Eporatio

Package leaflet: Information for the user

Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe, 2,000 IU/0.5 ml solution for injection in pre-filled syringe, 3,000 IU/0.5 ml solution for injection in pre-filled syringe, 4,000 IU/0.5 ml solution for injection in pre-filled syringe, 5,000 IU/0.5 ml solution for injection in pre-filled syringe, 10,000 IU/1 ml solution for injection in pre-filled syringe, 20,000 IU/1 ml solution for injection in pre-filled syringe, 30,000 IU/1 ml solution for injection in pre-filled syringe

epoetin theta
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Eporatio is and what it is used for
2. What you need to know before using Eporatio
3. How to use Eporatio
4. Possible side effects
5. How to store Eporatio
6. Contents of the pack and other information
7. Instructions for self-injection of the medicine

1. What Eporatio is and what it is used for

What Eporatio is
Eporatio contains the active substance epoetin theta, which is almost identical to erythropoietin, a natural hormone produced by the body. Epoetin theta is a protein produced by biotechnology. It works in exactly the same way as erythropoietin. Erythropoietin is produced by the kidneys and stimulates the bone marrow to produce red blood cells. Red blood cells are very important for oxygen delivery throughout the body.

What Eporatio is used for
Eporatio is used to treat symptomatic anaemia (for example, fatigue, weakness, and shortness of breath). Anaemia occurs when the blood does not contain enough red blood cells. Treatment of anaemia is given to adult patients with chronic renal failure or to adult patients with non-myeloid tumours (tumours not originating in the bone marrow) who are being treated at the same time with chemotherapy (medicines used to treat tumours).

2. What you need to know before using Eporatio

DO NOT use Eporatio

• if you are allergic to epoetin theta, to other epoetins, or to any of the other ingredients of this medicine (listed in section 6);
• if you have high blood pressure that cannot be controlled.

Warnings and precautions
General
This medicine may not be suitable for the following patients. Please consult your doctor if you belong to any of the following patient groups:

• patients with liver problems,
• patients with pathological red blood cell mutations (homozygous sickle cell anemia).

Blood pressure must be carefully monitored before and during treatment with this medicine. If your blood pressure increases, your doctor will prescribe medicines to reduce it. If you are already taking medicines for blood pressure, your doctor may increase your dose. It may also be necessary to reduce the dose of Eporatio or temporarily interrupt treatment with Eporatio.
If you experience headache, especially sudden, pulsating, migraine-like headache, confusion, speech disturbances, unsteady gait, seizures or convulsions, inform your doctor immediately. These may be signs of a severe increase in blood pressure, even if blood pressure is usually normal or low, and require immediate treatment.
Your doctor will perform regular blood tests to monitor various blood components and their levels. In addition, your iron levels will be checked both before and during treatment with this medicine. If your iron level is too low, your doctor may also prescribe an iron supplement.
If you experience fatigue and weakness, or shortness of breath, you should consult your doctor. These symptoms may indicate that treatment with this medicine is ineffective. Your doctor will investigate possible other causes of anemia and may perform blood tests and bone marrow examination.
The healthcare professional will always accurately record which product you are using. This allows for better monitoring of the safety of medicines such as this one.
Healthy individuals must not use Eporatio. Use of this medicine in healthy individuals may excessively increase certain blood parameters and thereby cause heart or blood vessel problems, which may even be life-threatening.
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with epoetin therapy. Stevens-Johnson syndrome and toxic epidermal necrolysis may initially appear as red target-like spots or circular patches, often with central blisters, on the trunk. Mouth, throat, nose, genital, and eye ulcers (red, swollen eyes) may also occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to skin peeling and life-threatening complications. If you develop a severe rash or any of these other skin symptoms, stop using Eporatio and contact your doctor immediately.

Anemia due to chronic renal failure
If you suffer from chronic renal failure, your doctor will monitor that a specific blood parameter (hemoglobin) does not exceed a certain threshold. Indeed, if this blood parameter increases excessively, cardiac or vascular problems may occur, increasing the risk of death.
If you suffer from chronic renal failure, and particularly if you do not respond adequately to Eporatio, your doctor will monitor the dose of Eporatio you receive, because if you do not respond to treatment, repeated dose increases of Eporatio may increase the risk of heart or blood vessel problems and could increase the risk of myocardial infarction, stroke, and death.
If you have hardening of the kidney blood vessels (nephrosclerosis) but do not require dialysis, your doctor will evaluate whether treatment is appropriate for you. This is necessary because a possible acceleration of kidney disease progression cannot be completely ruled out.
If you are on dialysis, medications that prevent blood clotting are used. If you are being treated with Eporatio, it may be necessary to increase the dose of the anticoagulant medication; otherwise, the increased number of red blood cells may cause blockage of the arteriovenous fistula (a surgically created connection between an artery and a vein used in dialysis patients).

Anemia in cancer patients
If you have cancer, you should be aware that this medicine can act as a growth factor for blood cells and, in certain circumstances, may have a negative impact on the tumor. Depending on your individual situation, a blood transfusion might be preferable. Discuss this with your doctor.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as there are no data demonstrating that it is safe and effective in this age group.

Other medicines and Eporatio
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
Eporatio has not been studied in pregnant women. It is important that you inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, as your doctor may decide that you should not use this medicine.
It is not known whether the active ingredient of this medicine passes into breast milk. Therefore, your doctor may decide that you should not use this medicine if you are breastfeeding.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

Eporatio contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per pre-filled syringe, i.e. it is practically "sodium-free".

3. How to use Eporatio

Treatment with this medicine should be initiated by a physician experienced in the above-mentioned indications.
Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is...
The dose of Eporatio (expressed in International Units or IU) depends on the severity of the disease, body weight, and the route of administration (subcutaneous injection [under the skin] or intravenous injection [into a vein]). Your doctor will select the appropriate dose for you.

Anaemia due to chronic renal failure
Injections are administered either subcutaneously or intravenously. Patients undergoing haemodialysis usually receive the injection at the end of the dialysis procedure via an arteriovenous fistula. Patients not undergoing dialysis usually receive the injection subcutaneously. Your doctor will regularly monitor your blood counts and, if necessary, adjust the dose or suspend treatment. Haemoglobin levels in the 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 review your dose and inform you if adjustments are needed.

Treatment with Eporatio consists of two phases:
a) Correction of anaemia
The initial dose for subcutaneous injections is 20 IU per kg of body weight, administered three times weekly. 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 three times weekly. If necessary, your doctor will increase the dose at monthly intervals.

b) Maintenance of adequate red blood cell levels
Once an adequate red blood cell count has been achieved, your doctor will determine the maintenance dose required to keep this count stable.
For subcutaneous injections, the weekly dose may be given either as a single weekly injection or divided into three weekly injections.
For intravenous injections, the dosing schedule may be adjusted to two injections per week.
If the frequency of administration is changed, a dose adjustment may be necessary.
Treatment with Eporatio is normally a long-term therapy.
The maximum dose should not exceed 700 IU per kg of body weight per week.

Anaemia in patients with cancer
Injections are administered subcutaneously (under the skin) once weekly. The initial dose is 20,000 IU. Your doctor will regularly monitor your blood counts and, if necessary, adjust the dose or discontinue treatment. Haemoglobin levels in the blood should not exceed 12 g/dl (7.45 mmol/l). Typically, treatment with Eporatio continues until one month after the end of chemotherapy.
The maximum dose should not exceed 60,000 IU.

How are the injections given?
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 via subcutaneous injection, your doctor may suggest that you learn to self-inject. Your doctor or nurse will provide you with all necessary instructions. Do not attempt to self-administer Eporatio without first receiving proper training. Some of the information needed to use the pre-filled syringe can be found at the end of this leaflet (see section 7 “Instructions for self-injecting the medicine”). However, proper management 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 prescribed, contact your doctor. Serious problems are unlikely. Even at high blood concentrations, no symptoms of poisoning have been observed.

If you forget to use Eporatio
If you miss an injection or inject a reduced amount of medicine, contact your doctor. Do not inject a double dose to make up for a missed dose.

If you stop using Eporatio
Before stopping treatment with this medicine, speak with your doctor.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Serious side effects:

• Severely increased blood pressure: If you experience headache, especially a sudden, throbbing, migraine-like headache, confusion, speech disturbances, unsteady gait, epileptic seizures or convulsions, contact your doctor immediately. These may be signs of a severe rise in blood pressure (common in patients with chronic renal failure, may affect up to 1 in 10 people), even though blood pressure is usually normal or low. This condition requires immediate treatment.
• Allergic reactions: Allergic reactions such as skin rash, itchy raised areas of skin, and severe allergic reactions with weakness, low blood pressure, breathing difficulties and facial swelling have been reported (frequency not known; cannot be estimated from the available data). If you suspect you are experiencing such a reaction, you must stop injecting Eporatio and contact your doctor immediately.
• Serious skin reactions: Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with epoetin therapy. These may appear as red, target-like spots or circular patches, often with central blisters on the trunk, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms. Stop using Eporatio and contact your doctor immediately if you develop any of these symptoms. See also section 2.

You may also experience the following additional side 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 clots in the arteriovenous fistula in dialysis patients.

Common in patients with tumours (may affect up to 1 in 10 people)

• Joint pain.

Frequency not known in patients with chronic renal failure (frequency cannot be estimated from the available data)

• Cases of a condition called pure red cell aplasia (PRCA) have been reported. PRCA is a disease characterized by the cessation or reduction of red blood cell production by the body, leading to severe anaemia. If your doctor suspects or confirms that you have this condition, you must not be treated with Eporatio or other epoetins.

Frequency not known in patients with tumour (frequency cannot be estimated from the available data)

• Thromboembolic events, e.g. increased blood clots.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eporatio

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and on the pre-filled syringe after Exp. The expiry date refers to the last day of that month.
Store in the refrigerator (2°C – 8°C).
Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Eporatio may be removed from the refrigerator and stored at a temperature not exceeding 25°C for a single period of up to 7 days, without exceeding the expiry date. Once removed from the refrigerator, the medicine must be used within this period or discarded.
Do not use this medicine if you notice cloudiness of the solution or visible particles.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Eporatio contains

• The active substance is epoetin theta.
  Eporatio 1,000 IU/0.5 ml: One pre-filled syringe contains 1,000 International Units (IU) (8.3 micrograms) of 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 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 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 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 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 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 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 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, tromethamine, hydrochloric acid (6 M) (for pH adjustment) and water for injections.

Description of the appearance of Eporatio and contents of the pack
Eporatio is a clear, colourless injectable solution in a pre-filled syringe with a needle for injection.
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. Packs 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. Packs 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.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany

Manufacturer
Merckle GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany

For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД ratiopharm GmbH
Teл: +359 24899585 Allemagne/Deutschland
Tél/Tel: +49 73140202

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
ratiopharm GmbH Teva Nederland B.V.
Tel: +49 73140202 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
TEVA HELLAS Α.Ε. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300

France Portugal
Teva Santé ratiopharm - Comércio e Indústria de Produtos
Tél: +33 155917800 Farmacêuticos, Lda.
Tel: +351 214248000

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
TEVA HELLAS Α.Ε. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117

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

7. Instructions for self-injecting the medicine

This section contains information on how to perform a subcutaneous self-injection of Eporatio.
It is important that you do not attempt to administer the medicine to yourself without first receiving
adequate training from your doctor or a nurse. If you have any doubts about how to self-inject the
medicine or have any questions, consult your doctor or nurse.

How Eporatio is used
The injection must be given into the tissue just beneath the skin and is called a subcutaneous injection.

Equipment you will need
To self-inject the medicine under the skin, you will need:

• a pre-filled syringe of Eporatio,
• an alcohol wipe,
• a sterile gauze pad or dressing,
• a puncture-resistant container (a plastic container provided by the hospital or pharmacy) for the safe disposal of used syringes.

What you should do before the injection

1. Remove one blister pack containing a pre-filled syringe from the refrigerator.

2. Open the blister pack and take out the pre-filled syringe and the needle cap from the blister. Do not handle the pre-filled syringe by the plunger or the needle cap.

3. Check the expiry date on the label of the pre-filled syringe (Exp.). Do not use if the date has passed the last day of the month indicated.

4. Check the appearance of Eporatio. The liquid in the syringe should be clear and colourless. If particles are visible or if the solution appears cloudy, do not use it.

5. The needle cap has a labelled seal at its end. Break the seal and remove the cap (see Figure 1).

6. Remove the needle cap from the pre-filled syringe (see Figure 2).

7. Attach the needle to the syringe (see Figure 3), without removing the needle protector yet.

8. For a more comfortable injection, allow the pre-filled syringe to reach room temperature (not exceeding 25 °C) for 30 minutes, or gently hold the syringe in your hands for a few minutes.
   Do not heat the Eporatio solution in any other way (for example, do not
   heat it in a microwave or in hot water).

9. Do not remove the needle protector from the syringe until you are ready to inject.

10. Find a comfortable, well-lit place. Arrange all necessary items within easy reach (the pre-filled syringe of Eporatio, an alcohol wipe, a sterile gauze pad or dressing, and the puncture-resistant container).

11. Wash your hands thoroughly.

3
How to prepare the injection
Before proceeding with the self-injection of Eporatio, follow these instructions:

1. Hold the syringe and remove the needle protector straight off, without twisting. Pull horizontally as shown in Figure 4. Do not touch the needle and do not press the plunger.
2. Small air bubbles may be visible in the pre-filled syringe. If present, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. With the syringe held upright, expel the air by slowly pushing the plunger upward.
3. The syringe barrel is graduated. Push the plunger to the number (IU) on the syringe that corresponds to the dose of Eporatio prescribed by your doctor.
4. Check again to ensure the correct dose of Eporatio is in the sy游戏副本

7. Information for self-injecting the medicine

This section contains information on how to perform a subcutaneous self-injection of Eporatio.
It is important that you do not attempt to self-administer the medicine without first receiving adequate training from your doctor or a nurse. If you have any doubts about how to self-inject the medicine or have any questions, consult your doctor or nurse.
How Eporatio is used
The injection must be given into the tissue just beneath the skin and is called a subcutaneous injection.
Equipment you will need
To self-inject the medicine under the skin, you will need:

• a pre-filled syringe of Eporatio,
• an alcohol swab,
• a sterile gauze pad or dressing,
• a puncture-proof container (a plastic container provided by the hospital or pharmacy) for the safe disposal of used syringes.

What to do before the injection

1. Remove a blister pack containing a pre-filled syringe from the refrigerator.
2. Open the blister pack and remove the pre-filled syringe and the needle pouch from the blister. Do not touch the pre-filled syringe by the plunger or the cap covering the needle tip.
3. Check the expiry date on the label of the pre-filled syringe (Exp.). Do not use if the date has passed the last day of the month indicated.
4. Check the appearance of Eporatio. The liquid in the syringe should be clear and colourless. If particles are visible in the solution or if it appears cloudy, do not use it.
5. The needle pouch has tabs at the end. Open the needle pouch at the tabs (see figure 1).
6. Remove the needle cap from the pre-filled syringe (see figure 2).
7. Attach the needle to the syringe (see figure 3), but do not remove the needle shield yet.
8. Move the safety shield in the direction opposite to the needle and towards the body of the syringe. The safety shield will lock into the new position (see figure 4).
9. For a more comfortable injection, allow the pre-filled syringe to reach room temperature (not exceeding 25 °C) for 30 minutes, or gently hold the pre-filled syringe in your hands for several minutes. Do not heat the Eporatio solution in any other way (for example, do not warm it in a microwave or in hot water).
10. Do not remove the needle shield from the syringe until you are ready for the injection.
11. Find a comfortable and well-lit place. Arrange all necessary items within easy reach (the pre-filled syringe of Eporatio, an alcohol swab, a sterile gauze dressing or pad, and the puncture-proof container).
12. Wash your hands thoroughly.

1 2

3 4
How to prepare the injection
Before proceeding with the self-injection of Eporatio, follow these instructions:

1. Hold the syringe and remove the needle shield by pulling it straight off, without twisting. Pull horizontally as shown in figure 5. Do not touch the needle and do not push the plunger.
2. Small air bubbles may be visible in the pre-filled syringe. If air bubbles are present, gently tap the syringe with your fingers until the air bubbles rise to the top. With the syringe held upright, slowly push the plunger upward to expel the air.
3. The syringe barrel is graduated. Push the plunger to the number (IU) on the syringe that corresponds to the dose of Eporatio prescribed by your doctor.
4. Check again to ensure the correct dose of Eporatio is in the syringe.
5. The pre-filled syringe is now ready for use.

5
Where to give the injection
The most suitable areas for injection are:

• the upper thigh,
• the abdomen, except the area around the navel (see the grey areas in figure 6).

If someone else is giving you the injection, the back and outer side of the upper arms may also be used (see the grey areas in figure 7).
It is advisable to change the injection site daily to reduce the risk of soreness at the injection site.

7
How to perform the self-injection

1. Clean the chosen injection site with an alcohol swab and pinch the skin between your thumb and index finger, without squeezing it tightly (see figure 8).
2. Insert the needle completely into the skin, as shown by your doctor or nurse. The angle between the syringe and the skin should not be too narrow (at least 45°, see figures 9 and 10).
3. Inject the liquid slowly and steadily into the tissue, keeping the skin pinched between your thumb and index finger (see figure 11).
4. After injecting the liquid, remove the needle and release the skin.
5. Press the injection site with a sterile gauze pad or dressing for a few seconds.
6. Push the safety shield toward the needle (see figure 12).
7. Place the safety shield at an angle of approximately 45° against a flat surface (see figure 13).
8. Push the needle downward with a quick, firm motion until you hear a distinct click (see figure 14).
9. Visually check that the needle is completely enclosed and locked inside the safety shield under the safety catch (see figure 15).
10. Use each syringe for only one injection. Do not reuse any remaining Eporatio in the syringe.

10 11

12 13

14 15
Remember
If you have any doubts or problems, consult your doctor or nurse.
How to dispose of used syringes

• Place used syringes into the puncture-proof container and keep this container out of sight and reach of children.
• Follow the instructions provided by your doctor, pharmacist, or nurse for the disposal of the puncture-proof container.
• Never throw used syringes into household waste bins.

7. Information on how to self-inject the medicine

This section contains information on how to perform a subcutaneous self-injection of Eporatio.
It is important that you do not attempt to self-administer the medicine without first receiving adequate training from your doctor or a nurse. If you have any doubts about how to self-inject the medicine or have any questions, please consult your doctor or nurse.
How Eporatio is used
The injection must be given into the tissue just beneath the skin and is called a subcutaneous injection.
Equipment you will need
To inject the medicine into the subcutaneous tissue, you will need:

• a pre-filled syringe of Eporatio,
• an alcohol wipe,
• a sterile gauze pad or dressing,

What you should do before the injection

1. Remove one blister pack containing a pre-filled syringe from the refrigerator.
2. Open the blister pack and take out the pre-filled syringe and the needle shield from the pack. Do not handle the pre-filled syringe by the plunger or the needle cap.
3. Check the expiry date on the label of the pre-filled syringe (Exp.). Do not use it if the date has passed the last day of the month indicated.
4. Check the appearance of Eporatio. The liquid in the syringe should be clear and colourless. If particles are visible or the solution appears cloudy, do not use it.
5. There is a cap on the end of the needle shield. Break the labelled seal and remove the cap (see Figure 1).
6. Remove the needle cap from the pre-filled syringe (see Figure 2).
7. Attach the needle to the syringe (see Figure 3), without removing the needle protector yet.
8. For a more comfortable injection, allow the pre-filled syringe to reach room temperature (not exceeding 25 °C) for 30 minutes, or gently hold the syringe in your hands for several minutes. Do not heat the Eporatio solution in any other way (for example, do not heat it in a microwave or in hot water).
9. Do not remove the needle protector from the syringe until you are ready to inject.
10. Find a comfortable, well-lit place. Arrange all necessary items within easy reach (the pre-filled syringe of Eporatio, an alcohol wipe, and a sterile gauze pad or dressing).
11. Wash your hands thoroughly.

3
How to prepare the injection
Before proceeding with the self-injection of Eporatio, follow these instructions:

1. Hold the syringe and remove the needle protector without twisting. Pull horizontally as shown in Figure 4. The needle is covered with a retractable needle shield. Do not touch the needle or the shield, and do not push the plunger (see Figure 5).
2. Small air bubbles may be visible in the pre-filled syringe. If air bubbles are present, gently tap the syringe with your fingers until the bubbles rise to the surface at the top of the syringe. With the syringe held upright, slowly push the plunger upward to expel the air.
3. The syringe barrel is graduated. Push the plunger to the number (IU) on the syringe corresponding to the dose of Eporatio prescribed by your doctor.
4. Double-check to ensure the correct dose of Eporatio is in the syringe.
5. The pre-filled syringe is now ready for use.

5
Where to give the injection
The most suitable areas for injection are:

• the upper thigh,
• the abdomen, except the area around the navel (see the grey areas in Figure 6).

If someone else is administering the injection for you, the back and outer sides of the upper arms may also be used (see the grey areas in Figure 7).
It is advisable to change the injection site daily to reduce the risk of soreness at the injection site.

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How to perform the self-injection

1. Clean the chosen injection site with an alcohol wipe and pinch the skin between your thumb and index finger, without squeezing too hard (see Figure 8).
2. Insert the needle with the needle shield smoothly and in one continuous motion completely into the skin, as shown by your doctor or nurse. The angle between the syringe and the skin should not be too shallow (at least 45°, see Figure 9). The needle shield will fully retract as the needle enters the skin (see Figure 10).
3. Inject the liquid slowly and evenly into the tissue, keeping the skin pinched between your thumb and index finger (see Figure 11).
4. After injecting the liquid, remove the needle and release the skin. The needle will be automatically covered and locked by the needle shield to prevent accidental needlestick injury (see Figure 12).
5. Press the injection site with a sterile gauze pad or dressing for a few seconds.
6. Use each syringe only once. Do not reuse any remaining Eporatio in the syringe.

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Remember
If you have any doubts or problems, consult 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 the safety syringes according to the instructions provided by your doctor, pharmacist, or nurse.