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Aranesp (darbepoetin alfa) – Package leaflet - B03XA02

Updated on site: 05-Oct-2017

Medication nameAranesp
ATC CodeB03XA02
Substancedarbepoetin alfa
ManufacturerAmgen Europe B.V.

Package leaflet: Information for the user

Aranesp 10 micrograms solution for injection in pre-filled syringe Aranesp 15 micrograms solution for injection in pre-filled syringe Aranesp 20 micrograms solution for injection in pre-filled syringe Aranesp 30 micrograms solution for injection in pre-filled syringe Aranesp 40 micrograms solution for injection in pre-filled syringe Aranesp 50 micrograms solution for injection in pre-filled syringe Aranesp 60 micrograms solution for injection in pre-filled syringe Aranesp 80 micrograms solution for injection in pre-filled syringe Aranesp 100 micrograms solution for injection in pre-filled syringe Aranesp 130 micrograms solution for injection in pre-filled syringe Aranesp 150 micrograms solution for injection in pre-filled syringe Aranesp 300 micrograms solution for injection in pre-filled syringe Aranesp 500 micrograms solution for injection in pre-filled syringe

darbepoetin alfa

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-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 Aranesp is and what is it used for

2.What you need to know before you use Aranesp

3.How to use Aranesp

4.Possible side effects

5.How to store Aranesp

6.Contents of the pack and other information

7.Instructions for injecting with the Aranesp pre-filled syringe

1.What Aranesp is and what it is used for

Your doctor has given you Aranesp (an anti-anaemic) to treat your anaemia. Anaemia is when your blood does not contain enough red blood cells and the symptoms may be fatigue, weakness and shortness of breath.

Aranesp works in exactly the same way as the natural hormone erythropoietin. Erythropoietin is produced in your kidneys and encourages your bone marrow to produce more red blood cells. The active substance of Aranesp is darbepoetin alfa produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).

If you have chronic renal failure

Aranesp is used to treat symptomatic anaemia that is associated with chronic renal failure (kidney failure) in adults and children. In kidney failure, the kidney does not produce enough of the natural hormone erythropoietin which can often cause anaemia.

Because it will take your body some time to make more red blood cells, it will be about four weeks before you notice any effect. Your normal dialysis routine will not affect the ability of Aranesp to treat your anaemia.

If you are receiving chemotherapy

Aranesp is used to treat symptomatic anaemia in adult cancer patients with non-bone marrow cancers (non-myeloid malignancies) who are receiving chemotherapy.

One of the main side effects of chemotherapy is that it stops the bone marrow producing enough blood cells. Towards the end of your chemotherapy course, particularly if you have had a lot of chemotherapy, your red blood cell count may fall making you anaemic.

2. What you need to know before you use Aranesp

Do not use Aranesp:

-if you are allergic to darbepoetin alfa or any of the other ingredients of this medicine (listed in section 6).

-if you have been diagnosed with high blood pressure which is not being controlled with other medicines prescribed by your doctor.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Aranesp.

Please tell your doctor if you are suffering or have suffered from:

-high blood pressure which is being controlled with medicines prescribed by your doctor;

-sickle cell anaemia;

-epileptic fits (seizures);

-convulsions (fits or seizures);

-liver disease;

-significant lack of response to medicines used to treat anaemia;

-an allergy to latex (the needle cap on the pre-filled syringe contains a derivative of latex); or

-hepatitis C.

Special warnings:

-If you have symptoms which include unusual tiredness and a lack of energy this could mean you have pure red cell aplasia (PRCA), which has been reported in patients. PRCA means that the body has stopped or reduced the production of red blood cells which causes severe anaemia. If you experience these symptoms you should contact your doctor who will determine the best course of action to treat your anaemia.

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

-If you are a patient with chronic renal failure, and particularly if you do not respond properly to Aranesp, your doctor will check your dose of Aranesp because repeatedly increasing your dose of Aranesp 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.

-Your doctor should try to keep your haemoglobin between 10 and 12 g/dl. Your doctor will check that your haemoglobin does not exceed a certain level, as high haemoglobin

concentrations could put you at 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 symptoms which include severe headache, drowsiness, confusion, problems with your eyesight, nausea, vomiting or fits (seizures), it could mean that you have very high blood pressure. If you experience these symptoms you should contact your doctor.

-If you are a cancer patient you should be aware that Aranesp 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.

-Misuse by healthy people can cause life-threatening problems with the heart or blood vessels.

Other medicines and Aranesp

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Cyclosporin and tacrolimus (medicines which suppress the immune system) may be affected by the number of red cells in your blood. It is important to tell your doctor if you are taking either of these medicines.

Using Aranesp with food and drink

Food and drink do not affect Aranesp.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Aranesp 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.

It is not known whether darbepoetin alfa is excreted in human milk. You must stop breast-feeding if you use Aranesp.

Driving and using machines

Aranesp should not affect your ability to drive or use machinery.

Aranesp contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

3.How to use Aranesp

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

Following blood tests, your doctor has decided you need Aranesp as your haemoglobin level is 10 g/dl or less. Your doctor will tell you how much and how often you must take Aranesp in order to maintain

a haemoglobin level between 10 and 12 g/dl. This may vary depending on whether you are an adult or a child.

Injecting Aranesp yourself

Your doctor may decide that it is best for you or a carer to inject Aranesp. Your doctor, nurse or pharmacist will show you how to inject yourself with the pre-filled syringe. Do not try to inject yourself if you have not been trained. Never inject Aranesp into a vein yourself.

If you have chronic renal failure

For all adult and paediatric patients 1 year of age with chronic renal failure, Aranesp is given as a single injection, either under your skin (subcutaneous) or into a vein (intravenous).

In order to correct your anaemia, your initial dose of Aranesp per kilogram of your body weight will be either:

0.75 micrograms once every two weeks, or

0.45 micrograms once weekly

For adult patients not on dialysis, 1.5 micrograms/kg once monthly may also be used as the initial dose.

For all adult and paediatric patients ≥ 1 years of age with chronic renal failure, once your anemia is corrected you will continue to receive Aranesp given as a single injection, either once a week or once every two weeks. For all adults and paediatric patients ≥ 11 years of age not on dialysis, Aranesp could also be given as an injection once monthly.

Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose once every four weeks as necessary in order to maintain long term control of your anaemia.

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

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

Your blood pressure will also be checked regularly, particularly at the beginning of your treatment.

In some cases, your doctor may recommend that you take iron supplements.

Your doctor may decide to change the way that your injection is given (either under the skin or into a vein). If this changes you will start on the same dose as you have been receiving and your doctor will take blood samples to make sure that your anaemia is still being managed correctly.

If your doctor has decided to change your treatment from r-HuEPO (erythropoietin produced by gene-technology) to Aranesp, they will choose whether you should receive your Aranesp injection once weekly or once every two weeks. The route of injection is the same as with r-HuEPO but your doctor will tell you how much you should take, and when, and may adjust your dose if necessary.

If you are receiving chemotherapy

Aranesp is given as a single injection, either once a week or once every three weeks, under your skin.

In order to correct your anaemia, your initial dose will be

500 micrograms once every three weeks (6.75 micrograms of Aranesp per kilogram of your body weight), or

2.25 micrograms (once weekly) of Aranesp per kilogram of your body weight.

Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose as necessary. Your treatment will continue until approximately four weeks after the end of your chemotherapy. Your doctor will tell you exactly when to stop taking Aranesp.

In some cases, your doctor may recommend that you take iron supplements.

If you use more Aranesp than you should

You could have serious problems if you use more Aranesp than you need, such as very high blood pressure. You should contact your doctor, nurse or pharmacist if this does happen. If you feel unwell in any way you should contact your doctor, nurse or pharmacist immediately.

If you forget to use Aranesp

Do not use a double dose to make up for a forgotten dose.

If you have forgotten a dose of Aranesp, you should contact your doctor to discuss when you should inject the next dose.

If you stop using Aranesp

If you want to stop using Aranesp, you should discuss it with your doctor first.

4.Possible side effects

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

The following side effects have been experienced by some patients taking Aranesp:

Chronic renal failure patients

Very common: may affect more than 1 in 10 people

High blood pressure (hypertension)

Allergic reactions

Common: may affect up to 1 in 10 people

Stroke

Pain around the area injected

Rash and/or redness of the skin

Uncommon: may affect up to 1 in 100 people

Blood clots (thrombosis)

Convulsions (fits and seizures)

Not known: frequency cannot be estimated from available data

Pure red cell aplasia (PRCA) – (anaemia, unusual tiredness, lack of energy)

Cancer patients

Very common: may affect more than 1 in 10 people

Allergic reactions

Fluid retention (oedema)

Common: may affect up to 1 in 10 people

High blood pressure (hypertension)

Blood clots (thrombosis)

Pain around the area injected

Rash and/or redness of the skin

Uncommon: may affect up to 1 in 100 people

Convulsions (fits and seizures)

All patients

Not known: frequency cannot be estimated from available data

Serious allergic reactions which may include:

-Sudden life-threatening allergic reactions (anaphylaxis)

-Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)

-Shortness of breath (allergic bronchospasm)

-Skin rash

-Hives (urticaria)

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.

5.How to store Aranesp

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 carton and on the pre-filled syringe label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C – 8 C). Do not freeze. Do not use Aranesp if you think it has been frozen.

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

When your syringe has been removed from the refrigerator and left at room temperature for approximately 30 minutes before injection it must either be used within 7 days or disposed of.

Do not use this medicine if you notice the pre-filled syringe contents are 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 Aranesp contains

-The active substance is darbepoetin alfa, r-HuEPO (erythropoietin produced by gene technology).

The pre-filled syringe contains either 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 or 500 micrograms of darbepoetin alfa.

-The other ingredients are sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80 and water for injections.

What Aranesp looks like and contents of the pack

Aranesp is a clear, colourless or slightly pearly solution for injection in a pre-filled syringe.

Aranesp is available in packs of 1 or 4 pre-filled syringes. The syringes are provided either with (1- and 4-pack) or without (1-pack) a blister-wrapping. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

Marketing Authorisation Holder:

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

Manufacturer:

Amgen Technology (Ireland) Unlimited Company

Pottery Road

Dun Laoghaire

Co Dublin

Ireland

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

België/Belgique/Belgien

Lietuva

s.a. Amgen n.v.

Amgen Switzerland AG Vilniaus filialas

Tel/Tél: +32 (0)2 7752711

Tel: +370 5 219 7474

България

Luxembourg/Luxemburg

Амджен България ЕООД

s.a. Amgen

Тел.: +359 (0)2 424 7440

Belgique/Belgien

 

Tel/Tél: +32 (0)2 7752711

Česká republika

Magyarország

Amgen s.r.o.

Amgen Kft.

Tel: +420 221 773 500

Tel.: +36 1 35 44 700

Danmark

Amgen, filial af Amgen AB, Sverige Tlf: +45 39617500

Deutschland

AMGEN GmbH

Tel.: +49 89 1490960

Eesti

Amgen Switzerland AG Vilniaus filialas Tel: +372 5125 501

Ελλάδα

Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε. Τηλ.: +30 210 3447000

España

Amgen S.A.

Tel: +34 93 600 18 60

France

Amgen S.A.S.

Tél: +33 (0)9 69 363 363

Hrvatska

Amgen d.o.o.

Tel: +385 (1) 562 57 20

Ireland

Amgen Limited

United Kingdom

Tel: +44 (0)1223 420305

Ísland

Vistor hf.

Sími: +354 535 7000

Italia

Amgen S.r.l.

Tel: +39 02 6241121

Kύπρος

Papaellinas & Co Ltd Τηλ.: +357 22741 741

Latvija

Amgen Switzerland AG Rīgas filiāle Tel: +371 292 84807

This leaflet was last revised in

Malta

Amgen B.V.

The Netherlands

Tel: +31 (0)76 5732500

Nederland

Amgen B.V.

Tel: +31 (0)76 5732500

Norge

Amgen AB

Tel: +47 23308000

Österreich

Amgen GmbH

Tel: +43 (0)1 50 217

Polska

Amgen Biotechnologia Sp. z o.o.

Tel.: +48 22 581 3000

Portugal

Amgen Biofarmacêutica, Lda.

Tel: +351 21 4220550

România

Amgen România SRL

Tel: +4021 527 3000

Slovenija

AMGEN zdravila d.o.o.

Tel: +386 (0)1 585 1767

Slovenská republika

Amgen Slovakia s.r.o.

Tel: +421 33 321 13 22

Suomi/Finland

Amgen AB, sivuliike Suomessa/Amgen AB, filial i Finland

Puh/Tel: +358 (0)9 54900500

Sverige

Amgen AB

Tel: +46 (0)8 6951100

United Kingdom

Amgen Limited

Tel: +44 (0)1223 420305

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

7.Instructions for injecting with the Aranesp pre-filled syringe

This section contains information on how to give yourself an injection of Aranesp. It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse or pharmacist. If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance.

How do you or the person injecting you, use the Aranesp pre-filled syringe?

Your doctor has prescribed an Aranesp pre-filled syringe for injection into the tissue just under the skin. Your doctor, nurse or pharmacist will tell you how much Aranesp you need and how frequently it should be injected.

Equipment:

To give yourself an injection you will need:

a new Aranesp pre-filled syringe; and

alcohol wipes or similar.

What should I do before I give myself a subcutaneous injection of Aranesp?

1.Remove the pre-filled syringe from the refrigerator. Leave the pre-filled syringe at room temperature for approximately 30 minutes. This will make the injection more comfortable. Do not warm Aranesp in any other way (for example, do not warm it in a microwave or in hot water). Additionally, do not leave the syringe exposed to direct sunlight.

2.Do not shake the pre-filled syringe.

3.Do not remove the cap from the syringe until you are ready to inject.

4.Check that it is the correct dose that your doctor has prescribed.

5.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.

6.Check the appearance of Aranesp. It must be a clear, colourless or slightly pearly liquid. If it is cloudy or there are particles in it, you must not use it.

7.Wash your hands thoroughly.

8.Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.

How do I prepare my Aranesp injection?

Before you inject Aranesp you must do the following:

1.To avoid bending the needle, gently pull the cap from the needle without twisting as shown in pictures 1 and 2.

2.Do not touch the needle or push the plunger.

3.You may notice a small air bubble in the pre-filled syringe. You do not have to remove the air bubble before injecting. Injecting the solution with the air bubble is harmless.

4.You can now use the pre-filled syringe.

Where should I give my injection?

The best places to inject yourself are the top of your thighs and the abdomen. If someone else is injecting for you, they can also use the back of your arms.

You may change the injection site if you notice the area is red or sore.

How do I give my injection?

1.Disinfect your skin by using an alcohol wipe and pinch (without squeezing) the skin between your thumb and forefinger.

2.Insert the needle fully into the skin as shown by your doctor, nurse or pharmacist.

3.Inject the prescribed dose subcutaneously as directed by your doctor, nurse or pharmacist.

4.Push the plunger with a slow constant pressure, always keeping your skin pinched, until the syringe is empty.

5.Remove the needle and let go of your skin.

6.If you notice a spot of blood you may gently dab it away with a cotton ball or tissue. Do not rub the injection site. If needed, you may cover the injection site with a plaster.

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

Remember: If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.

Disposing of used syringes

Do not put the cap back on used needles, as you may accidentally prick yourself.

Keep used syringes out of the reach and sight of children.

The used pre-filled syringe should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Package leaflet: Information for the user

Aranesp 10 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 15 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 20 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 30 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 40 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 50 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 60 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 80 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 100 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 130 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 150 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 300 micrograms solution for injection in pre-filled pen (SureClick) Aranesp 500 micrograms solution for injection in pre-filled pen (SureClick)

darbepoetin alfa

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-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 Aranesp is and what is it used for

2.What you need to know before you use Aranesp

3.How to use Aranesp

4.Possible side effects

5.How to store Aranesp

6.Contents of the pack and other information

7.Instructions for injecting with the Aranesp pre-filled pen

1. What Aranesp is and what it is used for

Your doctor has given you Aranesp (an anti-anaemic) to treat your anaemia. Anaemia is when your blood does not contain enough red blood cells and the symptoms may be fatigue, weakness and shortness of breath.

Aranesp works in exactly the same way as the natural hormone erythropoietin. Erythropoietin is produced in your kidneys and encourages your bone marrow to produce more red blood cells. The active substance of Aranesp is darbepoetin alfa produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).

If you have chronic renal failure

Aranesp is used to treat symptomatic anaemia that is associated with chronic renal failure (kidney failure) in adults and children. In kidney failure, the kidney does not produce enough of the natural hormone erythropoietin which can often cause anaemia.

Because it will take your body some time to make more red blood cells, it will be about four weeks before you notice any effect. Your normal dialysis routine will not affect the ability of Aranesp to treat your anaemia.

If you are receiving chemotherapy

Aranesp is used to treat symptomatic anaemia in adult cancer patients with non-bone marrow cancers (non-myeloid malignancies) who are receiving chemotherapy.

One of the main side effects of chemotherapy is that it stops the bone marrow producing enough blood cells. Towards the end of your chemotherapy course, particularly if you have had a lot of chemotherapy, your red blood cell count may fall making you anaemic.

2. What you need to know before you use Aranesp

Do not use Aranesp:

-if you are allergic to darbepoetin alfa or any of the other ingredients of this medicine (listed in section 6).

-if you have been diagnosed with high blood pressure which is not being controlled with other medicines prescribed by your doctor.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Aranesp

Please tell your doctor if you are suffering or have suffered from:

-high blood pressure which is being controlled with medicines prescribed by your doctor;

-sickle cell anaemia;

-epileptic fits (seizures);

-convulsions (fits or seizures);

-liver disease;

-significant lack of response to medicines used to treat anaemia;

-an allergy to latex (the needle cap on the pre-filled pen contains a derivative of latex); or

-hepatitis C.

Special warnings:

-If you have symptoms which include unusual tiredness and a lack of energy this could mean you have pure red cell aplasia (PRCA), which has been reported in patients. PRCA means that the body has stopped or reduced the production of red blood cells which causes severe anaemia. If you experience these symptoms you should contact your doctor who will determine the best course of action to treat your anaemia.

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

-If you are a patient with chronic renal failure, and particularly if you do not respond properly to Aranesp, your doctor will check your dose of Aranesp because repeatedly increasing your dose of Aranesp 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.

-Your doctor should try to keep your haemoglobin between 10 and 12 g/dl. Your doctor will check that your haemoglobin does not exceed a certain level, as high haemoglobin

concentrations could put you at 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 symptoms which include severe headache, drowsiness, confusion, problems with your eyesight, nausea, vomiting or fits (seizures), it could mean that you have very high blood pressure. If you experience these symptoms you should contact your doctor.

-If you are a cancer patient you should be aware that Aranesp 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.

-Misuse by healthy people can cause life-threatening problems with the heart or blood vessels.

Other medicines and Aranesp

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Cyclosporin and tacrolimus (medicines which suppress the immune system) may be affected by the number of red cells in your blood. It is important to tell your doctor if you are taking either of these medicines.

Using Aranesp with food and drink

Food and drink do not affect Aranesp.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Aranesp 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.

It is not known whether darbepoetin alfa is excreted in human milk. You must stop breast-feeding if you use Aranesp.

Driving and using machines

Aranesp should not affect your ability to drive or use machinery.

Aranesp contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

3. How to use Aranesp

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

Following blood tests, your doctor has decided you need Aranesp as your haemoglobin level is 10 g/dl or less. Your injection is to be given under the skin (subcutaneous), and so you may use the Aranesp

pre-filled pen. Your doctor will tell you how much and how often you must take Aranesp in order to maintain a haemoglobin level between 10 and 12 g/dl. This may vary depending on whether you are an adult or a child.

Injecting Aranesp yourself

Your doctor has decided that the Aranesp pre-filled pen is the best way for you, a nurse or a carer to inject Aranesp. Your doctor, nurse or pharmacist will show you how to inject yourself with the pre-filled pen. Do not try to inject yourself if you have not been trained. Never inject Aranesp into a vein yourself. The pre-filled pen is designed to inject the area under your skin only.

For instructions on use of the pre-filled pen, please read the section at the end of this leaflet.

If you have chronic renal failure

For all adult and paediatric patients 1 year of age with chronic renal failure, Aranesp pre-filled pen is given as a single injection, under your skin (subcutaneous).

In order to correct your anaemia, your initial dose of Aranesp per kilogram of your body weight will be either:

0.75 micrograms once every two weeks, or

0.45 micrograms once weekly

For adult patients not on dialysis, 1.5 micrograms/kg once monthly may also be used as the initial dose.

For all adult and paediatric patients ≥ 1 year of age with chronic renal failure, once your anemia is corrected you will continue to receive Aranesp given as a single injection, either once a week or once every two weeks. For all adults and paediatric patients ≥ 11 years of age not on dialysis, Aranesp could also be given as an injection once monthly.

Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose once every four weeks as necessary in order to maintain long term control of your anaemia.

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

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

Your blood pressure will also be checked regularly, particularly at the beginning of your treatment.

In some cases, your doctor may recommend that you take iron supplements.

Your doctor may decide to change the way that your injection is given (either under the skin or into a vein). If this changes you will start on the same dose as you have been receiving and your doctor will take blood samples to make sure that your anaemia is still being managed correctly.

If your doctor has decided to change your treatment from r-HuEPO (erythropoietin produced by gene-technology) to Aranesp, they will choose whether you should receive your Aranesp injection once weekly or once every two weeks. The route of injection is the same as with r-HuEPO but your doctor will tell you how much you should take, and when, and may adjust your dose if necessary.

If you are receiving chemotherapy

Aranesp is given as a single injection, either once a week or once every three weeks, under your skin.

In order to correct your anaemia, your initial dose will be

500 micrograms once every three weeks (6.75 micrograms of Aranesp per kilogram of your body weight), or

2.25 micrograms (once weekly) of Aranesp per kilogram of your body weight.

Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose as necessary. Your treatment will continue until approximately four weeks after the end of your chemotherapy. Your doctor will tell you exactly when to stop taking Aranesp.

In some cases, your doctor may recommend that you take iron supplements.

If you use more Aranesp than you should

You could have serious problems if you use more Aranesp than you need, such as very high blood pressure. You should contact your doctor, nurse or pharmacist if this does happen. If you feel unwell in any way you should contact your doctor, nurse or pharmacist immediately.

If you forget to use Aranesp

Do not use a double dose to make up for a forgotten dose.

If you have forgotten a dose of Aranesp, you should contact your doctor to discuss when you should inject the next dose.

If you stop using Aranesp

If you want to stop using Aranesp, you should discuss it with your doctor first.

4. Possible side effects

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

The following side effects have been experienced by some patients taking Aranesp:

Chronic renal failure patients

Very common: may affect more than 1 in 10 people

High blood pressure (hypertension)

Allergic reactions

Common: may affect up to 1 in 10 people

Stroke

Pain around the area injected

Rash and/or redness of the skin

Uncommon: may affect up to 1 in 100 people

Blood clots (thrombosis)

Convulsions (fits and seizures)

Not known: frequency cannot be estimated from available data

Pure red cell aplasia (PRCA) – (anaemia, unusual tiredness, lack of energy)

Cancer patients

Very common: may affect more than 1 in 10 people

Allergic reactions

Fluid retention (oedema)

Common: may affect up to 1 in 10 people

High blood pressure (hypertension)

Blood clots (thrombosis)

Pain around the area injected

Rash and/or redness of the skin

Uncommon: may affect up to 1 in 100 people

Convulsions (fits and seizures)

All patients

Not known: frequency cannot be estimated from available data

Serious allergic reactions which may include:

-Sudden life-threatening allergic reactions (anaphylaxis)

-Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)

-Shortness of breath (allergic bronchospasm)

-Skin rash

-Hives (urticaria)

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.

5. How to store Aranesp

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 carton and on the pre-filled pen label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C – 8 C). Do not freeze. Do not use Aranesp if you think it has been frozen.

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

When your pen has been removed from the refrigerator and left at room temperature for approximately 30 minutes before injection it must either be used within 7 days or disposed of.

Do not use this medicine if you notice the pre-filled pen contents are 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 Aranesp contains

-The active substance is darbepoetin alfa, r-HuEPO (erythropoietin produced by gene technology).

The pre-filled pen contains either 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 or 500 micrograms of darbepoetin alfa.

-The other ingredients are sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80 and water for injections.

What Aranesp looks like and contents of the pack

Aranesp is a clear, colourless or slightly pearly solution for injection in a pre-filled pen.

Aranesp (SureClick) is available in packs containing 1 or 4 pre-filled pens. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

Marketing Authorisation Holder:

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

Manufacturer:

Amgen Technology (Ireland) Unlimited Company

Pottery Road

Dun Laoghaire

Co Dublin

Ireland

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

België/Belgique/Belgien

Lietuva

s.a. Amgen n.v.

Amgen Switzerland AG Vilniaus filialas

Tel/Tél: +32 (0)2 7752711

Tel: +370 5 219 7474

България

Luxembourg/Luxemburg

Амджен България ЕООД

s.a. Amgen

Тел.: +359 (0)2 424 7440

Belgique/Belgien

 

Tel/Tél: +32 (0)2 7752711

Česká republika

Magyarország

Amgen s.r.o.

Amgen Kft.

Tel: +420 221 773 500

Tel.: +36 1 35 44 700

Danmark

Amgen, filial af Amgen AB, Sverige Tlf: +45 39617500

Deutschland

AMGEN GmbH

Tel.: +49 89 1490960

Eesti

Amgen Switzerland AG Vilniaus filialas Tel: +372 5125 501

Ελλάδα

Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε. Τηλ.: +30 210 3447000

España

Amgen S.A.

Tel: +34 93 600 18 60

France

Amgen S.A.S.

Tél: +33 (0)9 69 363 363

Hrvatska

Amgen d.o.o.

Tel: +385 (1) 562 57 20

Ireland

Amgen Limited

United Kingdom

Tel: +44 (0)1223 420305

Ísland

Vistor hf.

Sími: +354 535 7000

Italia

Amgen S.r.l.

Tel: +39 02 6241121

Kύπρος

Papaellinas & Co Ltd Τηλ.: +357 22741 741

Latvija

Amgen Switzerland AG Rīgas filiāle Tel: +371 292 84807

This leaflet was last revised in

Malta

Amgen B.V.

The Netherlands

Tel: +31 (0)76 5732500

Nederland

Amgen B.V.

Tel: +31 (0)76 5732500

Norge

Amgen AB

Tel: +47 23308000

Österreich

Amgen GmbH

Tel: +43 (0)1 50 217

Polska

Amgen Biotechnologia Sp. z o.o.

Tel.: +48 22 581 3000

Portugal

Amgen Biofarmacêutica, Lda.

Tel: +351 21 4220550

România

Amgen România SRL

Tel: +4021 527 3000

Slovenija

AMGEN zdravila d.o.o.

Tel: +386 (0)1 585 1767

Slovenská republika

Amgen Slovakia s.r.o.

Tel: +421 33 321 13 22

Suomi/Finland

Amgen AB, sivuliike Suomessa/Amgen AB, filial i Finland

Puh/Tel: +358 (0)9 54900500

Sverige

Amgen AB

Tel: +46 (0)8 6951100

United Kingdom

Amgen Limited

Tel: +44 (0)1223 420305

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

7.Instructions for injecting with the Aranesp pre-filled pen (SureClick)

This section contains information on how to properly use the Aranesp pre-filled pen. It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse or pharmacist. If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance.

How do you, or the person injecting you, use Aranesp pre-filled pen (SureClick)?

Your doctor has prescribed the Aranesp pre-filled pen for injection into the tissue just under the skin. Your doctor, nurse or pharmacist will tell you how much Aranesp you need and how frequently it should be injected. Only use each pre-filled pen for one injection.

Equipment:

To give yourself an injection you will need:

a new Aranesp pre-filled pen and

alcohol wipes or similar.

Preparing for an Aranesp injection?

1.Remove the pen from the refrigerator. For a more comfortable injection, leave the pen at room temperature for approximately 30 minutes. Do not warm Aranesp in any other way (for example, do not warm it in a microwave or in hot water). Additionally, do not leave the pre-filled pen exposed to direct sunlight.

2.Do not shake the pre-filled pen.

3.Do not remove the grey needle cap from the pre-filled pen until you are ready to inject.

4.Check that it is the correct dose that your doctor has prescribed.

5.Check the expiry date on the pre-filled pen label (EXP). Do not use it if the date has passed the last day of the month shown

6.Check the appearance of Aranesp through the inspection window. It must be a clear, colourless or slightly pearly liquid. Do not use the pre-filled pen if:

The solution is cloudy or there are particles in it

The pre-filled pen or syringe appears cracked or broken:

-If dropped onto a hard surface the syringe in the pre-filled pen may have broken and a break may not be visible.

7.Wash your hands thoroughly.

8.Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.

Grey needle cap

Red button

Inspection window

7a. Choosing and preparing an injection site

1.Choose an injection site

The injection site must be firm for the device to work properly.

The preferred injection site for using the Aranesp pre-filled pen is the front of the thigh.

Rotate injection site:

You may rotate the site for each injection to avoid soreness at any one site.

Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks.

2a. Instructions for preferred injection site

The front of the thigh is the preferred injection site.

2b. Instructions for alternate injection sites

When using alternate injection sites, it is particularly important to create enough surface tension on the site to be able to successfully complete the injection.

Stretch technique

Stretch

Make sure that skin under and around the pre-filled pen is firm and tight to provide enough resistance to fully retract the safety guard and “unlock” the pen.

You can use the abdomen, except for the 2 inch/5 cm area around the belly button (navel). For the abdomen, it is recommended to lie down on your back, and stretch the skin at the injection site to create a firm and tight surface.

If someone else is giving you the injection, they can also use the outer area of the upper arms. For the upper arms, it is recommended to stretch the skin at the injection site to create a firm and tight surface.

3.Prepare the site

To prepare the area of skin where Aranesp will be injected, wipe the injection site with an alcohol wipe. Do not touch this area again before giving the injection.

7b. Injecting Aranesp using the pre-filled pen

1.When you are ready to inject, pull the grey needle cap straight off to avoid damaging the needle inside the pre-filled pen. Do not twist or bend the grey needle cap while you are removing it. Do not try and put the grey needle cap back onto the pre-filled pen.

When you remove the grey needle cap, there may be a drop of liquid at the end of the needle, this is normal.

Pull off the grey needle cap

Do not twist the grey needle cap

Do not try to put the needle cap back onto the pre- filled pen

Do pull the grey cap straight off

Safety guard

2.Do not touch the red button. Press the pre-filled pen onto the skin to unlock the safety guard.

Locked with safety guard out

Unlocked with safety guard fully retracted

Do not press the red button until the safety guard is fully retracted.

Do keep enough downward pressure to fully retract the yellow safety guard and to keep the red button unlocked.

Do hold the pre-filled pen at a right angle (90º) to the injection site.

3.Briefly press and release red button.

Release button

CLICK

Do maintain pressure on the skin during the injection

4.Count slowly to 15 seconds for injection to end.

Medicine will be automatically injected

Do not move the pre-filled pen during the injection.

Do wait for the injection to finish before releasing pressure.

You may hear a second click as the red button pops back up.

5.Check window to confirm delivery of full dose

Do check the inspection window to confirm it has turned yellow.

!If the inspection window is not yellow, you must contact your doctor, nurse or pharmacist.

Safety guard down after use.

There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site

Do not rub the injection site. If needed, you may cover the injection site with a plaster.

Remember

If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.

Disposing of used pre-filled pens

The Aranesp pre-filled pen should NEVER be reused.

NEVER put the grey needle cap back into the used pre-filled pen.

The used pre-filled pen should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Optional separate additional insert:

FRONT- Aranesp getting started guide:

 

Aranesp SureClick Pre-filled pen - Read package leaflet before use

 

 

 

 

 

 

 

Preferred site is front of

Alternate sites are

Stretch the skin on

Turn over for

ENGLISH

the thigh

the abdomen or

alternate injection

injection steps

 

outer area of upper

sites

 

 

arms

 

 

 

 

Stretch

 

 

 

 

 

 

 

 

Injection site must

 

 

 

 

be firm and tight

 

BACK- Aranesp getting started guide:

 

 

(1)

Pull off grey

 

(2)

Do not touch

 

(3)

Briefly press

 

(4)

Count slowly

 

(5)

Check

 

 

needle cap

 

red

button. Press

 

and

release red

 

to

15 for

 

window

 

 

 

 

 

the pen onto the

 

button.

 

injection to end.

 

 

 

ENGLISH

 

 

 

 

skin to unlock

 

 

 

 

 

 

 

 

 

 

 

 

 

safety guard.

 

 

 

 

 

 

 

 

 

 

Do not twist

 

X Locked

 

Click

 

 

 

 

Complete

 

the grey

 

 

 

 

 

 

 

 

 

 

when yellow

 

 

needle cap

 

Unlocked

 

Keep unlocked

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

against skin

 

 

 

 

 

 

Package leaflet: Information for the user

Aranesp 10 micrograms solution for injection in pre-filled syringe Aranesp 15 micrograms solution for injection in pre-filled syringe Aranesp 20 micrograms solution for injection in pre-filled syringe Aranesp 30 micrograms solution for injection in pre-filled syringe Aranesp 40 micrograms solution for injection in pre-filled syringe Aranesp 50 micrograms solution for injection in pre-filled syringe Aranesp 60 micrograms solution for injection in pre-filled syringe Aranesp 80 micrograms solution for injection in pre-filled syringe Aranesp 100 micrograms solution for injection in pre-filled syringe Aranesp 130 micrograms solution for injection in pre-filled syringe Aranesp 150 micrograms solution for injection in pre-filled syringe Aranesp 300 micrograms solution for injection in pre-filled syringe Aranesp 500 micrograms solution for injection in pre-filled syringe

darbepoetin alfa

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-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 Aranesp is and what is it used for

2.What you need to know before you use Aranesp

3.How to use Aranesp

4.Possible side effects

5.How to store Aranesp

6.Contents of the pack and other information

1. What Aranesp is and what it is used for

Your doctor has given you Aranesp (an anti-anaemic) to treat your anaemia. Anaemia is when your blood does not contain enough red blood cells and the symptoms may be fatigue, weakness and shortness of breath.

Aranesp works in exactly the same way as the natural hormone erythropoietin. Erythropoietin is produced in your kidneys and encourages your bone marrow to produce more red blood cells. The active substance of Aranesp is darbepoetin alfa produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).

If you have chronic renal failure

Aranesp is used to treat symptomatic anaemia that is associated with chronic renal failure (kidney failure) in adults and children. In kidney failure, the kidney does not produce enough of the natural hormone erythropoietin which can often cause anaemia.

Because it will take your body some time to make more red blood cells, it will be about four weeks before you notice any effect. Your normal dialysis routine will not affect the ability of Aranesp to treat your anaemia.

If you are receiving chemotherapy

Aranesp is used to treat symptomatic anaemia in adult cancer patients with non-bone marrow cancers (non-myeloid malignancies) who are receiving chemotherapy.

One of the main side effects of chemotherapy is that it stops the bone marrow producing enough blood cells. Towards the end of your chemotherapy course, particularly if you have had a lot of chemotherapy, your red blood cell count may fall making you anaemic.

2. What you need to know before you use Aranesp

Do not use Aranesp:

-if you are allergic to darbepoetin alfa or any of the other ingredients of this medicine (listed in section 6).

-if you have been diagnosed with high blood pressure which is not being controlled with other medicines prescribed by your doctor.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Aranesp.

Please tell your doctor if you are suffering or have suffered from:

-high blood pressure which is being controlled with medicines prescribed by your doctor;

-sickle cell anaemia;

-epileptic fits (seizures);

-convulsions (fits or seizures);

-liver disease;

-significant lack of response to medicines used to treat anaemia;

-an allergy to latex (the needle cap on the pre-filled syringe contains a derivative of latex); or

-hepatitis C.

Special warnings:

-If you have symptoms which include unusual tiredness and a lack of energy this could mean you have pure red cell aplasia (PRCA), which has been reported in patients. PRCA means that the body has stopped or reduced the production of red blood cells which causes severe anaemia. If you experience these symptoms you should contact your doctor who will determine the best course of action to treat your anaemia.

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

-If you are a patient with chronic renal failure, and particularly if you do not respond properly to Aranesp, your doctor will check your dose of Aranesp because repeatedly increasing your dose of Aranesp 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.

-Your doctor should try to keep your haemoglobin between 10 and 12 g/dl. Your doctor will check that your haemoglobin does not exceed a certain level, as high haemoglobin concentrations could put you at 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 symptoms which include severe headache, drowsiness, confusion, problems with your eyesight, nausea, vomiting or fits (seizures), it could mean that you have very high blood pressure. If you experience these symptoms you should contact your doctor.

-If you are a cancer patient you should be aware that Aranesp 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.

-Misuse by healthy people can cause life-threatening problems with the heart or blood vessels.

Other medicines and Aranesp

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Cyclosporin and tacrolimus (medicines which suppress the immune system) may be affected by the number of red cells in your blood. It is important to tell your doctor if you are taking either of these medicines.

Using Aranesp with food and drink

Food and drink do not affect Aranesp.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Aranesp 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.

It is not known whether darbepoetin alfa is excreted in human milk. You must stop breast-feeding if you use Aranesp.

Driving and using machines

Aranesp should not affect your ability to drive or use machinery.

Aranesp contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

3. How to use Aranesp

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

Following blood tests, your doctor has decided you need Aranesp as your haemoglobin level is 10 g/dl or less. Your doctor will tell you how much and how often you must take Aranesp in order to maintain a haemoglobin level between 10 and 12 g/dl. This may vary depending on whether you are an adult or a child.

Injecting Aranesp yourself

Your doctor may decide that it is best for you or a carer to inject Aranesp. Your doctor, nurse or pharmacist will show you how to inject yourself with the pre-filled syringe. Do not try to inject yourself if you have not been trained. Never inject Aranesp into a vein yourself.

If you have chronic renal failure

For all adult and paediatric patients 1 year of age with chronic renal failure, Aranesp is given as a single injection, either under your skin (subcutaneous) or into a vein (intravenous).

In order to correct your anaemia, your initial dose of Aranesp per kilogram of your body weight will be either:

0.75 micrograms once every two weeks, or

0.45 micrograms once weekly

For adult patients not on dialysis, 1.5 micrograms/kg once monthly may also be used as the initial dose.

For all adult and paediatric patients ≥ 1 year of age with chronic renal failure, once your anemia is corrected you will continue to receive Aranesp given as a single injection, either once a week or once every two weeks. For all adults and paediatric patients ≥ 11 years of age not on dialysis, Aranesp could also be given as an injection once monthly.

Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose once every four weeks as necessary in order to maintain long term control of your anaemia.

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

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

Your blood pressure will also be checked regularly, particularly at the beginning of your treatment.

In some cases, your doctor may recommend that you take iron supplements.

Your doctor may decide to change the way that your injection is given (either under the skin or into a vein). If this changes you will start on the same dose as you have been receiving and your doctor will take blood samples to make sure that your anaemia is still being managed correctly.

If your doctor has decided to change your treatment from r-HuEPO (erythropoietin produced by gene-technology) to Aranesp, they will choose whether you should receive your Aranesp injection once weekly or once every two weeks. The route of injection is the same as with r-HuEPO but your doctor will tell you how much you should take, and when, and may adjust your dose if necessary.

If you are receiving chemotherapy

Aranesp is given as a single injection, either once a week or once every three weeks, under your skin.

In order to correct your anaemia, your initial dose will be

500 micrograms once every three weeks (6.75 micrograms of Aranesp per kilogram of your body weight), or

2.25 micrograms (once weekly) of Aranesp per kilogram of your body weight.

Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose as necessary. Your treatment will continue until approximately four weeks after the end of your chemotherapy. Your doctor will tell you exactly when to stop taking Aranesp.

In some cases, your doctor may recommend that you take iron supplements.

If you use more Aranesp than you should

You could have serious problems if you use more Aranesp than you need, such as very high blood pressure. You should contact your doctor, nurse or pharmacist if this does happen. If you feel unwell in any way you should contact your doctor, nurse or pharmacist immediately.

If you forget to use Aranesp

Do not use a double dose to make up for a forgotten dose.

If you have forgotten a dose of Aranesp, you should contact your doctor to discuss when you should inject the next dose.

If you stop using Aranesp

If you want to stop using Aranesp, you should discuss it with your doctor first.

4. Possible side effects

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

The following side effects have been experienced by some patients taking Aranesp:

Chronic renal failure patients

Very common: may affect more than 1 in 10 people

High blood pressure (hypertension)

Allergic reactions

Common: may affect up to 1 in 10 people

Stroke

Pain around the area injected Rash and/or redness of the skin

Uncommon: may affect up to 1 in 100 people

Blood clots (thrombosis)

Convulsions (fits and seizures)

Not known: frequency cannot be estimated from available data

Pure red cell aplasia (PRCA) – (anaemia, unusual tiredness, lack of energy)

Cancer patients

Very common: may affect more than 1 in 10 people

Allergic reactions

Fluid retention (oedema)

Common: may affect up to 1 in 10 people

High blood pressure (hypertension)

Blood clots (thrombosis)

Pain around the area injected

Rash and/or redness of the skin

Uncommon: may affect up to 1 in 100 people

Convulsions (fits and seizures)

All patients

Not known: frequency cannot be estimated from available data

Serious allergic reactions which may include:

-Sudden life-threatening allergic reactions (anaphylaxis)

-Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)

-Shortness of breath (allergic bronchospasm)

-Skin rash

-Hives (urticaria)

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.

5. How to store Aranesp

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 carton and on the pre-filled syringe label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C – 8 C). Do not freeze. Do not use Aranesp if you think it has been frozen.

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

When your syringe has been removed from the refrigerator and left at room temperature for approximately 30 minutes before injection it must either be used within 7 days or disposed of.

Do not use this medicine if you notice the pre-filled syringe contents are 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 Aranesp contains

-The active substance is darbepoetin alfa, r-HuEPO (erythropoietin produced by gene technology).

The pre-filled syringe contains either 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300 or 500 micrograms of darbepoetin alfa.

-The other ingredients are sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80 and water for injections.

What Aranesp looks like and contents of the pack

Aranesp is a clear, colourless or slightly pearly solution for injection in a pre-filled syringe.

Aranesp is available in packs of 1 or 4 pre-filled syringes with automatic needle guard in a blister wrapping. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

Marketing Authorisation Holder:

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

Manufacturer:

Amgen Technology (Ireland) Unlimited Company

Pottery Road

Dun Laoghaire

Co Dublin

Ireland

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

België/Belgique/Belgien

Lietuva

s.a. Amgen n.v.

Amgen Switzerland AG Vilniaus filialas

Tel/Tél: +32 (0)2 7752711

Tel: +370 5 219 7474

България

Luxembourg/Luxemburg

Амджен България ЕООД

s.a. Amgen

Тел.: +359 (0)2 424 7440

Belgique/Belgien

 

Tel/Tél: +32 (0)2 7752711

Česká republika

Magyarország

Amgen s.r.o.

Amgen Kft.

Tel: +420 221 773 500

Tel.: +36 1 35 44 700

Danmark

Malta

Amgen, filial af Amgen AB, Sverige

Amgen B.V.

Tlf: +45 39617500

The Netherlands

 

Tel: +31 (0)76 5732500

Deutschland

Nederland

AMGEN GmbH

Amgen B.V.

Tel.: +49 89 1490960

Tel: +31 (0)76 5732500

Eesti

Norge

Amgen Switzerland AG Vilniaus filialas

Amgen AB

Tel: +372 5125 501

Tel: +47 23308000

Ελλάδα

Österreich

Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.

Amgen GmbH

Τηλ.: +30 210 3447000

Tel: +43 (0)1 50 217

España

Polska

Amgen S.A.

Amgen Biotechnologia Sp. z o.o.

Tel: +34 93 600 18 60

Tel.: +48 22 581 3000

France

Portugal

Amgen S.A.S.

Amgen Biofarmacêutica, Lda.

Tél: +33 (0)9 69 363 363

Tel: +351 21 4220550

Hrvatska

România

Amgen d.o.o.

Amgen România SRL

Tel: +385 (1) 562 57 20

Tel: +4021 527 3000

Ireland

Slovenija

Amgen Limited

AMGEN zdravila d.o.o.

United Kingdom

Tel: +386 (0)1 585 1767

Tel: +44 (0)1223 420305

 

Ísland

Slovenská republika

Vistor hf.

Amgen Slovakia s.r.o.

Sími: +354 535 7000

Tel: +421 33 321 13 22

Italia

Suomi/Finland

Amgen S.r.l.

Amgen AB, sivuliike Suomessa/Amgen AB, filial

Tel: +39 02 6241121

i Finland

 

Puh/Tel: +358 (0)9 54900500

Kύπρος

Sverige

Papaellinas & Co Ltd

Amgen AB

Τηλ.: +357 22741 741

Tel: +46 (0)8 6951100

Latvija

United Kingdom

Amgen Switzerland AG Rīgas filiāle

Amgen Limited

Tel: +371 292 84807

Tel: +44 (0)1223 420305

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

 

Instructions for use:

 

 

 

Guide to parts

 

 

Before use

After use

 

 

Plunger

Used plunger

 

Syringe label

Used syringe barrel

Finger grips

 

Syringe label

Used needle

Syringe barrel

 

Syringe safety guard

 

 

Used needle safety

Needle safety spring

spring

 

Grey needle cap on

Grey needle cap off

 

Important

Before you use an Aranesp pre-filled syringe with automatic needle guard, read this important information:

It is important that you do not try to give yourself the injection unless you have received training from your doctor or healthcare provider.

Aranesp is given as an injection into the tissue just under the skin (subcutaneous injection).

Tell your doctor if you have an allergy to latex. The needle cap on the pre-filled syringe contains a derivative of latex and may cause severe allergic reactions.

Do not remove the grey needle cap from the pre-filled syringe until you are ready to inject.

Do not use the pre-filled syringe if it has been dropped on a hard surface. Use a new pre-filled syringe and call your doctor or healthcare provider.

Do not attempt to activate the pre-filled syringe prior to injection.

Do not attempt to remove the clear pre-filled syringe safety guard from the pre-filled syringe.

Do not attempt to remove the peelable label on the pre-filled syringe barrel before administering your injection.

Call your doctor or healthcare provider if you have any questions.

Step 1: Prepare

ARemove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included).

Put the original package with any unused pre-filled syringes back in the refrigerator.

For a more comfortable injection, leave the pre-filled syringe at room temperature for about 30 minutes before injecting. Wash your hands thoroughly with soap and water.

On a clean, well-lit work surface, place the new pre-filled syringe and the other supplies.

Do not try to warm the syringe by using a heat source such as hot water or microwave

Do not leave the pre-filled syringe exposed to direct sunlight Do not shake the pre-filled syringe

Keep pre-filled syringes out of the sight and reach of children

BOpen the tray, peeling away the cover. Grab the pre-filled syringe safety guard to remove the pre-filled syringe from the tray.

Grab here

For safety reasons:

Do not grasp the plunger

Do not grasp the grey needle cap

CInspect the medicine and pre-filled syringe.

Medicine

Do not use the pre-filled syringe if:

The medicine is cloudy or there are particles in it. It must be a clear and colourless liquid.

Any part appears cracked or broken.

The grey needle cap is missing or not securely attached.

The expiry date printed on the label has passed the last day of the month shown.

In all cases, call your doctor or healthcare provider.

Step 2: Get ready

AWash your hands thoroughly. Prepare and clean your injection site.

Upper arm

Belly

Upper thigh

You can use:

Upper part of your thigh

Belly, except for a 5 cm (2-inch) area right around your belly button

Outer area of upper arm (only if someone else is giving you the injection)

Clean the injection site with an alcohol wipe. Let your skin dry. Do not touch the injection site before injecting

Choose a different site each time you give yourself an injection. If you need to use the same injection site, just make sure it is not the same spot on that site you used last time. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.

BCarefully pull the grey needle cap straight out and away from your body.

CPinch your injection site to create a firm surface.

It is important to keep the skin pinched when injecting.

Step 3: Inject

AHold the pinch. INSERT the needle into skin.

Do not touch the cleaned area of the skin

BPUSH the plunger with slow and constant pressure until you feel or hear a “snap”. Push all the way down through the snap.

“SNAP”

It is important to push down through the “snap” to deliver your full dose.

CRELEASE your thumb. Then LIFT the syringe off skin.

After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle. Do not put the grey needle cap back on used pre-filled syringes.

Healthcare Providers only

Remove and save the pre-filled syringe label.

Turn the plunger to move the label into a position where you can remove the syringe label.

Step 4: Finish

ADiscard the used pre-filled syringe and other supplies in a sharps disposal container.

Medicines should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Keep the syringe and sharps disposal container out of sight and reach of children.

Do not reuse the pre-filled syringe

Do not recycle pre-filled syringes or throw them into household waste

BExamine the injection site.

If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site.

Apply a plaster if needed.

Package leaflet: Information for the user

Aranesp 25 micrograms solution for injection in vial Aranesp 40 micrograms solution for injection in vial Aranesp 60 micrograms solution for injection in vial Aranesp 100 micrograms solution for injection in vial Aranesp 200 micrograms solution for injection in vial Aranesp 300 micrograms solution for injection in vial

darbepoetin alfa

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor, pharmacist or nurse.

-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 Aranesp is and what is it used for

2.What you need to know before you use Aranesp

3.How to use Aranesp

4.Possible side effects

5.How to store Aranesp

6.Contents of the pack and other information

1. What Aranesp is and what it is used for

Your doctor has given you Aranesp (an anti-anaemic) to treat your anaemia. Anaemia is when your blood does not contain enough red blood cells and the symptoms may be fatigue, weakness and shortness of breath.

Aranesp works in exactly the same way as the natural hormone erythropoietin. Erythropoietin is produced in your kidneys and encourages your bone marrow to produce more red blood cells. The active substance of Aranesp is darbepoetin alfa produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).

If you have chronic renal failure

Aranesp is used to treat symptomatic anaemia that is associated with chronic renal failure (kidney failure) in adults and children. In kidney failure, the kidney does not produce enough of the natural hormone erythropoietin which can often cause anaemia.

Because it will take your body some time to make more red blood cells, it will be about four weeks before you notice any effect. Your normal dialysis routine will not affect the ability of Aranesp to treat your anaemia.

If you are receiving chemotherapy

Aranesp is used to treat symptomatic anaemia in adult cancer patients with non-bone marrow cancers (non-myeloid malignancies) who are receiving chemotherapy.

One of the main side effects of chemotherapy is that it stops the bone marrow producing enough blood cells. Towards the end of your chemotherapy course, particularly if you have had a lot of chemotherapy, your red blood cell count may fall making you anaemic.

2. What you need to know before you use Aranesp

Do not use Aranesp:

-if you are allergic to darbepoetin alfa or any of the other ingredients of this medicine (listed in section 6).

-if you have been diagnosed with high blood pressure which is not being controlled with other medicines prescribed by your doctor.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Aranesp.

Please tell your doctor if you are suffering or have suffered from:

-high blood pressure which is being controlled with medicines prescribed by your doctor;

-sickle cell anaemia;

-epileptic fits (seizures);

-convulsions (fits or seizures);

-liver disease;

-significant lack of response to medicines used to treat anaemia; or

-hepatitis C.

Special warnings:

-If you have symptoms which include unusual tiredness and a lack of energy this could mean you have pure red cell aplasia (PRCA), which has been reported in patients. PRCA means that the body has stopped or reduced the production of red blood cells which causes severe anaemia. If you experience these symptoms you should contact your doctor who will determine the best course of action to treat your anaemia.

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

-If you are a patient with chronic renal failure, and particularly if you do not respond properly to Aranesp, your doctor will check your dose of Aranesp because repeatedly increasing your dose of Aranesp 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.

-Your doctor should try to keep your haemoglobin between 10 and 12 g/dl. Your doctor will check that your haemoglobin does not exceed a certain level, as high haemoglobin concentrations could put you at 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 symptoms which include severe headache, drowsiness, confusion, problems with your eyesight, nausea, vomiting or fits (seizures), it could mean that you have very high blood pressure. If you experience these symptoms you should contact your doctor.

-If you are a cancer patient you should be aware that Aranesp 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.

-Misuse by healthy people can cause life-threatening problems with the heart or blood vessels.

Other medicines and Aranesp

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Cyclosporin and tacrolimus (medicines which suppress the immune system) may be affected by the number of red cells in your blood. It is important to tell your doctor if you are taking either of these medicines.

Using Aranesp with food and drink

Food and drink do not affect Aranesp.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Aranesp 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.

It is not known whether darbepoetin alfa is excreted in human milk. You must stop breast-feeding if you use Aranesp.

Driving and using machines

Aranesp should not affect your ability to drive or use machinery.

Aranesp contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

3. How to use Aranesp

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

Following blood tests, your doctor has decided you need Aranesp as your haemoglobin level is 10 g/dl or less. Your doctor will tell you how much and how often you must take Aranesp in order to maintain a haemoglobin level between 10 and 12 g/dl. This may vary depending on whether you are an adult or a child.

The injections will be given by a healthcare professional.

If you have chronic renal failure

For all adult and paediatric patients 1 year of age with chronic renal failure, Aranesp is given as a single injection by a healthcare professional, either under your skin (subcutaneous) or into a vein (intravenous).

In order to correct your anaemia, your initial dose of Aranesp per kilogram of your body weight will be either:

0.75 micrograms once every two weeks, or

0.45 micrograms once weekly

For adult patients not on dialysis, 1.5 micrograms/kg once monthly may also be used as the initial dose.

For all adult and paediatric patients ≥ 1 year of age with chronic renal failure, once your anemia is corrected you will continue to receive Aranesp given as a single injection, either once a week or once every two weeks. For all adults and paediatric patients ≥ 11 years of age not on dialysis, Aranesp could also be given as an injection once monthly.

Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose once every four weeks as necessary in order to maintain long term control of your anaemia.

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

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

Your blood pressure will also be checked regularly, particularly at the beginning of your treatment.

In some cases, your doctor may recommend that you take iron supplements.

Your doctor may decide to change the way that your injection is given (either under the skin or into a vein). If this changes you will start on the same dose as you have been receiving and your doctor will take blood samples to make sure that your anaemia is still being managed correctly.

If your doctor has decided to change your treatment from r-HuEPO (erythropoietin produced by gene-technology) to Aranesp, they will choose whether you should receive your Aranesp injection once weekly or once every two weeks. The route of injection is the same as with r-HuEPO but your doctor will tell you how much you should take, and when, and may adjust your dose if necessary.

If you are receiving chemotherapy

Aranesp is given as a single injection, either once a week or once every three weeks, under your skin.

In order to correct your anaemia, your initial dose will be

500 micrograms once every three weeks (6.75 micrograms of Aranesp per kilogram of your body weight), or

2.25 micrograms (once weekly) of Aranesp per kilogram of your body weight.

Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose as necessary. Your treatment will continue until approximately four weeks after the end of your chemotherapy. Your doctor will tell you exactly when to stop taking Aranesp.

In some cases, your doctor may recommend that you take iron supplements.

If you use more Aranesp than you should

You could have serious problems if you receive more Aranesp than you need, such as very high blood pressure. You should contact your doctor, nurse or pharmacist if this does happen. If you feel unwell in any way you should contact your doctor, nurse or pharmacist immediately.

If you miss a dose of Aranesp

Do not use a double dose to make up for a forgotten dose.

If you miss a dose of Aranesp, you should contact your doctor to discuss when you should receive the next dose.

If you stop using Aranesp

If you want to stop using Aranesp, you should discuss it with your doctor first.

4. Possible side effects

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

The following side effects have been experienced by some patients taking Aranesp:

Chronic renal failure patients

Very common: may affect more than 1 in 10 people

High blood pressure (hypertension)

Allergic reactions

Common: may affect up to 1 in 10 people

Stroke

Pain around the area injected

Rash and/or redness of the skin

Uncommon: may affect up to 1 in 100 people

Blood clots (thrombosis)

Convulsions (fits and seizures)

Not known: frequency cannot be estimated from available data

Pure red cell aplasia (PRCA) – (anaemia, unusual tiredness, lack of energy)

Cancer patients

Very common: may affect more than 1 in 10 people

Allergic reactions

Fluid retention (oedema)

Common: may affect up to 1 in 10 people

High blood pressure (hypertension)

Blood clots (thrombosis)

Pain around the area injected

Rash and/or redness of the skin

Uncommon: may affect up to 1 in 100 people

Convulsions (fits and seizures)

All patients

Not known: frequency cannot be estimated from available data

Serious allergic reactions which may include:

-Sudden life-threatening allergic reactions (anaphylaxis)

-Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)

-Shortness of breath (allergic bronchospasm)

-Skin rash

-Hives (urticaria)

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.

5. How to store Aranesp

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 carton and on the vial label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C – 8 C). Do not freeze. Do not use Aranesp if you think it has been frozen.

Keep the vial in the outer carton in order to protect from light.

When your vial has been removed from the refrigerator and left at room temperature for approximately 30 minutes before injection it must either be used within 7 days or disposed of.

Do not use this medicine if you notice the vial contents are 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 Aranesp contains

-The active substance is darbepoetin alfa, r-HuEPO (erythropoietin produced by gene technology).

The vial contains either 25, 40, 60, 100, 200 or 300 micrograms of darbepoetin alfa.

-The other ingredients are sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80 and water for injections.

What Aranesp looks like and contents of the pack

Aranesp is a clear, colourless or slightly pearly solution for injection in vial. Aranesp is available in packs of 1 or 4 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

Marketing Authorisation Holder:

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

The Netherlands

Manufacturer:

Amgen Technology (Ireland) Unlimited Company

Pottery Road

Dun Laoghaire

Co Dublin

Ireland

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

België/Belgique/Belgien s.a. Amgen n.v.

Tel/Tél: +32 (0)2 7752711

България

Амджен България ЕООД Тел.: +359 (0)2 424 7440

Česká republika

Amgen s.r.o.

Tel: +420 221 773 500

Danmark

Amgen, filial af Amgen AB, Sverige Tlf: +45 39617500

Deutschland

AMGEN GmbH

Tel.: +49 89 1490960

Eesti

Amgen Switzerland AG Vilniaus filialas Tel: +372 5125 501

Ελλάδα

Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε. Τηλ.: +30 210 3447000

Lietuva

Amgen Switzerland AG Vilniaus filialas Tel: +370 5 219 7474

Luxembourg/Luxemburg s.a. Amgen Belgique/Belgien

Tel/Tél: +32 (0)2 7752711

Magyarország

Amgen Kft.

Tel.: +36 1 35 44 700

Malta

Amgen B.V.

The Netherlands

Tel: +31 (0)76 5732500

Nederland

Amgen B.V.

Tel: +31 (0)76 5732500

Norge

Amgen AB

Tel: +47 23308000

Österreich

Amgen GmbH

Tel: +43 (0)1 50 217

España

Polska

Amgen S.A.

Amgen Biotechnologia Sp. z o.o.

Tel: +34 93 600 18 60

Tel.: +48 22 581 3000

France

Portugal

Amgen S.A.S.

Amgen Biofarmacêutica, Lda.

Tél: +33 (0)9 69 363 363

Tel: +351 21 4220550

Hrvatska

România

Amgen d.o.o.

Amgen România SRL

Tel: +385 (1) 562 57 20

Tel: +4021 527 3000

Ireland

Slovenija

Amgen Limited

AMGEN zdravila d.o.o.

United Kingdom

Tel: +386 (0)1 585 1767

Tel: +44 (0)1223 420305

 

Ísland

Slovenská republika

Vistor hf.

Amgen Slovakia s.r.o.

Sími: +354 535 7000

Tel: +421 33 321 13 22

Italia

Suomi/Finland

Amgen S.r.l

Amgen AB, sivuliike Suomessa/Amgen AB, filial

Tel: +39 02 6241121

i Finland

 

Puh/Tel: +358 (0)9 54900500

Kύπρος

Sverige

Papaellinas & Co Ltd

Amgen AB

Τηλ.: +357 22741 741

Tel: +46 (0)8 6951100

Latvija

United Kingdom

Amgen Switzerland AG Rīgas filiāle

Amgen Limited

Tel: +371 292 84807

Tel: +44 (0)1223 420305

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

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