MIRCERA. 50 mcg./0.3ml.

What MIRCERA is and what it is used
This medicine has been prescribed for you because you have anemia caused by your chronic kidney disease and is associated with characteristic symptoms such as fatigue , weakness and shortness of breath . This means that you have too few red blood cells and your hemoglobin level is too low ( the tissues in your body may not get enough oxygen).
MIRCERA is indicated for the management of symptomatic anemia caused by chronic kidney disease. Its use is limited in adult patients (aged 18 years or more) .
MIRCERA is a drug which is produced by gene technology . Like the natural hormone erythropoietin , MIRCERA increases the number of red blood cells and hemoglobin in your blood.

2 . What you should know before using MIRCERA
Do not use MIRCERA
if you are allergic to methoxy polyethylene glycol - epoetin beta or any of the other ingredients of this medicine (listed in Section 6) ;
if you have high blood pressure , which can not be controlled .
Warnings and Precautions
Safety and efficacy of MIRCERA therapy in other indications including anemia in cancer patients have not been established .

Prior to treatment with MIRCERA
In some patients treated with erythropoiesis-stimulating agents (ESAs ), including MIRCERA, there was a condition called pure red blood cells ( PRCA stopped or reduced production of red blood cells ) due to anti-erythropoietin antibodies;
If your doctor suspects or confirms that you have these antibodies in your blood , you should be treated with MIRCERA;
If you are suffering from hepatitis C and receive interferon and ribavirin , you should discuss this with your doctor because the combination of ESAs with interferon and ribavirin , in rare cases leading to loss of effect and development of PRCA and severe anemia . ESAs are not approved for the treatment of anemia associated with hepatitis C;
If you have chronic kidney disease and anemia treated with ESAs, and you also have cancer , you should know that ESAs may have a negative impact on your condition. You should discuss the treatment options for anemia with your doctor ;
It is unknown whether MIRCERA has a different effect in patients with hemoglobinopathies (disorders associated with abnormal hemoglobin ) , bleeding in the past or currently , seizures or with high numbers of platelets in the blood. If you have any of these conditions , your doctor will discuss this with you and you need to treat you with caution ;
MIRCERA should not be used by healthy people . Its use can lead to too high hemoglobin levels and cause problems with the heart or blood vessels , which may be life-threatening.
During treatment with MIRCERA
Your doctor may start treatment with MIRCERA, if your hemoglobin level is 10 g / dl (6,21 mmol / l) or lower. Following initiation of therapy , your doctor will work to maintain your hemoglobin 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 treatment with MIRCERA. If the amount is too low , your doctor may prescribe additional iron therapy ;
Your doctor will check your blood pressure before and during treatment with MIRCERA. If your blood pressure is high and can not be controlled with appropriate medication or a special diet , your doctor will interrupt your MIRCERA treatment or reduce the dose ;
Your doctor will check that your hemoglobin does not exceed a certain level as high hemoglobin could put you at risk of heart problems or blood vessels and can increase the risk of thrombosis, including pulmonary embolism , myocardial infarction, stroke ( stroke) and death ;
Contact your doctor if you feel tired , weak or have shortness of breath because it can mean that your MIRCERA treatment is not effective. Your doctor will check that no other causes of anemia and may perform blood tests or your bone marrow. If you develop PRCA your MIRCERA treatment will be discontinued. You will not receive another ESA and your doctor will treat you for this condition.
Children and adolescents
MIRCERA treatment is not recommended in children and adolescents because it has not been studied in these patients.

Take special care with other products that stimulate red blood cell : MIRCERA belongs to a group of products that stimulate red blood cell , which is the human protein erythropoietin . Your healthcare professional will always record the exact product you are using.

Other medicines and MIRCERA
Tell your doctor or pharmacist if you are using or have recently used it is possible to use other drugs.
No studies of interactions . There is no evidence that MIRCERA interact with other medicines .

MIRCERA with food and drink
Food and drink do not affect MIRCERA.

Pregnancy, lactation and fertility
Ask your doctor or pharmacist before taking any medicine .
No studies of MIRCERA in pregnant or lactating women.
Tell your doctor if you are pregnant, think you may be pregnant or planning a pregnancy . Your doctor will decide what is the best treatment for you during pregnancy .
Tell your doctor if you are breastfeeding or plan to breastfeed . Your doctor will advise you if you should stop or continue breast feeding and stop or continue treatment.
There is no evidence that MIRCERA impair fertility in animals. The potential risk for humans is unknown .

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 drug contains sodium, less than 1 mmol ( 23 mg) per milliliter , i.e., essentially sodium .

3 . How to use MIRCERA
Always use this medicine exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.
MIRCERA therapy should be initiated under the supervision of a medical professional.
Further injections can be made by a medical professional , or after you have been trained , you can give yourself an injection MIRCERA ( see instructions at the end of this leaflet) .
MIRCERA can be injected under the skin of the abdomen , arm or thigh , or into a vein. Your doctor will decide which is best for you.

Your doctor will do regular blood tests to track by measuring hemoglobin how your anemia responds to treatment .

If you are not currently treated with an ESA
If you are not on dialysis , the recommended starting dose of MIRCERA is 1.2 microgram per kilogram of your body weight and will be administered subcutaneously once monthly as a single injection . Alternatively , your doctor may decide to MIRCERA starting dose of 0.6 micrograms per kilogram of your body weight. The dose will be administered once every two weeks as a single injection under the skin or into a vein. After correction of anemia , your doctor may change the dose to once a month ;
If you are on dialysis , the recommended starting dose is 0.6 micrograms for every kilogram of your body weight. The dose will be administered once every two weeks as a single injection under the skin or into a vein. After correction of anemia , your doctor may change the dose to once a month .
Your doctor may increase or decrease your dose or temporarily stop your treatment to correct hemoglobin levels as appropriate for you. Dose changes will be made more frequently than once a month.

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

Your doctor may increase or decrease your dose or temporarily stop your treatment to correct hemoglobin levels as appropriate for you. Dose changes will be made more frequently than once a month.

If you use more than the amount of MIRCERA
Please contact your doctor or pharmacist if you have used too large a dose MIRCERA, as may be necessary to carry out 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 possible and talk to your doctor about the timing of subsequent doses .

If you stop using MIRCERA
Treatment with MIRCERA is continuous . It may , however, be interrupted at any time on the advice of your doctor.

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

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

The frequency of possible adverse reactions is given below :
Common side effects ( likely to affect 1 in 10 people) is hypertension (high blood pressure).

Uncommon side effects (may affect up to 1 in 100 people) :
headache ;
vascular access thrombosis (blood clots in your dialysis ) .
Rare side effects (may affect up to 1 in 1000 people) :
hypertensive encephalopathy (very high blood pressure, which can cause headaches , especially sudden, stabbing, migraine headache , confusion, speech disorder, seizures or convulsions) . If you have these symptoms , please contact your doctor immediately to receive treatment;
maculopapular rash ( reaction with reddening of the skin , which may include pimples or spots ) ;
hot flashes ;
hypersensitivity ( allergic reaction that can cause unusual wheezing or difficulty breathing , swelling of tongue, face or throat , or swelling around the injection site , or make you feel dizzy , you feel faint or collapse) . If you have these symptoms , please contact your doctor to get treatment.
In clinical studies, patients had a slight decrease in the number of platelets in the blood. Spontaneous platelet count below normal (thrombocytopenia) .
There have been spontaneous reports of hypersensitivity reactions , including cases of anaphylactic reactions; frequency is known ( from the available data can not be estimated ) .
As with other ESAs, is in post-marketing reports of thrombosis, including pulmonary embolism , not known .
In some patients treated with ESAs, including MIRCERA, there was a condition called pure red blood cells ( PRCA stopped or reduced production of red blood cells ) due to anti-erythropoietin antibodies.

If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet .

5 . How to store MIRCERA
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and label the pre-filled syringe 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 to protect from light. You may remove your syringe with MIRCERA from the refrigerator and store it at room temperature not exceeding 30 ° C, once for a period of 1 month . During this period , when store MIRCERA at room temperature not higher than 30 ° C, does not have to return MIRCERA back in the refrigerator before use. Once you have removed the drug from the refrigerator , you must use it within the one-month period.
Should be injected only clear, colorless to pale yellow solution , free from visible particles .
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.

6 . Contents of the pack and other information
What does MIRCERA
The active substance is methoxy polyethylene glycol - epoetin beta. A pre-filled syringe contains : 30, 40 , 50, 60 , 75, 100, 120 , 150, 200 or 250 micrograms in 0,3 ml and 360 micrograms in 0,6 ml.
The other ingredients are sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol ( E421), methionine , poloxamer 188 and water for injections.

MIRCERA looks like and contents of the pack
MIRCERA is a solution for injection in pre-filled syringe. The solution is clear , colorless to slightly yellowish and free of visible particles.
MIRCERA comes in pre- filled syringes with laminated plunger stopper and tip cap with a needle 27G1 / 2 . Each pre -filled syringe contains 0,3 ml or 0,6 ml. All concentrations of Mircera are available in packs of 1 prefilled syringe and the concentration of 30 , 50, 75 mikrograma/0.3 ml - and in packing 3 x 1 pre- filled syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Roche Registration Limited, United Kingdom.

manufacturer:
Roche Pharma AG, Germany .

HOW TO INJECT MIRCERA
Always use MIRCERA exactly as your doctor tells you . If you are not sure , ask your doctor or nurse .
MIRCERA pre-filled syringe is ready for use and can be self- injected by yourself or under the skin or if you are on dialysis over hemodialysis line on the advice of your doctor . The pre-filled syringe contains no preservatives and should be used for only one injection. Should not be more than a single dose syringe.
Do not mix the solution with other injectable medicines . Keep the pre- filled syringe in the outer carton .

Safety Tips
Make sure that the pre-filled syringe has not been removed from the refrigerator for more than a period of 1 month;
Do not use pre-filled syringe that has been frozen and do not expose it to temperatures over 30 ° C;
Do not use the prefilled syringe after the expiry date stated on the label ;
Use a pre-filled syringe if the solution is clear, colorless (slightly yellow in color is acceptable ) with no visible particles;
Do not shake the prefilled syringe if the solution was shaken and foam , do not use (shaking MIRCERA or exposure to light can damage the drug ) ;
When handling the syringe , do not touch the needle ;
Do not use a syringe more than once.
Preparation for injection
Gather all the materials that you will need for an injection on a clean surface :
Included in the package:
One pre-filled syringe MIRCERA separate injection needle .
Included in the package:
Alcohol swabs for cleaning;
Sterile gauze ;
Waste container .
The following instructions explain how to use pre-filled syringes with MIRCERA, 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 with MIRCERA the box without removing the protective tape .
Wash your hands thoroughly with soap and warm water.
Remove the plastic film of the plastic container and remove the syringe and needle.
Preparation of MIRCERA pre- filled syringe and injection needle for injection
1. Grasp the needle with both hands. Break the seal on the needle with twisting motion and remove the cap. Do not remove the needle cover .
2 . Remove the rubber cap from the syringe tip ( twist and pull ) .
3 . Attach the needle to the syringe , pressing firmly together.
4 . Choose one of the recommended injection sites , arm , abdomen or thigh (without navel or waistline ) . Do not inject MIRCERA in a place that is sensitive or that heals .
5 . Clean the area with a new swab with alcohol and wait for the area to dry.
Hold the syringe and needle shield and pull the strong safety. To remove air bubbles from the syringe , hold the syringe with the needle pointing upwards . Gently tap the syringe to make any bubbles to the top. Press the plunger slowly to the correct dose , as shown by medical professionals.

Injecting the solution
If your doctor has advised you to inject MIRCERA through the hemodialysis line into a vein , please inject your dose as shown by medical professionals. If you are advised to inject MIRCERA under your skin please administer your dose as shown below.
6 . Pinch a fold of skin at the injection site and insert the needle . Insert the needle with a quick motion, " dart " .
7 . Slowly push the plunger all the way down until the medicine is injected . Do not release the plunger.

Removing the needle
8 . Withdraw the needle from the skin without pushing the plunger.
9. Submit plunger allowing the needle guard to secure .
Place a cotton ball over the injection site .
Do not massage the injection site.
If bleeding can not be covered with an adhesive bandage.

disposal
Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.