Eporatio - patient leaflet, side effects, dosage

Patient leaflet - Eporatio

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Eporatio is and what it is used for
2. What you need to know before you use Eporatio
3. How to use Eporatio
4. Possible side effects
5. How to store Eporatio
6. Contents of the pack and other information
7. Information for injecting yourself

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 your body. Epoetin theta is a protein produced by biotechnology. It works in exactly the same way as erythropoietin. Erythropoietin is produced in your kidneys and stimulates your bone marrow to produce red blood cells. Red blood cells are very important for distributing oxygen within your body.

What Eporatio is used for

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

2. What you need to know before you use Eporatio

Do NOT use Eporatio

– if you are allergic to epoetin theta, another epoetin or 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 speak with your doctor if you belong to one of these patient groups: – patients with liver problems, – patients with pathological changes in their red blood cells (homozygous sickle cell anaemia).

Your blood pressure needs to be checked closely before and during treatment with this medicine. If your blood pressure rises, your doctor may give you medicines to reduce your blood pressure. If you are already taking a medicine to reduce your blood pressure, your doctor might increase the dose. It may also be necessary to reduce your dose of Eporatio or to stop the treatment with Eporatio for a short period of time.

If you get headaches, especially sudden, stabbing, migraine-like headaches, confusion, speech disturbance, unsteady walking, fits or convulsions, tell your doctor immediately. These may be signs of severely elevated blood pressure, even if your blood pressure is usually normal or low. It needs to be treated at once.

Your doctor will carry out regular blood tests in order to monitor various blood components and their levels. In addition, the iron level in your blood will be checked before and during treatment with this medicine. If your iron level is too low, your doctor may also prescribe you an iron preparation.

If you feel tired and weak or experience breathlessness, you must consult your doctor. These symptoms could indicate that your treatment with this medicine is ineffective. Your doctor will check that you do not have other causes of anaemia and may perform blood tests or examine your bone marrow.

Your healthcare professional will always record the exact product you are using. This can help to provide more information on the safety of medicines like this one.

Healthy people should not use Eporatio. The use of this medicine by healthy people can excessively increase certain blood parameters and in so doing cause problems with the heart or blood vessels that can be life threatening.

Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment. SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications. If you develop a serious rash or another of these skin symptoms, stop using Eporatio and contact your doctor or seek medical attention immediately.

Anaemia caused by chronic renal failure

If you are a patient with chronic renal failure, your doctor will check that a particular blood parameter (haemoglobin) does not exceed a defined threshold. If this blood parameter becomes too high, heart or vascular problems might occur, increasing the risk of death.

If you are a patient with chronic renal failure, and particularly if you do not respond properly to Eporatio, your doctor will check your dose of Eporatio because repeatedly increasing your dose of Eporatio if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.

If you have hardening of the blood vessels in your kidneys (nephrosclerosis) but do not need to undergo dialysis, your doctor will consider whether treatment is suitable for you. This is because one cannot rule out a possible acceleration of progression of kidney disease with absolute certainty.

If you are on dialysis, medicines that prevent blood coagulation are used. If you are being treated with Eporatio, the dose of the anticoagulant medicine may have to be increased. Otherwise the increased number of red blood cells may cause blocking of the arterio-venous fistula (an artificial connection between an artery and a vein which is surgically prepared in dialysis patients).

Anaemia in cancer patients

If you are a cancer patient you should be aware that this medicine may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer. Depending on your individual situation a blood transfusion may be preferable. Please discuss this with your doctor.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age because there are no data that show that this medicine is safe and works in this age group.

Other medicines and Eporatio

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

Eporatio has not been tested in pregnant women. It is important to tell your doctor if you are pregnant, think you may be pregnant or plan to get pregnant, as the doctor may decide that you should not use this medicine.

It is unknown whether the active substance in this medicine passes over to the breast milk. Therefore, your doctor may decide that you should not use this medicine if you are breast-feeding.

Driving and using machines

This medicine does not affect your ability to drive and use machines.

Eporatio contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, i.e. essentially ‘sodium-free’.

3. How to use Eporatio

Your treatment with this medicine is being initiated by a doctor who is experienced in the above-mentioned indications.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is…

The dose of Eporatio (expressed in International Units or IU) depends on your disease condition, your body weight and the way the injection is given (under the skin [subcutaneous injection] or into a vein [intravenous injection]). Your doctor will work out the right dose for you.

Anaemia caused by chronic renal failure

The injections are given under the skin or into a vein. Patients on haemodialysis will usually receive the injection at the end of dialysis via an arterio-venous fistula. Patients who do not have to undergo dialysis are usally given the injections under the skin. Your doctor will carry out blood tests regularly and adjust the dosage or suspend the treatment if necessary. The haemoglobin values in your blood should not exceed a value of 12 g/dl (7.45 mmol/l). Your doctor will use the lowest effective dose to control the symptoms of your anaemia. If you do not respond adequately to Eporatio, your doctor will check your dose and will inform you if you need to change doses of Eporatio.

Treatment with Eporatio is divided into two stages:

a) Correcting the anaemia

The initial dose for injections under the skin is 20 IU per kg of bodyweight, given 3 times per week. If necessary, your doctor will increase your dose at monthly intervals.

The initial dose for injections into veins is 40 IU per kg of bodyweight, given 3 times per week. If necessary, your doctor will increase your dose at monthly intervals.

b) Maintaining sufficient red blood cell levels

Once an adequate number of red blood cells has been reached, the maintenance dose required to keep the number constant will be determined by your doctor.

In the case of injections under the skin, the weekly dose can be given either as 1 injection per week or as 3 divided injections per week.

In the case of injections into veins, your dosage may be switched to 2 injections weekly.

If the frequency of administration is changed, dose adjustments may be necessary.

Treatment with Eporatio is normally a long-term therapy.

The maximum dose should not exceed 700 IU per kg of bodyweight per week.

Anaemia in cancer patients

Injections are given under the skin. The injection will be given once-weekly. The initial dose is 20,000 IU. Your doctor will carry out blood tests regularly and adjust the dosage or suspend the treatment if necessary. The haemoglobin values in your blood should not exceed a value of 12 g/dl (7.45 mmol/l). You will usually receive Eporatio until 1 month after the end of chemotherapy.

The maximum dose should not exceed 60,000 IU.

How are the injections given?

This medicine is given as an injection using a pre-filled syringe. The injection is given either into a vein (intravenous injection) or into the tissue just under the skin (subcutaneous injection).

If you are receiving Eporatio as an injection under the skin, your doctor may suggest that you learn how to inject yourself this medicine. Your doctor or nurse will give you instructions on how to do this. Do not attempt to give this medicine to yourself without this training. Some of the information required for using the pre-filled syringe can be found at the end of this package leaflet (see section “7. Information for injecting yourself”). Proper treatment of your disease, however, requires close and constant co-operation 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 your doctor has given you. If you think you have injected more Eporatio than you should, contact 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 injected too little, talk to your doctor. Do not inject a double dose to make up for a forgotten dose.

If you stop using Eporatio

Before you stop using this medicine, talk to your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

– Severely elevated blood pressure:

If you get headaches, especially sudden, stabbing, migraine-like headaches, confusion, speech disturbance, unsteady walking, fits or convulsions, tell your doctor immediately. These may be signs of severely elevated blood pressure (common in patients with chronic renal failure, may affect up to 1 in 10 people), even if your blood pressure is usually normal or low. It needs to be treated at once.

– Allergic reactions:

Allergic reactions such as skin rash, raised areas of the skin that itch and severe allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported (not known, frequency cannot be estimated from the available data). If you think you are having this type of reaction, you must stop your Eporatio injection and get medical help immediately.

– Serious skin rashes:

Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with epoetin treatment. These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. Stop using Eporatio if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.

You may 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 of weakness, tiredness;
– Skin reactions, such as rash, itching or reactions around the injection site.

Common in patients with chronic renal failure (may affect up to 1 in 10 people) – Blood clot in the arterio-venous fistula in patients on dialysis.

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

– Joint pain.

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 means that the body has stopped or reduced the production of red blood cells which causes severe anaemia. If your doctor suspects or confirms that you have this condition, you must not be treated with Eporatio or another epoetin.

Not known in cancer patients (frequency cannot be estimated from the available data) – Thromboembolic events, e.g. increase in blood clots.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed inBy 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 which is stated on the outer carton and on the pre-filled syringe after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C – 8 °C).

Do not freeze.

Keep the pre-filled syringe in the outer carton, in order to protect from light.

You may remove Eporatio from the refrigerator and store it not above 25 °C for a single period of up to 7 days without exceeding the expiry date. Once you have removed your medicine from the refrigerator you must use it within this period or it must be discarded.

Do not use this medicine if you notice it is cloudy or there are particles in it.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack 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) epoetin theta in 0.5 ml solution for injection corresponding 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) epoetin theta in 0.5 ml solution for injection corresponding 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) epoetin theta in 0.5 ml solution for injection corresponding 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) epoetin theta in 0.5 ml solution for injection corresponding 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) epoetin theta in 0.5 ml solution for injection corresponding 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) epoetin theta in 1 ml solution for injection corresponding 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) epoetin theta in 1 ml solution for injection corresponding 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) epoetin theta in 1 ml solution for injection corresponding to

30,000 international units (IU) (250 micrograms) per ml.

– The other ingredients are sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, hydrochloric acid (6 M) (for pH adjustment) and water for injections.

What Eporatio looks like and contents of the pack

Eporatio is a clear and colourless solution for injection in pre-filled syringe along 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. 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

Teva Biotech GmbH

Dornierstraße 10

89079 Ulm

Germany

Merckle GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgique/Belgien

Teva Pharma Belgium N.V./S.A./AG

Tél/Tel: +32 38207373

Efcnrapua

TeBa OapMa EAfl

Ten: +359 24899585

Česká republika

Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251007111

Danmark

Teva Denmark A/S

Tlf: +45 44985511

Deutschland

ratiopharm GmbH

Tel: +49 73140202

Eesti

Lietuva

UAB Teva Baltics

Tel: +370 52660203

Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland Tel/Tel: +49 73140202

Magyarorszag

Teva Gyogyszergyar Zrt.

Tel: +36 12886400

Malta

Teva Pharmaceuticals Ireland L-Irlanda

Tel: +44 2075407117

Nederland

Teva Nederland B.V.

Tel: +31 8000228400

Norge

UAB Teva Baltics Eesti filiaal Tel: +372 6610801

Teva Norway AS Tlf: +47 66775590

EÀÀàôa

Specifar A.B.E.E.

Tql: +30 2118805000

Österreich

ratiopharm Arzneimittel Vertriebs-GmbH

Tel: +43 1970070

España

Teva Pharma, S.L.U.

Tel: +34 913873280

Polska

Teva Pharmaceuticals Polska Sp. z o.o.

Tel: +48 223459300

France

Teva Santé

Tél: +33 155917800

Portugal

ratiopharm – Comércio e Indústria de Produtos

Farmaceuticos, Lda.

Tel: +351 214248000

Hrvatska

Pliva Hrvatska d.o.o.

Tel: +385 13720000

Romania

Teva Pharmaceuticals S.R.L.

Tel: +40 212306524

Ireland

Teva Pharmaceuticals Ireland

Tel: +44 2075407117

Slovenija

Pliva Ljubljana d.o.o.

Tel: +386 15890390

Ísland

Teva Pharma Iceland ehf.

Sími: +354 5503300

Slovenská republika

TEVA Pharmaceuticals Slovakia s.r.o.

Tel: +421 257267911

Italia

Teva Italia S.r.l.

Tel: +39 028917981

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 201805900

Kùnpoç

Specifar A.B.E.E.

EMdSa

Sverige

Teva Sweden AB

Tel: +46 42121100

Tql: +30 2118805000

Latvija

UAB Teva Baltics filiäle Latvijä

Tel: +371 67323666

United Kingdom (Northern Ireland)

Teva Pharmaceuticals Ireland

Ireland

Tel: +44 2075407117

This leaflet was last approved in.

Detailed information on this medicine is available on the European Medicines Agency web site:

7. Information for injecting yourself

This section contains information on how to give yourself an injection of Eporatio under the skin. It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse. If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.

How Eporatio is used

You will need to give yourself the injection into the tissue just under the skin. This is known as a subcutaneous injection.

Equipment that you need

To give yourself an injection into the tissue under the skin you will need:

– a pre-filled syringe of Eporatio,
– an alcohol wipe,
– a piece of gauze bandage or a sterile gauze swab,
– a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can

dispose of used syringes safely.

What you should do before your injection

1. Take one blister with a pre-filled syringe out of the refrigerator.
2. Open the blister and take the pre-filled syringe and the needle container out of the blister. Do not pick up the pre-filled syringe by the plunger or tip cap.
3. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed the last day of the month shown.
4. Check the appearance of Eporatio. It must be a clear and colourless liquid. If there are particles in it or if it is cloudy, you must not use it.
5. There is a cap at the end of the needle container. Break the labelled seal and remove the cap (see picture 1).
6. Remove the tip cap from the pre-filled syringe (see picture 2).
7. Attach the needle to the syringe (see picture 3). Do not remove the needle cover at this time.
8. For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room

temperature (not above 25 °C) or hold the pre-filled syringe gently in your hand for a few minutes. Do not warm Eporatio in any other way (for example, do not warm it in a microwave or in hot water).

9. Do not remove the needle cover from the syringe until you are ready to inject.
10. Find a comfortable, well-lit place. Put everything you need within easy reach (the Eporatio

pre-filled syringe, an alcohol wipe, a piece of gauze bandage or a sterile gauze swab and the puncture-proof container).

11. Wash your hands thoroughly.

How to prepare for your injection

Before you give yourself an Eporatio injection, you must do the following:

1. Hold the syringe and gently remove the cover from the needle without twisting. Pull straight as

shown in picture 4. Do not touch the needle or push the plunger.

2. You may notice small air bubbles in the pre-filled syringe. If there are air bubbles present, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. With the syringe pointing upwards, expel all air from the syringe by pushing the plunger slowly upwards.
3. The syringe has a scale on the syringe barrel. Push the plunger up to the number (IU) on the syringe that matches the dose of Eporatio that your doctor prescribed.
4. Check again to make sure the correct dose of Eporatio is in the syringe.
5. You can now use the pre-filled syringe.

Where your injection should be given

The most suitable places to inject yourself are:

– the top of your thighs,
– the abdomen, except for the area around the navel (see grey areas in picture 5).

If someone else is injecting you, they can also use the back and side of your upper arms (see grey areas in picture 6).

It is better to change the injection site every day to avoid the risk of soreness at any one site.

How you should inject yourself

1. Disinfect the injection site on the skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 7).
2. Put the needle fully into the skin as shown by your doctor or nurse. The angle between the syringe and skin should not be too narrow (at least 45°, see picture 8).
3. Inject the liquid into the tissue slowly and evenly, always keeping your skin pinched.
4. After injecting the liquid, remove the needle and let go of your skin.
5. Press the injection site with a piece of gauze bandage or a sterile gauze swab for several

seconds.

6. Only use each syringe for one injection. Do not use any Eporatio that is left in the syringe.

Remember

If you have any problems, please ask your doctor or nurse for help and advice.

Disposing of used syringes

– Do not put the cover back on used needles.
– Put used syringes into the puncture-proof container and keep this container out of the sight and reach of children.
– Dispose of the full puncture-proof container as instructed by your doctor, pharmacist or nurse.
– Never put the syringes that you have used into your normal household rubbish bin.

7. Information for injecting yourself

How Eporatio is used

You will need to give yourself the injection into the tissue just under the skin. This is known as a subcutaneous injection.

Equipment that you need

To give yourself an injection into the tissue under the skin you will need:

– a pre-filled syringe of Eporatio,
– an alcohol wipe,
– a piece of gauze bandage or a sterile gauze swab,
– a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can

dispose of used syringes safely.

What you should do before your injection

1. Take one blister with a pre-filled syringe out of the refrigerator.
2. Open the blister and take the pre-filled syringe and the needle bag out of the blister. Do not pick up the pre-filled syringe by the plunger or tip cap.
3. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed

the last day of the month shown.

4. Check the appearance of Eporatio. It must be a clear and colourless liquid. If there are particles in it or if it is cloudy, you must not use it.
5. There are flaps at the end of the needle bag. Open the needle bag at the flaps (see picture 1).
6. Remove the tip cap from the pre-filled syringe (see picture 2).
7. Attach the needle to the syringe (see picture 3). Do not remove the needle cover at this time.
8. Move the safety shield away from the needle and toward the syringe barrel. The safety shield will remain in the position you set (see picture 4)
9. For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room

10. Do not remove the needle cover from the syringe until you are ready to inject.
11. Find a comfortable, well-lit place. Put everything you need within easy reach (the Eporatio

pre-filled syringe, an alcohol wipe, a piece of gauze bandage or a sterile gauze swab and the puncture-proof container).

12. Wash your hands thoroughly.

How to prepare for your injection

Before you give yourself an Eporatio injection, you must do the following:

1. Hold the syringe and gently remove the cover from the needle without twisting. Pull straight as shown in picture 5. Do not touch the needle or push the plunger.
2. You may notice small air bubbles in the pre-filled syringe. If there are air bubbles present, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. With the syringe pointing upwards, expel all air from the syringe by pushing the plunger slowly upwards.
3. The syringe has a scale on the syringe barrel. Push the plunger up to the number (IU) on the syringe that matches the dose of Eporatio that your doctor prescribed.
4. Check again to make sure the correct dose of Eporatio is in the syringe.
5. You can now use the pre-filled syringe.

Where your injection should be given

The most suitable places to inject yourself are:

– the top of your thighs,
– the abdomen, except for the area around the navel (see grey areas in picture 6).

If someone else is injecting you, they can also use the back and side of your upper arms (see grey areas in picture 7).

It is better to change the injection site every day to avoid the risk of soreness at any one site.

How you should inject yourself

1. Disinfect the injection site on the skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 8).
2. Put the needle fully into the skin as shown by your doctor or nurse. The angle between the syringe and skin should not be too narrow (at least 45°, see pictures 9 and 10).
3. Inject the liquid into the tissue slowly and evenly, always keeping your skin pinched (see picture 11).
4. After injecting the liquid, remove the needle and let go of your skin.
5. Press the injection site with a piece of gauze bandage or a sterile gauze swab for several

seconds.

6. Push the safety shield towards the needle (see picture 12).
7. Position the safety shield approximately 45° against a flat surface (see picture 13).

Disposing of used syringes

– Put used syringes into the puncture-proof container and keep this container out of the sight and

reach of children.

– Dispose of the full puncture-proof container as instructed by your doctor, pharmacist or nurse.
– Never put the syringes that you have used into your normal household rubbish bin.

7. Information for injecting yourself

How Eporatio is used

You will need to give yourself the injection into the tissue just under the skin. This is known as a subcutaneous injection.

Equipment that you need

To give yourself an injection into the tissue under the skin you will need:

– a pre-filled syringe of Eporatio,
– an alcohol wipe,
– a piece of gauze bandage or a sterile gauze swab.

What you should do before your injection

1. Take one blister with a pre-filled syringe out of the refrigerator.
2. Open the blister and take the pre-filled syringe and the needle container out of the blister. Do not pick up the pre-filled syringe by the plunger or tip cap.
3. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed the last day of the month shown.
4. Check the appearance of Eporatio. It must be a clear and colourless liquid. If there are particles in it or if it is cloudy, you must not use it.
5. There is a cap at the end of the needle container. Break the labelled seal and remove the cap (see picture 1).
6. Remove the tip cap from the pre-filled syringe (see picture 2).
7. Attach the needle to the syringe (see picture 3). Do not remove the needle cover at this time.
8. For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room

9. Do not remove the needle cover from the syringe until you are ready to inject.
10. Find a comfortable, well-lit place. Put everything you need within easy reach (the Eporatio

pre-filled syringe, an alcohol wipe and a piece of gauze bandage or a sterile gauze swab).

11. Wash your hands thoroughly.

3

How to prepare for your injection

Before you give yourself an Eporatio injection, you must do the following:

1. Hold the syringe and gently remove the cover from the needle without twisting. Pull straight as shown in picture 4. The needle is surrounded by a retractable needle shield. Do not touch the needle or needle shield or push the plunger (see picture 5).
2. You may notice small air bubbles in the pre-filled syringe. If there are air bubbles present, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. With the syringe pointing upwards, expel all air from the syringe by pushing the plunger slowly upwards.
3. The syringe has a scale on the syringe barrel. Push the plunger up to the number (IU) on the syringe that matches the dose of Eporatio that your doctor prescribed.
4. Check again to make sure the correct dose of Eporatio is in the syringe.
5. You can now use the pre-filled syringe.

Where your injection should be given

The most suitable places to inject yourself are:

– the top of your thighs,
– the abdomen, except for the area around the navel (see grey areas in picture 6).

If someone else is injecting you, they can also use the back and side of your upper arms (see grey areas in picture 7).

It is better to change the injection site every day to avoid the risk of soreness at any one site.

How you should inject yourself

1. Disinfect the injection site on the skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 8).
2. Put the shielded needle without hesitation and in one continuous motion fully into the skin as shown by your doctor or nurse. The angle between the syringe and skin should not be too narrow (at least 45°, see picture 9). The needle shield will retract completely when you insert the needle into the skin (see picture 10).
3. Inject the liquid into the tissue slowly and evenly, always keeping your skin pinched (see picture 11).
4. After injecting the liquid, remove the needle and let go of your skin. The needle will be shielded and locked automatically so that you can not prick yourself (see picture 12).
5. Press the injection site with a piece of gauze bandage or a sterile gauze swab for several

seconds.

6. Only use each syringe for one injection. Do not use any Eporatio that is left in the syringe.

Eporatio - patient leaflet, side effects, dosage

Table of contents

Patient leaflet - Eporatio

1. What Eporatio is and what it is used for

2. What you need to know before you use Eporatio

3. How to use Eporatio

4. Possible side effects

5. How to store Eporatio

6. Contents of the pack and other information