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Generated Narrative: Bundle TEST PURPOSES ONLY - eporatio

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Generated Narrative: MedicinalProductDefinition mpf46407e1e0462c87d0387a21507bffa2

identifier: http://ema.europa.eu/identifier/EU/1/09/573/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-f46407e1e0462c87d0387a21507bffa2

identifier: http://ema.europa.eu/identifier/EU/1/09/573/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - eporatio

Attesters

7. Information for injecting yourself

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

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).

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 .

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.

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 in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

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-Stra e 3 89079 Ulm Germany

Manufacturer Merckle GmbH Graf-Arco-Stra e 3 89079 Ulm Germany

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

Belgi /Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG T l/Tel: +32 38207Lietuva UAB Teva Baltics Tel: +370 52660

Te : +359 24899Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland T l/Tel: +49 73140 esk republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007Magyarorsz g Teva Gy gyszergy r Zrt. Tel: +36 12886Danmark Teva Denmark A/S Tlf: +45 44985Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407Deutschland ratiopharm GmbH Tel: +49 73140Nederland Teva Nederland B.V. Tel: +31 8000228Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610Norge Teva Norway AS Tlf: +47 66775
TEVA HELLAS . . sterreich ratiopharm Arzneimittel Vertriebs-GmbH : +30 2118805Tel: +43 1970Espa a Teva Pharma, S.L.U. Tel: +34 913873Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459France Teva Sant
T l: +33 155917Portugal ratiopharm - Com rcio e Ind stria de Produtos Farmac uticos, Lda. Tel: +351 214248Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720Rom nia Teva Pharmaceuticals S.R.L. Tel: +40 212306Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890 sland Teva Pharma Iceland ehf. S mi: +354 5503Slovensk republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267Italia Teva Italia S.r.l. Tel: +39 028917Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805
TEVA HELLAS . .

: +30 2118805Sverige Teva Sweden AB Tel: +46 42121Latvija UAB Teva Baltics fili le Latvij
Tel: +371 67323United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407This leaflet was last approved in .

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