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What NeoRecormon is and what it is used for
NeoRecormon is a clear, colorless solution that is injected under the skin (subcutaneously) or into a vein (intravenously). It contains a hormone called epoetin beta that stimulates the formation of red blood cells. Epoetin beta is produced by genetic engineering and acts exactly the same way as the natural hormone erythropoietin. You should speak to your doctor if you do not feel well or if you feel worse.
NeoRecormon is indicated for:
Treatment of symptomatic anemia caused by chronic kidney disease (kidney anemia) in dialysis patients or patients not already undergoing dialysis;
Prophylaxis of anemia in premature babies (birth weight ranging from 750 to 1,500 g and under 34 weeks);
Treatment of anemia and associated symptoms in adult cancer patients receiving chemotherapy;
Treatment of patients who give blood before surgery. Injecting epoetin beta will increase the amount of blood that can be taken by your body before surgery and overflowing during or after it (this is called autologous transfusion).
2. What you need to know before using NeoRecormon
Do not use NeoRecormon:
If you are allergic to epoetin beta or any of the other ingredients of this medicine (listed in section 6);
If you have problems with blood pressure that can not be controlled;
If you are giving blood before surgery, and:
You have had myocardial infarction or stroke during the month before treatment;
Have unstable angina - new or rising chest pain;
You are at risk of blood clots in the veins (deep vein thrombosis) - for example, You had blood clots before.
If any of this is or may be related to you, tell your doctor immediately.
Warnings and precautions
Talk to your doctor before using NeoRecormon:
If your baby needs treatment with NeoRecormon, it will be carefully monitored for possible side effects from the eyes;
If your anemia is not improving with epoetin therapy;
If you have low levels of certain B vitamins (folic acid or vitamin B12);
If you have very high levels of aluminum in your blood;
If the number of platelets in your blood is high;
If you have chronic liver disease;
If you have epilepsy;
If you have developed antibodies to erythropoietin and pure red cell aplasia (reduced or absent red blood cell production) during previous contact with any erythropoietin. In this case, you should not switch to NeoRecormon.
Take special care with other products that stimulate red blood cell production:
NeoRecormon is one of the group of products that stimulate the production of red blood cells, such as the human protein erythropoietin. Your healthcare professional will always mark the exact product you are using.
During treatment with NeoRecormon
If you are a patient with chronic kidney disease, especially if you are not sufficiently affected by NeoRecormon, your doctor will check your NeoRecormon dose because repeatedly increasing NeoRecormon if you do not respond to treatment may increase the risk of heart problems or Blood vessels and increase the risk of myocardial infarction, stroke and death.
If you have cancer, you should know that NeoRecormon may have a blood cell growth factor effect and, under certain circumstances, may have a negative effect on the cancer. Depending on your individual condition, blood transfusion may be preferable. Please discuss this with your doctor.
If you have nephrosclerosis and you are not already on dialysis, your doctor will decide if this treatment is right for you. This is because absolute safety can not rule out the possibility of accelerating the progression of kidney disease.
Your treating physician can perform regular blood tests to check:
The level of potassium. If you have high or rising potassium levels, your doctor may rethink your treatment;
The level of platelets in your blood. Platelet counts may increase mildly or moderately during treatment with epoetin, and this may cause changes in blood clotting.
If you have kidney disease on hemodialysis, your doctor may adjust the dose of heparin. This will avoid clogging of the dialysis system.
If you have kidney disease on hemodialysis at risk of shunt thrombosis, blood clots (thromboses) in the shunt (a vessel used to bind the dialysis system) may form. Your doctor may prescribe acetylsalicylic acid or change the shunt.
If you are giving blood before surgery, your doctor will need to:
Check if you can give blood, especially if you weigh less than 50 kg;
To check that the level of red blood cells is high enough (hemoglobin at least 11 g / dl);
To make sure that only 12% of your blood is taken at once.
Do not abuse NeoRecormon:
The misuse of NeoRecormon by healthy individuals can lead to excessive blood cell enlargement and subsequent blood compression. This can in turn lead to life-threatening complications from the heart and blood vessels.
Other medicines and NeoRecormon
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Pregnancy, breastfeeding and fertility
There is not much experience with NeoRecormon in pregnant women or nursing mothers.
Ask your doctor or pharmacist for advice before taking any medicine.
NeoRecormon has no evidence of fertility damage in animals. The potential risk to humans is unknown.
Driving and using machines
No effects on ability to drive and use machines have been observed.
NeoRecormon contains phenylalanine and sodium
This medicine contains phenylalanine. It may be harmful for people with phenylketonuria. If you have phenylketonuria, talk to your doctor about your NeoRecormon treatment.
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie. Practically does not contain sodium.
3. How to use NeoRecormon
NeoRecormon should be started by a doctor who has experience in the treatment of your condition. The first dose is usually administered under medical supervision due to the possibility of an allergic reaction.
NeoRecormon injections can be given by a trained nurse, doctor or other healthcare professional. Once you are shown how to do it, you can also inject your solution yourself.
NeoRecormon pre-filled syringe is a ready-to-use solution. Each syringe should only be used for one injection. Do not mix NeoRecormon with other injection or infusion solutions.
Instructions for use
First wash your hands!
1. Remove one syringe from the package.
Check the fluid in the syringe:
Is it clear?
Is it colorless?
Are there any solid particles?
If the answer to any of the questions is NO, do not put the injection. Discard it and start again with another syringe.
If your answer to the three questions is yes, remove the syringe cap and proceed to step 2.
2. Remove one needle from the pack, attach it firmly to the syringe and remove the needle guard from the needle.
3. Drain the air out of the syringe and needle. Do this by gently tapping the upper half of the syringe. This will cause the bubbles to rise upwards. Then hold the syringe vertically with the needle up and gently push the plunger up. Push the plunger until the amount of NeoRecormon in the syringe is as prescribed.
4. Clean the skin at the injection site using cotton wool dipped in alcohol. Form a skin fold by gripping the skin between your thumb and forefinger.
5. Holding the syringe near the needle, insert the needle into the skin fold with a quick, vigorous motion. Inject the NeoRecormon solution. Draw the needle quickly and press the injection site with a dry, sterile swab.
Dosage of NeoRecormon
The dose of NeoRecormon depends on the condition of your illness, the mode of injection (subcutaneously or in the vein) and your body weight. Your doctor will determine the dose you need.
Your doctor will use the lowest effective dose to control the symptoms of anemia.
If you do not respond enough to NeoRecormon, your doctor will check your dose and will inform you if NeoRecormon is to be changed.
Symptomatic anemia caused by chronic kidney disease
Injecting is done under the skin or in a vein. If the solution is used in your vein, it should be injected for about 2 minutes, e.g. In hemodialysis patients the injection will be through the arteriovenous fistula at the end of dialysis. People who are not on hemodialysis are usually given injections subcutaneously.
Treatment with NeoRecormon is divided into two stages:
A) Correction of anemia
The starting dose for subcutaneous injections is 20 IU for every 1 kg of your body weight per injection, which is done three times a week.
After 4 weeks, the doctor will perform the tests and, if the response to the treatment is not enough, may increase your dose to 40 IU / kg per injection, which is done three times a week. If necessary, your doctor may continue to increase your dose in a month. The weekly dose may also be divided into daily doses.
The initial intravenous injection dose is 40 IU / kg per injection for every 1 kg of your body weight, which is done three times a week.
After 4 weeks, the doctor will do the research and if the answer is
The maximum dose should not exceed:
When injected into the veins: 1,600 IU for every 1 kg of body weight per week;
When injected under the skin: 1 200 IU per 1 kg of body weight per week.
If you inject too much NeoRecormon
Do not increase the dose your doctor has determined. If you think you have injected more NeoRecormon than you should, contact your doctor. The consequences are unlikely to be serious. Even at very high blood levels, no symptoms of poisoning have been observed.
If you forget to use NeoRecormon
If you miss an injection or have injected too little, talk to your doctor.
Do not take a double dose to make up for the missed dose.
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 everyone gets them.
Adverse reactions that may occur in any patient:
In most people (very common, it may affect more than 1 in 10 people), the levels of iron in the blood are decreasing. Almost all patients should be treated with iron supplements during treatment with NeoRecormon;
Rare (may affect up to 1 in 1,000 people): allergic or skin reactions such as rash or urticaria, pruritus or reactions around the injection site;
Very rarely (may affect up to 1 in 10,000 people), a severe form of allergic reaction appears, especially immediately after the injection. It should be treated immediately. If you get abnormal wheezing or difficulty in breathing, swelling of the tongue, face or throat or swelling around the injection site, if you feel dizzy or collapse, call your doctor immediately.
Very rarely (may affect up to 1 in 10,000 people), people get flu-like symptoms, especially when they have just started treatment. These include fever, chills, headaches, pain in the limbs, bone pain, and / or a feeling of general malaise. These reactions are usually mild to moderate and resolve within a few hours or days.
Additional side effects in people with chronic kidney disease (kidney anemia):
Increased blood pressure, worsening of existing high blood pressure and headache are the most common side effects (very common, may affect more than 1 in 10 people). Your doctor will check your blood pressure regularly, especially at the beginning of therapy. Your doctor may treat high blood pressure with medicines or temporarily discontinue NeoRecormon treatment;
Immediately call a doctor if you get a headache, especially sudden, piercing, migraine-like headache, confusion, speech disorders, unsteady gait, seizures or seizures. These symptoms may be signs of a marked increase in blood pressure (hypertensive crisis) even if your blood pressure is usually normal or low. It should be treated immediately;
If you have low blood pressure or shunt complications, you may be at risk of shunt thrombosis (a blood clot in the dialysis system used for dialysis);
Very rare (may affect up to 1 in 10,000 people) patients have had elevated levels of potassium or phosphate in the blood. Your doctor can treat this;
Pure red cell aplasia (CHAC), caused by neutralizing antibodies, has been observed with erythropoietin therapy, including in some cases during treatment with NeoRecormon. CHACKK means that the body stops or reduces the formation of red blood cells. This causes severe anemia, the symptoms of which include unusual fatigue and lack of energy. If your body produces neutralizing antibodies, your doctor will stop NeoRecormon treatment and determine the best way to treat your anemia.
Additional side effects in adults receiving chemotherapy for cancer:
Sometimes you may experience an increase in blood pressure and headache. Your doctor can treat high blood pressure with medicines;
An increased incidence of blood clotting has been observed.
Additional side effects in people who give blood before surgery:
There was a slight increase in the incidence of blood clots.
Reporting of side effects
If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information about the safety of this medicine.
How to store NeoRecormon
Keep out of the reach and sight of children.
Do not use NeoRecormon after the expiry date which is stated on the carton and the label.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Store in a refrigerator (2 ° C - 8 ° C).
The syringe can be removed from the refrigerator and stored at room temperature (but not above 25 ° C) once for a maximum of 3 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What NeoRecormon contains
The active substance is: epoetin beta. One pre-filled syringe contains 500, 2000, 3000, 4000, 5000, 6000, 10,000, 20,000 or 30,000 IU (International Units) of epoetin beta in 0.3 ml or 0.6 ml of solution.
The other ingredients are: urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, L-Phenylalanine and water for Injections.
What NeoRecormon looks like and contents of the pack
NeoRecormon is a solution for injection in a pre-filled syringe. The solution is colorless, clear to slightly opalescent.
NeoRecormon 500 IU, 2000 IU, 3000 IU, 4,000 IU, 5000 IU and 6,000 IU: Each pre-filled syringe contains 0.3 ml of solution.
NeoRecormon 10,000 IU, 20,000 IU and 30,000 IU: Each pre-filled syringe contains 0,6 ml of solution.
NeoRecormon is available in the following packs:
NeoRecormon 500 IU
1 pre-filled syringe with one needle (30 G1 / 2) or 6 pre-filled syringes with 6 needles (30 G1 / 2).
NeoRecormon 2,000 IU, 3,000 IU, 4,000 IU, 5,000 IU, 6,000 IU, 10,000 IU and 20,000 IU
1 pre-filled syringe with one needle (27 G1 / 2) or 6 pre-filled syringes with 6 needles (27 G1 / 2).
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