MIRCERA 60 micrograms/0.3 ml solution for injection inpre-filled syringe

This medicine is prescribed to you because you have anaemia caused by your chronic kidney disease and associated whith typical symptoms, such as tiredness, weakness and shortness of breath. This means that you have too few red blood cells and your haemoglobin level is too low (your body?s tissues might not receive enough oxygen).

MIRCERA is used to treat only the symptomatic anaemia caused by your chronic kidney disease. It has not been shown that MIRCERA can be used to treat anaemia caused by other diseases.

MIRCERA is a medicine produced by gene-technology. Like the natural hormone erythropoietin, MIRCERA increases the number of red blood cells and haemoglobin level in your blood.

Compared to other medicines of the same class called erythropoiesis stimulating agents (or ESA), MIRCERA can stay in your body longer, therefore fewer injections are required for your treatment.

Do not use MIRCERA

• if you are allergic (hypersensitive) to methoxy polyethylene glycol-epoetin beta or to any of the other ingredients of MIRCERA (see section 6)
• if you have high blood pressure that cannot be controlled

Take special care with MIRCERA

MIRCERA is indicated to treat only the symptomatic anaemia caused by chronic kidney disease. The safety and efficacy of MIRCERA therapy in other indications has not been established.

Before treatment with MIRCERA

• A condition called Pure Red Cell Aplasia (stopped or reduced production of red blood cells) due to anti-erythropoietin antibodies was observed in some patients treated with other ESAs.
• If your doctor suspects or confirms that you have these antibodies in your blood you must not be treated with MIRCERA.
• If you are a cancer patient be aware that MIRCERA, like other ESAs may act as a growth factor. Please discuss this with your doctor.
• It is not known if MIRCERA has a different effect in patients with haemoglobinopathies (disorders associated with abnormal haemoglobin), past or present bleeding, seizures or with a high blood platelet count. If you have any of these conditions your doctor will discuss it with you and must treat you with caution.
• Healthy people should not use MIRCERA. Using it can lead to too high haemoglobin levels and cause problems with the heart or blood vessels that may be life-threatening.

During treatment with MIRCERA

• Your doctor may initiate treatment with MIRCERA if your haemoglobin level is 10 g/dl (6.21 mmol/l) or less. After initiation of therapy, your doctor will seek to maintain your haemoglobin level between 10 and 12 g/dl (7.45 mmol/l).
• Your doctor will check the amount of iron in your blood before and during MIRCERA treatment. If the amount is too low your doctor may give you an additional iron supplement.
• Your doctor will check your blood pressure before and during your MIRCERA treatment. If your blood pressure is high and cannot be controlled either by appropriate medicines or a special diet, your doctor will interrupt your MIRCERA treatment or reduce the dose.
• Your doctor will check that your haemoglobin does not exceed a certain level, as high haemoglobin could put you at risk of having a problem of the heart or the blood vessels and could increase risk of death.
• Contact your doctor if you feel tired, weak or have shortness of breath as this could mean that your MIRCERA treatment is not effective. Your doctor will check that you do not have other causes of anaemia and may perform blood tests or examine your bone marrow. If you have developed Pure Red Cell Aplasia your MIRCERA treatment will be discontinued. You will not receive another ESA and your doctor will treat you for this condition.

Children and adolescents

Treatment with MIRCERA is not recommended in children and adolescents as it has not been studied in these patients.

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

Using other medicines

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
No interaction studies have been performed. There is no evidence that MIRCERA interacts with other medicines.

Using MIRCERA with food and drink

Food and drink do not affect MIRCERA.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.
MIRCERA has not been studied in pregnant or breast-feeding women.
Tell your doctor if you are pregnant, think you are pregnant or intend to become pregnant. Your doctor will consider what is the best treatment for you during pregnancy.
Tell your doctor if you are breast-feeding or intend to breast-feed. Your doctor will advise if you should stop or continue breast-feeding and stop or continue your treatment.

Driving and using machines

MIRCERA does not affect your ability to drive and use machines.

Important information about some of the ingredients of MIRCERA

This medicine contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ?sodium-free?.

Always use MIRCERA exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Treatment with MIRCERA must be started under the supervision of a healthcare professional. Further injections can be given by a healthcare professional or, after you have been trained, you can inject MIRCERA yourself (see instructions at the end of this leaflet.)

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

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

• If you are not currently treated with an ESA
• If you are not on dialysis, the recommended starting dose of MIRCERA is 1.2 micrograms for every kilogram of your body weight to be administered under the skin once every month as a single injection. Alternatively, your doctor may decide to administer a starting dose of MIRCERA of 0.6 micrograms for every kilogram of your body weight. The dose is to be administered once every two weeks as a single injection under the skin or into a vein. Once your anaemia is corrected your doctor may change your dosing to once a month administration.
• If you are on dialysis, the recommended starting dose is 0.6 micrograms for every kilogram of your body weight. The dose is to be administered once every two weeks as a single injection under the skin orinto a vein. Once your anaemia iscorrected your doctor may change your dosing to once a month administration.

Your doctor may increase or decrease your dose or temporarily stop your treatment to adjust your haemoglobin level, as appropriate for you. Dose changes will not be made more often than once a month.

• If you are currently being treated with another ESA Your doctor may replace your current medicine with MIRCERA. Your doctor will decide to treat you with MIRCERA administered as a single injection once a month. Your doctor will calculate your MIRCERA starting dose based on the last dose of your previous medicine. The first MIRCERA dose will be given on the planned injection day of your previous medicine.

Your doctor may increase or decrease your dose or temporarily stop your treatment to adjust your haemoglobin to an appropriate level for you. Dose changes will not be made more often than once a month.

If you are a patient with hepatitis C and you receive interferon and ribavirin

you should discuss this with your doctor because a combination of ESAs with interferon and ribavirin has lead to a loss of effect and development of a condition called pure red cell aplasia (PRCA), a severe form of anemia, in rare cases. ESAs are not approved in the management of anaemia associated with hepatitis C.

• If you are a patient with chronic kidney disease and anemia treated with an ESA and are also a cancer patient you should be aware that ESAs might have a negative impact on your condition. You should discuss options for anemia treatment with your doctor.

If you use more MIRCERA than you should

Please contact your doctor or pharmacist if you used too large a dose of MIRCERA as it may be necessary to perform some blood tests and interrupt your treatment.

If you forget to use MIRCERA

If you miss a dose of MIRCERA administer the missed dose as soon as you remember and talk to your doctor about when to use the next doses.

If you stop using MIRCERA

Treatment with MIRCERA is normally long-term. It can, however, be stopped on the advice of your doctor at any time.

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

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

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10); common (affects 1 to 10 users in 100); uncommon (affects 1 to 10 users in 1?000); rare (affects 1 to 10 users in 10?000); very rare (affects less than 1 user in 10?000); not known (frequency cannot be estimated from the available data).

A common side effect is hypertension (high blood pressure).

Uncommon side effects are:

• headache
• vascular access thrombosis (blood clots in your dialysis access).

Rare side effects are:

• hypertensive encephalopathy (very high blood pressure that can result in headache, especially sudden, stabbing, migraine-like headache, confusion, speech disturbances, fits or convulsions). If you have these symptoms please contact your doctor immediately to receive treatment.
• maculo-papular rash (red skin reaction that can include pimples or spots)
• hot flush
• hypersensitivity (allergic reaction that can cause unusual wheezing or difficulty in breathing; swollen tongue, face or throat, or swelling around the injection site, or make you feel light-headed, faint or cause you to collapse). If you have these symptoms please contact your doctor immediately to receive treatment.

Hypersensitivity reactions, including cases of anaphylactic reaction, have been spontaneously reported, frequency unknown.

During clinical studies patients had a slight decrease in their platelet blood counts. Some patients had platelet counts below the normal range.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use MIRCERA after the expiry date which is stated on the outer carton and 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.
Keep the pre-filled syringe in the outer carton in order to protect from light.
You may remove your MIRCERA pre-filled syringe from the refrigerator and store it at a room temperature not above 30 °C for a single period of one month. During this period when you have stored MIRCERA at a room temperature not above 30 °C you may not put MIRCERA back in the refrigerator before use. Once you have removed your medicine from the refrigerator you must use it within this period of one month.

Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

What MIRCERA contains

• The active substance is methoxy polyethylene glycol-epoetin beta. One pre-filled syringe with 0.3 ml or 0.6 ml contains 30, 40, 50, 60, 75, 100, 120, 150, 200, 250 micrograms or 360 micrograms.
• The other ingredients are sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, poloxamer 188 and water for injections.

What MIRCERA looks like and contents of the pack

MIRCERA 0.3 ml or 0.6 ml is a solution for injection in pre-filled syringe.
The solution is clear, colourless to slightly yellowish and free of visible particles.

MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2. Each pre-filled syringe contains 0.3 ml or 0.6 ml. MIRCERA is available, for all strengths, in pack sizes of 1 and also multipacks of 3 x 1pre-filled syringes for the strengths 30, 50, 75 micrograms/0.3ml. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Manufacturer

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

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

LuxembourgLuxemburg Voirsiehe BelgiqueBelgien BelgiëBelgiqueBelgien N.V. Roche S.A. TélTel 32 0 2 525 82 11

359 2 818 44 44 Magyarország Roche Magyarország Kft. Tel 36 - 23 446 800

Malta See United Kingdom eská republika Roche s. r. o. Tel 420 - 2 20382111

Danmark Roche as Tlf 45 - 36 39 99 99 Nederland Roche Nederland B.V. Tel 31 0 348 438050

Deutschland Roche Pharma AG Tel 49 0 7624 140 Norge Roche Norge AS Tlf 47 - 22 78 90 00

Eesti Roche Eesti OÜ Tel 372 - 6 177 380 Österreich Roche Austria GmbH Tel 43 0 1 27739

Roche Hellas A.E. 30 210 61 66 100 Polska Roche Polska Sp.z o.o. Tel 48 - 22 345 18 88

España Roche Farma S.A. Tel 34 - 91 324 81 00 Portugal Roche Farmacêutica Química, Lda Tel 351 - 21 425 70 00

France Roche Tél 33 0 1 46 40 50 00 România Roche România S.R.L. Tel 40 21 206 47 01

Ireland Roche Products Ireland Ltd. Tel 353 0 1 469 0700 Slovenija Roche farmacevtska druba d.o.o. Tel 386 - 1 360 26 00

Slovenská republika Roche Slovensko, s.r.o. Tel 421 - 2 52638201 Ísland Roche as co Icepharma hf Sími 354 540 8000

Italia Roche S.p.A. Tel 39 - 039 2471 SuomiFinland Roche Oy PuhTel 358 0 10 554 500

K .. . 357 - 22 76 62 76 Sverige Roche AB Tel 46 0 8 726 1200

Latvija Roche Latvija SIA Tel 371 6 7039831 United Kingdom Roche Products Ltd. Tel 44 0 1707 366000

Lietuva

UAB ?Roche Lietuva?
Tel: +370 5 2546799

This leaflet was last approved in {MM/YYYY}.

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HOW TO SELF INJECT MIRCERA

Always use MIRCERA exactly as your doctor has told you. Check with your doctor or nurse if you are unsure.
The MIRCERA pre-filled syringe is ready for use and can be self-injected by yourself either under the skin or if you are on haemodialysis, through the haemodialysis line according to your doctor?s advice. The pre-filled syringe does not contain any preservative and is to be used for one single injection only. More than one dose must not be administered per pre-filled syringe.
Do not mix the solution with other injectable medicines. Store the pre-filled syringe in the outer carton box.

Safety tips

- Make sure that the pre-filled syringe has not been removed from the fridge for more than a single period not extending 1 month.
- Do not use a pre-filled syringe that has been frozen and do not expose it to temperatures above 30°C.
- Do not use a pre-filled syringe after the expiry date stated on the label.
- Only use the pre-filled syringe if the solution is clear, colourless (slightly yellow in colour is acceptable) and is free of visible particles.
- Do not shake the pre-filled syringe, if the solution has been shaken and appears foamy, do not use it (shaking MIRCERA or exposing it to light may damage the medicine). - When handling the syringe, do not touch the needle.
- Do not use a syringe more than once

Setting up for an injection

Assemble all of the supplies you will need for an injection on a clean surface:
Included in the pack:
- A pre-filled syringe of MIRCERA and a separate injection needle
Not included in the pack:
- Cleansing alcohol swabs
- Sterile gauze
- A container for the waste material

The following instructions explain how to use MIRCERA pre-filled syringes to inject yourself. Please read the instructions carefully and follow them step by step.

Remove the box containing MIRCERA from the refrigerator. Keep the medicine in the box to protect it from light and allow it to reach room temperature for at least 30 minutes

Remove the plastic tray of MIRCERA from the box without peeling back the protective film.

Wash your hands well with soap and warm water.

Peel back plastic foil from plastic tray and remove syringe and needle

Preparing the MIRCERA pre-filled syringe and the needle for injection

Picture 1. Grasp the needle firmly in both hands. Break seal of the needle, using a twisting motion and remove the cap. Do not remove the needle shield.

Picture 2. Remove the rubber tip cap from the syringe bend and pull

Picture 3. Attach the needle to the syringe by pushing firmly together.

Picture 4. Choose one of the recommended injection sites, arm abdomen or thigh exept the navel or waistline. Do not inject MIRCERA into an area that is tender or healing

Picture 5. Clean the site with a new alcohol swab and wait for the area to dry. Grab syringe and needle shield and pull firmly to remove shield. To remove air bubbles from the syringe, hold the syringe with the needle pointing up. Tap the syringe gently to bring any bubbles to the top. Push the plunger up slowly to the correct dose, as shown to you by a health care professional.

Injecting the solution

If your doctor has advised you to inject MIRCERA through the haemodialysis line or into a vein, please administer your dose as shown by your health care professional.
If you are advised to inject MIRCERA under your skin please administer your dose as described below.

Picture 6. Pinch a fold of skin at the site and insert the needle. Insert the needle in a quick, dart-like motion.

Picture 7. Slowly push the plunger all the way down until all the medicine is injected. Do not release plunger.

Removing the needle

Picture 8 Take the needle out of the skin without releasing the plunger.

Picture 9. Release the plunger allowing the needle guard to protect the needle.

Place a cotton ball over the injection site.
Do not massage the injection site.
Any bleeding may be covered with an adhesive bandage.

Disposal

The syringe is intended for single use and must be thrown away after the injection. Dispose of the syringe in a puncture-proof disposal container..
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.