Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - neorecormon

Document Subject

Generated Narrative: MedicinalProductDefinition mpb49a3ab45641cdaf6bd8a0f7bc20385d

identifier: http://ema.europa.eu/identifier/EU/1/97/031/025-026

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: NeoRecormon 500 IU solution for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-b49a3ab45641cdaf6bd8a0f7bc20385d

identifier: http://ema.europa.eu/identifier/EU/1/97/031/025-026

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - neorecormon

Attesters

What is in this leaflet

1. What NeoRecormon is and what it is used for
2. What you need to know before you use NeoRecormon
3. How to use NeoRecormon
4. Possible side effects
5. How to store NeoRecormon
6. Content of the pack and other information

NeoRecormon is a clear, colourless solution for injection under the skin (subcutaneously) or into a vein (intravenously). It contains a hormone called epoetin beta, which stimulates the production of red blood cells. Epoetin beta is produced by a specialised genetic technology and works in exactly the same way as the natural hormone erythropoietin. You must talk to your doctor if you do not feel better or if you feel worse.

NeoRecormon is indicated for:

• Treating symptomatic anaemia caused by chronic kidney disease (renal anaemia) in patients on dialysis, or not yet on dialysis.
• Preventing anaemia in premature infants (weighing 750 to 1500 g and born at less than 34 weeks).
• Treating anaemia with related symptoms in adult cancer patients receiving chemotherapy
• Treating people donating their own blood before surgery. The injections of epoetin beta will increase the amount of blood that can be taken from your body before surgery and given back during or after the operation (this is an autologous transfusion).

Do not use NeoRecormon

• if you are allergic to epoetin beta or any of the other ingredients of this medicine (listed in section 6)
• if you have blood pressure problems that cannot be controlled
• if you are donating your own blood before surgery, and:
• you had a heart attack or stroke in the month before your treatment
• you have unstable angina pectoris new or increasing chest pain
• you are at risk of blood clots in the veins (deep venous thrombosis) for example, if you have had clots before. If any of these apply to you, or might apply, tell your doctor at once.

Warnings and precautions Talk to your doctor before using NeoRecormon

• if your baby needs treatment with NeoRecormon, your baby will be carefully monitored for any potential effects on the eye
• if your anaemia does not improve with epoetin treatment
• if you are low in certain B vitamins (folic acid or vitamin B12)
• if you have very high levels of aluminium in your blood
• if your blood platelet count is high
• if you have chronic liver disease
• if you have epilepsy
• if you have developed anti-erythropoietin antibodies and pure red cell aplasia (reduced or stopped production of red blood cells) during prior exposure to any erythropoietic substance. In this case you should not be switched to NeoRecormon.

Take special care with other products that stimulate red blood cell production:
NeoRecormon is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does. Your doctor will always record the exact product you are using.

Serious skin reaction 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-likes 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 taking NeoRecormon and contact your doctor or seek medical attention immediately.

Special Warning: During treatment with NeoRecormon

If you are a patient with chronic kidney disease, and particularly if you do not respond properly to NeoRecormon, your doctor will check your dose of NeoRecormon because repeatedly increasing your dose of NeoRecormon 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 are a cancer patient, you should be aware that NeoRecormon 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.

If you are a nephrosclerotic patient and you are not on dialysis, your doctor will decide whether treatment is right for you. This is because one cannot rule out a possible acceleration of progression of kidney disease with absolute certainty.

Your doctor may do regular blood tests to check:

• your potassium levels. If you have high or rising potassium levels your doctor may reconsider your treatment
• your blood platelet count. The number of platelets can rise slightly to moderately during epoetin treatment, and this can cause changes in blood clotting.

If you are a kidney patient under haemodialysis, your doctor may adjust your dose of heparin. This should avoid a blockage in the tubing of the dialysis system.

If you are a kidney patient under haemodialysis and at risk of shunt thrombosis, blood clots (thromboses) may form in your shunt (vessel used for connection to the dialysis system). Your doctor might prescribe acetylsalicylic acid or modify the shunt.

If you are donating your own blood before surgery, your doctor will need to:

• check that you are capable of giving blood, especially if you weigh less than 50 kg
• check that you have a sufficient level of red blood cells (haemoglobin of at least 11 g/dL)
• make sure that only 12% of your blood will be donated at once.

Do not misuse NeoRecormon: Misuse of NeoRecormon by healthy people may lead to an increase in blood cells and consequently thicken the blood. This can in turn lead to life-threatening complications of the heart or blood vessels.

Other medicines and NeoRecormon Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Pregnancy, breast-feeding and fertility
There is not much experience with NeoRecormon in pregnant women or women who are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. NeoRecormon has not shown evidence of impaired fertility in animals. The potential risk for humans is unknown.

Driving and using machines No effects on ability to drive or use machines have been observed.

NeoRecormon contains phenylalanine and sodium This medicine contains phenylalanine. May be harmful for people with phenylketonuria.
If you have phenylketonuria, talk to your doctor about your treatment with NeoRecormon.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium- free .

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

Your doctor will use the lowest effective dose to control the symptoms of your anaemia.

If you do not respond adequately to NeoRecormon, your doctor will check your dose and will inform you if you need to change doses.

Treatment must be started under the supervision of your doctor. Further injections are given by your doctor or, after you have been trained, you can inject NeoRecormon yourself (see instructions at the end of this leaflet.)

NeoRecormon can be injected under the skin in the abdomen, arm or thigh, or into a vein. Your doctor will decide which is best for you.

Your doctor will carry out regular blood tests to monitor how your anaemia is responding to treatment by measuring your haemoglobin level.

NeoRecormon dosing The dose of NeoRecormon depends on your disease condition, the way the injection is given (under the skin or into a vein) and your body weight. Your doctor will work out the right dose for you. Your doctor will use the lowest effective dose to control the symptoms of your anaemia.

If you do not respond adequately to NeoRecormon, your doctor will check your dose and will inform you if you need to change doses of NeoRecormon.

• Symptomatic anaemia caused by chronic kidney disease

Your injections are given under the skin or into a vein. If the solution is given into your vein it should be injected over about 2 minutes, e.g. people on haemodialysis will receive the injection via the arteriovenous fistula at the end of dialysis. People who are not on haemodialysis will usually have injections under the skin.

Treatment with NeoRecormon is divided into two stages:

a) Correcting the anaemia The initial dose for injections under the skin is 20 IU per injection for every 1 kg of your body weight, given three times per week. After 4 weeks, the doctor will do tests and, if the treatment response is not sufficient, your dose may be raised to 40 IU/kg per injection, given three times per week. The doctor may continue to increase your dose at monthly intervals if necessary. The weekly dose can also be divided into daily doses. The initial dose for injections into veins is 40 IU per injection for every 1 kg of your body weight, given three times per week. After 4 weeks, the doctor will do tests and, if the treatment response is not sufficient, your dose may be raised to 80 IU/kg per injection, given three times per week. The doctor may continue to increase your dose at monthly intervals if necessary. For both types of injection, the maximum dose should not exceed 720 IU for every 1 kg of your body weight per week.

b) Maintaining sufficient red blood cell levels The maintenance dose: Once your red blood cells reach an acceptable level, the dose is reduced to half the dose used to correct the anaemia. The weekly dose can be given once per week or divided into three or seven doses per week. If your red blood cell level is stable on a once weekly dosing regimen, your dose may be switched to once every two weeks administration. In this case dose increases may be necessary. Every one or two weeks, the doctor may adjust your dose to find your individual maintenance dose. Children will start by following the same guidelines. In trials, children usually needed higher doses of NeoRecormon (the younger the child, the higher the dose). Treatment with NeoRecormon is normally a long-term therapy. However, it can be interrupted at any time, if necessary.

• Anaemia in premature infants

Injections are given under the skin.

The initial dose is 250 IU per injection for every 1 kg the infant weighs, three times a week.

Premature infants who have been transfused before the start of treatment with NeoRecormon are not likely to benefit as much as untransfused infants.

The recommended treatment duration is 6 weeks.

• Adults with symptomatic anaemia receiving chemotherapy for cancer

Injections are given under the skin.

Your doctor may initiate treatment with NeoRecormon if your haemoglobin level is 10 g/dL or less. After initiation of therapy, your doctor will maintain your haemoglobin level between 10 and 12 g/dL.

The initial weekly dose is 30,000 IU. This may be given as one injection per week, or in divided doses as 3 to 7 injections per week. Your doctor will take regular blood samples. He or she may raise or lower your dose or interrupt your treatment according to the test results. The haemoglobin values should not exceed a value of 12 g/dL.

The therapy should be continued for up to 4 weeks after the end of chemotherapy.

The maximum dose should not exceed 60,000 IU per week.

• People donating their own blood before surgery

Injections are given into a vein over 2 minutes, or under the skin.

The dose of NeoRecormon depends on your condition, red blood cell levels and how much blood will be donated before surgery.

The dose worked out by your doctor will be given twice per week for 4 weeks. When you donate blood, NeoRecormon will be given to you at the end of a donation session.

The maximum dose should not exceed

• for injections into veins: 1600 IU for every 1 kg of your body weight per week
• for injections under the skin: 1200 IU for every 1 kg of your body weight per week.

If you inject too much NeoRecormon Do not increase the dose your doctor has given you. If you think you have injected more NeoRecormon 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 NeoRecormon If you have missed an injection, or injected too little, talk to your doctor.

Do not take a double dose to make up for any forgotten doses.

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

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

Side effects which can affect any patient

• Most people (very common may affect more than 1 in 10 people) get lower levels of iron in their blood. Almost all patients have to be treated with iron supplements during their NeoRecormon therapy.
• Rarely (may affect up to 1 in 1,000 people), allergies or skin reactions, such as rash or hives, itching or reactions around the injection site have occurred.
• Very rarely (may affect up to 1 in 10,000 people) a severe form of allergic reaction has occurred, especially just after an injection. It needs to be treated at once. If you get unusual wheezing or difficulty breathing; swollen tongue, face or throat, or swelling around the injection site; if you feel light-headed or faint or if you collapse, call your doctor at once.
• Very rarely (may affect up to 1 in 10,000 people) people experienced flu-like symptoms, especially when they just started treatment. These include fever, chills, headaches, pain in the limbs, bone pain and/or feeling generally unwell. These reactions were usually mild to moderate and went away within a few hours or days.
• 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 NeoRecormon if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2. Additional side effects in people with chronic kidney disease (renal anaemia)
• Increase in blood pressure, worsening of existing high blood pressure and headaches are the most common side effects (very common may affect more than 1 in 10 people). Your doctor will regularly check your blood pressure, particularly at the beginning of therapy. Your doctor may treat the high blood pressure with drugs or temporarily interrupt your NeoRecormon therapy.
• Call a doctor at once if you get headaches, especially sudden, stabbing, migraine-like headaches, confusion, speech disturbance, unsteady walking, fits or convulsions. These may be signs of severely elevated blood pressure (hypertensive crisis), even if your blood pressure is usually normal or low. It needs to be treated at once.
• If you have low blood pressure or shunt complications, you may be at risk of shunt thrombosis (a blood clot in the vessel used for connection to the dialysis system).
• Very rarely (may affect up to 1 in 10,000 people), patients have had rising levels of potassium or phosphates in the blood. This can be treated by your doctor.
• Pure red cell aplasia (PRCA) caused by neutralising antibodies has been observed during erythropoietin therapy, including in isolated cases during therapy with NeoRecormon. PRCA means that the body stopped or reduced the production of red blood cells. This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy. If your body produces neutralising antibodies, your doctor will discontinue therapy with NeoRecormon, and determine the best course of action to treat your anaemia.

Additional side effects in adults receiving chemotherapy for cancer

• Increase in blood pressure and headaches may occasionally occur. Your doctor may treat the high blood pressure with drugs.
• An increase in the occurrence of blood clots has been observed.

Additional side effects in people donating their own blood before surgery

• A slight increase in the occurrence of blood clots has been observed.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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 NeoRecormon after the expiry date which is stated on the carton and label.
• Store in a refrigerator (2 C 8 C).
• The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 3 days (but not above 25 C).
• Keep the pre-filled syringe in the outer carton, in order to protect from light.
• 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 protect the environment.

What NeoRecormon contains

• The active substance is epoetin beta. One pre-filled syringe contains either 500, 2000, 3000, 4000, 5000, 6000, 10,000, 20,000 or 30,000 IU (international units) epoetin beta in 0.3 ml or 0.6 ml solution.
• The other ingredients are: urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, and L-Phenylalanine and water for injections (see section 2 NeoRecormon contains phenylalanine and sodium ).

What NeoRecormon looks like and contents of the pack

NeoRecormon is a solution in a pre-filled syringe for injection The solution is colourless, clear to slightly opalescent.

NeoRecormon 500 IU, 2000 IU, 3000 IU, 4000 IU, 5000 IU and 6000 IU: Each pre-filled syringe contains 0.3 ml solution. NeoRecormon 10,000 IU, 20,000 IU and 30,000 IU: Each pre-filled syringe contains 0.6 ml solution.

NeoRecormon is provided in the following pack-sizes:

NeoRecormon 500 IU 1 pre-filled syringe with 1 needle (30G1/2) or 6 pre-filled syringes with 6 needles (30G1/2).

NeoRecormon 2000 IU, 3000 IU, 4000 IU, 5000 IU, 6000 IU, 10,000 IU and 20,000 IU 1 pre-filled syringe with 1 needle (27G1/2) or 6 pre-filled syringes with 6 needles (27G1/2).

NeoRecormon 30,000 IU 1 pre-filled syringe with 1 needle (27G1/2) or 4 pre-filled syringes with 4 needles (27G1/2).

Not all pack sizes may be marketed. Marketing Authorisation Holder Roche Registration GmbH
Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany

Manufacturer Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany

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

Belgi /Belgique/Belgien N.V. Roche S.A. T l/Tel: +32 (0) 2 525 82 Lietuva UAB Roche Lietuva
Tel: +370 5 2546

: +359 2 818 44 Luxembourg/Luxemburg (Voir/siehe Belgique/Belgien)

esk republika Roche s. r. o. Tel: +420 - 2 20382Magyarorsz g Roche (Magyarorsz g) Kft. Tel: +36 - 1 279 4Danmark Roche Pharmaceuticals A/S Tlf: +45 - 36 39 99 Malta (See Ireland)

Deutschland Roche Pharma AG Tel: +49 (0) 7624 Nederland Roche Nederland B.V. Tel: +31 (0) 348 438Eesti Roche Eesti O
Tel: + 372 - 6 177 Norge Roche Norge AS Tlf: +47 - 22 78 90
Roche (Hellas) A.E.
: +30 210 61 66 sterreich Roche Austria GmbH Tel: +43 (0) 1 27Espa a Roche Farma S.A. Tel: +34 - 91 324 81 Polska Roche Polska Sp.z o.o. Tel: +48 - 22 345 18 France Roche T l: +33 (0) 1 47 61 40 Portugal Roche Farmac utica Qu mica, Lda Tel: +351 - 21 425 70 Hrvatska Roche d.o.o Tel: +385 1 4722 Rom nia Roche Rom nia S.R.L. Tel: +40 21 206 47 Ireland Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0Slovenija Roche farmacevtska dru ba d.o.o. Tel: +386 - 1 360 26 sland
Roche Pharmaceuticals A/S c/o Icepharma hf S mi: +354 540 8Slovensk republika
Roche Slovensko, s.r.o. Tel: +421 - 2 52638Italia Roche S.p.A. Tel: +39 - 039 2Suomi/Finland Roche Oy
Puh/Tel: +358 (0) 10 554 K
. . & . : +357 - 22 76 62 Sverige Roche AB Tel: +46 (0) 8 726 1Latvija Roche Latvija SIA Tel: +371 - 6 7039United Kingdom (Northern Ireland) Roche Products (Ireland) Ltd. Tel: +44 (0) 1707 366This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>

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