BINOCRIT. 1000 IU 0.5 ml. 6 syringes
BINOCRIT. 1000 IU / 0.5 ml. 6 syringes
Each 1 ml of solution contains 1000 IU epoetin alfa (epoetin alfa), equivalent to 8.4 micrograms per ml. Pre-filled syringe contains 0,5 ml of 1, 000 international units (IU), equivalent to 8.4 micrograms epoetin alfa. Produced by recombinant DNA technology in a cell line from ovarian cells of Chinese hamster ovary . Excipients : Sodium dihydrogen phosphate dihydrate , disodium phosphate dihydrate, sodium chloride , glycine, polysorbate 80, water for injections, hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH).
Treatment of symptomatic anemia associated with chronic renal failure ( CRF) in adult and pediatric patients : Treatment of anemia associated with chronic renal failure in pediatric and adult patients on hemodialysis and adult patients on peritoneal dialysis. ; Treatment of severe anemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis . ; Treatment of anemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumors, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the general condition of the patient ( eg cardiovascular status, pre-existing anemia start of chemotherapy).
Binocrit can be used to increase the yield of autologous blood from patients enrolled in the program for the disposal of autologous blood . Its application for this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to non-iron deficient patients with moderate anemia
Dosage and administration :
Binocrit treatment should be initiated under the supervision of physicians experienced in the treatment of patients with the above indications.
Hypersensitivity to the active substance or to any of the excipients ; Patients who develop acquired (pure ) red cell aplasia following treatment with any erythropoietin should not receive Binocrit or any other erythropoietin ; Uncontrolled hypertension ; Patients who for any reason can not receive adequate antithrombotic prophylaxis.
The use of epoetin alfa in the indication "increasing the yield of autologous blood" is contraindicated in patients with myocardial infarction or stroke in the month before treatment ; with unstable angina pectoris ; increased risk of deep venous thrombosis such as e. history of venous thromboembolic disease .
The use of epoetin alfa in patients scheduled for major elective orthopedic surgery and not participating in the program prior to making autologous blood is contraindicated in patients with severe coronary , peripheral arterial , carotid or cerebral vascular disease , including patients with recent myocardial infarction or cerebrovascular accident .
Special warnings and precautions for use :
Interaction with other medicinal products and other forms of interaction : There is no evidence that treatment with epoetin alfa alters the metabolism of other drugs. There is a potential for interaction with cyclosporine , as it binds to the erythrocytes. If epoetin alfa is given concomitantly with cyclosporin , blood levels of cyclosporin should be monitored and the dose of cyclosporin adjusted as the hematocrit rises . No evidence of reaction between the epoetin alfa and granulocyte colony-stimulating factor (G-CSF) or granulocyte macrophage -colony stimulating factor (GM-CSF) with respect to haematological differentiation or proliferation of tumor biopsy specimens in vitro.
Pregnancy and lactation :
There are no adequate and well-controlled studies with epoetin alfa in pregnant women. Studies in animals have shown reproductive toxicity. In patients with chronic renal failure , Binocrit should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus ; Not recommended for use of epoetin alfa in pregnant or lactating surgical patients participating in the program for the disposal of autologous blood .
Special precautions for storage :
Store and transport refrigerated ( 2 ° C- 8 ° C). Do not freeze . Keep the pre- filled syringe in the outer carton to protect from light. In ambulatory use, the patient may remove Binocrit from the refrigerator and store it at a temperature below 25 ° C for a single period up to 3 days.
Binocrit 1000 IU / 0,5 ml solution for injection in pre-filled syringe (glass type I), with or without a needle safety guard , with plunger ( Teflon-faced rubber ) sealed in a blister. The syringes contain 0,5 ml ( 1000 IU) of solution. Pack of 1 or 6 syringes.