Eporatio 20,000 IU/1 ml solution for injection in pre-filled syringe
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Eporatio 1,000 IU/0.5 ml solution for injection in a pre-filled syringe
Eporatio 2,000 IU/0.5 ml solution for injection in a pre-filled syringe
Eporatio 3,000 IU/0.5 ml solution for injection in a pre-filled syringe
Eporatio 4,000 IU/0.5 ml solution for injection in a pre-filled syringe
Eporatio 5,000 IU/0.5 ml solution for injection in a pre-filled syringe
Eporatio 10,000 IU/1 ml solution for injection in a pre-filled syringe
Eporatio 20,000 IU/1 ml solution for injection in a pre-filled syringe
Eporatio 30,000 IU/1 ml solution for injection in a pre-filled syringe
Epoetin zeta (epoetin theta)
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as 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, and you must not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Eporatio is and what it is used for
- What you need to know before using Eporatio
- How to use Eporatio
- Possible side effects
- How to store Eporatio
- Contents of the pack and other information
- Information for self-injection
1. What Eporatio is and what it is used for
What Eporatio is
Eporatio contains the active substance epoetin zeta (epoetin theta), which is almost identical to erythropoietin, a natural hormone produced by the body. Epoetin zeta (epoetin theta) is a protein produced by biotechnology. It works in exactly the same way as erythropoietin. Erythropoietin is produced in the kidneys and stimulates the bone marrow to produce red blood cells. Red blood cells are essential for distributing oxygen throughout the body.
What Eporatio is used for
Eporatio is used for the symptomatic treatment of anaemia and its symptoms (for example, fatigue, weakness and shortness of breath). Anaemia occurs when the blood cells do not contain enough red blood cells. Treatment of anaemia is given to adult patients with chronic renal failure or adult patients with non-myeloid cancer (cancer not originating in the bone marrow) who are simultaneously receiving chemotherapy (medicines used to treat cancer).
2. What you need to know before using Eporatio
Do not use Eporatio
- if you are allergic to epoetin zeta (epoetin theta), to other epoetins, or to any of the other components of this medicine (listed in section 6);
- if you have uncontrolled hypertension.
Warnings and precautions
General
This medicine may not be suitable for the following patients. Please consult your doctor if you belong to any of these patient groups:
- patients with liver problems;
- patients with pathological changes in their red blood cells (homozygous sickle cell anemia).
Blood pressure must be closely monitored before and during treatment with this medicine. If your blood pressure increases, your doctor may prescribe medication to lower it. If you are already taking medication to lower your blood pressure, your doctor may increase the dose. It may also be necessary to reduce the dose of Eporatio or temporarily interrupt treatment with Eporatio.
Contact your doctor immediately if you experience sudden, severe, migraine-like headache, confusion, speech disturbances, difficulty walking, seizures, or convulsions. These may be signs of very high blood pressure, even if your blood pressure is normally normal or low. Immediate treatment is required.
Your doctor will regularly perform blood tests to monitor various blood components and their levels. In addition, iron levels in the blood must be monitored before and during treatment with this medicine. If your iron levels are too low, your doctor may also prescribe an iron supplement.
If you feel tired, weak, or experience fatigue, consult your doctor. These symptoms may indicate that treatment with this medicine is ineffective. Your doctor will check for other causes of anemia and may perform blood tests or a bone marrow examination.
The healthcare professional treating you will accurately record the product you are using at all times. This may help provide further information on the safety of medicines such as this.
Healthy individuals must not use Eporatio. Use of this medicine in healthy individuals may excessively increase certain blood parameters and thereby cause problems in the heart or blood vessels, potentially endangering life.
Severe cutaneous adverse reactions, such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been observed with administration of epoetins. SJS/TEN may initially appear as macules or circular red, target-like spots, often with central blisters on the trunk. Ulcers may also develop in the mouth, throat, nose, genitals, and eyes (eye irritation and swelling). These severe skin rashes are often preceded by fever or flu-like symptoms. The skin rash may progress to widespread skin peeling and potentially life-threatening complications. If you develop a severe skin rash or any of these other skin symptoms, stop using Eporatio and contact your doctor or seek immediate medical attention.
Anemia due to chronic renal failure
If you are a patient with chronic renal failure, your doctor will ensure that a specific blood parameter (hemoglobin) does not exceed the defined threshold. If blood parameters become too high, cardiac or vascular problems may occur, increasing the risk of death.
If you are a patient with chronic renal failure and, in particular, do not respond adequately to Eporatio, your doctor will monitor your Eporatio dose, as repeated increases in the dose of Eporatio when you are not responding to treatment may increase the risk of heart or vascular problems and could increase the risk of myocardial infarction, stroke, and death.
If you have renal vascular hardening (nephrosclerosis) but do not require dialysis treatment, your doctor will consider whether treatment is appropriate for you. In this case, a possible acceleration of the progression of renal function deterioration cannot be completely ruled out.
If you are on dialysis, medications that prevent blood clotting are used. If you are being treated with Eporatio, the dose of the anticoagulant medication may need to be increased. Otherwise, the increase in red blood cells may cause blockage of the arteriovenous fistula (a surgically created artificial connection between an artery and a vein used in dialysis patients).
Anemia in cancer patients
If you are a cancer patient, you should know that this medicine may act as a growth factor for blood cells and, under certain circumstances, may have a negative impact on cancer. Depending on the individual situation, a blood transfusion may be preferable. Please discuss this with your doctor.
Children and adolescents
Do not administer this medicine to children and adolescents under 18 years of age, as there are no data demonstrating the safety and efficacy of this medicine in this age group.
Other medicines and Eporatio
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
The use of Eporatio in pregnant women has not been investigated. It is important that you inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant, so that your doctor can decide whether it is advisable not to use this medicine.
It is unknown whether the active ingredient of this medicine passes into breast milk. Therefore, your doctor will decide whether it is advisable not to use this medicine while breastfeeding.
Driving and use of machines
This medicine does not affect your ability to drive or operate machinery.
Eporatio contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per pre-filled syringe; this is essentially “sodium-free”.
3. How to use Eporatio
Your treatment with this medicine will be initiated by a doctor experienced in the previously mentioned indications.
Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is…
The dose of Eporatio (expressed in International Units or IU) depends on your condition, body weight, and the route of administration (under the skin [subcutaneous injection] or into a vein [intravenous injection]). Your doctor will determine the correct dose for you.
Anaemia caused by chronic renal failure
Injections may be administered either subcutaneously or intravenously. Patients on haemodialysis usually receive the injection at the end of dialysis via an arteriovenous fistula. Patients not undergoing dialysis usually receive the injection subcutaneously. Your doctor will perform regular blood tests and adjust the dose or discontinue treatment if necessary. Haemoglobin levels in blood should not exceed 12 g/dl (7.45 mmol/l). Your doctor will use the lowest effective dose to control the symptoms of anaemia. If you do not respond adequately to Eporatio, your doctor will monitor your dose and inform you if it is necessary to change the Eporatio dosage.
Treatment with Eporatio consists of two phases:
- Correction of anaemia
The initial dose for subcutaneous injections is 20 IU per kg of body weight, administered 3 times a week. If necessary, your doctor will increase the dose at monthly intervals.
The initial dose for intravenous injections is 40 IU per kg of body weight, administered 3 times a week. If necessary, your doctor will increase the dose at monthly intervals.
- Maintenance of red blood cell levels
Once an adequate number of red blood cells has been achieved, the maintenance dose required to sustain a stable count will be determined by your doctor.
For subcutaneous injections, the weekly dose may be administered either as one injection per week or as three divided injections per week.
For intravenous injections, the dose may be adjusted to two injections per week.
If you change the frequency of administration, a dose adjustment may be necessary.
Treatment with Eporatio is usually long-term.
The maximum dose should not exceed 700 IU per kg of body weight per week.
Anaemia in cancer patients
Subcutaneous injections administered once weekly. The initial dose is 20,000 IU. Your doctor will perform regular blood tests and adjust the dose or discontinue treatment if necessary. Haemoglobin levels in blood should not exceed 12 g/dl (7.45 mmol/l). You will usually receive Eporatio for up to 1 month after completion of chemotherapy.
The maximum dose should not exceed 60,000 IU.
How are the injections administered?
This medicine is administered by injection using a pre-filled syringe. The injection is given either into a vein (intravenous injection) or into the tissue just beneath the skin (subcutaneous injection).
If you are receiving Eporatio treatment as a subcutaneous injection, your doctor may suggest that you learn to self-inject this medicine. Your doctor or nurse will provide instructions on how to do this. Do not attempt to self-administer this medicine without proper instruction. Some information required for using the pre-filled syringe can be found at the end of this leaflet (see section “7. Information for self-injection”). However, optimal treatment of your condition requires close and continuous cooperation with your doctor.
Each pre-filled syringe is for single use only.
If you use more Eporatio than you should
Do not increase the dose prescribed by your doctor. If you think you have injected more Eporatio than you should have, consult your doctor. It is unlikely to be serious. Even at very high blood levels, no symptoms of poisoning have been observed.
If you forget to use Eporatio
If you have missed an injection or administered too low a dose, inform your doctor. Do not use a double dose to make up for a missed dose.
If you stop using Eporatio
Before stopping treatment with this medicine, consult your doctor.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Serious adverse effects:
- Very high blood pressure:
Contact a doctor immediately if you suddenly develop a severe, migraine-like headache, confusion, speech disturbances, impaired walking, seizures or convulsions. These may be signs of very high blood pressure (common in patients with chronic renal failure, may affect up to 1 in 10 people), even if your blood pressure is normally normal or low. Immediate treatment is required.
- Allergic reactions:
Allergic reactions such as skin rash, widespread itching, severe allergic reactions with weakness, low blood pressure, breathing difficulties and facial swelling have been reported (frequency not known, cannot be estimated from available data). If you think you have experienced such reactions, you must stop treatment with Eporatio and seek immediate medical help.
- Severe skin rashes:
Severe skin rashes such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been observed with epoetin administration. These reactions may appear as macules or circular red patches, often 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 Eporatio if you experience these symptoms and contact your doctor or seek immediate medical attention. See also section 2.
You may experience the following additional adverse effects:
Common (may affect up to 1 in 10 people)
- Headache;
- High blood pressure;
- Flu-like symptoms, such as fever, chills, feeling weak or tired;
- Skin reactions, such as rash, itching or reactions at the injection site.
Common in patients with chronic renal failure (may affect up to 1 in 10 people)
- Blood clot in the arteriovenous fistula in dialysis patients.
Common in cancer patients (may affect up to 1 in 10 people)
- Joint pain.
Frequency not known in patients with chronic renal failure (cannot be estimated from available data)
- Cases of a condition called pure red cell aplasia (PRCA) have been reported. PRCA means that the body stops or reduces production of red blood cells, leading to severe anaemia. If your doctor suspects or confirms that you have this condition, you must not be treated with Eporatio or any other epoetin.
Frequency not known in cancer patients (cannot be estimated from available data)
- Thromboembolic episodes, for example blood clots.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Eporatio
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 outer carton and on the prefilled syringe after EXP. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2°C and 8°C).
Do not freeze.
Keep the prefilled syringe in the outer packaging to protect it from light.
You may remove Eporatio from the refrigerator and store it at a temperature not exceeding 25°C for a period of up to 7 days, provided this does not extend beyond the expiry date. Once removed from the refrigerator, the medicine must be used within this time period or must be discarded.
Do not use this medicine if you notice cloudiness or particles in the solution.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Eporatio
- The active substance is epoetin zeta (epoetin theta).
Eporatio 1,000 IU/0.5 ml: One pre-filled syringe contains 1,000 International Units (IU) (8.3 micrograms) of epoetin zeta (epoetin theta) in 0.5 ml of injectable solution, equivalent to 2,000 International Units (IU) (16.7 micrograms) per ml.
Eporatio 2,000 IU/0.5 ml: One pre-filled syringe contains 2,000 International Units (IU) (16.7 micrograms) of epoetin zeta (epoetin theta) in 0.5 ml of injectable solution, equivalent to 4,000 International Units (IU) (33.3 micrograms) per ml.
Eporatio 3,000 IU/0.5 ml: One pre-filled syringe contains 3,000 International Units (IU) (25 micrograms) of epoetin zeta (epoetin theta) in 0.5 ml of injectable solution, equivalent to 6,000 International Units (IU) (50 micrograms) per ml.
Eporatio 4,000 IU/0.5 ml: One pre-filled syringe contains 4,000 International Units (IU) (33.3 micrograms) of epoetin zeta (epoetin theta) in 0.5 ml of injectable solution, equivalent to 8,000 International Units (IU) (66.7 micrograms) per ml.
Eporatio 5,000 IU/0.5 ml: One pre-filled syringe contains 5,000 International Units (IU) (41.7 micrograms) of epoetin zeta (epoetin theta) in 0.5 ml of injectable solution, equivalent to 10,000 International Units (IU) (83.3 micrograms) per ml.
Eporatio 10,000 IU/1 ml: One pre-filled syringe contains 10,000 International Units (IU) (83.3 micrograms) of epoetin zeta (epoetin theta) in 1 ml of injectable solution, equivalent to 10,000 International Units (IU) (83.3 micrograms) per ml.
Eporatio 20,000 IU/1 ml: One pre-filled syringe contains 20,000 International Units (IU) (166.7 micrograms) of epoetin zeta (epoetin theta) in 1 ml of injectable solution, equivalent to 20,000 International Units (IU) (166.7 micrograms) per ml.
Eporatio 30,000 IU/1 ml: One pre-filled syringe contains 30,000 International Units (IU) (250 micrograms) of epoetin zeta (epoetin theta) in 1 ml of injectable solution, equivalent to 30,000 International Units (IU) (250 micrograms) per ml.
- The other components are disodium hydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, hydrochloric acid (6M) (for pH adjustment) and water for injections.
Nature of the product and contents of the container
Eporatio is a clear, colourless injectable solution in a pre-filled syringe with an injection needle.
Eporatio 1,000 IU/0.5 ml, Eporatio 2,000 IU/0.5 ml, Eporatio 3,000 IU/0.5 ml, Eporatio 4,000 IU/0.5 ml and Eporatio 5,000 IU/0.5 ml: Each pre-filled syringe contains 0.5 ml of solution.
Pack sizes of 6 pre-filled syringes; 6 pre-filled syringes with safety needle or 6 pre-filled syringes with safety device.
Eporatio 10,000 IU/1 ml, Eporatio 20,000 IU/1 ml and Eporatio 30,000 IU/1 ml: Each pre-filled syringe contains 1 ml of solution. Pack sizes of 1, 4 and 6 pre-filled syringes; 1, 4 and 6 pre-filled syringes with safety needle or 1, 4 and 6 pre-filled syringes with safety device.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder
ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Manufacturer
Teva Biotech GmbH
Dornierstrasse 10
89079 Ulm
Germany
For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Belgium/Belgium/Belgium Teva Pharma Belgium N.V./S.A./AG Tel/Tel: +32 3 820 73 73 | Lithuania UAB "Sicor Biotech" Tel: +370 5 266 0203 |
Bulgaria Teva Bulgaria EOOD Tel: +359 2 489 95 85 | Luxembourg/Luxembourg ratiopharm GmbH, Germany/Germany Tel/Tel: +49 731 402 02 |
Czech Republic Teva Pharmaceuticals CR, s.r.o. Tel: +420 251 007 111 | Hungary Teva Gyógyszergyár Zrt. Tel.: +36 1 288 64 00 |
Denmark Teva Denmark A/S Tlf: +45 44 98 55 11 | Malta Teva Pharmaceuticals Ireland, L-Ireland Tel: +353 51 321740 |
Germany ratiopharm GmbH Tel: +49 731 402 02 | Netherlands Teva Nederland B.V. Tel: +31 800 0228 400 |
Estonia UAB "Sicor Biotech" Estonia branch Tel: +372 661 0801 | Norway Teva Norway AS Tlf: +47 66 77 55 90 |
Greece Teva Hellas S.A. Tel: +30 210 72 79 099 | Austria ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97 007 |
Spain Teva Pharma, S.L.U. Tel: +34 91 387 32 80 | Poland Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +48 22 345 93 00 |
France Teva Santé Tél: +33 1 55 91 78 00 | Portugal ratiopharm, Comércio e Indústria de Produtos Farmacêuticos, Lda Tel: +351 21 424 80 00 |
Croatia Pliva Hrvatska d.o.o. Tel: +385 1 37 20 000 | Romania Teva Pharmaceuticals S.R.L Tel: +40 21 230 65 24 |
Ireland Teva Pharmaceuticals Ireland Tel: +353 51 321740 | Slovenia Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390 |
Iceland ratiopharm Oy, Finland Sími: +358 20 180 5900 | Slovakia TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 2 57 26 79 11 |
Italy Teva Italia S.r.l. Tel: +39 02 89 17 98 1 | Finland/Suomi ratiopharm Oy Puh/Tel: +358 20 180 5900 |
Cyprus Teva Hellas S.A., Greece Tel: +30 210 72 79 099 | Sweden Teva Sweden AB Tel: +46 42 12 11 00 |
Latvia UAB "Sicor Biotech" Latvia branch Tel: +371 673 23 666 | United Kingdom Teva UK Limited Tel: +44 1977 628500 |
Date of the latest review of this leaflet:
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
7. Information on self-injection
This section contains information on how to administer a subcutaneous injection of Eporatio yourself. It is important that you do not attempt to administer an injection without first receiving the necessary instructions from your doctor or nurse. If you are unsure whether you can self-inject or if you have any doubts, consult your doctor or nurse.
How to administer Eporatio
The injection must be given into the tissue just beneath the skin. This is known as a subcutaneous injection.
Equipment needed for administration
To administer the injection into the tissue just beneath the skin, you will need:
- a pre-filled syringe of Eporatio,
- an alcohol wipe,
- a sterile gauze pad or swab,
- a sharps container (plastic container provided by a hospital or pharmacy) for the safe disposal of used syringes.
What you should do before administering the injection
- Remove a blister pack containing a pre-filled syringe from the refrigerator.
- Open the blister pack and remove the pre-filled syringe and needle. Do not handle the pre-filled syringe by the plunger or the syringe cap.
- Check the expiry date shown on the label of the pre-filled syringe (EXP). Do not use if the date is later than the last day of the month indicated.
- Check the appearance of Eporatio. It should be a clear, colourless liquid. Do not use if particles are present or if the solution is cloudy.
- There is a cap at the end of the needle. Break the safety seal and remove the cap (see image 1).
- Remove the cap from the pre-filled syringe (see image 2).
- Attach the needle to the syringe (see image 3). Do not remove the syringe cap yet.
- For a more comfortable injection, allow the syringe to stand for 30 minutes to reach room temperature (not above 25 °C), or gently hold the pre-filled syringe in your hands for a few minutes. Do not heat Eporatio in any other way (for example, do not heat in a microwave or in hot water).
- Do not remove the syringe cap until you are ready to administer the injection.
- Choose a comfortable, well-lit area. Place all necessary items within reach (the pre-filled syringe of Eporatio, alcohol wipe, sterile gauze pad or swab, and a sharps container).
- Wash your hands thoroughly.
2
3
How to prepare for administering the Eporatio injection
Before administering the Eporatio injection yourself, you should do the following:
- Hold the syringe and carefully remove the protective needle cap without tilting it. Pull apart as shown in images 4. Do not touch the needle or push the plunger.
- Small air bubbles may appear in the pre-filled syringe. If bubbles are present, gently tap the syringe with your fingers until the bubbles rise to the top. With the syringe pointing upwards, expel all air from the syringe by slightly pushing the plunger upwards.
- The syringe has a scale on its barrel. Push the plunger to the number (IU) on the syringe corresponding to the dose of Eporatio prescribed by your doctor.
- Double-check that the dose of Eporatio in the syringe is correct.
- The pre-filled syringe is now ready for use.
4
Where to administer the injection
The most suitable injection sites are:
- the upper thighs,
- the abdomen, except the area around the navel (see the grey areas in image 5).
If someone is assisting you with the injection, it may also be administered into the back and side of the upper arms (see the grey areas in image 6).
It is advisable to change the injection site daily to reduce the risk of discomfort at any one site.
5
6
How to administer the injection
- Disinfect the injection site using an alcohol wipe and pinch the skin between your thumb and index finger, without squeezing tightly (see image 7).
- Insert the needle completely into the skin as instructed by your doctor or nurse. The angle between the syringe and the skin should not be too shallow (at least 45°, see image 8).
- Inject the liquid slowly and steadily into the tissue, keeping the skin pinched throughout.
- After injecting the liquid, withdraw the needle from the skin.
- Press the injection site with a sterile gauze pad or swab for several seconds.
- Use each syringe only once. Do not use any remaining Eporatio left in the syringe.
7
8
Remember
If you experience any problems, please seek help or advice from your doctor or nurse.
How to dispose of used syringes
- Do not recap used syringes.
- Place used syringes into a sharps container and keep this container out of sight and reach of children.
- Dispose of the full sharps container according to the instructions provided by your doctor, pharmacist, or nurse.
- Never place used syringes in your household waste bin.
7. Information on self-injection
This section contains information on how to administer a subcutaneous injection of Eporatio yourself. It is important that you do not attempt to administer an injection without first receiving the necessary instructions from your doctor or nurse. If you are unsure whether you can self-inject or if you have any doubts, consult your doctor or nurse.
How to administer Eporatio
The injection must be given into the tissue just beneath the skin. This is known as a subcutaneous injection.
Equipment needed for administration
To administer the injection into the tissue just beneath the skin, you will need:
- a pre-filled syringe of Eporatio,
- an alcohol wipe,
- a sterile gauze pad or swab.
What you should do before administering the injection
- Remove a blister pack containing a pre-filled syringe from the refrigerator.
- Open the blister pack and remove the pre-filled syringe and needle. Do not handle the pre-filled syringe by the plunger or the syringe cap.
- Check the expiry date shown on the label of the pre-filled syringe (EXP). Do not use if the date is later than the last day of the month indicated.
- Check the appearance of Eporatio. It should be a clear, colourless liquid. Do not use if particles are present or if the solution is cloudy.
- There is a cap at the end of the needle. Break the safety seal and remove the cap (see image 1).
- Remove the cap from the pre-filled syringe (see image 2).
- Attach the needle to the syringe (see image 3). Do not remove the syringe cap yet.
- For a more comfortable injection, allow the syringe to stand for 30 minutes to reach room temperature (not above 25 °C), or gently hold the pre-filled syringe in your hands for a few minutes. Do not heat Eporatio in any other way (for example, do not heat in a microwave or in hot water).
- Do not remove the syringe cap until you are ready to administer the injection.
- Choose a comfortable, well-lit area. Place all necessary items within reach (the pre-filled syringe of Eporatio, alcohol wipe, and sterile gauze pad or swab).
- Wash your hands thoroughly.
1
2
3
How to prepare for administering the Eporatio injection
Before administering the Eporatio injection yourself, you should do the following:
- Hold the syringe and carefully remove the protective needle cap without tilting it. Separate as shown in images 4. The needle is surrounded by a retractable needle shield. Do not touch the needle, the needle shield, or push the plunger (see image 5).
- Small air bubbles may appear in the pre-filled syringe. If bubbles are present, gently tap the syringe with your fingers until the bubbles rise to the top. With the syringe pointing upwards, expel all air from the syringe by slightly pushing the plunger upwards.
- The syringe has a scale on its barrel. Push the plunger to the number (IU) on the syringe corresponding to the dose of Eporatio prescribed by your doctor.
- Double-check that the dose of Eporatio in the syringe is correct.
- The pre-filled syringe is now ready for use.
4
5
Where to administer the injection
The most suitable injection sites are:
- the upper thighs,
- the abdomen, except the area around the navel (see the grey areas in image 6).
If someone is assisting you with the injection, it may also be administered into the back and side of the upper arms (see the grey areas in image 7).
It is advisable to change the injection site daily to reduce the risk of discomfort at any one site.
6
7
How to administer the injection
- Disinfect the injection site using an alcohol wipe and pinch the skin between your thumb and index finger, without squeezing tightly (see image 8).
- Insert the shielded needle completely into the skin without hesitation and with a continuous motion, as instructed by your doctor or nurse. The angle between the syringe and the skin should not be too shallow (at least 45°, see image 9). The needle shield will fully retract as the needle enters the skin (see image 10).
- Inject the liquid slowly and steadily into the tissue, keeping the skin pinched throughout (see image 11).
- After injecting the liquid, withdraw the needle from the skin. The needle will be automatically protected and locked to prevent accidental needlestick injuries (see image 12).
- Press the injection site with a sterile gauze pad or swab for several seconds.
- Use each syringe only once. Do not use any remaining Eporatio left in the syringe.
8
9
10
11
12
Remember
If you experience any problems, please seek help or advice from your doctor or nurse.
How to dispose of used syringes
The safety device prevents needlestick injuries after use, so no special precautions are required for disposal. Dispose of syringes with safety devices according to the instructions provided by your doctor, pharmacist, or nurse.