about the risk of developing blood cancer. If you develop or may develop blood cancer, do not use Ziextenzo, except if your doctor advises you to.

Loss of Response to Pegfilgrastim

If you experience a loss of response or if you are unable to maintain a response to treatment with pegfilgrastim, your doctor will investigate the causes, including whether you have developed antibodies that may neutralize the activity of pegfilgrastim.

Other Medications and Ziextenzo

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication. Pegfilgrastim has not been used in pregnant women. It is essential to inform your doctor if:

• you are pregnant;
• you think you may be pregnant; or
• you intend to become pregnant.

If you become pregnant during treatment with Ziextenzo, please inform your doctor.

Unless your doctor advises you otherwise, you should stop breastfeeding if you use Ziextenzo.

Driving and Operating Machines

The influence of Ziextenzo on the ability to drive and operate machines is negligible or insignificant.

Ziextenzo contains sorbitol (E 420) and sodium.

This medication contains 30 mg of sorbitol in each pre-filled syringe equivalent to 50 mg/ml.

This medication contains less than 1mmol of sodium (23mg) per 6mg dose; this is essentially "sodium-free".

Ziextenzo is indicated for patients aged 18 years and above.

Follow exactly the administration instructions for Ziextenzo as indicated by your doctor. If in doubt, ask your doctor or pharmacist. The usual dose is a subcutaneous injection of 6 mg (under the skin) using a preloaded syringe, which should be administered at the end of each chemotherapy cycle, starting 24 hours after your last chemotherapy dose.

Ziextenzo Self-Administration

Your doctor may consider it more convenient for you to administer Ziextenzo yourself. Your doctor or nurse will teach you how to do it. Do not attempt to do it if you have not been taught.

For more instructions on how to self-administer Ziextenzo, read the section at the end of this leaflet.

Do not shake Ziextenzo vigorously as it may affect its activity.

If you use more Ziextenzo than you should

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

If you forgot to use Ziextenzo

If you are self-administering and have forgotten to administer your dose of Ziextenzo, contact your doctor to decide when the next dose should be administered.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately if you experience any of the following side effects:

• swelling that may be associated with urinating less frequently, difficulty breathing, swelling, and a feeling of abdominal fullness, and a general feeling of fatigue. These symptoms usually develop very quickly.

These may be symptoms of a rare disease (which can affect up to 1 in 100 people) called "capillary leak syndrome" and may cause blood toescape from a small blood vessel to other parts of your body and require urgent medical attention.

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

• bone pain. Your doctor will inform you about what you can take to alleviate the pain.
• nausea and headache.

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

• pain at the injection site.
• general pain and pain in the joints and muscles.
• some changes in your blood may occur, which will be detected through periodic blood tests. You may experience an increase in white blood cells for a short period of time. You may experience a decrease in platelets, which may cause bruising.

Rare side effects(may affect up to 1 in 100patients):

• allergic reactions, which include redness and flushing/flushes, appearance of hives, and skin inflammation with itching.
• severe allergic reactions, which include anaphylaxis (weakness, fall in blood pressure, difficulty breathing, facial swelling).
• enlargement of the spleen.
• spleen rupture. Some cases of spleen rupture were fatal. It is essential to contact your doctor immediately if you experience pain in the upper left abdomen or left shoulder, as it may be related to a spleen problem.
• respiratory problems. If you have a cough, fever, and difficulty breathing, consult your doctor.
• cases of Sweet syndrome (painful, inflamed, violaceous lesions on the extremities and, in some cases, on the face and neck, accompanied by fever) have been reported, but may be related to other factors.
• cutaneous vasculitis (inflammation of skin blood vessels).
• damage to the small filters within the kidneys (glomerulonephritis).
• redness at the injection site.
• coughing up blood (hemoptysis).
• hematological disorders (myelodysplastic syndrome [MDS] or acute myeloid leukemia [AML]).

Rare side effects(may affect up to 1 in 10,000patients):

• aortic inflammation (the large blood vessel that carries blood from the heart to the rest of the body), see section2.
• pulmonary hemorrhage.
• Stevens-Johnson syndrome, which may appear as concentric or circular red patches often with central blisters on the trunk, exfoliation, ulcers in the mouth, throat, nose, genitals, and eyes; and may be preceded by fever and flu-like symptoms. Stop using Ziextenzo if you develop these symptoms and contact your doctor or seek immediate medical attention. See section2.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly tothrough thenational reporting system included in theAppendixV. By reportingside effects, you can contribute to providing more information about the safety of thismedicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the carton and on the syringe label after CAD. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C).

Ziextenzo may be removed from the refrigerator at room temperature (as long as it does not exceed 35°C) for a maximum of 120 hours. Once a syringe has been removed from the refrigerator and has reached room temperature (which does not exceed 35°C), it must be used within 120 hours or discarded.

Do not freeze. Ziextenzo can be used in case of accidental freezing, within a period of less than 24 hours.

Store the container in the outer packaging to protect it from light.

Do not use this medication if you observe that the solution is not completely transparent or contains particles.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Ziextenzo

• The active ingredient 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 (E 420), polisorbate 20, sodium hydroxide, and water for injection. See section 2 “Ziextenzo contains sorbitol (E 420) and sodium”.

Appearance of the product and contents of the pack

Ziextenzo is a transparent, colourless to slightly yellowish injectable solution in pre-filled syringe (6 mg/0.6 ml).

Each pack contains 1 pre-filled syringe of glass with a rubber stopper (bromobutyl rubber, latex-free), a plunger rod, a stainless steel needle of calibre 29, and a needle cap (thermoplastic elastomer, latex-free). The syringes are supplied with an automatic needle guard.

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 about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the leaflet:.

Other sources of information

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

The information on this medicinal product is available in all the languages of the European Union/European Economic Area on the website of the European Medicines Agency.

Instructions for use of the pre-filled syringe of Ziextenzo with automatic needle guard

To help prevent possible infections and ensure that you use the medicinal product correctly, it is important to follow these instructions.

Read ALL the instructions before injecting. It is essential that you do not attempt to self-inject until a doctor, nurse or pharmacist has taught you how to do it. The pack contains the pre-filled syringe sealed individually in a plastic blister.

After injecting the medicinal product, the automatic needle guard is activated to cover the needle. The purpose of the automatic needle guard is to prevent healthcare professionals, carers and patients from accidentally pricking themselves with the needle after injection.

Important safety information

Warning: Keep the pre-filled syringe out of sight and reach of children.

1. Do not open the pack until you are ready to use the pre-filled syringe.

1. Do not use the pre-filled syringe if the blister seal is broken, as it may not be safe to use.
2. 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 correctly placed. In that case, return the entire pack to the pharmacy.
3. Never leave the pre-filled syringe unattended where others may handle it.
4. Do not shake the pre-filled syringe.
5. Take care not to touch the needle guard flaps before use. If you do, it may activate the needle guard too soon.
6. Do not remove the needle cap until the moment of injection.
7. The pre-filled syringe cannot be reused. Dispose of the used pre-filled syringe immediately after use in a sharps container.
8. Do not use if the pre-filled syringe has fallen onto a hard surface or has been dropped after removing the needle cap.

Storage of the pre-filled syringe of Ziextenzo

1. Store the pre-filled syringe in its original packaging in a blister to protect it from light.

1. Store in a refrigerator at a temperature between 2°C and 8°C.Do not freeze.
2. 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 15-30 minutes, approximately.
3. Do not usethe pre-filled syringe after the expiry date shown on the pack or the label on the pre-filled syringe. If it has expired, return the entire pack to the pharmacy.

Injection site

Preparing the pre-filled syringe of Ziextenzo ready for use

1. Remove the pre-filled syringe from the refrigerator and leave itunopenedfor 15-30 minutes, approximately, to allow Ziextenzo to reach room temperature.

1. When you are ready to use the pre-filled syringe, open the blister and wash your hands thoroughly with soap and water.
2. Clean the injection site with an alcohol wipe.
3. Remove the pre-filled syringe from the blister, holding it by the middle section, as shown below. Do not grasp the plunger. Do not grasp the needle cap.

1. Check that the transparent plastic needle guard is in place over the glass syringe body. If the transparent plastic needle guard covers the needle cap (as shown below), the needle guard has been activated andDO NOTuse this pre-filled syringe but a new one. The figure below shows a ready-to-use pre-filled syringe.

1. Examine the pre-filled syringe. The liquid should be transparent, colourless to slightly yellowish. You may see a small air bubble in the liquid, but this is normal.Do not usethe pre-filled syringe if you see any other particles or discoloration.
2. Do not usethe pre-filled syringe if it is broken or activated. Return the pre-filled syringe of Ziextenzo and the pack to the pharmacy.

How to use the pre-filled syringe of Ziextenzo

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