BINOCRIT 4000 IU / 0.4 ml. 6 ampoules

SANDOZ
BINOCRIT 4000 IU / 0.4 ml. 6 ampoules
€ 439.00
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What is Binocrit is and what it is used
Binocrit contains epoetin alfa, a protein that stimulates the bone marrow to produce more red blood cells which carry hemoglobin (a substance that carries oxygen). Epoetin alfa is a copy of the human protein erythropoietin and acts in the same way.

Binocrit is used to treat symptomatic anemia caused by kidney disease:
in children on hemodialysis;
in adults on hemodialysis or peritoneal dialysis;
in adults with severe anemia, which have not yet undergoing dialysis (given by injection into a vein).
If you have kidney disease, you may have a shortage of red blood cells if your kidneys do not produce sufficient amounts of erythropoietin (necessary for the production of red blood cells). Binocrit is prescribed to stimulate your bone marrow to produce more red blood cells.
Binocrit is used to treat anemia if you are receiving chemotherapy for solid tumors, malignant lymphoma or multiple myeloma (bone marrow cancer) and your doctor decides that you may have an increased need for transfusion. Binocrit can reduce the need for blood transfusion.
Binocrit is used in patients with moderate anemia that deposited some of their blood before surgery, so that it, may be transfused back during or after surgery. Because Binocrit stimulates the production of red blood cells it is possible to download more doctors blood of these patients.
Binocrit can be used in adults with moderate anemia who are about to undergo major orthopedic surgery (eg operations for hip or knee joints) in order to reduce the potential need for transfusions.

2. What you should know before using Binocrit
Do not use Binocrit:
if you are allergic (hypersensitive) to epoetin alfa or any of the other ingredients of this medicine (listed in section 6);
if you have been diagnosed acquired (pure) red cell aplasia (bone marrow is unable to produce enough red blood cells) after previous treatment with other products that stimulate the production of red blood cells (including Binocrit) see. point 4;
if you have high blood pressure, which is not successfully controlled with medication;
if need be undergoing major orthopedic surgery (such as hip or knee) and:
have severe heart disease;
you have severe disorders of the veins and arteries;
have recently had a heart attack or stroke;
you can not take medicines to thin the blood.
This medicine may not be suitable for you. Please discuss this with your doctor. When treatment with Binocrit, some people need medicines to reduce the risk of clots. If you can not take medicines prevent the formation of blood clots should not take Binocrit;
to stimulate the production of its own red blood cells (so that doctors can take more blood from you) if you can not get a transfusion of his own blood during or after surgery.
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before using Binocrit.
It is important to tell your doctor if any of these apply to you. It is nevertheless possible to use Binocrit, but discuss it with your doctor.

If you know you suffer or have suffered from:
heart disease, including angina;
high blood pressure;
blood clots, or you have an increased risk for blood clots (eg. if you are overweight, have diabetes or if you had to lie for a long time because of surgery or illness);
epileptic seizures or convulsions;
anemia due to other reasons;
liver disease;
porphyria (a rare blood disorder).
If you have cancer, you should know that products that stimulate the production of red blood cells (like Binocrit) in theory may affect the development of cancer.
Depending on your individual situation may have been preferable to spill your blood. Please discuss this with your doctor.

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 epoetin alfa with interferon and ribavirin is bringing in rare cases loss of effect and development of a condition called acquired (net) aplasia erythrocyte, severe anemia. Binocrit is not approved for the treatment of anemia associated with hepatitis C.

Take special care with other products that stimulate the production of red blood cells:
Binocrit belongs to the group of products that stimulate the production of red blood cells like human erythropoietin. Your healthcare professional will always record exactly which product you use. If you are given another medicine of the same group other than Binocrit, during your treatment, talk about this with your doctor or pharmacist before using it.

Other medicines and Binocrit
Binocrit not normally react with other medicines but please tell your doctor if you are using (or have recently used) any other medicines, including medicines obtained without a prescription.
If you are taking a drug called cyclosporine (used eg. After a kidney transplant) during therapy with Binocrit, your doctor may order special blood tests to determine the levels of cyclosporine.
Iron supplements and other blood stimulants may increase the effectiveness of Binocrit. Your doctor will decide whether it is appropriate for you to take them.
If you visit a hospital, clinic or family doctor, tell them that you are being treated with Binocrit. It may affect other treatments or test results.

Pregnancy, lactation and fertility
It is important to tell your doctor if any of these apply to you. It is nevertheless possible to use Binocrit, but discuss it with your doctor:
if you are pregnant or think you may be pregnant;
if you are breastfeeding.
Binocrit contains sodium:
Binocrit contains sodium, less than 1 mmol (23 mg) per dose, ie contains virtually no sodium.

3. How to use Binocrit
Your doctor has carried out blood tests and decided that you need Binocrit.

Binocrit can be administered by injection:
or into a vein, or in a system which is incorporated into a vein (intravenous);
or under the skin (subcutaneous).
Your doctor will decide how to inject Binocrit. Usually the injections will be administered by a doctor, nurse or other medical professional. Some people, depending on why they need treatment with Binocrit, it is possible to later learn to put themselves subcutaneous injections: see "Instructions for self-injection of Binocrit" at the end of this leaflet.

Binocrit should not be used:
after the expiry date stated on the label and outer packaging;
if you know or think you may have been accidentally frozen;
if the refrigerator has been damaged.
Dose Binocrit, you receive depends on your body weight in kilograms. The cause of your anemia is also a factor in the decision of your doctor about the right dose.
Your doctor will monitor your blood pressure while you are using Binocrit.

Patients with kidney disease
Your doctor will maintain your hemoglobin level between 10 and 12 g / dl, because high hemoglobin levels may increase the risk of blood clots and death;
The usual starting dose of Binocrit for adults and children is 50 International Units (IU) per kilogram (kg) of body weight, given three times a week. In patients on peritoneal dialysis Binocrit is given twice a week;
For adults and children Binocrit is given by injection into a vein (intravenously) or in a system that is turned into a vein. Binocrit must be injected under the skin (subcutaneously) in patients with kidney disease;
Your doctor will order regular blood tests to monitor how the anemia responds, and may adjust the dose, usually every four weeks;
When the anemia has been corrected, your doctor will continue to regularly monitor the condition of your blood and your dose may be further adjusted to maintain your response to treatment;
If you are more extended dose range (more than once a week) of Binocrit, can not maintain adequate levels of hemoglobin and you need to increase the dose or frequency of administration Binocrit;
You may be given iron supplements before and during treatment with Binocrit, to make it more efficient;
If you are receiving dialysis treatment when you begin treatment with Binocrit, it is possible to have your mode of dialysis to be corrected. Your doctor will decide this.
Adults on chemotherapy
Your doctor can begin treatment with Binocrit, if your hemoglobin is 10 g / dl or less;
Your doctor will maintain your hemoglobin level between 10 and 12 g / dl, because high hemoglobin level may increase the risk of blood clots and death;
The starting dose is either 150 IU per kilogram of body weight, administered 3 times a week, or 450 IU / kg once a week;
Binocrit is given by injection under the skin;
Your doctor will order blood tests, and may adjust the dose depending on how your anemia responds to treatment with Binocrit;
You may be given iron supplements before and during treatment with Binocrit, to make it more efficient;
Usually you should continue treatment with Binocrit for 1 month after the end of chemotherapy.
Adults donating their own blood
The usual dose is 600 IU per kg body weight twice a week;
Binocrit is given by injection into a vein three weeks before surgery, after you have donated blood;
You may be given iron supplements before and during treatment with Binocrit, in order to increase its effectiveness.
Adults scheduled for major orthopedic surgery
The recommended dose is 600 IU per kilogram of body weight once a week;
Binocrit is given by injection under the skin for three weeks before surgery and on the day of surgery;
If there is a medical need to shorten the time before your operation, you will be given a daily dose of 300 IU / kg to a maximum of ten days before surgery, on the day of surgery and for four days immediately thereafter;
If blood tests show that your hemoglobin level is too high before the operation, the treatment will be terminated;
You may be given iron supplements before and during treatment with Binocrit, to make it more effective.
Instructions for injecting Binocrit under the skin
Warning: If you have kidney disease, Binocrit has to be given by injection into a vein. Do not give by injection under the skin (subcutaneously).
Do not attempt to inject yourself unless you have been trained to do so by your doctor or nurse;
Always use Binocrit exactly as directed by your doctor or nurse;
Make sure that only inject the amount of liquid as instructed by your doctor or nurse;
Use Binocrit if it has been stored correctly - see section 5;
Before use, leave the Binocrit syringe to reach room temperature. Typically this requires between 15 and 30 minutes. Use the syringe within 3 days after you remove it from the refrigerator.
Apply only one dose of Binocrit from each syringe.
If Binocrit injected under the skin (subcutaneous) injection amount is usually not more than one milliliter (1 ml) per injection.
Binocrit administered alone, and must not be mixed with other injectable liquids.
Do not shake the syringe Binocrit. Prolonged vigorous shaking may damage the product. If the product has been shaken vigorously, do not use it.
Instructions on how to give yourself an injection Binocrit was found at the end of this leaflet.

If you use more than the amount of Binocrit
Tell your doctor or nurse immediately if you think it is injected too much Binocrit. Less likely to experience adverse effects of overdose of Binocrit.

If you forget to use Binocrit
Place the next injection as soon as you remember. If there is less than one day to the next injection, not the missed and continue with your normal schedule. Do not use two injections.

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

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

Tell your doctor or nurse if you notice any of the effects in this list.
Very common side effects - may affect more than 1 in every 10 people using Binocrit:
Flu-like symptoms such as headache, joint pain, fever, feeling of weakness, tiredness and dizziness. They may be more common at the beginning of treatment. If you have these symptoms during intravenous injection, a slower delivery of the injection may help to avoid them in the future;
There are reports of respiratory tract congestion, such as stuffy nose and sore throat in patients with kidney disease who are not yet on dialysis.
Common side effects - likely to affect fewer than 10 in every 100 people using Binocrit:
Increased blood pressure in patients with cancer and in patients with symptomatic anemia caused by kidney disease. Headache, especially sudden, stabbing migraine-like headaches, feeling confused or seizures may be signs of a sudden rise in blood pressure. This requires urgent treatment. Elevated blood pressure may require treatment with some other medicines (or adjustment to any medicines for blood pressure, you already take);
Chest pain, breathlessness, painful swelling in the leg which may be symptoms of blood clots (thrombosis);
Skin rash and swelling around the eyes (edema), which may be due to an allergic reaction.
If you are receiving hemodialysis:
It is possible in dialysis shunt blood clots (thrombosis). This is more likely if you have low blood pressure, or if you have a fistula complications;
It is possible to form clots in your hemodialysis system. Your doctor may decide to increase your heparin dose during dialysis.
Very rare side effects - may affect fewer than 1 in 10,000 people using Binocrit:
Symptoms of acquired red cell aplasia (PRCA)
PRCA means the inability to produce enough red blood cells from the bone marrow. PRCA can result in sudden and severe anemia. The symptoms are:
unusual tiredness;
feeling dizzy;
shortness of breath.
There are very rare reports of PRCA after treatment for months to years with epoetin alfa and other products that stimulate the production of red blood cells in patients with chronic renal failure.
If you are receiving hemodialysis to an increase in levels of small blood cells (called platelets), which are involved in the formation of clots, especially in early treatment. Your doctor will check on this.
You may experience redness, burning and pain at the injection site.
If you get any side effects, tell your doctor, pharmacist or nurse. This includes any possible effects not listed in this leaflet.

Adverse event reporting
If you get any side effects, tell your doctor, pharmacist or nurse. This includes any possible effects not listed in this leaflet. You can also report adverse events directly through the national reporting system. As reported adverse reactions, you can do your bit to get more information on the safety of this medicine.

5. How to store Binocrit
Keep out of the reach and sight of children.
Store and transport refrigerated (2 ° C-8 ° C).
Do not freeze or shake.
Store in the original package in order to protect from light.
May remove Binocrit from the refrigerator and store it at room temperature (25 ° C) for no more than 3 days. Once a syringe is removed from the refrigerator and has reached room temperature (25 ° C) must either be used within 3 days or disposed of.

Do not use this medicine:
if the liquid is colored or if you see particles floating in it;
if compromised the integrity of the packaging;
after the expiry date stated on the label after "EXP" on the carton after "EXP". The expiry date refers to the last day of that month;
if you know or think that the solution has been accidentally frozen;
if the refrigerator was defective.
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 Binocrit contains
The active substance is epoetin alfa (for quantities see following table).
The other ingredients are sodium hydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH) and water for injections.
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