MIRCERA 100 mcg. / 0.3 ml. 1 injection

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MIRCERA 100 mcg. / 0.3 ml. 1 injection
€ 299.00
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What is MIRCERA and what it is used
This medicine is prescribed for you, because you have anemia caused by your chronic kidney disease and is associated with typical 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 (your body's tissues might not receive enough oxygen).
MIRCERA is indicated only for the treatment of symptomatic anemia caused by chronic kidney disease. Its use is limited to adult patients (aged 18 years or more).
MIRCERA is a medicine produced by gene technology. As the natural hormone erythropoietin, MIRCERA increases the number of red blood cells and hemoglobin level in your blood.

2. What you need to know before you use 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 patients with cancer, has not been established.

Before treatment with MIRCERA
In some patients treated with erythropoiesis-stimulating agents (ESAs), including MIRCERA, is observed condition called pure 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 not be treated with MIRCERA;
If you are suffering from hepatitis C and receive interferon and ribavirin, you should discuss this with your doctor because a combination of ESAs with interferon and ribavirin in rare cases leads to loss of effect and development of PRCA, 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 an ESA and you also have cancer, you should know that ESAs might have a negative impact on your condition. You should discuss treatment options for anemia with your doctor;
It is not known if MIRCERA has a different effect in patients with hemoglobinopathies (disorders associated with abnormal hemoglobin), bleeding in the past or present, seizures or with a high number of platelets in the blood. If you have any of these conditions, your doctor will discuss this with you and must 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 that may be life-threatening.
During treatment with MIRCERA
Your doctor may initiate treatment with MIRCERA, if your hemoglobin level is 10 g / dl (6,21 mmol / l) or lower. Following initiation of therapy, your doctor will seek 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 treatment with iron;
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 medicine 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 could 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 this could mean that your MIRCERA treatment is not effective. Your doctor will check if you do not have other causes of anemia and may perform blood tests or examine your bone marrow. If you have developed 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
Treatment with MIRCERA 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 production: MIRCERA belongs to a group of products that stimulate the production of red blood cells, such as 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, have recently used or might use any other medicines.
No studies of interaction. There is no evidence that MIRCERA interacts 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 consider what is the best treatment for you during pregnancy.
Tell your doctor if you are breastfeeding or plan to breastfeed. Your doctor will advise if you should stop or continue breast-feeding and stop or continue your treatment.
There is no evidence that MIRCERA impaired 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., contains virtually no sodium.

3. How to use MIRCERA
Always use this medicine exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
Treatment with MIRCERA must be started under the supervision of a medical professional.
Further injections can be given by a medical specialist, or after you have been trained, you can self-inject 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 follow by measuring your hemoglobin level how the 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 micrograms for every kilogram of your body weight, it will be administered subcutaneously once monthly as a single injection. Alternatively, your doctor may decide to apply a starting dose of MIRCERA of 0.6 micrograms for every kilogram of your body weight. The dose will be administered every two weeks as a single injection under the skin or into a vein. After correcting the anemia, your doctor may change the dose once monthly;
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 every two weeks as a single injection under the skin or into a vein. After correcting the anemia, your doctor may change the dose once monthly.
Your doctor may increase or decrease your dose or temporarily stop your treatment to adjust your hemoglobin level, as appropriate for you. Dose changes will not 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. 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 day the planned injection of your previous medicine.

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

If you use more MIRCERA dose
Please contact your doctor or pharmacist if you used too large a dose of MIRCERA, as 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 possible and talk to your doctor about when to use the next doses.

If you stop using MIRCERA
Usually MIRCERA treatment is prolonged. 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 (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;
vascular access thrombosis (blood clots in your dialysis access).
Rare side effects (may affect up to 1 in 1000 people) are:
hypertensive encephalopathy (very high blood pressure, which can cause headaches, especially sudden, stabbing, migraine headache, confusion, speech disturbances, fits 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 the tongue, face or throat, or swelling around the injection site, or make you feel dizzy, you feel faint or feel faint). If you have these symptoms, please contact your doctor immediately to receive treatment.
In clinical studies patients had a slight decrease in the number of platelets in the blood. There have been spontaneous reports of platelet counts below the normal range (thrombocytopenia).
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, in post-marketing have been reported cases of thrombosis, including pulmonary embolism, not known.
In some patients treated with ESAs, including MIRCERA, is observed condition called pure 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 any possible effects not listed in this leaflet.

5. How to store MIRCERA
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton and label of 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 in order to protect from light. You may remove your pre-filled syringe of MIRCERA from the refrigerator and store it at room temperature no higher than 30 ° C, for a single period of 1 month. During this period when stored MIRCERA at a room temperature not higher than 30 ° C, must 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.
Should be injected only clear, colorless to pale yellow solutions without 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 MIRCERA contains
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 phosphate monobasic monohydrate, sodium sulfate, mannitol (E421), methionine, poloxamer 188 and water for injection.

What MIRCERA looks like and contents of the pack
MIRCERA is a solution for injection in pre-filled syringe. The solution is clear, colorless to pale yellow 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. All concentrations of Mircera are available in packs of 1 pre-filled syringe, and the concentrations of 30, 50, 75 micrograms / 0.3 ml - and in packing with 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 ALONE
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 you can be self-injected by yourself either under the skin or if you are on hemodialysis, through the hemodialysis line according to the advice of your doctor. Pre-filled syringe does not contain preservatives and should be used only for 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 one 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 pre-filled syringe after the expiry date stated on the label;
Use the pre-filled syringe if the solution is clear, colorless (slightly yellow in color 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.
Preparing for injection
Gather all the materials you will need for an injection on a clean surface
Included in the package:
One pre-filled syringe MIRCERA and a 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 make injection alone. 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 removing the protective film.
Wash your hands thoroughly with soap and warm water.
Remove the plastic foil from plastic tray and remove syringe and needle.
Preparation of MIRCERA pre-filled syringe and injection needle for injection
1. Grasp the needle firmly in both hands. Break the seal of the needle with a twisting motion and remove the cap. Do not remove the needle shield.
2. Remove the rubber tip cap from the syringe (bend and pull).
3. Attach the needle to the syringe by pressing strongly one to the other.
4. Select one of the recommended injection sites, arm abdomen or thigh (except your navel or waistline). Do not inject MIRCERA into an area that is tender or healing.
5. Clean the site with a new swab with alcohol, and wait for the area to dry.
Hold the syringe and needle shield and pull strongly fuse. To remove air bubbles from the syringe, hold the syringe with the needle upwards. Tap the syringe gently to bring any bubbles to the top. Slowly press the plunger to the correct dose, as shown by the medical specialist.

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

Removing the needle
8. Remove the needle from the skin without releasing the plunger.
9. Release the plunger allowing the needle guard to secure.
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 should be discarded after the injection. Dispose of the syringe in a container that can not be drilled. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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