1,000 IU / 0.5 ml, 2,000 IU / 0.5 ml, 3,000 IU / 0.5 ml, 4,000 IU / 0.5 ml, 5,000 IU / 0.5 ml, 10,000 IU / 1 ml, 20,000 IU / 1 ml and 30,000 IU / 1 ml solution for injection , respectively , in pre-filled syringe
epoetin theta
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 acts in 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 very important for distributing oxygen in the body.
What Eporatio is used for
Eporatio is used to treat symptomatic anemia (eg fatigue, weakness, and shortness of breath). Anemia occurs when the blood does not contain enough red blood cells. Treatment for anemia with Eporatio is given to adult patients with chronic kidney failure or to adult patients with non-myeloid cancer (cancer that has not started in the bone marrow ) who are also receiving chemotherapy (medicine to treat cancer).
2. What you need to know before using 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 can not be controlled.
Warnings and cautions
Generally
This medicine may be inappropriate for the following patients. Talk to your doctor if you belong to any of the following patient groups:
- patients with liver problems
- patients with pathological changes in the red blood cells ( homozygous sickle cell anemia ).
Blood pressure must be carefully monitored before and during treatment with this medicine. If your blood pressure rises, the doctor may give you medicine to lower blood pressure, etc. If you are already taking a medicine to lower your blood pressure, your doctor may increase the dose. It may also be necessary to reduce your dose of Eporatio or to stop taking Eporatio for a short period of time.
If you experience headaches, especially sudden, stinging, migraine-like headaches, confusion, speech disturbances, unsteady gait, seizures, or seizures, tell your doctor immediately. These can be signs of severe high blood pressure, even if your blood pressure is usually normal or low. It needs to be treated immediately.
Your doctor will perform regular blood tests to check for different blood components and their levels. Also, 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 supplement.
If you feel tired or weak or experience shortness of breath, you must contact your doctor. These symptoms may indicate that your treatment with this medicine is ineffective. Your doctor will check that you have no other causes for anemia and can do blood tests or examine your bone marrow.
Healthcare professionals always write down exactly which medicine you are using. It may help to provide more information on the safety of medicines like this.
Healthy people should not use Eporatio. The use of this medicine in healthy people can raise certain blood levels too much and thus cause any life-threatening problems with the heart or blood vessels.
Serious skin reactions such as Steven-Johnson syndrome and toxic epidermal necrolysis have been reported during treatment with epoetin. Steven-Johnson syndrome and toxic epidermal necrolysis can begin as reddish-purple target-like or round spots on the torso, often with blisters in the middle. Sores in the mouth, throat, nose, genitals, and eyes (red and swollen eyes) may also occur. These severe skin reactions are often preceded by fever and/or flu-like symptoms. The rash can develop into widespread areas with scaly skin and life-threatening complications. If you get a severe rash or any of these skin symptoms, stop using Eporatio and contact a doctor or hospital immediately.
Anemia caused by chronic renal failure
If you are a patient with chronic kidney failure, your doctor will check that a specific blood level ( hemoglobin ) does not exceed a set threshold. If this blood value becomes too high, cardiovascular problems can occur, including the risk of death.
If you are a patient with chronic kidney failure, and especially if you do not get enough effect of Eporatio, your doctor will check your dose of Eporatio as repeated dose increases of Eporatio if you do not respond to treatment may increase the risk of heart or blood vessel problems. and may increase the risk of heart attack, stroke, and death.
If you have calcifications in the blood vessels of your kidneys (nephrosclerosis) but do not need dialysis, your doctor will consider whether Eporatio is suitable for you. This is because a possible faster development of kidney disease cannot be ruled out with certainty.
If you are undergoing dialysis, medicines that prevent blood clotting are used. If you are being treated with Eporatio, the dose of one of the anticoagulants may need to be increased. Otherwise, the increased number of red blood cells can cause blockage of the arteriovenous fistula (an artificial connection between an artery and a vein that is surgically inserted in dialysis patients).
Anemia in cancer patients
If you are a cancer patient, you should be aware that this medicine may act as a growth factor for blood cells and may, under certain circumstances, hurt your cancer. Depending on your individual situation, a blood transfusion may be preferable. Discuss this with your doctor.
Children and young people
Do not give this medicine to children and adolescents under 18 years of age as no data are available showing that this medicine is safe and works in that age group.
Other medicines and Eporatio
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
Eporatio has not been studied in pregnant women. It is important that you tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby as your doctor may decide not to take this medicine.
It is unknown whether the active substance in this medicine passes into 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 or use machines.
Eporatio contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, ie essentially ‘sodium-free’.
3. How to use Eporatio
Treatment with this medicine should be started by a doctor who has experience in the indications listed above.
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is…
The dose of Eporatio (expressed in International Units or IU) depends on your disease state, your weight, and how the injection is given (under the skin [subcutaneous injection] or in a vein [intravenous injection]). Your doctor will prescribe the right dose for you.
Anemia caused by chronic renal failure
The injections are given under the skin or in a friend. Hemodialysis patients usually receive an injection at the end of dialysis via an arteriovenous fistula. Patients who do not need dialysis usually receive injections under the skin. Your doctor will do blood tests regularly and if necessary adjust the dosage one or discontinue treatment. Hemoglobin levels in the blood should not exceed 12 g / dl (7.45 mmol / l). Your doctor will use the lowest effective dose to control your anemia symptoms. If you do not get enough effect of Eporatio, your doctor will check the dose one and inform you if you need to change the dose one of Eporatio.
Treatment with Eporatio is divided into two phases:
a) Correction of the anemia
The starting dose for injection under the skin is 20 IU per kg body weight 3 times per week. If necessary, your doctor will increase your dose at one-month intervals.
The starting dose for injections into veins is 40 IU per kg body weight 3 times per week. If necessary, your doctor will increase your dose at one-month intervals.
b) Maintenance of adequate levels of red blood cells
Once a sufficient number of red blood cells has been reached, your doctor will determine the maintenance dose needed to keep the number constant.
In case of injection under the skin, the weekly dose can be given either as 1 injection per week or divided into 3 injections per week.
When you are injected into a vein, your dosage can be changed to 2 injections per week.
If the frequency of administration changes, dose adjustments may be required.
Treatment with Eporatio is usually a long-term treatment.
The maximum dose should not exceed 700 IU per kg body weight per week.
Anemia in cancer patients
The injections are given under the skin. The injection is given once a week. The starting dose is 20,000 IU. Your doctor will do blood tests regularly and if necessary adjust the dosage one or discontinue treatment. Hemoglobin levels in the blood should not exceed 12 g / dl (7.45 mmol / l). You 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?
The drug is given as an injection with 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 with this medicine. Your doctor or nurse will give you instructions on how to do this. Do not try to give yourself this drug without this exercise. Some of the information needed to use the pre-filled syringe can be found at the end of this leaflet (see section 7 “Information on how to inject yourself”). However, proper treatment of your disease requires close and constant cooperation with your doctor.
Each pre-filled syringe is for single use only.
If you use more Eporatio than you should
You should not increase the dose prescribed by your doctor. If you think you have injected more Eporatio than you should, contact your doctor. This is unlikely to be serious. No symptoms of poisoning have been observed even with very high blood levels.
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
Talk to your doctor before stopping this medicine.
If you have any further questions on the use of this product, 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:
- Severe high blood pressure:
- If you experience headaches, especially sudden, stinging, migraine-like headaches, confusion, speech disorders, unsteady gait, seizures, or seizures, tell your doctor immediately. These may be signs of severe high blood pressure(common in patients with chronic kidney failure, which may affect up to 1 in 10 people), although your blood pressure is usually normal or low. It needs to be treated immediately.
- Allergic reactions:
- Allergic reactions such as skin rash raised areas on the skin that itch, and severe allergic reactions with weakness, drop in blood pressure, difficulty breathing, and swelling of the face have been reported (no known frequency, can not be calculated from the available data). If you think you have this type of reaction, you must stop injection engines with Eporatio and seek medical help immediately.
- Severe rash:
- Severe skin rashes such as Steven-Johnson syndrome and toxic epidermal necrolysis have been reported during treatment with epoetin. These conditions can cause symptoms such as reddish-purple target-like or round spots on the torso, often with blisters in the middle, scaly skin, sores in the mouth, throat, nose, genitals, and eyes and may be preceded by fever and flu-like symptoms. Stop using Eporatio if you experience these symptoms and contact a doctor or hospital immediately. See also section 2.
You may also experience the following side effects:
Common (may affect up to 1 in 10 people)
- headache
- high blood pressure
- flu-like symptoms such as fever, chills, weakness, fatigue;
- 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)a
- blood clot in the arteriovenous fistula in dialysis patients.
Common in cancer patients (may affect up to 1 in 10 people)
- joint pain.
Not known in patients with chronic renal failure (frequency can not be calculated from the available data)
- cases of a condition called pure red cell aplasia ( PRCA) have been reported. Pure erythrocyte plasma means that the body has stopped producing or produces smaller red blood cells, which causes severe anemia. 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 calculated from the available data)
- thromboembolic events e.g. increased incidence of blood clots.
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 the pre-filled syringe after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Do not freeze.
Store the pre-filled syringe in the outer carton. Sensitive to light.
You can take Eporatio out of the refrigerator and store it at room temperature (maximum 25 ° C) for a single period of up to 7 days without exceeding the expiry date. Once you have taken your medicine out of the refrigerator, you must use it within this period or discard it.
Do not use this medicine if you notice that it is cloudy or contains particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is epoetin theta.Eporatio 1,000 IU / 0.5 ml: A pre-filled syringe contains 1,000 International Units (IU) (8.3 micrograms) epoetin theta in 0.5 ml solution for injection equivalent to 2,000 IU (16.7 micrograms) epoetin theta per ml.Eporatio 2,000 IU / 0.5 ml: A pre-filled syringe contains 2,000 International Units (IU) (16.7 micrograms) epoetin theta in 0.5 ml solution for injection equivalent to 4,000 IU (33.3 micrograms) epoetin theta per ml.Eporatio 3,000 IU / 0.5 ml: A pre-filled syringe contains 3000 International Units (IU) (25 micrograms) epoetin theta in 0.5 ml solution for injection equivalent to 6,000 IU (50 micrograms) epoetin theta per ml.Eporatio 4,000 IU / 0.5 ml: A pre-filled syringe contains 4,000 international units (IU) 33.3 micrograms) epoetin theta in 0.5 ml solution for injection equivalent to 8,000 IU (66.7 micrograms) epoetin theta per ml.Eporatio 5,000 IU / 0.5 ml: A pre-filled syringe contains 5,000 international units (IU) (41.7 micrograms) epoetin theta in 0.5 ml solution for injection equivalent to 10,000 IU (83.3 micrograms) epoetin theta per ml.Eporatio 10,000 IU / 1 ml: A pre-filled syringe contains 10,000 International Units (IU) (83.3 micrograms) epoetin theta in 1 ml solution for injection equivalent to 10,000 IU (83.3 micrograms) epoetin theta per ml.Eporatio 20,000 IU / 1 ml: A pre-filled syringe contains 20,000 International Units (IU) (166.7 micrograms) epoetin theta in 1 ml solution for injection equivalent to 20,000 IU (166.7 micrograms) epoetin theta per ml.Eporatio 30,000 IU / 1 ml: A pre-filled syringe contains 30,000 International Units (IU) (250 micrograms) epoetin theta in 1 ml solution for injection equivalent to 30,000 IU (250 micrograms) epoetin theta 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 the medicine looks like and the contents of the pack
Eporatio is a clear and colorless solution for injection in a pre-filled syringe together with a syringe.
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 syringecontains 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 a 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
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienTeva Pharma Belgium NV / SA / AGTel: +32 3 820 73 73 | LithuaniaUAB “Sicor Biotech”Tel: +370 5 266 0203 |
| BulgariaOctavis FADTel: +359 2 489 95 85 | Luxembourg / Luxemburgratiopharm GmbH, Germany / GermanyTel: +49 731 402 02 |
| Czech RepublicTeva Pharmaceuticals CR, sroTel: +420 251 007 111 | HungaryTeva Gyógyszergyár Zrt.Tel .: +36 1 288 64 00 |
| DenmarkTeva Denmark A / STel: +45 44 98 55 11 | MaltaTeva Pharmaceuticals Ireland, L IrelandTel: +353 51 321740 |
| Germanyratiopharm GmbHTel: +49 731 402 02 | The NetherlandsTeva Nederland BVTel: +31 800 0228 400 |
| EestiUAB “Sicor Biotech” Eesti subsidiaryTel: +372 661 0801 | NorwayTeva Norway ASTel: +47 66 77 55 90 |
| GreeceTeva Αλλάς Α.Ε.:Ηλ: +30 210 72 79 099 | Austriaratiopharm Arzneimittel Vertriebs GmbHTel: +43 1 97 007 |
| SpainTeva Pharma, SLUTel: +34 91 387 32 80 | PolandTeva Pharmaceuticals Polska Sp. z ooTel .: +48 22 345 93 00 |
| FranceTeva HealthTel: +33 1 55 91 78 00 | Portugalratiopharm, Commerce, and Industry of Pharmaceutical Products, LdaTel: +351 21 424 80 00 |
| CroatiaPliva Hrvatska dooTel: +385 1 37 20 000 | RomaniaTeva Pharmaceuticals SRLTel: +40 21 230 65 24 |
| IrelandTeva Pharmaceuticals IrelandTel: +353 51 321740 | SloveniaPliva Ljubljana dooTel: +386 1 58 90 390 |
| Icelandratiopharm Oy, FinlandPhone: +358 20 180 5900 | Slovak RepublicTEVA Pharmaceuticals Slovakia sroTel: +421 2 57 26 79 11 |
| ItalyTeva Italia SrlTel: +39 02 89 17 98 1 | Finland / Finlandratiopharm OyPuh / Tel: +358 20 180 5900 |
| LatviaUAB “Sicor Biotech” branch of LatviaTel: +371 673 23 666 | United KingdomTeva UK LimitedTel: +44 1977 628500 |