1,000 IU / 0.3 ml; 2,000 IU / 0.6 ml; 3,000 IU / 0.9 ml; 4,000 IU / 0.4 ml; 5,000 IU / 0.5 ml; 6,000 IU / 0 .6 ml; 8,000 IU / 0.8 ml; 10,000 IU / 1.0 ml; 20,000 IU / 0.5 ml; 30,000 IU / 0.75 ml; 40,000 IU / 1.0 solution for injection in pre-filled syringe
epoetin zeta
What Retacrit is and what it is used for
Retacrit contains the active substance epoetin zeta – a protein that stimulates the bone marrow to produce more red blood cells that contain hemoglobin (a substance that carries oxygen). Epoetin zeta is a copy of the human protein et erythropoetin and acts in the same way.
- Retacrit is used to treat symptomatic anemia ( anemia ) caused by kidney disease
- in children on hemodialysis
- in adults on hemodialysis or peritoneal dialysis
- in adults with severe anemia, who have not yet undergone dialysis.
If you have kidney disease, you may have a lack of red blood cells if the kidneys do not produce enough erythropoietin (necessary for the production of red blood cells ). Retacrit is prescribed to stimulate the bone marrow to produce more red blood cells.
- Retacrit is used to treat anemia in adults who are receiving chemotherapy for solid tumors, malignant lymphoma, or multiple myeloma (bone marrow cancer) and who may need a blood transfusion. Retacrit may reduce the need for blood transfusions in these patients.
- Retacrit is used in adults with moderate anemia who donate a certain amount of their blood before their operation so that they can get it back during or after the operation. Because Retacrit stimulates the production of red blood cells, a larger volume of blood can be taken from these individuals.
- Retacrit is used in adults with moderate anemia who need major orthopedic surgery (eg hip or knee surgery) to reduce the need for blood transfusions.
- Retacrit is used to treat anemia in adults with a bone marrow disease that causes a serious disorder in the formation of blood cells ( myelodysplastic syndrome ). Retacrit may reduce the need for blood transfusions.
What you need to know before you use Retacrit
Do not use Retacrit:
- If you are allergic to epoetin zeta or any of the other ingredients of this medicine (listed in section 6).
- If you have been diagnosed with erythrocyte aplasia (meaning that your bone marrow cannot produce enough red blood cells ) after previous treatment with any drug that stimulates the formation of red blood cells (including Retacrit). See section 4.
- If you have high blood pressure that is not under control with the help of medication.
- To stimulate the production of your red blood cells (so that the doctor can take a larger volume of blood from you) if you can not get a transfusion with your blood during or after surgery.
- If you are going to undergo a major scheduled orthopedic surgery ( eg hip or knee surgery), and you:
- have severe heart disease
- have severe disease of the veins or arteries
- recently had a heart attack or stroke
- can not take blood thinners.
Retacrit may be inappropriate for you. Discuss with your doctor. Some people taking Retacrit may also need medicines that reduce the risk of blood clots (blood-thinning medicines). If you can not take blood-thinning drugs, do not use Retacrit.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Retacrit.
Take special care with Retacrit
Retacrit and other products that stimulate the formation of red blood cells may increase the risk of developing blood clots in all patients. This risk may be higher if you have other risk factors for developing blood clots (eg if you have had a blood clot before or if you are overweight, have diabetes, have heart disease, or are in bed for a long time due to surgery or illness). Tell your doctor if you have any of these risk factors. Your doctor will decide if Retacrit is right for you.
Talk to your doctor if any of the following apply to you. You may still be able to use Retacrit, but first, discuss this with your doctor:
- If you know you are suffering from or have suffered from:
- high blood pressure
- epileptic seizures or seizures
- liver disease
- anemia of other causes
- porphyria (a rare blood disease).
- If you are a patient with chronic kidney failure, and especially if you do not respond adequately to Retacrit, your doctor will check your dose of Retacrit, as repeated dose increases of Retacrit if you do not respond to treatment may increase the risk of heart or blood vessel problems and may increase the risk of heart attack, stroke, and death.
- If you are a cancer patient, you should be aware that products that stimulate the formation of red blood cells such as Retacrit can act as a growth factor and could therefore theoretically affect the development of your cancer. Depending on your condition, a blood transfusion may be preferable. Discuss this with your doctor.
- If you are a cancer patient, you should be aware that the use of Retacrit may be associated with shorter survival and higher mortality in head and neck cancer as well as metastatic breast cancer in patients treated with chemotherapy.
- Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported during treatment with epoetin.
Stevens-Johnson syndrome and toxic epidermal necrolysis can begin as reddish-purple target-like spots or round spots on the torso, often with blisters in the middle. Sores in the mouth, throat, nose, genitals, and eyes (red and swollen eyes) may also occur. These severe skin reactions are often preceded by fever and/or flu-like symptoms. The rash can develop into widespread areas with scaly skin and life-threatening complications.
If you get a severe rash or any of these skin symptoms, stop taking Retacrit and contact a doctor or hospital immediately.
Take special care with other drugs that stimulate the formation of red blood cells:
Retacrit belongs to a group of medicines that stimulate the formation of red blood cells, as does the human protein erythropoietin. Your healthcare professional will always document exactly which medicine you are using.
If you get any product in this group other than Retacrit during your treatment, talk to your doctor or pharmacist before using it.
Other medicines and Retacrit
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking the drug ciclosporin (used, for example, after a kidney transplant), your doctor may prescribe blood tests to check your ciclosporin levels while you are taking Retacrit.
Iron supplements and other blood-stimulating drugs may increase the effect of Retacrit. Your doctor will decide if you should take such or not.
If you are visiting a hospital or going to your clinic or GP, tell them that you are being treated with Retacrit. It may affect other treatments or test results.
Pregnancy, breastfeeding, and fertility
You must tell your doctor if any of the following apply to you. You may still be able to take Retacrit but talk to your doctor first.
- If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- If you are breastfeeding.
There are no data available on the effect of epoetin zeta on fertility.
Driving and using machines
Retacrit has no or negligible effect on the ability to drive or use machines.
Retacrit contains phenylalanine
This medicine contains 0.5 mg phenylalanine per ml.
Phenylalanine can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.
Retacrit contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.
How to use Retacrit
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Your doctor has taken blood samples and decided that you need Retacrit.
Retacrit can be given as an injection:
- either in a vein or in a tube that enters a vein ( intravenously )
- or under the skin ( subcutaneously ).
Your doctor will decide how to inject Retacrit. You will usually receive injections from a doctor, nurse, or other healthcare professional. Depending on why they need treatment with Retacrit, some people may later learn to inject themselves under the skin: see How to inject Retacrit yourself.
Retacrit should not be used:
- after the expiry date which is stated on the label and the outer carton
- if you know or believe that it may have been accidentally frozen, or
- if the refrigerator has stopped working.
Retacrit dose is based on your body weight in kilograms. The cause of your anemia is also included as a factor when your doctor decides which dose is right for you.
Your doctor will monitor your blood pressure regularly while you are using Retacrit.
People with kidney disease
- Your doctor will maintain a hemoglobin level of between 10 and 12 g / dl as a high hemoglobin level may increase the risk of blood clots and death. In children, the hemoglobin level should be kept between 9.5 and 11 g / dl.
- The usual starting dose of Retacrit for adults and children is 50 international units (IU) per kilogram (kg) body weight given three times a week.
- For patients on peritoneal dialysis, Retacrit can be given twice a week.
- For adults and children, Retacrit is given as an injection either into a vein or into a tube that goes into a vein. When this entry (via a vein or tube) is not easily accessible, your doctor may decide to inject Retacrit under the skin ( subcutaneously ). This includes patients undergoing dialysis and patients not yet undergoing dialysis.
- Your doctor will prescribe regular blood tests to see how your anemia responds to treatment and may adjust dose one, usually no more often than every four weeks. An increase in hemoglobin of more than 2 g / dl over four weeks should be avoided.
- After your anemia has improved, your doctor will continue to check your blood regularly. Your Retacrit dose and frequency of administration can be further adjusted to maintain your response to treatment. Your doctor will use the lowest effective dose to keep the symptoms of your anemia under control.
- If you do not respond well enough to Retacrit, your doctor will check your dose and tell you if you need to change the dose of Retacrit.
- If you are on a longer dosing interval of Retacrit (less frequently than once a week), you may not be able to maintain adequate hemoglobin levels and you may need to increase your Retacrit dose or the frequency of administration.
- You may be given iron supplements before and during your Retacrit treatment to make it more effective.
- If you are undergoing dialysis treatment when you start treatment with Retacrit, your dialysis treatment may need to be adjusted. Your doctor will decide this.
Adults receiving chemotherapy
- Your doctor may start treatment with Retacrit if your hemoglobin level is 10 g / dl or lower.
- Your doctor will keep your hemoglobin level between 10 and 12 g / dl, as a high hemoglobin level may increase the risk of blood clots and death.
- The initial dose is either 150 IU per kilogram of body weight three times a week or 450 IU per kilogram of body weight once a week.
- Retacrit is given as an injection under the skin.
- Your doctor will prescribe blood tests and may adjust dose one, depending on how your anemia responds to Retacrit treatment.
- You may be given iron supplements before and during your Retacrit treatment to make it more effective.
- You will usually continue your Retacrit treatment for one month after stopping the chemotherapy.
Adults who donate their blood
- The usual dose is 600 IU per kilogram of body weight twice a week.
- Immediately after you donate blood, Retacrit is given by injection into a vein for three weeks before your operation.
- You may be given iron supplements before and during your Retacrit treatment to make it more effective.
Adults undergoing major orthopedic surgery
- The recommended dose is 600 IU per kilogram of body weight once a week.
- Retacrit is given by injection under the skin every week for three weeks before the operation and on the day of the operation.
- If there is a medical need to reduce the time until your surgery, you will receive a daily dose of 300 IU / kg for up to ten days before the operation, on the day of the operation, and for four days immediately thereafter.
- If blood tests show that your hemoglobin is too high before the operation, treatment will be stopped.
- You may be given iron supplements before and during your Retacrit treatment to make it more effective.
Adults with myelodysplastic syndrome
- Your doctor may start treatment with Retacrit if your hemoglobin value is 10 g / dl or lower. The goal of treatment is to maintain a hemoglobin level of between 10 and 12 g / dl as a higher hemoglobin value may increase the risk of blood clots and death.
- Retacrit is given as an injection under the skin.
- The starting dose is 450 IU per kilogram of body weight once a week.
- Your doctor will order blood tests and may adjust the dose depending on how your anemia responds to Retacrit treatment.
How to inject Retacrit yourself
When starting treatment, Retacrit is usually injected by a healthcare professional. Later, your doctor may suggest that you or your caregiver learn how to inject Retacrit under the skin ( subcutaneously ).
- Do not try to inject yourself without first being instructed by your doctor or nurse on how to do it.
- Always use Retacrit exactly as your doctor or nurse has told you.
- Only use this medicine if it has been stored correctly (see section 5, How to store Retacrit ).
- Take out the pre-filled syringe before using it and leave it until it has reached room temperature. It usually takes 15-30 minutes.
Take only one dose of Retacrit from each syringe.
If Retacrit is injected under the skin ( subcutaneously ), the amount injected is usually no more than one milliliter (1 ml) in a single injection.
Retacrit is given alone and should not be mixed with other solutions for injection.
Do not shake the Retacrit syringes. Prolonged, vigorous shaking can damage the product. Do not use the product if it has been shaken vigorously.
How to inject yourself with a pre-filled syringe
- Take the syringe out of the refrigerator. Allow the liquid to reach room temperature. Do not remove the dipstick while waiting for the syringe to reach room temperature.
- Check the syringe to see that it contains the correct dose, that the expiry date has not passed, that it is not damaged, and that the liquid is clear and not frozen.
- Choose an injection site. Good places are on the top of the thigh and around the abdomen (abdomen) but not near the navel. Vary the injection site from day to day.
- Wash your hands. Use an antiseptic wipe at the injection site to disinfect it.
- Hold the plastic cover that encloses the pre-filled syringe with the protected needle pointing upwards.
- Do not touch any part of the plunger or the plug.
- Never pull back the piston.
- Do not remove the needle cover from the pre-filled syringe until you are ready to inject the medicine.
- Remove the puncture guard from the syringe by holding the syringe and gently pulling off the cap without twisting it. Do not press on the plunger, do not touch the needle, or shake the syringe.
- Pinch a fold of skin between the thumb and forefinger. Do not squeeze.
- Push the needle down completely. Your doctor or nurse may have shown you how to do this.
- Press the plunger with your thumb as far as it will go to inject the entire amount of liquid. Press it in slowly and evenly with a preserved grip on the skin fold.
- When the plunger has been pushed in as far as it will go, remove the needle and release the skin.
- When the needle is pulled out, there may be a small amount of bleeding at the injection site. This is normal. You can press an antiseptic wipe over the injection site for a few seconds after injection one.
- Dispose of the used syringe in a safe container. Do not try to put the stitch guard back on.
- Never dispose of used syringes among the ordinary household waste.
How to inject yourself with a pre-filled syringe
The pre-filled syringe can be fitted with automatic puncture protection to protect against puncture damage.
- Take the syringe out of the refrigerator. Allow the liquid to reach room temperature. Do not remove the dipstick while waiting for the syringe to reach room temperature.
- Check the syringe to see that it contains the correct dose, that the expiry date has not passed, that it is not damaged, and that the liquid is clear and not frozen.
- Choose an injection site. Good places are on the top of the thigh and around the abdomen (abdomen) but not near the navel. Vary the injection site from day to day.
- Wash your hands. Use an antiseptic wipe at the injection site to disinfect it.
- Hold the plastic cover that encloses the pre-filled syringe with the protected needle pointing upwards.
- Do not touch any part of the plunger or the plug.
- Never pull back the piston.
- Do not remove the needle cover from the pre-filled syringe until you are ready to inject the medicine.
- Remove the puncture guard from the syringe by holding the syringe and gently pulling off the cap without twisting it. Do not press on the plunger, do not touch the needle, or shake the syringe.
- Pinch a fold of skin between the thumb and forefinger. Do not squeeze.
- Push the needle down completely. Your doctor or nurse may have shown you how to do this.
- Press the plunger while holding the finger flange until the full dose has been given. The puncture protection is NOT activated unless the ENTIRE dose has been given.
- When the plunger has been pushed in as far as it will go, remove the needle and release the skin.
- Then release the plunger and allow the syringe to move upwards until the entire needle is protected and has clicked into place.
- When the needle is pulled out, there may be a small amount of bleeding at the injection site. This is normal. You can press an antiseptic wipe over the injection site for a few seconds after injection one.
- Dispose of the used syringe in a safe container. Do not try to put the stitch guard back on.
- Never dispose of used syringes among the ordinary household waste.
How to inject yourself with a pre-filled syringe
The pre-filled syringe is equipped with manual puncture protection specially designed to protect against accidental puncture injuries after proper administration of the injection. It consists of plastic puncture protection that is firmly attached to the syringe label. The puncture protection and the syringe label together constitute the puncture protection (safety) device.
The user is required to perform special measures to “activate” the manual needle guard, which renders the needle harmless after the injection has been administered:
- Take the syringe out of the refrigerator. Allow the liquid to reach room temperature. Do not remove the dipstick while waiting for the syringe to reach room temperature.
- Check the syringe to see that it contains the correct dose, that the expiry date has not passed, that it is not damaged, and that the liquid is clear and not frozen.
- Choose an injection site. Good places are on the top of the thigh and around the abdomen (abdomen) but not near the navel. Vary the injection site from day to day.
- Wash your hands. Use an antiseptic wipe at the injection site to disinfect it.
- Hold the plastic cover that encloses the pre-filled syringe with the protected needle pointing upwards.
- Do not touch any part of the plunger or the plug.
- Never pull back the piston.
- Grasp the tip of the colored needle guard and bend it away from the needle guard.
- Do not remove the needle cover from the pre-filled syringe until you are ready to inject the medicine.
- Remove the puncture guard from the syringe by holding the syringe and gently pulling off the cap without twisting it. Do not press on the plunger, do not touch the needle, or shake the syringe.
- Pinch a fold of skin between the thumb and forefinger. Do not squeeze.
- Push the needle down completely. Your doctor or nurse may have shown you how to do this.
- Press the plunger with your thumb as far as it will go to inject the entire amount of liquid. Press it in slowly and evenly with a preserved grip on the skin fold.
- When the plunger has been pushed in as far as it will go, remove the needle and release the skin.
- Place the colored needle guard against a hard, stable surface, and turn the syringe with one hand upwards so that the needle is forced into the needle guard where it locks in place (a “click” is heard when the needle gets stuck in the needle guard). Then bend the needle further until the syringe exceeds a 45 ° angle to the flat surface to make it permanently unusable.
- When the needle is pulled out, there may be a small amount of bleeding at the injection site. This is normal. You can press an antiseptic wipe over the injection site for a few seconds after injection one.
- Dispose of the used syringe in a safe container. Do not try to put the stitch guard back on.
- Never dispose of used syringes among the ordinary household waste.
If you use more Retacrit than you should
Tell your doctor or nurse immediately if you think you have been given too much Retacrit. Side effects due to overdose of Retacrit are unlikely.
If you forget to use Retacrit
Take the next injection as soon as you remember. If there is one day left or less until it is time for the next injection, skip the missed dose and continue as usual. Do not take double injections to compensate for a missed dose.
If you have hepatitis C and are being treated with interferon and ribavirin
Talk to your doctor as concomitant treatment with epoetin alfa and interferon and ribavirin may lead to loss of efficacy and, in rare cases, the development of a condition called erythrocyte plasma (PRCA), a severe form of anemia. Retacrit is not approved for the treatment of anemia associated with hepatitis C.
If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
Severe skin rashes such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported during treatment with epoetin. These conditions can cause symptoms such as reddish-purple target-like or round spots on the torso, often with blisters in the middle, scaly skin, sores in the mouth, throat, nose, genitals, and eyes and may be preceded by fever and flu-like symptoms. Stop taking Retacrit if you experience these symptoms and contact a doctor or hospital immediately. See also section 2.
Very common: may affect more than 1 in 10 people.
- Diarrhea
- Nausea
- Vomiting
- Fever
- Narrow airways such as nasal congestion and sore throat have been reported in patients with kidney disease who have not yet undergone dialysis.
Common: may affect up to 1 in 10 people.
- High blood pressure. Headaches, especially sudden, stabbing migraine-like headaches, feelings of confusion or seizures can be signs of a sudden increase in blood pressure. This requires urgent treatment. High blood pressure may require medication (or adjustment of the medications you are already taking for high blood pressure ).
- Blood clots (including deep vein thrombosis and embolism) that may require urgent treatment. You may experience chest pain, shortness of breath, painful swelling, and redness, usually in the leg, as symptoms.
- Cough
- Skin rash may be due to an allergic reaction.
- Skeletal or muscle pain
- Influenza-like symptoms, such as headache, joint pain, pain, feeling weak, chills, fatigue, and dizziness. These may be more common at the beginning of treatment. If you get these symptoms by intravenous injection, they can be avoided in the future by giving injection more slowly.
- Redness, burning, and pain at the injection site
- Swelling of the ankles, feet, and fingers
- Pain in arms or legs
Uncommon: may affect up to 1 in 100 people.
- High levels of potassium in the blood can cause abnormal heart rhythms (this is a very common side effect in patients undergoing dialysis )
- Seizures
- Nasal congestion or narrow airways
- Allergic reaction
- Hives
Rare: may affect up to 1 in 1,000 people.
- Symptoms of erythrocyte plasma (PRCA)PRCA means the inability to produce enough red blood cells in the bone marrow. PRCA can lead to sudden and severe anemia. The symptoms are:
- unusual fatigue,
- dizziness,
- respiratory distress.
PRCA has in very rare cases, mainly in patients with kidney disease, been reported after several months to years of treatment with Retacrit and other products that stimulate the formation of red blood cells.
- An increase in the level of small blood cells (so-called platelets ), which are normally involved in the formation of blood clots, can occur, especially at the beginning of treatment. Your doctor will check this
- The severe allergic reaction may include:
- swelling of the face, lips, mouth, tongue, or throat
- difficulty swallowing or breathing
- itchy rash ( hives )
- Problems with the blood that can cause pain, dark-colored urine, or increased sensitivity of the skin to sunlight ( porphyria )
If you are undergoing hemodialysis:
- Blood clots ( thrombosis ) can form in your dialysis shunt. There is a greater risk of this if you have low blood pressure or if there are complications with your fistula.
- Blood clots can also form in your hemodialysis system. Your doctor can decide to increase your heparin dose during dialysis.
Tell your doctor or nurse immediately if you notice any of these side effects, or if you notice any other side effects while you are being treated with Retacrit.
How to store Retacrit
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 carton and the label after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C-8 ° C). Retacrit can be taken out of the refrigerator and then stored at room temperature (maximum 25 ° C) for a maximum of 3 days. Once a syringe has been removed from the refrigerator and has reached room temperature (maximum 25 ° C), it must either be used within 3 days or discarded.
Do not freeze or shake.
Store in the original package. Sensitive to light.
Do not use this medicine if you notice that the seal is broken or if the liquid is colored or if you see particles in it. If you see any of this, discard the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is epoetin zeta (produced by recombinant DNA technology in Chinese hamster ovary cells (CHO).
Retacrit 1,000 IU / 0.3 ml solution for injection in a pre-filled syringe
1 pre-filled syringe with 0.3 ml solution for injection contains 1,000 international units (IU) epoetin zeta ( recombinant human erythropoietin). The solution contains 3,333 IU epoetin zeta per ml.
Retacrit 2,000 IU / 0.6 ml solution for injection in a pre-filled syringe
1 pre-filled syringe with 0.6 ml solution for injection contains 2,000 International Units (IU) epoetin zeta ( recombinant human erythropoietin). The solution contains 3,333 IU epoetin zeta per ml.
Retacrit 3,000 IU / 0.9 ml solution for injection in a pre-filled syringe
1 pre-filled syringe with 0.9 ml solution for injection contains 3,000 international units (IU) epoetin zeta ( recombinant human erythropoietin). The solution contains 3,333 IU epoetin zeta per ml.
Retacrit 4,000 IU / 0.4 ml solution for injection in a pre-filled syringe
1 pre-filled syringe with 0.4 ml solution for injection contains 4,000 international units (IU) epoetin zeta ( recombinant human erythropoietin). The solution contains 10,000 IU epoetin zeta per ml.
Retacrit 5,000 IU / 0.5 ml solution for injection in a pre-filled syringe
1 pre-filled syringe with 0.5 ml solution for injection contains 5,000 international units (IU) epoetin zeta ( recombinant human erythropoietin). The solution contains 10,000 IU epoetin zeta per ml.
Retacrit 6,000 IU / 0.6 ml solution for injection in a pre-filled syringe
1 pre-filled syringe with 0.6 ml solution for injection contains 6,000 international units (IU) epoetin zeta ( recombinant human erythropoietin). The solution contains 10,000 IU epoetin zeta per ml.
Retacrit 8,000 IU / 0.8 ml solution for injection in a pre-filled syringe
1 pre-filled syringe with 0.8 ml solution for injection contains 8,000 international units (IU) epoetin zeta ( recombinant human erythropoietin). The solution contains 10,000 IU epoetin zeta per ml.
Retacrit 10,000 IU / 1 ml solution for injection in a pre-filled syringe
1 pre-filled syringe with 1 ml solution for injection contains 10,000 international units (IU) epoetin zeta ( recombinant human erythropoietin). The solution contains 10,000 IU epoetin zeta per ml.
Retacrit 20,000 IU / 0.5 ml solution for injection in a pre-filled syringe
1 pre-filled syringe with 0.5 ml solution for injection contains 20,000 international units (IU) epoetin zeta ( recombinant human erythropoietin). The solution contains 40,000 IU epoetin zeta per ml.
Retacrit 30,000 IU / 0.75 ml solution for injection in a pre-filled syringe
1 pre-filled syringe with 0.75 ml solution for injection contains 30,000 international units (IU) epoetin zeta ( recombinant human erythropoietin). The solution contains 40,000 IU epoetin zeta per ml.
Retacrit 40,000 IU / 1 ml solution for injection in a pre-filled syringe
1 pre-filled syringe with 1 ml solution for injection contains 40,000 international units (IU) epoetin zeta ( recombinant human erythropoietin). The solution contains 40,000 IU epoetin zeta per ml.
The other ingredients are disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride (see section 2 ” Retacrit contains sodium”), calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, see phenylalanine section (phenylalanine). , sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment).
What the medicine looks like and the contents of the pack
Retacrit is a clear and colorless solution for injection in a pre-filled syringe with a fixed injection needle.
The pre-filled syringes contain between 0.3 and 1 ml of solution, depending on the amount of epoetin zeta (see “Contents of contents”).
One package contains 1, 4, or 6 pre-filled syringes with or without automatic or manual puncture protection.
The multipack contains 4 (4×1) or 6 (6×1) pre-filled syringes.
Marketing Authorization Holder and Manufacturer
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
D-61118 Bad Vilbel
Germany
Hospira Zagreb doo
Prudnička Cesta 60
10291 Prigorje Brdovečko
Croatia
Contact the representative of the marketing authorization holder to find out more about this medicine:
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