Mircera

Patient Information Leaflet: Information for the User

MIRCERA

30 micrograms/0.3 mL solution for injection in pre-filled syringe
50 micrograms/0.3 mL solution for injection in pre-filled syringe
75 micrograms/0.3 mL solution for injection in pre-filled syringe
100 micrograms/0.3 mL solution for injection in pre-filled syringe
120 micrograms/0.3 mL solution for injection in pre-filled syringe
150 micrograms/0.3 mL solution for injection in pre-filled syringe
200 micrograms/0.3 mL solution for injection in pre-filled syringe
250 micrograms/0.3 mL solution for injection in pre-filled syringe
360 micrograms/0.6 mL solution for injection in pre-filled syringe
methoxy polyethylene glycol-epoetin beta
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

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

1. What MIRCERA is and what it is used for

This medicine has been prescribed for you because you suffer from anaemia caused by chronic kidney disease and associated with typical symptoms such as fatigue, weakness, and breathlessness. This means that your blood contains an insufficient number of red blood cells and your haemoglobin level is too low (the body's tissues may not be receiving enough oxygen).
MIRCERA is indicated for the treatment of symptomatic anaemia caused by chronic kidney disease in adult and paediatric patients (aged between 3 months and under 18 years) who are on maintenance therapy with ESAs (erythropoiesis-stimulating agents), after their haemoglobin level has been stabilised with a previous ESA. MIRCERA is a medicine produced using recombinant DNA technology. Like the natural hormone erythropoietin, MIRCERA increases the number of red blood cells and the level of haemoglobin in the blood.

2. What you should know before using MIRCERA

Do not use MIRCERA

• if you are allergic to methoxy polyethylene glycol-epoetin beta or to any of the excipients of this medicine (listed in section 6)
• if you have high blood pressure that cannot be controlled

Warnings and precautions
The safety and efficacy of MIRCERA therapy have not been established for other indications,
including the treatment of anaemia in patients with cancer.
The safety and efficacy of MIRCERA in paediatric patients have been established only in
patients whose haemoglobin levels have previously been stabilised by treatment with an ESA.

Before treatment with MIRCERA

• In some patients treated with erythropoiesis-stimulating agents (ESAs), including MIRCERA, a condition called pure red cell aplasia (PRCA, interruption or reduction in red blood cell production) due to anti-erythropoietin antibodies has been observed.
• If your doctor suspects or confirms the presence of these antibodies in your blood, you must not be treated with MIRCERA.
• If you are a patient with hepatitis C being treated with interferon and ribavirin, you should speak with your doctor, as the combination of ESAs with interferon and ribavirin may lead to loss of efficacy and, in rare cases, the development of a condition called pure red cell aplasia (PRCA), a severe form of anaemia. ESAs are not approved for the treatment of anaemia associated with hepatitis C.
• If you are a patient with chronic kidney disease and anaemia, being treated with an ESA, and also have cancer, you should be aware that ESAs might negatively affect your health condition. You should discuss with your doctor alternative treatments for anaemia.
• It is not known whether MIRCERA has a different effect in patients with haemoglobinopathies (disorders associated with abnormal haemoglobin), past or current bleeding, seizures, or elevated platelet count. If you have any of these conditions, your doctor will discuss them with you and treatment should be administered with caution.
• Healthy individuals must not use MIRCERA. Use of this medicine may lead to excessively high haemoglobin levels and cause problems to the heart or blood vessels, with potentially fatal effects.

During treatment with MIRCERA

• If you have chronic renal failure, and particularly if you do not respond adequately to MIRCERA, your doctor will monitor your MIRCERA dose carefully, because if you do not respond to treatment, repeated increases in the MIRCERA dose may increase the risk of heart or blood vessel problems and could increase the risk of myocardial infarction, stroke, and death.
• Your doctor may start treatment with MIRCERA if your haemoglobin level is less than or equal to 10 g/dL (6.21 mmol/L). After starting therapy, your doctor will aim to maintain your haemoglobin level between 10 and 12 g/dL (7.45 mmol/L).
• Before and during treatment with MIRCERA, your doctor will check your iron levels in the blood. If they are too low, your doctor may give you an additional iron supplement.
• Before and during treatment with MIRCERA, your doctor will monitor your blood pressure. If it becomes too high and cannot be controlled with appropriate medicines or a specific diet, your doctor will stop treatment with MIRCERA or reduce the dose.
• Your doctor will ensure that haemoglobin levels do not exceed a certain limit, because high haemoglobin may put you at risk of heart or blood vessel problems and could increase the risk of thrombosis, including cases of pulmonary embolism, myocardial infarction, stroke, and death.
• If you experience fatigue, weakness, or shortness of breath, contact your doctor, as these symptoms may indicate that treatment with MIRCERA is not effective. Your doctor will check for other possible causes of anaemia and may request blood tests or bone marrow examinations. If you develop PRCA, treatment with MIRCERA will be stopped. You will not receive any other ESAs, and your doctor will treat this condition appropriately.

Children and adolescents
MIRCERA may be used to treat children and adolescents aged between 3 months and under 18 years with anaemia associated with chronic kidney disease. These patients must be stabilised on maintenance therapy with an ESA before switching to MIRCERA and may or may not be receiving dialysis.
Inform your doctor, pharmacist, or nurse before taking this medicine if you or your child are under 18 years of age.
Exercise particular caution with other products that stimulate red blood cell production:
MIRCERA belongs to a group of products that stimulate red blood cell production, such as the human protein erythropoietin. Your doctor must always record the specific product you are using.
Severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with epoetin treatment.
SJS/TEN may initially appear as red, target-like spots or circular patches, often with central blisters, typically on the trunk. Mouth, throat, nose, genital, and eye ulcers (red and swollen eyes) may also occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and potentially life-threatening complications.
If you develop a severe skin rash or any of these other skin symptoms, stop taking MIRCERA immediately and contact your doctor right away or go to the emergency room immediately.

Other medicines and MIRCERA
Inform your doctor or pharmacist if you are taking, have recently taken, or plan to take any other medicines.
No studies have been conducted on pharmacological interactions. There is no evidence that MIRCERA interacts with other medicines.

MIRCERA with food and drink
Food and drink have no effect on MIRCERA.

Pregnancy, breastfeeding, and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
MIRCERA has not been studied in pregnant or breastfeeding women.
Inform your doctor if you suspect or confirm pregnancy or if you plan to become pregnant. Your doctor will evaluate the most appropriate treatment during pregnancy.
Inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor will inform you whether you need to discontinue breastfeeding or treatment.
MIRCERA has not shown impairment of fertility in animals. The potential risk in humans is unknown.

Driving and using machines
MIRCERA does not affect the ability to drive vehicles or operate machinery.

Important information about some excipients of MIRCERA
This medicine contains less than 1 mmol of sodium (23 mg) per mL, i.e., essentially 'sodium-free'.

3. How to use MIRCERA

Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will use the lowest effective dose to control your anaemia symptoms.
If you do not respond adequately to MIRCERA, your doctor will review your dose and inform you if any
adjustment is needed.
Treatment with MIRCERA should be initiated under the supervision of a healthcare professional.
Subsequent injections may be administered by a healthcare professional or, after appropriate training,
you may self-inject MIRCERA yourself (self-inject) as an adult.
Children and adolescents under 18 years of age must not self-inject MIRCERA; administration must be
performed by a healthcare professional or an appropriately trained adult (follow the instructions at the
end of this leaflet on how to use the MIRCERA pre-filled syringe for self-injection or for injection into
another person).
MIRCERA may be injected subcutaneously into the abdomen, arm, or thigh, or intravenously. Your
doctor will decide which method is best for you.
Your doctor will perform regular blood tests to monitor your response to anaemia treatment by measuring haemoglobin levels.

• If you are an adult not currently being treated with an ESA
  If you are not on dialysis, the recommended starting dose of MIRCERA is 1.2 micrograms per kilogram of body weight, administered subcutaneously once every month as a single injection.
  Alternatively, your doctor may decide to administer an initial dose of MIRCERA of 0.6 micrograms per kilogram of body weight, given once every two weeks as a single intravenous or subcutaneous injection. Once anaemia is corrected, your doctor may change the dosing to once every month.
  If you are on dialysis, the recommended starting dose is 0.6 micrograms per kilogram of body weight, administered once every two weeks as a single intravenous or subcutaneous injection. Once anaemia is corrected, your doctor may change the dosing to once every month.

Your doctor may increase or decrease the dose, or temporarily interrupt treatment, to appropriately adjust your haemoglobin level. Dose adjustments will not be made more than once per month.

• If you are currently being treated with another ESA
  Your doctor may switch your current medication to MIRCERA. Your doctor will decide to treat you with MIRCERA administered as a single injection once every month. The initial dose of MIRCERA will be calculated based on your last dose of the previous medication. The first dose of MIRCERA will be given on the day scheduled for your previous medication injection.

Your doctor may increase or decrease the dose, or temporarily interrupt treatment, to appropriately adjust your haemoglobin level. Dose adjustments will not be made more than once per month.

If you use more MIRCERA than you should
If you have administered an excessive dose of MIRCERA, contact your doctor or pharmacist immediately, as blood tests may be required and treatment may need to be interrupted.

If you forget to use MIRCERA
If you miss a dose of MIRCERA, administer the missed dose as soon as possible and consult your doctor to determine when to take subsequent doses.

If you stop using MIRCERA
Treatment with MIRCERA is generally long-term. However, it may be stopped at any time on the advice of your doctor.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Below is a list of possible side effects and how often they may occur:
A common side effect (may affect up to 1 in 10 people) is hypertension (high blood pressure).
Uncommon side effects (may affect up to 1 in 100 people) are:

• headache
• thrombosis at the vascular access site (blood clots at the dialysis access site)
• thrombocytopenia
• thrombosis.

Rare side effects (may affect up to 1 in 1,000 people) are:

• hypertensive encephalopathy (very high blood pressure which may cause headache, especially sudden, severe, migraine-like headache, confusion, speech disturbances, seizures or convulsions)
• pulmonary embolism
• maculopapular rash (a skin reaction with redness that may include pustules or spots)
• hot flushes
• hypersensitivity (an allergic reaction which may cause unusual shortness of breath or difficulty breathing, swelling of the tongue, face or throat, or at the injection site, dizziness, fainting or collapse). If you experience these symptoms, contact your doctor immediately to receive treatment.

During clinical studies, patients showed a slight decrease in platelet count in the blood. After marketing, there have been reports of platelet counts below the normal range (thrombocytopenia).
Hypersensitivity reactions have been reported with epoetin treatment, including cases of anaphylactic reaction and severe skin rashes such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis. These may appear as reddish, target-shaped macules or circular patches, often with central blisters on the trunk, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms. If you experience these symptoms, stop taking Mircera and contact your doctor immediately or go straight to the emergency department; see also section 2.
As with other ESAs, cases of thrombosis, including pulmonary embolism, have been reported after marketing.
A condition called pure red cell aplasia (PRCA, interruption or reduction in red blood cell production) due to antibodies against erythropoietin has been observed in some patients treated with ESAs, including MIRCERA.

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

5. How to store MIRCERA

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 packaging and on the label of the pre-filled syringe after 'Exp./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 its outer packaging to protect it from light.
The pre-filled syringe of MIRCERA may be removed from the refrigerator and stored at room temperature not exceeding 30 °C for a single period of one month. During the time MIRCERA is stored at room temperature not exceeding 30 °C, it is not necessary to return MIRCERA to the refrigerator before use. Once the medicine has been taken out of the refrigerator, it must be used within this one-month period.
Only clear, colourless to slightly yellowish solutions free from visible particles should be injected.
Do not dispose of medicines via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MIRCERA contains

• The active substance is methoxy polyethylene glycol-epoetin beta. A pre-filled syringe contains 30, 50, 75, 100, 120, 150, 200 or 250 micrograms in 0.3 mL and 360 micrograms in 0.6 mL.
• The excipients are monosodium phosphate monohydrate, sodium sulfate, mannitol (E421), methionine, poloxamer 188 and water for injections.

Description of the appearance of MIRCERA and contents of the pack
MIRCERA is an injectable solution in a pre-filled syringe.
The solution is clear, colourless to slightly yellowish, and free from visible particles.
MIRCERA is supplied in a pre-filled syringe with a laminated plunger stopper and a needle cap with a 27G1/2 needle. Each pre-filled syringe contains 0.3 mL or 0.6 mL of solution. The pre-filled syringes are not designed for administration of partial doses. MIRCERA is available in packs of 1 syringe for all strengths; packs of 3 pre-filled syringes are additionally available for the strengths 30, 50 and 75 micrograms/0.3 mL. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

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

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

België/Belgique/Belgien Lietuva
N.V. Roche S.A. UAB “Roche Lietuva”
Tél/Tel: +32 (0) 2 525 82 11 Tel: +370 5 2546799

България Luxembourg/Luxemburg
Рош България ЕООД (Voir/siehe Belgique/Belgien)
Тел: +359 2 2 474 5444

Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel: +420 - 2 20382111 Tel: +36 - 1 279 4500

Danmark Malta
Roche Pharmaceuticals A/S (See Ireland)
Tlf: +45 - 36 39 99 99

Deutschland Nederland
Roche Pharma AG Roche Nederland B.V.
Tel: +49 (0) 7624 140 Tel: +31 (0) 348 438050

Eesti Norge
Roche Eesti OÜ Roche Norge AS
Tel: + 372 - 6 177 380 Tlf: +47 - 22 78 90 00

Ελλάδα Österreich
Roche (Hellas) A.E. Roche Austria GmbH
Τηλ: +30 210 61 66 100 Tel: +43 (0) 1 27739

España Polska
Roche Farma S.A. Roche Polska Sp.z o.o.
Tel: +34 - 91 324 81 00 Tel: +48 - 22 345 18 88

France Portugal
Roche Roche Farmacêutica Química, Lda
Tél: +33 (0) 1 47 61 40 00 Tel: +351 - 21 425 70 00

Hrvatska România
Roche d.o.o. Roche România S.R.L.
Tel: +385 1 4722 333 Tel: +40 21 206 47 01

Ireland Slovenija
Roche Products (Ireland) Ltd. Roche farmacevtska družba d.o.o.
Tel: +353 (0) 1 469 0700 Tel: +386 - 1 360 26 00

Ísland Slovenská republika
Roche Pharmaceuticals A/S Roche Slovensko, s.r.o.
c/o Icepharma hf Tel: +421 - 2 52638201
Sími: +354 540 8000

Italia Suomi/Finland
Roche S.p.A. Roche Oy
Tel: +39 - 039 2471 Puh/Tel: +358 (0) 10 554 500

Kύπρος Sverige
Roche (Hellas) A.E. Roche AB
Τηλ: +30 210 61 66 100 Tel: +46 (0) 8 726 1200

Latvija
Roche Latvija SIA
Tel: +371 – 6 7039831

More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.

MIRCERA pre-filled syringe
Instructions for use
The instructions below describe how to use the MIRCERA pre-filled syringe for self-injection or for administering an injection to another person.
It is important to read and carefully follow these instructions to ensure correct and safe use of the pre-filled syringe.
Do not attempt to administer an injection until you are certain you understand how to use the pre-filled syringe. If in doubt, contact your healthcare provider. Children and adolescents under 18 years of age must not self-inject MIRCERA; administration must be performed by a healthcare professional or a trained adult.
Always follow all instructions provided in these Instructions for Use, as they may differ from your previous experience. These instructions will help prevent incorrect treatment or risks such as needle-stick injuries, premature activation of the needle safety device, or problems related to needle attachment.

IMPORTANT INFORMATION

• Use the MIRCERA pre-filled syringe only as prescribed by your doctor.
• Read the information on the packaging and ensure that the dose corresponds to the one prescribed by your doctor.
• Do not use MIRCERA if the syringe, needle, packaging or plastic tray appears damaged.
• The needle is fragile; handle with care.
• Do not touch the activation guards (see Figure A), as this may damage the syringe and render it unusable.
• Do not use the syringe if the contents are cloudy, opaque or contain particles.
• Never attempt to disassemble the syringe.
• Never pull or handle the syringe by the plunger.
• Do not remove the needle cap until you are ready to administer the injection.
• Do not ingest the medicine contained in the syringe.
• Do not administer the injection through clothing.
• Do not reuse or re-sterilise the syringe or needle.
• Pre-filled syringes are not designed for administration of partial doses.
• Keep the syringe, needle and accessories out of the reach of children.

STORAGE
Keep the pre-filled syringe, needle and sharps container out of the reach of children.
Store the syringe and needle in their original packaging until ready for use.
Always store the syringe and needle in a refrigerator at a temperature of 2–8°C.
Do not freeze the medicine and protect the medicine and needle from light. Keep the syringe and needle dry.

CONTENTS OF THE PACKAGE (Figure A):

• One MIRCERA pre-filled syringe
• One separate injection needle

Figure A
ITEMS NOT INCLUDED IN THE PACKAGE (Figure B):
Alcohol swabs for cleaning the Cotton ball or sterile gauze Sharps container or puncture-
injection site resistant container for safe
disposal of used needle and syringe

Figure B
Place all necessary materials for an injection on a clean, flat, well-lit surface, such as a table.

HOW TO ADMINISTER THE INJECTION
Step 1. Allow the syringe to reach room temperature
Carefully remove the packaging containing
the MIRCERA pre-filled syringe from the
refrigerator.
Keep the syringe and needle in their
packaging to protect them from light and
wait at least 30 minutes for the syringe to
reach room temperature (Figure C).
Figure C

• Not allowing the medicine to warm to room temperature may result in an uncomfortable injection and difficulty in depressing the plunger.
• Do not warm the syringe in any other way.

Open the packaging and remove the
plastic tray of the MIRCERA pre-filled
syringe without opening the protective
film (Figure D).

Figure D
Step 2. Clean your hands
Wash your hands thoroughly with warm
water and soap or use a hand sanitiser
(Figure E).

Figure E
Step 3. Remove the pre-filled syringe from the tray and inspect it visually
Open the protective film of the plastic
tray and remove the packaged needle
and syringe, holding the syringe by the
central body without touching the
activation guards (Figure F).
Hold the syringe only by the central body,
as any contact with the activation guards
could cause premature release of the
safety device.

Figure F
Examine the syringe for possible
damage and check the expiry date
printed on the syringe and packaging.
This is important to ensure safe use of
the syringe and medicine (Figure G).

Do not use the syringe if:

• It has been accidentally dropped.
• Any part of the syringe appears damaged.
• The contents are cloudy, opaque or contain particles.
• The solution colour is not within the range from colourless to slightly yellowish.
• The expiry date has passed.

Figure G
Step 4. Attach the needle to the syringe
Firmly hold the syringe by the central
body, hold the rubber cap, then remove
the rubber cap from the syringe (bend
and pull) (Figure H).

• Immediately after removal, place the rubber cap into the sharps container/puncture-resistant container.
• Do not touch the activation guards of the safety device.
• Do not press the plunger.
• Do not pull the plunger.
  Figure H
  Firmly hold the packaged needle with
  both hands and inspect the needle for
  damage. Break the seal with a twisting
  motion and remove the needle cap
  (Figure I).

Immediately dispose of the needle cap
into the sharps container/puncture-
resistant container.

• Do not remove the needle protective cap.
  Do not use the needle if:

• You accidentally dropped the needle.

• Any part of the needle appears damaged.

Attach the needle to the syringe by
pressing it firmly onto the syringe and
rotating it slightly (Figure J).

Figure J
Step 5. Remove the needle cap and prepare for injection
Firmly hold the syringe by the central
body with one hand and remove the
needle protective cap by pulling it
horizontally with the other hand.
Dispose of the needle cap immediately
into the sharps container/puncture-
resistant container (Figure K).

Figure K

• Once the needle cap is removed, do not touch the needle or allow it to come into contact with any surface to avoid contamination and to prevent injury or pain.
• A small drop of liquid at the tip of the needle may be visible. This is normal.
• Never reinsert the needle cap after removal.

To remove air bubbles from the
pre-filled syringe, hold the syringe with
the needle pointing upwards.
Gently tap the syringe to move any air
bubbles upwards (Figures L and M).


Figure L
Slowly push the plunger upwards to
expel all air, as demonstrated by your
healthcare provider (Figure M).
Figure M
Step 6. Administer the injection
There are two different ways (routes) to inject MIRCERA. Follow your healthcare provider's instructions on how to inject MIRCERA.
SUBCUTANEOUS ROUTE:
If you have been advised to inject MIRCERA under the skin, administer the dose as described below.
Choose one of the recommended
injection sites illustrated in the figure.
You may inject MIRCERA into the upper
arm, thigh or abdomen, but not in the
area around the navel (Figure N).
The back of the arm is not a recommended
site for self-injection. Use this injection
site only when injecting another person.

When selecting an injection site:

• Use a different injection site each time, at least 3 cm away from the area used for the previous injection.
• Do not inject into areas that may be irritated by a belt or bandage.
• Do not inject into moles, scars, bruises or areas where the skin is tender, red, hardened or not intact.
  Figure N
  Clean the selected injection site area
  using an alcohol swab to reduce the
  risk of infection; follow the instructions
  for the alcohol swab carefully (Figure
  O).
• Allow the skin to dry for about 10 seconds.
• Do not touch the cleaned area before injection and do not fan or blow on the cleaned area.
• Immediately dispose of the used alcohol swab.
  Figure O
  Adopt a comfortable position before
  administering the MIRCERA injection.
  To ensure correct needle placement
  under the skin, use your free hand to
  create a skin fold at the cleaned
  injection site. Forming a skin fold is
  important to ensure the injection is
  given under the skin (into the fatty
  tissue) and not deeper (into the muscle).
  Injection into the muscle may be
  uncomfortable (Figure P).

Insert the needle completely into the
skin at a 90° angle with a quick, firm
motion. Keep the syringe in position
and release the skin fold.

• Do not move the needle once it is inserted into the skin.
  Figure P
  Once the needle is fully inserted into
  the skin, slowly depress the plunger
  with your thumb, holding the syringe
  with your index and middle fingers
  against the shaped grips, until all the
  medicine has been injected (Figure Q).
  The plunger rod should be fully
  depressed, and you should hear a
  click indicating activation of the needle
  safety guard.
  Figure Q
  Do not release the plunger before
  the end of the injection or before it has
  been fully depressed.
  Remove the needle from the skin
  WITHOUT releasing the plunger
  (Figure R).

Figure R
Release the plunger so that the needle
cover protects the needle (Figure S).

Figure S
Now you may remove the removable
label if necessary (Figure T).

Figure T
After the injection:

• Press gently on the injection site for several seconds with a cotton ball or sterile gauze.
• Immediately dispose of the used cotton ball or gauze.
• Do not rub the injection site with dirty tissues or hands.
• If needed, you may cover the injection site with a plaster.

Disposal of the syringe:

• Do not attempt to re-cap the needle.
• Do not reuse or re-sterilise the syringe and/or needle.
• Do not dispose of the used syringe with the needle in household waste.
• Dispose of used syringes in a sharps/puncture-resistant container according to local regulations.
• Dispose of the entire sharps container/puncture-resistant container.

INTRAVENOUS ROUTE:
If your healthcare provider has recommended injecting MIRCERA into a vein, follow the procedure described below.
After completing syringe preparation as described in Steps 1 to 5:
Clean the vascular access for haemodialysis with an alcohol swab, following the supplier’s or manufacturer’s instructions. Immediately dispose of the used alcohol swab.

Insert the needle of the pre-filled syringe into the **clean** vascular access (Figure U). * **Do not** touch the injection site of the vascular access. *Figure U* Depress the plunger with your thumb, holding the syringe with your index and middle fingers against the shaped grips, until all the medicine has been injected (Figure V). Remove the pre-filled syringe from the vascular access **WITHOUT** releasing the plunger. Once removed, release the plunger so that the needle cover protects the needle. Now you may remove the removable label if necessary (See Figure T). *Figure V* **Step 7. Dispose of the used syringe with needle**

• Do not attempt to re-cap the needle.
• Do not reuse or re-sterilise the syringe and/or needle.
• Do not dispose of the used syringe with the needle in household waste.
• Dispose of used syringes in a sharps/puncture-resistant container according to local regulations.
• Dispose of the entire sharps container/puncture-resistant container.