RETACRIT solution 10000 IU ml 1. 6 syringes
RETACRIT solution 10000 IU / ml 1. 6 syringes
What Retacrit and what it is used?
Retacrit contains protein called epoetin zeta , which stimulates the bone marrow to produce more red blood cells which transport hemoglobin (a substance that carries oxygen ) . Epoetin zeta is a copy of human erythropoietin Protein and act the same way.
Retacrit apply :
- In adults, children and adolescents on hemodialysis to treat symptomatic anemia ( low red blood cells) associated with chronic renal failure (kidney disease).
- Adults of peritoneal dialysis for the treatment of symptomatic anemia associated with chronic renal failure ( renal disease) .
- In adult patients with renal failure who are not yet on dialysis in the treatment of anemia associated with kidney disease associated with clinical symptoms.
- In adult patients receiving chemotherapy for solid tumors, malignant lymphoma (cancer of the lymphatic system) or relapsed myeloma ( bone marrow cancer ) to treat anemia and reduce the need for blood transfusion, if the physician determines that there may be increased risk and need for transfusions .
- In moderately anemic patients undergoing surgery and prior to it, donate blood so that their own blood can spill over to them during or after surgery ( autologous transfusion ) .
- In moderately anemic adult patients undergoing major orthopedic ( bone ) surgery (eg hip replacement or knee replacement ) to reduce the need for blood transfusion .
2 . Announces What to know before using Retacrit?
Do not use Retacrit
- If you are allergic ( hypersensitive) to erythropoietin or any of the other ingredients of this medicine (listed in Section 6)
- If you have acquired (pure ) red cell aplasia ( PRCA erythroblastopenia ; lack of very young red blood cells) following treatment with any erythropoietin
- If you have high blood pressure that is not properly controlled with blood pressure-lowering medicines
- If you do not have to take medication to thin the blood to prevent blood clots
- If you are donating your own blood before surgery , and :
• you have had a myocardial infarction or stroke in the month before treatment with Retacrit
• you have unstable angina ( angina pectoris ) - new or increasing pain in the chest area
• are at risk of blood clots in the veins ( deep vein thrombosis ) - for example . if you have had blood clots .
• If you need to undergo major orthopedic surgery such as hip replacement or knee and:
• have severe heart disease or severe vascular disorders of the veins and arteries
• you have recently had a heart attack or stroke.
Warnings and Precautions
Talk to your doctor before using Retacrit, if you know that you suffer or have suffered from any of the following :
- Seizures (fits)
- Liver disease
- Anemia from other causes
- Cardiovascular disease (such as angina)
- Infringement of blood circulation in the body , leading to a feeling of discomfort and tingling in the limbs or extremities and cramp , paralysis or painful spasms of the muscles of the legs
- Blood clots / disorders clotting
- Kidney disease.
Special precautions during treatment with Retacrit
Your doctor will monitor your hemoglobin does not exceed a certain level as high hemoglobin concentrations could put you at risk of heart problems or problems with blood vessels and can increase the risk of myocardial infarction, stroke and death.
Your doctor should try to keep your hemoglobin levels between 10 and 12 g / dl. Hemoglobin should not exceed the limit of 12 g / dl.
During treatment with Retacrit, your doctor will measure your blood pressure regularly . If you get headaches, particularly sudden , stabbing migraine- like headaches or start to feel disoriented and / or have fits , tell your doctor or nurse. These can be warning signs of a sudden rise in blood pressure requiring immediate treatment .
During treatment , the amount of platelets in the blood can rise ( cells that help the blood to clot ) . It will be stabilized during the course of treatment. It is recommended to regularly monitor the platelet count during the first 8 weeks of treatment.
If you need to visit the hospital or family doctor for any treatment that requires a blood test , remember that you must tell your doctor that you are treated with Retacrit, as Retacrit may affect the results.
Take special care with other products that stimulate the production of red blood cells :
Retacrit is one of a group of products that stimulate the production of red blood cells like human erythropoietin protein . Your healthcare professional will always record the exact product that you are using.
Patients with kidney disease
Obtained (pure ) red cell aplasia ( erythroblastopenia , PRCA ) is rarely observed after months to years of treatment with other products containing erythropoietin administered subcutaneously , and can not be ruled out in the treatment with Retacrit. Acquired (pure ) red cell aplasia ( PRCA ) is the inability to produce red blood cells in the bone marrow. If it appears , can cause severe anemia , symptoms of which are unusual tiredness , dizziness , or trouble breathing. PRCA may be caused by the production of antibodies against the erythropoietin product and subsequently to your own erythropoietin ..
You should discuss this information with your doctor. If an acquired (pure ) red cell aplasia ( rare ), treatment with Retacrit should be stopped and your doctor
will determine the most appropriate way to treat anemia. Although these complications are rare , you should be aware that if you develop PRCA to you , it will need regular blood transfusion, with likely to be lifelong, to treat your anemia and treatment Retacrit will be discontinued. Tell your doctor if you suddenly feel very tired or dizzy or if you have shortness of breath . Your doctor will decide whether Retacrit properly for you and , if necessary, discontinue treatment.
In patients with chronic renal failure patients receiving erythropoietin , hemoglobin (the part of the red blood cell that carries oxygen ) is regularly measured , until a steady value and then periodically checked in order to minimize the risk by an increase in blood pressure .
If you are a patient with chronic kidney disease , your doctor will check that your hemoglobin does not exceed a certain level as high hemoglobin could be a risk factor for heart or vascular problem and can increase the risk of death.
Increasing potassium in the blood is observed in isolated cases. In patients with chronic renal failure , the treatment of anemia can lead to increased appetite, and potassium and protein . If you are on dialysis , when you begin treatment with Retacrit, you may need to adjust the dialysis regimen to normalize urea, creatinine and potassium in the blood. Your doctor will make this decision .
The amount of serum electrolytes ( substances in the blood ) must be monitored in patients with chronic renal failure. If it is determined that the level of serum potassium is elevated (or increases ) , the physician should consider to stop treatment with Retacrit until the level is back to normal .
Increasing the dose of a particular drug blood thinners (heparin ) during hemodialysis is frequently required during the course of treatment with Retacrit, to minimize the likelihood of blood clots . Occlusion of the dialysis system is possible if heparinisation is not optimum.
Patients with cancer are more likely to suffer from blood clots if receiving erythropoietin medicines as Retacrit ( see section 4 ) . Therefore, you should discuss the benefits of Retacrit with your doctor , especially if you are overweight or have had blood clots or abnormalities in blood clotting .
Hemoglobin (the part of the red blood cell that carries oxygen ) in cancer patients treated with erythropoietin should be measured regularly until stable level is achieved , and periodically thereafter .
If you are a cancer patient , you should know that Retacrit can act as a growth factor for blood cells and in certain circumstances can adversely affect your tumor. Depending on the individual history, blood transfusion may be preferable . Please discuss this with your doctor.
Other medicines and Retacrit
Tell your doctor or pharmacist if you are taking , have recently taken or taking other medicines.
In particular , if you are taking a medicine containing the active substance ciclosporin to suppress your immune system after a kidney transplant , your doctor may prescribe a special blood test that will determine the level of cyclosporine in your blood while you are taking Retacrit.
Iron supplements and other blood stimulants may increase the effectiveness of Retacrit. Your doctor will evaluate and decide whether it is right to take them.
Pregnancy and lactation
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , ask your doctor or pharmacist before taking this medicine.
If you are pregnant or breast-feeding , Retacrit should be used only if the benefit outweighs the potential risk to the fetus .
Ask your doctor before taking any medicine .
Driving and using machines
Retacrit has no or negligible influence on the ability to drive and use machines.
Retacrit contains phenylalanine
This medicine contains phenylalanine and may be harmful for people with phenylketonuria (a genetic enzyme deficiency that increases the release of a chemical ( ketone ) in the urine and can lead to nervous system disorders ) .
This product contains less than 1 mmol sodium (23 mg) per dose , i.e. essentially sodium .
3 . How to use Retacrit?
Treatment usually begins with Retacrit under medical supervision. Injections can be given by a doctor , trained nurse or other medical professional.
In the event that Retacrit is injected under the skin (subcutaneously) You can also inject the solution yourself once you have been shown how to do this . Always use this medicine exactly as your doctor has told you . If you are not sure, ask your doctor.
The dose you receive is based on your body weight in kilograms.
Your doctor will perform tests , eg . blood tests that will help determine whether you need to take Retacrit. He / She will calculate the correct dose Retacrit, to take , how long is the treatment and how to introduce medicines. These decisions will be influenced by what causes anemia.
You may be given iron supplements before and during treatment with Retacrit.
Use in patients with renal disease
Retacrit should be administered either under the skin (subcutaneously) or as an injection into a vein or vein source.
Use in adult patients on hemodialysis
Your doctor will maintain your hemoglobin levels between 10 and 12 g / dl (6,2 - 7,5 mmol / l).
Retacrit can be administered during the dialysis session or after it has ended .
The recommended starting dose Retacrit is 50 IU / kg ( International Units per kg. Bodyweight). Apply three times a week. If the solution is administered into a vein , it has to be injected for 1 -5 minutes .
Depending on how the anemia responds, the dose may be adjusted approximately every 4 weeks , until the condition is under control. The dose you receive should not normally exceed 200 IU / kg three times a week.
Your doctor will order regular blood tests to make sure that your medicine is continuing to work properly. When your condition has been brought under control , you will start taking regular doses of Retacrit, 2 or 3 times a week. These doses may not be so high , as the doses received in the beginning of the treatment.
Use in children and adolescents below 18 years of hemodialysis
In children, the doctor will maintain hemoglobin levels between 9.5 and 11 g / dl.
Retacrit should be administered after the patient has received a dialysis session.
The dose for children is based on body weight in kilograms. The recommended starting dose is 50 IU / kg. This is given three times a week by injection into a vein (over 1-5 minutes).
Depending on how the anemia responds, the dose may be adjusted approximately every 4 weeks , until the condition is under control. Your doctor will order regular blood tests to determine whether this has been achieved .
Use in adult patients on peritoneal dialysis
Your doctor will maintain your hemoglobin levels between 10 and 12 g / dl.
The recommended starting dose is 50 IU / kg. Apply 2 times a week.
Depending on how the anemia responds , the dose may be adjusted approximately every 4 weeks , until the condition is under control. The total weekly dose you receive should not exceed 200 IU / kg.
Your doctor will order regular blood tests to make sure that your medicine is continuing to work properly.
Use in patients with renal disease who are not on dialysis
The recommended starting dose is 50 IU / kg. Apply three times a week.
Your doctor may adjust the initial dose until your condition is under control. Once your condition is under control you will receive regular doses of Retacrit, 3 times a week. Generally, the dose should not exceed 200 IU / kg, 3 times a week.
Your doctor will order regular blood tests to make sure that your medicine is continuing to work properly.
Use in adult patients receiving chemotherapy
Your doctor may start treatment with Retacrit, if your hemoglobin is 10 g / dl or lower.
Following initiation of therapy , your doctor will maintain your hemoglobin levels between 10 and 12 g / dl.
The recommended starting dose is 150 IU / kg. Given 3 times per week by subcutaneous injection. Alternatively , your doctor may recommend a starting dose of 450 IU / kg, once a week. The initial dose may be adjusted by your doctor depending on your weight and how your anemia responds to treatment ; Retacrit will receive up to 1 month after the end of chemotherapy.
Use in patients enrolled in a program for pre- deposit of autologous blood
The recommended starting dose is 600 IU / kg. Apply 2 times a week by injection into a vein. Retacrit will take for 3 weeks before surgery . Furthermore, in order to increase the effectiveness of the drug, will accept and iron supplements , before and during the whole treatment with Retacrit.
Adult patients scheduled for major orthopedic ( bone) surgery
Dose of 600 IU / kg is given by injection under the skin once a week for three weeks prior to surgery and on the day of surgery. In cases where it is necessary prior to the period of operation can be shortened , a dose of 300 IU / kg per day 10 days prior to surgery, on the day of surgery and 4 days immediately thereafter. If blood tests in the period before the operation show too high hemoglobin levels, treatment should be discontinued.
It is also important , the level of iron in your blood to be normal during treatment with Retacrit. If appropriate , you will be taking iron orally, it is best to start before beginning treatment with Retacrit.
Information about the application
The pre-filled syringe is ready for use. Each syringe is to be used only for a single injection . Retacrit should not be shaken or mixed with other liquids.
If Retacrit injected subcutaneously , the amount injected in any one place should not exceed 1 ml. Suitable sites for injection are the upper thigh and abdomen , but away from the navel. Change the site every day.
Always follow the instructions when using the Retacrit:
1. Take a sealed blister pack with syringe prior to use, let it stand for a few minutes until it reaches room temperature. It usually takes 15 to 30 minutes. Do not shake .
2 . Remove the syringe from the blister pack and check that the solution is clear, colorless and practically free of any visible particles
3 . Carefully remove the needle shield and expel air from the syringe and needle by holding the syringe vertically ( needle up) and gently pressing the plunger upwards .
4 . Inject the solution as you shown by your doctor. If you are unsure , you should check with your doctor or pharmacist.
Do not use Retacrit if:
• sealing of the blister is broken or the packaging is damaged in any way