Label: information for the user

Retacrit 1 000UI/0,3ml injectable solution in pre-filled syringe

Retacrit 2 000UI/0,6ml injectable solution in pre-filled syringe

Retacrit 3 000UI/0,9ml injectable solution in pre-filled syringe

Retacrit 4 000UI/0,4ml injectable solution in pre-filled syringe

Retacrit 5 000UI/0,5ml injectable solution in pre-filled syringe

Retacrit 6 000UI/0,6ml injectable solution in pre-filled syringe

Retacrit 8 000UI/0,8ml injectable solution in pre-filled syringe

Retacrit 10000UI/1ml injectable solution in pre-filled syringe

Retacrit 20000UI/0,5ml injectable solution in pre-filled syringe

Retacrit 30000UI/0,75ml injectable solution in pre-filled syringe

Retacrit 40000UI/1ml injectable solution in pre-filled syringe

epoetina zeta

Read this label carefully before starting to use the medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they 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 label. See section 4.

Retacrit contains the active ingredient epoetina zeta, a protein that stimulates the bone marrow to produce more red blood cells, cells that carry hemoglobin (the substance that transports oxygen). Epoetina zeta is a copy of the human protein erythropoietin and acts in the same way.

• Retacrit is indicated for the treatment of symptomatic anemia caused by kidney disease

• in children undergoing hemodialysis;
• in adults undergoing hemodialysis or peritoneal dialysis;
• in adults with severe anemia who have not yet undergone dialysis.

If you have kidney disease, you may have a low number of red blood cells if your kidney does not produce enough erythropoietin (necessary for red blood cell production). Retacrit is prescribed to stimulate the bone marrow to produce more red blood cells.

• Retacrit is indicated for the treatment of anemia in adults receiving chemotherapy for the treatment of solid tumors, malignant lymphoma or multiple myeloma (bone marrow neoplasia) that may require blood transfusion. Retacrit may reduce the need for blood transfusion in these patients.

• Retacrit is indicated in adults with moderate anemia who are about to donate blood beforeundergoing a surgical operation, so that it can be readministered during or after the surgical intervention. Since Retacrit stimulates red blood cell production, doctors can extract more blood from these individuals.

• Retacrit is indicated in adults with moderate anemia about to undergo a major orthopedic surgery (for example, hip or knee replacement operations)to reduce the potential need for blood transfusion.

• Retacrit is indicated in adult patients with anemia due to a bone marrow disorder that causes a severe alteration in blood cell creation (myelodysplastic syndromes).Retacrit may reduce the need for blood transfusion.

No use Retacrit

• If you are allergicto epoetin zetaor to any of the other components ofthis medication (listed in section6).

• If you have been diagnosed with pure red cell aplasia(your bone marrow cannot produce enough red blood cells) after previous treatment with any product that stimulates red blood cell production (including Retacrit). See section4.

• If you have uncontrolled high blood pressurethat is not adequately controlled with medication.

• To stimulate red blood cell production (so that your doctors can take more blood from you)if you cannot receive blood transfusions from your own bloodduring surgery or after it.

• If you are about to undergo a major orthopedic surgery (such as hip or knee surgery) and you:

• have a serious heart disease;
• have severe venous or arterial abnormalities;
• have recently had a heart attack or stroke;
• cannot take medications to thin your blood.

Retacrit may not be suitable for you. Talk to your doctor. Some people need medications to reduce the risk of blood clots during Retacrit treatment.If you cannot take medications to prevent blood clots, do not take Retacrit.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Retacrit.

Be especially careful with Retacrit

Retacrit and other erythropoiesis-stimulating agents may increase the risk of blood clots in all patients. This risk may be higher if you have other risk factorsfor blood clots(for example, if you have had a blood clot in the past or have obesity, diabetes, heart disease, or are bedridden for a long time due to surgery or illness). Inform your doctor about any of these things. Your doctor will help you decide if Retacrit is suitable for you.

Consult your doctorif you identify with any of the following situations.You may still be able to use Retacrit, but discuss it with your doctor first.

• If you know you haveor have had:
• high blood pressure;
• seizures or convulsions;
• liver disease;
• anemia due to other causes;
• porphyria (a rare blood disorder).

• If you have chronic kidney disease,and especially if you do not respond well to Retacrit, your doctor will check your Retacrit dose, because repeatedly increasing the Retacrit dose if you do not respond to treatment may increase the risk of heart or vascular problems and may increase the risk of heart attack, stroke, and death.

• If you have cancer,you should know that erythropoiesis-stimulating agents (such as Retacrit) may act as a growth factor and, in theory, may affect the progression of cancer.Depending on your individual situation, it may be preferable to receive a blood transfusion. Discuss this with your doctor.

• If you have cancer,you should know that the use of Retacrit may be associated with lower survival rates and higher mortality rates in patients with head and neck cancer and metastatic breast cancer receiving chemotherapy.

• Severe skin reactionssuch as Stevens-Johnson syndrome (SSJ) and toxic epidermal necrolysis (TEN) have been observed with the administration of epoetins.SSJ/TEN may initially appear as red spots like targets or circular patches, often with central blisters on the trunk. They may also appear as ulcers in the mouth, throat, nose, genitals, and eyes (eye irritation and swelling). These severe skin reactions are often preceded by fever or flu-like symptoms. The skin reactions may progress to generalized skin peeling and potentially life-threatening complications.

If you experience a severe skin reaction or any of these other skin symptoms, stop taking Retacrit and seek medical attention immediately.

Be especially careful with other erythropoiesis-stimulating agents

Retacrit belongs to one of the groups of erythropoiesis-stimulating agents that work like human erythropoietin. Your doctor should record the exact name of the product you are using.

If, during your treatment, you are administered a product belonging to this group, different from Retacrit, consult your doctor or pharmacist before using it.

Other medications and Retacrit

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

If you are using Retacrit with a medication called ciclosporin(e.g., after a kidney transplant), your doctor may request blood tests to monitor ciclosporin levels.

Iron supplements and other erythropoiesis-stimulating agentsmay increase the effectiveness of Retacrit. Your doctor will decide if you should use them.

If you visit a hospital, clinic, or general practitioner, tell them that you are receiving treatment with Retacrit, as it may affect other treatments or test results.

Pregnancy, breastfeeding, and fertility

It is essential that you inform your doctorif you identify with any of the following situations.You may still be able to use Retacrit, but discuss it with your doctor first.

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.
• If you are breastfeeding.

No data are available on the effects of epoetin zeta on fertility.

Driving and operating machinery

Retacrit has no or negligible influence on the ability to drive and operate machinery.

Retacrit contains phenylalanine

Retacritcontains 0.5mg of phenylalanine per ml.

Phenylalanine may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly (see section

Retacrit contains sodium

This medication contains less than 1mmol of sodium (23mg) per dose, which is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor again.

Your doctor has performed blood testsand has decided that you need Retacrit.

Retacrit can be administered by injection:

Your doctor will decide how Retacrit will be injected. The injections will usually be administered by a doctor, nurse, or other healthcare professional. Later, depending on the reason for the treatment with Retacrit, some people may learn to inject the medication themselves: seeInstructions on how to inject Retacrit.

Retacrit should not be used:

The dose of Retacrit you will receive is based on your body weight in kilograms. The cause of your anemia is also a factor that your doctor will take into account when deciding on the correct dose.

Your doctor will monitor your blood pressureperiodically while you are on treatment with Retacrit.

Patients with renal insufficiency

Adults undergoing chemotherapy

Adult bone marrow donors

Adults scheduled for major orthopedic surgery

Adults with myelodysplastic syndrome

Instructions on how to inject Retacrit

When treatment begins, medical or nursing staff usually administer Retacrit. Later, your doctor may suggest that you or your caregiver learn to inject Retacrit under the skin (subcutaneously) yourself.

Use only one dose of Retacrit from each syringe.

When Retacrit is injected under the skin (subcutaneously), the amount injected is not usually more than 1milliliter (1ml) in a single injection. In cases of larger volumes, more than one injection site should be chosen.

Retacrit is administered alone and is not mixed with other injectable liquids.

Do not shake the Retacrit syringes.A vigorous shaking can damage the product. If the product has been shaken vigorously, do not use it.

How to inject yourself using a pre-filled syringe

• Remove the carton containing the pre-filled syringe from the refrigerator.
• Remove the blister pack containing the pre-filled syringe from the carton. When the carton contains blister packs with more than one pre-filled syringe, cut the blister pack with a pre-filled syringe along the perforated part, return the remaining blister packs with pre-filled syringes to the carton and return the carton to the refrigerator.
• Open the blister pack with the pre-filled syringe after removing it from the refrigerator. The liquid should reach room temperature.Do notremove the needle cover from the syringe while the syringe is reaching room temperature.

• Check the syringe to ensure it is the correct dose, has not expired, is not damaged, and the liquid is clear and not frozen.
• Do not use the pre-filled syringe if:
• • The carton is open or damaged.
  • The medicine is cloudy or has changed color or the liquid has particles floating in it.
  • Any part of the pre-filled syringe appears cracked or broken or the liquid has leaked from the syringe.
  • The pre-filled syringe has fallen. The pre-filled syringe may be broken even if you cannot see the break.
  • The needle cover is missing or not properly placed.
  • The expiration date printed on the label has passed.

In all the above cases, discard the pre-filled syringe and use a new pre-filled syringe.

• Choose an injection site. Good sites are the upper thigh and around the abdomen (stomach) but away from the navel. Vary the site each day.
• Wash your hands. Use an antiseptic swab on the injection site to disinfect it.
• Hold the syringe by the body of the syringe with the needle covered pointing upwards.
• • Do nothold it by the plunger, plunger or needle cover.
  • Do notpull the plunger at any time.
  • Do notremove the needle cover from the syringe until you are ready to inject the medication.

• Remove the needle cover from the syringe by holding the body of the syringe and pulling the needle cover out carefully, without turning it.Discard the needle cover.Do notreplace the needle cover.Do notpush the plunger, touch the needle, or shake the syringe.

• Pinch a fold of skin between your thumb and index finger.Do notcompress it.
• With the other hand, hold the syringe like a pencil. Use a quick "dart" motion to insert the needle at an angle of approximately 45 degrees into the skin.

• Insert the needle completely. Your doctor or nurse has shown you how to do this.
• Push the plunger with your thumb as far as you can to inject the entire amount of liquid. Push slowly and steadily, keeping the skin fold pinched.
• When the plunger has stopped moving, remove the needle and release the skin.
• When the needle is removed from the skin, there may be some bleeding at the injection site. This is normal. You can press an antiseptic swab on the injection site for a few seconds after the injection.
• Do notattempt to replace the needle cover.Dispose of the used syringe in a sharps container (safety needle container).

• Never put used syringes in the normal household trash.

How to inject yourself using a pre-filled syringe with a needle protection mechanism

Your syringe has a needle protection mechanism attached to help prevent accidental needlestick injuries after proper administration of injectable medications.

• Remove the carton containing the pre-filled syringe with the needle protection mechanism from the refrigerator.
• Remove the blister pack containing the pre-filled syringe from the carton. When the carton contains blister packs with more than one pre-filled syringe, cut the blister pack with a pre-filled syringe along the perforated part, return the remaining blister packs with pre-filled syringes to the carton and return the carton to the refrigerator.
• Open the blister pack with the pre-filled syringe by removing the lid.
• Remove the pre-filled syringe from the blister pack by holding it by the body of the syringe.

• Check the syringe to ensure it is the correct dose, has not expired, is not damaged, and the liquid is clear and not frozen.

• Do not use the pre-filled syringe if:
• • The carton is open or damaged.
  • The mechanism of needle protection is missing, has come loose, or has been activated.
  • Themedicine is cloudy or has changed color or the liquid has particles floating in it.Do notinspect the product through the plastic of the safety device.
  • Any part of the pre-filled syringe appears cracked or broken or the liquid has leaked from the syringe.
  • The pre-filled syringe has fallen. The pre-filled syringe may be broken even if you cannot see the break.
  • The needle cover is missing or not properly placed.
  • The expiration date printed on the label has passed.

In all the above cases, discard the pre-filled syringe and use a new pre-filled syringe.

• Choose an injection site. Good sites are the upper thigh and around the abdomen (stomach) but away from the navel. Vary the site each day.
• Wash your hands. Use an antiseptic swab on the injection site to disinfect it.
• Hold the syringe by the body of the syringe with the needle covered pointing upwards.
• • Do nothold it by the plunger, plunger or needle cover.
  • Do notpull the plunger at any time.
  • Hold the plastic tip of the needle and move it away from the needle cover.

• Remove the needle cover from the syringe by holding the body of the syringe and pulling the needle cover out carefully, without turning it.Discard the needle cover.Do notreplace the needle cover.Do notpush the plunger, touch the needle, or shake the syringe.

• Pinch a fold of skin between your thumb and index finger.Do notcompress it.
• With the other hand, hold the syringe like a pencil. Use a quick "dart" motion to insert the needle at an angle of approximately 45 degrees into the skin.

• Insert the needle completely. Your doctor or nurse has shown you how to do this.
• Push the plunger while holding the collar with your fingers until the entire dose has been administered. The needle protection mechanism will not be activated unless the entire dose has been administered.

.

• When the plunger has stopped moving, remove the needle and release the skin.
• Release the plunger and allow the syringe to move upwards until the entire needle is stored and blocked in its place.

• When the needle is removed from the skin, there may be some bleeding at the injection site. This is normal. You can press an antiseptic swab on the injection site for a few seconds after the injection.
• Do notattempt to replace the needle cover.Dispose of the used syringe in a sharps container (safety needle container).
• Never put used syringes in the normal household trash.

How to inject yourself using apre-filled syringe with a needle trap (needle trap)

Your syringe has a needle trap (needle trap) attached, which is specifically designed to help prevent accidental needlestick injuries after proper administration of injectable medications. It consists of a plastic device that blocks the needle and is firmly attached to the syringe label. Together, these two components perform the function of the needle trap (safety).

The plastic blocking device attached to the syringe labelrequires specific actions from the user to "activate" it, which will make the needle harmless after administering the injection:

• Remove the carton containing the pre-filled syringe from the refrigerator.
• Remove the blister pack containing the pre-filled syringe from the carton. When the carton contains blister packs with more than one pre-filled syringe, cut the blister pack with a pre-filled syringe along the perforated part, return the remaining blister packs with pre-filled syringes to the carton and return the carton to the refrigerator.
• Open the blister pack with the pre-filled syringe with needle trapby removing the lid after removing it from the refrigerator.
• Hold the body of the syringe to remove the pre-filled syringe from the blister pack.

• Do notremove the needle cover from the syringe until you are ready to inject the medication.
• The liquid should reach room temperature.Do notremove the needle cover from the syringe while the syringe is reaching room temperature.
• Check the syringe to ensure it is the correct dose, has not expired, is not damaged, and the liquid is clear and not frozen.

• Do not use the pre-filled syringe if:
• • The carton is open or damaged.
  • The needle trap is missing, has come loose, or has been activated.
  • Themedicine is cloudy or has changed color or the liquid has particles floating in it.Do notinspect the product through the plastic of the safety device.
  • Any part of the pre-filled syringe appears cracked or broken or the liquid has leaked from the syringe.
  • The pre-filled syringe has fallen. The pre-filled syringe may be broken even if you cannot see the break.
  • The needle cover is missing or not properly placed.
  • The expiration date printed on the label has passed.

In all the above cases, discard the pre-filled syringe and use a new pre-filled syringe.

• Choose an injection site. Good sites are the upper thigh and around the abdomen (stomach) but away from the navel. Vary the site each day.
• Wash your hands. Use an antiseptic swab on the injection site to disinfect it.
• Hold the syringe by the body of the syringe with the needle covered pointing upwards.
• • Do nothold it by the plunger, plunger or needle cover.
  • Do notpull the plunger at any time.
  • Hold the plastic tip of the needle and move it away from the needle cover.

• Remove the needle cover from the syringe by holding the body of the syringe and pulling the needle cover out carefully, without turning it.Discard the needle cover.Do notreplace the needle cover.Do notpush the plunger, touch the needle, or shake the syringe.

• Pinch a fold of skin between your thumb and index finger.Do notcompress it.
• With the other hand, hold the syringe like a pencil. Use a quick "dart" motion to insert the needle at an angle of approximately 45 degrees into the skin.

• Insert the needle completely. Your doctor or nurse has shown you how to do this.
• Push the plunger with your thumb as far as you can and inject the entire amount of liquid. Push slowly and steadily, keeping the skin fold pinched.
• When the plunger has stopped moving, remove the needle and release the skin.
• Place the needle trap on a hard, stable surface, and with one hand, give the syringe a clockwise turn against the needle, forcing the needle into the trap, where it will be blocked (an audible click is heard when the needle is blocked in the trap). Continue to fold the needle of the syringe until it exceeds an angle of 45 degrees with the flat surface so that it is definitely out of use.

• When the needle is removed from the skin, there may be some bleeding at the injection site. This is normal. You can press an antiseptic swab on the injection site for a few seconds after the injection.
• Do notattempt to replace the needle cover.Dispose of the used syringe in a sharps container (safety needle container).
• Never put used syringes in the normal household trash.

If you use more Retacrit than you should

Inform your doctor or nurse immediately if you think you have been given too much Retacrit. It is unlikely that you will experience adverse effects as a result of an overdose of Retacrit.

If you forgot to use Retacrit

Take the next injection as soon as you remember. If there is less than a day to the next injection, skip the missed dose and continue with your regular program. Do not double the injections to compensate for the missed doses.

If you are a patient with hepatitisC who receives interferon and ribavirin

You should discuss it with your doctor because, in rare cases, the combination of epoetin zeta with interferon and ribavirin has produced a loss of effect and the appearance of a disease called pure red cell aplasia (PRCA), a severe form of anemia. Retacrit is not approved for the treatment of anemia associated with hepatitisC.

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

Like all medicines,this medicinecancauseside effects, although not everyone will experience them.

Inform your doctor or nurse immediatelyif you experience any of the side effects listed below.

Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been observed with the administration of epoetins. These reactions may appear as red circular patches or macules with central blisters on the trunk, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms. Stop using Retacrit if you experience these symptoms and contact your doctor or seek medical attention immediately. See also section2.

Very common: may affect more than 1 in 10 people.

• Diarrhea
• Stomach discomfort
• Vomiting
• Fever

• In patients with renal insufficiency who have not yet undergone dialysis, congestion in the respiratory tract, such as nasal congestion and sore throat, has been reported.

Common: may affect up to 1 in 10 people.

• Increased blood pressure. Sudden, stabbing, and migrainous headaches,especially those that are sudden, stabbing, and migrainous, and a feeling of confusion or convulsionsmay be signs of a sudden increase in blood pressure. This requires urgent treatment. This increase may require treatment with medication (or adjustment of the dosage of medications you are already taking for high blood pressure).
• Blood clots(including deep vein thrombosis and embolism) that may require urgent treatment. You may experiencechest pain, difficulty breathing, and painful and inflamed swelling, usually in a leg.
• Coughing.
• Itching on the skin, which may be due to an allergic reaction.
• Muscle or bone pain.
• Flu-like symptoms,such as headache, pinpricks, and joint pain, feeling weak, chills, fatigue, and dizziness. These may be more frequent at the beginning of treatment. If you experience these symptoms during intravenous injection, a slower administration of the injection may help prevent them from occurring again.
• Redness, burning, and pain at the injection site.
• Swelling of the ankles, feet, or fingers.
• Pain in the arm or leg.

Rare: may affect up to1 in 100 people.

• High levels of potassium in the bloodthat may cause an abnormal heart rhythm (this is a very common side effect in patients undergoing dialysis).
• Tremors.
• Congestion of the nose or airway.
• Allergic reaction.
• Rash (hives).

Very rare: may affect up to 1in 1,000 people.

• Symptoms of pure red cell aplasia (PRCA).

PRCA is the inability to produce enough red blood cells in the bone marrow. PRCA can cause asevere and sudden anemia..The symptoms are:

PRCA has been reported in rare cases, mainly in patients with kidney disease after months or years of treatment with Retacrit and other products that stimulate red blood cell production.

• A temporary increase in the number of small blood cells (called platelets) that normally participate in blood clot formation, especially when treatment begins. Your doctor will check this.

• Severe allergic reactions that may include:
• • Swollen face, lips, mouth, tongue, or throat;
  • Difficulty swallowing or breathing;
  • Rash with itching (hives).

• A blood disorder that can cause pain, dark urine, or increased sensitivity to sunlight (porphyria).

If you are receiving hemodialysis:

• Blood clots(thrombosis)may form in the dialysis fistula. This is more common if you have low blood pressure or if your fistula has complications.
• Blood clotsmay also form in your dialysis system.Your doctor may decide to increase your heparin dose during dialysis.

If you experience any of these side effects or notice any other side effects while taking Retacrit,inform your doctor or nurse immediately.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor,pharmacistor nurse,even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly throughthe Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and labelafter “EXP”. The expiration date is the last day of the month indicated.

Store in refrigerator (2°C‑8°C). You can remove Retacrit from the refrigerator and keep it at room temperature (up to 25°C) for a maximum period of 3days. Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25°C), it must be used within three days or discarded.

Do not freeze or shake.

Store in the outer packaging to protect it from light.

Do not use this medication if you observe that the seal is broken or if the liquid has a color or you can see particles floating in it. If you observe any of these situations, discard the medication.

Medications should not be thrown away through the drains or in the trash..Ask your pharmacist how to dispose ofthe packaging and the medications thatyou no longerneed. This way, you will help protect the environment.

Composition of Retacrit

The active ingredient is epoetin zeta (produced by recombinant DNA technology in Chinese hamster ovary cell lines).

Retacrit 1 000UI/0.3ml injectable solution in pre-filled syringe

1 pre-filled syringe with 0.3 ml of injectable solution contains 1 000 units international (UI) of epoetin zeta (recombinant human erythropoietin). The solution contains 3 333 UI of epoetin zeta per ml.

Retacrit 2 000UI/0.6ml injectable solution in pre-filled syringe

1 pre-filled syringe with 0.6 ml of injectable solution contains 2 000 units international (UI) of epoetin zeta (recombinant human erythropoietin). The solution contains 3 333 UI of epoetin zeta per ml.

Retacrit 3 000UI/0.9ml injectable solution in pre-filled syringe

1 pre-filled syringe with 0.9 ml of injectable solution contains 3 000 units international (UI) of epoetin zeta (recombinant human erythropoietin). The solution contains 3 333 UI of epoetin zeta per ml.

Retacrit 4 000UI/0.4ml injectable solution in pre-filled syringe

1 pre-filled syringe with 0.4 ml of injectable solution contains 4 000 units international (UI) of epoetin zeta (recombinant human erythropoietin). The solution contains 10 000 UI of epoetin zeta per ml.

Retacrit 5 000UI/0.5ml injectable solution in pre-filled syringe

1 pre-filled syringe with 0.5 ml of injectable solution contains 5 000 units international (UI) of epoetin zeta (recombinant human erythropoietin). The solution contains 10 000 UI of epoetin zeta per ml.

Retacrit 6 000UI/0.6ml injectable solution in pre-filled syringe

1 pre-filled syringe with 0.6 ml of injectable solution contains 6 000 units international (UI) of epoetin zeta (recombinant human erythropoietin). The solution contains 10 000 UI of epoetin zeta per ml.

Retacrit 8 000UI/0.8ml injectable solution in pre-filled syringe

1 pre-filled syringe with 0.8 ml of injectable solution contains 8 000 units international (UI) of epoetin zeta (recombinant human erythropoietin). The solution contains 10 000 UI of epoetin zeta per ml.

Retacrit 10 000UI/1ml injectable solution in pre-filled syringe

1 pre-filled syringe with 1 ml of injectable solution contains 10 000 units international (UI) of epoetin zeta (recombinant human erythropoietin). The solution contains 10 000 UI of epoetin zeta per ml.

Retacrit 20 000UI/0.5ml injectable solution in pre-filled syringe

1 pre-filled syringe with 0.5 ml of injectable solution contains 20 000 units international (UI) of epoetin zeta (recombinant human erythropoietin). The solution contains 40 000 UI of epoetin zeta per ml.

Retacrit 30 000UI/0.75ml injectable solution in pre-filled syringe

1 pre-filled syringe with 0.75 ml of injectable solution contains 30 000 units international (UI) of epoetin zeta (recombinant human erythropoietin). The solution contains 40 000 UI of epoetin zeta per ml.

Retacrit 40 000UI/1ml injectable solution in pre-filled syringe

1 pre-filled syringe with 1 ml of injectable solution contains 40 000 units international (UI) of epoetin zeta (recombinant human erythropoietin). The solution contains 40 000 UI of epoetin zeta per ml.

The other components are sodium dihydrogen phosphate dihydrate, sodium phosphate dihydrate, sodium chloride (see section 2 “Retacrit contains sodium”), calcium chloride dihydrate, polisorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine (see section 2 “Retacrit contains phenylalanine”), water for injections, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment).

Appearance of the product and contents of the pack

Retacrit is a transparent and colourless injectable solution that is presented in transparent glass syringes with a fixed needle.

The pre-filled syringes contain between 0.3 and 1 ml of solution, depending on the epoetin zeta content (see “Composition of Retacrit”).

Each pack includes 1, 4 or 6 pre-filled syringes with or without a safety needle protector or with a plastic needle blocker attached to the syringe label.

The multi-pack contains 4 (4 packs of 1) or 6 (6 packs of 1) pre-filled syringes.

Marketing authorisation holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Manufacturers responsible

Hospira Zagreb d.o.o.

Prudnicka cesta 60

10291 Prigorje Brdovecko

Croatia

For further information on this medicinal product, please contact the local representative of the marketing authorisation holder:

Spain

Pfizer, S.L.

Tel: +34 91 490 99 00

Last update of this leaflet: 07/2023.

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