ABSEAMED 1000 IU/0.5 ML Roztwór do wstrzykiwań

Treść ulotki

1. Abseamed 1 000 IU/0.5 mL injectable solution in pre-filled syringe, 2 000 IU/1 mL injectable solution in pre-filled syringe, 3 000 IU/0.3 mL injectable solution in pre-filled syringe, 4 000 IU/0.4 mL injectable solution in pre-filled syringe
   1. What is Abseamed and what is it used for
   2. What you need to know before using Abseamed
   3. How to use Abseamed
   4. Possible side effects
   5. How to store Abseamed
   6. Content of the pack and other information

Abseamed 1 000 IU/0.5 mL injectable solution in pre-filled syringe, 2 000 IU/1 mL injectable solution in pre-filled syringe, 3 000 IU/0.3 mL injectable solution in pre-filled syringe, 4 000 IU/0.4 mL injectable solution in pre-filled syringe

Abseamed 5 000 IU/0.5 mL injectable solution in pre-filled syringe
Abseamed 6 000 IU/0.6 mL injectable solution in pre-filled syringe
Abseamed 7 000 IU/0.7 mL injectable solution in pre-filled syringe
Abseamed 8 000 IU/0.8 mL injectable solution in pre-filled syringe
Abseamed 9 000 IU/0.9 mL injectable solution in pre-filled syringe
Abseamed 10 000 IU/1 mL injectable solution in pre-filled syringe
Abseamed 20 000 IU/0.5 mL injectable solution in pre-filled syringe
Abseamed 30 000 IU/0.75 mL injectable solution in pre-filled syringe
Abseamed 40 000 IU/1 mL injectable solution in pre-filled syringe
epoetin alfa

Read this leaflet carefully before you use this medicine as it contains important
information for you.

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

Contents of this leaflet

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

1. What is Abseamed and what is it used for

Abseamed contains the active substance epoetin alfa, a protein that stimulates the bone marrow to
produce more red blood cells that carry hemoglobin (a substance that transports oxygen).
Epoetin alfa is a copy of the human protein erythropoietin and acts in the same way.

Abseamed is used for the treatment of symptomatic anemia caused by kidney disease:

• in children undergoing hemodialysis
• in adults undergoing hemodialysis or peritoneal dialysis,
• in severely anemic adults not yet on dialysis

In case of kidney disease, there may be a deficiency of red blood cells if the kidney does not produce enough
erythropoietin (necessary for the production of red blood cells). Abseamed is prescribed to stimulate
the bone marrow to produce more red blood cells.

Abseamed is used for the treatment of anemia in adults undergoing chemotherapyfor
solid tumors, malignant lymphoma or multiple myeloma (bone marrow tumor) who may
require a blood transfusion. Abseamed may reduce the need for blood transfusions in
these patients.

Abseamed is used in moderately anemic adults who donate part of their own blood before
surgery, so that the collected blood can be administered to them during or
after surgery. Because Abseamed stimulates the production of red blood cells, doctors
can collect more blood from these people.

Abseamed is used in moderately anemic adults who are about to undergo
major orthopedic surgery(e.g. hip or knee replacement surgery) to reduce the potential need for blood transfusions.

Abseamed is used for the treatment of anemia in adults with a bone marrow disease
that causes a severe disruption in the creation of blood cells (myelodysplastic syndromes). Abseamedmay reduce the need for blood transfusions.

2. What you need to know before using Abseamed

Do not use Abseamed

• if you are allergicto epoetin alfa or any of the other ingredients of this medicine (listed in section 6).
• if you have been diagnosed with pure red cell aplasia(the bone marrow fails to produce enough red blood cells) following treatment with any medicine that stimulates the production of red blood cells (including Abseamed). See section 4.
• if you have high blood pressure, not sufficiently controlled with medicines.
• to stimulate the production of red blood cells (so that doctors can take more blood from you) if you cannot receive transfusions with your own bloodduring or after surgery.
• if you are about to undergo elective major orthopedic surgery(such as hip or knee replacement) and:
• you have serious heart disease
• you have severe disorders of the veins or arteries
• you have recently had a heart attack or stroke
• you cannot take medicines to make the blood more fluid. Abseamed may not be suitable for you. Discuss this with your doctor. During treatment with Abseamed some people need medicines to reduce the risk of blood clots. If you cannot take medicines that prevent the formation of clots, you should nottake Abseamed.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Abseamed.

Abseamed and other products that stimulate the production of red blood cells may increase in
all patients the risk of blood clots forming. This risk may be higher if you
have other risk factorsfor the development of blood clots ( for example if you have had a

blood clot in the past or if you are overweight, have diabetes, have heart disease or if you have to stay

lying down for a long period due to surgery or illness).Tell your
doctor about any such situations. The doctor will help you decide if Abseamed is suitable for
you.

It is important to tell your doctorif any of the following situations apply to you.
You may still be able to use Abseamed, but you must discuss this with your doctor first.

If you know you sufferor have suffered in the past from:

• high blood pressure;
• convulsions or epileptic seizures;
• liver disease;
• anemia from other causes;
• porphyria (a rare blood disorder).

If you are a patient with chronic kidney failure, and especially if you do not respond adequately
to Abseamed, the doctor will check the dose of Abseamed you receive, because repeatedly increasing the
dose of Abseamed if you do not respond to treatment may increase the risk of heart or
blood vessel problems and the risk of myocardial infarction, stroke and death.

If you are a cancer patient, be aware that medicines that stimulate the production of
red blood cells (such as Abseamed) can act as growth factors and therefore theoretically could
affect tumor progression.

Depending on your personal situation, a blood transfusion may be preferable. Discuss this
with your doctor.
If you are a cancer patient, be aware that Abseamed may be associated with a
shorter survival and a higher rate of death in patients with malignant head and neck cancer and metastatic breast cancer undergoing chemotherapy.
Severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with epoetin treatment.
SJS and TEN can initially appear as reddish target-like spots or circular patches, often with blisters in the center on the trunk. Mouth, throat, nose, genitals and eyes (red and swollen eyes) ulcers may also occur. These severe skin rashes are
often preceded by fever and/or flu-like symptoms. The skin rashes can progress to
widespread skin exfoliation and life-threatening complications.
If you develop a severe rash or any other of these skin symptoms, stop taking
Abseamed and contact your doctor immediately.

Take particular care with other products that stimulate the production of red blood cells:
Abseamed belongs to a group of products that, like human erythropoietin protein, stimulate the
production of red blood cells. The healthcare professional will always note the specific product you are
using. If you are given a medicine from this group, different from
Abseamed, during treatment, talk to your doctor or pharmacist before using it.

Other medicines and Abseamed
Tell your doctor if you are taking, have recently taken or might take any other
medicines.

If you are a patient with hepatitis C and are receiving interferon and ribavirin
You must discuss this with your doctor, because a combination of epoetin alfa with interferon and ribavirin
has led to a loss of effect and the development of a condition called pure red cell aplasia (PRCA), a serious form of anemia, in rare cases. Abseamed is not approved in the management
of anemia associated with hepatitis C.

If you are taking a medicine called cyclosporine(used, for example, after kidney transplants),
the doctor may have blood tests performed to measure cyclosporine levels while taking
Abseamed.

Iron supplements and other blood stimulantsmay increase the effectiveness of Abseamed. The
doctor will decide if it is right for you to take them.

If you go to hospital, clinic or see your general practitioner, tell them that you are being treated with
Abseamed. This may affect other treatments or test results.

Pregnancy, breastfeeding and fertility
It is important to tell your doctorif any of the following situations apply to you.
You may still be able to use Abseamed, but you must discuss this with your doctor first:

• If you are pregnant, suspect you may be pregnant, are planning a pregnancy or if you are breastfeedingwith breast milk, ask your doctor or pharmacist for advice before taking this medicine.

There are no data on the effects of Abseamed on fertility.

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

3. How to use Abseamed

Use this medicine following the doctor's instructions exactly at all times.If you have any doubts, consult your doctor.

The doctor has performed blood testsand decided that you need Abseamed.
Abseamed can be administered by injection:

• into avein or into a tube leading to a vein (intravenously)
• orunder the skin (subcutaneously).

The doctor will decide how Abseamed will be injected. Usually, injections are performed by a
doctor, nurse or other healthcare professional. Some people, depending on the reason why
they need treatment with Abseamed, may subsequently learn to self-inject it.
Abseamed must not be used:

• after the expiry date stated on the label and outer packaging
• if you know or suspect that it has been accidentally frozen or
• if the refrigerator has malfunctioned.

The dose of Abseamed that will be administered to you depends on your body weight in kilograms. The
cause of the anemia is also important for the doctor to choose the correct dose.

The doctor will regularly check your blood pressureduring therapy with Abseamed.

People with kidney disease

• The doctor will keep the hemoglobin level between 10 and 12 g/dL, as a high hemoglobin level may increase the risk of blood clots and death. In children, the hemoglobin level should be maintained between 9.5 and 11 g/dL.
• The usual initial doseof Abseamed in adults and children is 50 International Units (IU) per kilogram (/kg) of body weight, to be administered three times a week. In patients undergoing peritoneal dialysis, Abseamed may be administered twice a week.
• In adults and children, Abseamed is administered as an injection into a vein (intravenously) or into a tube leading to a vein. When this access (through a vein or a tube) is not readily available, the doctor may decide to inject Abseamed under the skin (subcutaneously). This concerns patients on dialysis and patients not yet on dialysis.
• The doctor will regularly prescribe blood tests to see how the anemia responds to therapy and may adjust the dose, usually at most every four weeks. An increase in hemoglobin greater than 2 g/dL over four weeks should be avoided.
• Once the anemia has been corrected, the doctor will continue to check the blood regularly. The dosage and frequency of administration of Abseamed may be further modified to maintain the response to treatment. The doctor will use the lowest effective dose to control the symptoms of anemia.
• If you do not respond adequately to Abseamed, the doctor will check the dose you are receiving and inform you if the doses of Abseamed need to be changed.
• If you are using a longer interval (more than once a week) between doses of Abseamed, you may not be able to maintain adequate hemoglobin levels and may need an increase in the dose or frequency of administration of Abseamed.
• Before and during treatment with Abseamed, you may also receive iron supplementation to increase the effectiveness of treatment.
• If you are undergoing dialysis when you start treatment with Abseamed, it may be necessary to change the dialysis schedule. The doctor will decide on this.

Adults undergoing chemotherapy

• The doctor may start therapy with Abseamed if hemoglobin is equal to or less than 10 g/dL.
• The doctor will keep the hemoglobin level between 10 and 12 g/dL, as a high hemoglobin level may increase the risk of blood clots and death.
• The usual initial dose is 150 IU per kilogram of body weight three times a week or450 IU per kilogram of body weight once a week.
• Abseamed is administered by injection under the skin.
• The doctor will prescribe blood tests for you and may adjust the dose depending on how the anemia responds to treatment.
• Before and during treatment with Abseamed, you may also receive iron supplementation to increase the effectiveness of treatment.
• Treatment with Abseamed usually continues for one month after the end of chemotherapy.

Adults who donate their blood

• The usual doseis 600 IU per kilogram of body weight, twice a week.
• Abseamed is administered by injection into a vein, immediately after donating blood, for 3 weeks before surgery.
• Before and during treatment with Abseamed, you may also receive iron supplementation to increase the effectiveness of treatment.

Adults awaiting major orthopedic surgery

• The recommended doseis 600 IU per kilogram of body weight once a week.
• Abseamed is administered by injection under the skin every week for three weeks before surgery and on the day of surgery.
• If it is necessary to shorten the time before surgery, a daily dose of 300 IU/kg is administered for a maximum of ten days before surgery, on the day of surgery and for the following four days.
• If blood tests show hemoglobin levels that are too high before surgery, treatment will be discontinued.
• Before and during treatment with Abseamed, you may receive iron supplementation to increase the effectiveness of treatment.

Adults with myelodysplastic syndromes

• The doctor may start therapy with Abseamed if hemoglobin is equal to or less than 10 g/dL. Treatment is intended to maintain hemoglobin levels between 10 and 12 g/dL as a higher hemoglobin level may increase the risk of blood clots and death.
• Abseamed is administered by injection under the skin.
• The initial dose is 450 IU per kilogram of body weight once a week.
• The doctor will prescribe blood tests for you and may adjust the dose depending on how the anemia responds to treatment with Abseamed.

Instructions for self-injection of Abseamed
At the beginning of treatment, Abseamed is generally injected by medical or paramedical personnel.
Subsequently, the doctor may suggest that you, or a person assisting you, learn to inject
Abseamed under the skin (subcutaneously) independently.

• Do not attempt to self-inject the medicine unless the doctor or nurse has shown you how to do it.
• Always use Abseamed exactly as shown by the doctor or nurse.
• Make sure to inject only the amount of liquid indicated by the doctor or nurse.
• Use Abseamed only if it has been stored correctly - see section 5, How to store Abseamed.
• Before use, let the Abseamed syringe rest until it reaches room temperature. Usually 15-30 minutes are needed. Use the syringe within 3 days of removal from the refrigerator.

Take only one dose of Abseamed from each syringe.
If Abseamed is injected under the skin (subcutaneously), the volume injected generally does not
exceed one milliliter (1 mL) per single injection.
Abseamed is administered alone and not mixed with other injectable liquids.

Do not shake the Abseamed syringes. Vigorous shaking can damage the product.
If the product has been shaken vigorously, do not use it.
Instructions for self-injection of Abseamed are provided at the end of this leaflet.

If you use more Abseamed than you should
Immediately inform your doctor or nurse if you believe that an excessive amount of
Abseamed has been injected. Adverse effects are unlikely in the event of an overdose with
Abseamed.

If you forget to use Abseamed
Administer the next injection as soon as you remember. If less than one day remains until the next
injection, skip the missed injection and continue with the normal schedule. Do not use a double dose
to make up for the missed dose.
If you have any doubts about using this medicine, consult your doctor, nurse or
pharmacist.

4. Possible side effects

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

Tell your doctor or nurse immediatelyif you notice any of the side effects listed below.
In association with treatment with epoetin, serious skin reactions have been reported, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear as red, target-like lesions or circular patches often with blisters in the centre on the trunk, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes and may be preceded by fever and flu-like symptoms. Stop using Abseamed if you develop any of these symptoms and contact your doctor immediately. See also section 2.
Very common side effects
May affect more than 1 in 10 people.

• Diarrhoea
• Nausea
• Vomiting
• Fever
• Upper respiratory tract congestion,such as a blocked nose and sore throat, has been reported in patients with kidney disease not yet on dialysis.

Common side effects
May affect up to 1 in 10 people.

• Increased blood pressure. The following signs may indicate a sudden increase in blood pressure: headache, especially if sudden in onset and throbbing like a migraine, confusion or seizures. These signs require urgent treatment. Increased blood pressure may require treatment with medicines (or an adjustment to the dose of medicines you are already taking for high blood pressure).
• Blood clots(including deep vein thrombosis and embolism) which may require urgent intervention. Symptoms may include chest pain, shortness of breathand swelling with pain and redness, usually in the legs.
• Cough.
• Skin rashes, which may be due to an allergic reaction.
• Bone or muscle pain.
• Flu-like symptomssuch as headache, aches and pains in the joints, feeling weak, chills, fatigue and dizziness. These symptoms may be more common

at the start of treatment. If you experience these symptoms during the injection into the vein,
a slower injection may help to avoid them in the future.

• Redness, burning and pain at the injection site.
• Swelling of the ankles, feet or fingers.
• Pain in the arm or leg.

Uncommon side effects
May affect up to 1 in 100 people.

• High levels of potassium in the blood,which can cause abnormal heart rhythms (this is a very common side effect in patients on dialysis).
• Seizures.
• Nasal or airway congestion.
• Allergic reaction.
• Hives.

Rare side effects
May affect up to 1 in 1,000 people.

• Symptoms of pure red cell aplasia (PRCA)

Pure red cell aplasia (PRCA) means that the bone marrow does not produce enough red blood cells. PRCA causes sudden and severe anaemia. Symptoms are:

• unusual tiredness,
• feeling dizzy,
• shortness of breath.

PRCA has been reported very rarely, especially in patients with kidney disease, after months or
years of treatment with epoetin alfa and other medicines that stimulate the production of red blood cells.

• An increase in the number of some small blood cells (called platelets), which are normally involved in blood clotting, may occur, particularly at the start of treatment. Your doctor will carry out the relevant checks.
• Severe allergic reaction which may include:
• swelling of the face, lips, mouth, tongue or throat,
• difficulty swallowing or breathing,
• itchy skin rash (urticaria).
• Blood problem that can cause pain, dark urine or increased sensitivity of the skin to sunlight (porphyria).

If you are on haemodialysis:

• Clots(thrombosis) may form in the dialysis fistula. This is more likely to happen if you have low blood pressure or if there are complications with the fistula.
• Clotsmay also form in the haemodialysis system. Your doctor may decide to increase the dose of heparin during dialysis.

Tell your doctor or nurse immediatelyif you notice any of these effects or if
you notice any other effects during treatment with Abseamed.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet

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

5. How to store Abseamed

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is stated on the label after “EXP” and on the package after “Scad.”. The expiry date refers to the last day of that month.
• Store and transport in a refrigerator (2 °C - 8 °C).
• You can remove Abseamed from the refrigerator and store it at room temperature (up to 25 °C) for a maximum of 3 days. Once the syringe has been removed from the refrigerator and has reached room temperature (up to 25 °C) it must be used within 3 days or discarded.
• Do not freeze or shake.
• Store in the original package to protect the medicine from light.

Do not use this medicine if you notice

• that it has been accidentally frozen or
• that the refrigerator has malfunctioned
• that the liquid is discolored or if you see particles floating in it
• that the seal is broken.

Do not dispose of any medicine in wastewater.Ask your pharmacist how to dispose of medicines
that you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Abseamed contains

• The active substance isepoetin alfa (see the following table for the amount).
• The other ingredients aremonobasic sodium phosphate dihydrate, dibasic sodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.

Description of the appearance of Abseamed and contents of the pack
Abseamed is presented as a clear and colourless injection solution in a pre-filled syringe. The syringes are sealed in blisters.

Packs of 1, 4 or 6 pre-filled syringes with or without a needle safety device.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Medice Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn
Germany

Manufacturer
Sandoz GmbH
Biochemiestr. 10
6336 Langkampfen
Austria
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
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Instructions for self-injection (only for patients with symptomatic anaemia caused by kidney disease, for adult patients undergoing chemotherapy, adult patients awaiting orthopaedic surgery, or adult patients with myelodysplastic syndromes)
This section contains information on how to inject Abseamed yourself. It is important that you do not attempt to inject the medicine yourself before being specifically trained by your doctor or nurse.Abseamed is supplied with or without a needle safety device: your doctor or nurse will show you how to use it. If you have any doubts or questions about self-injection, please contact your doctor or nurse.
WARNING: Do not use if the syringe has fallen onto a hard surface or has fallen after the needle cap has been removed. Do not use the Abseamed pre-filled syringe if it is broken. Return the pre-filled syringe and the packaging it came in to the pharmacy

• 1. Wash your hands.
• 2. Remove a syringe from the pack and remove the protective cap from the needle. The syringes are marked with raised graduations; this allows for partial use if necessary. Each graduation corresponds to a volume of 0.1 mL. If a partial use of the syringe is required, discard the unnecessary solution before administering the injection.
• 3. Disinfect the skin at the injection site with an alcohol-soaked swab.
• 4. Pinch the skin to create a skin fold between your thumb and index finger.
• 5. With a quick and firm movement, insert the needle into the skin fold. Inject the Abseamed solution as shown by your doctor. If you have any doubts, consult your doctor or pharmacist.

Prefilled syringe without needle safety device

• 6. Keeping the skin fold between your fingers, press down slowly and evenly on the plunger.
• 7. After injecting the liquid, withdraw the needle and release the skin. Press the injection site with a sterile dry gauze pad.
• 8. Dispose of unused medicine and any waste materials. Use each syringe only for a single injection.

Prefilled syringe with needle safety device

• 6. Keeping the skin fold between your fingers, press down slowly and evenly on the plunger until the entire dose is released and until the plunger can no longer be pressed down. Do not release pressure on the plunger!
• 7. After injecting the liquid, withdraw the needle while maintaining pressure on the plunger and then release the skin. Press the injection site with a sterile dry gauze pad.
• 8. Release the plunger. The safety device will quickly cover the needle.
• 9. Dispose of unused medicine and any waste materials. Use each syringe only for a single injection.