Indications

Epoetin Beta is indicated for:

Treatment of symptomatic anemia associated with chronic kidney disease (CKD) in patients on dialysis.

Treatment of symptomatic renal anemia in patients not yet undergoing dialysis.

Prevention of anemia of prematurity in infants with a birth weight of 750 to 1500 g and a gestational age of less than 34 weeks.

Treatment of symptomatic anemia in adult patients with non-myeloid malignancies receiving chemotherapy.

Increasing the yield of autologous blood from patients in a pre-donation programme.

Its use in this indication must be balanced against the reported increased risk of thromboembolic events. Treatment should only be given to patients with moderate anemia (Hb 10–13 g/dl [6.21–8.07 mmol/l], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).

Dosage & Administration

Therapy with Recormon should be initiated by physicians experienced in the above- mentioned indications. As anaphylactoid reactions were observed in isolated cases, it is recommended that the first dose be administered under medical supervision. Substitution by any other biological medicinal product requires the consent of the prescribing physician.

Lyophilisate and solvent for solution for injection: The multidose preparation can be used for several patients. To avoid the risk of cross-infection, always follow aseptic techniques and use disposable sterile syringes and needles for each administration.

Solution for injection in pre-filled syringe: The Recormon pre-filled syringe is ready for use. Under no circumstances should more than one dose be administered per syringe; the medicinal product is for single use only.

Treatment of patients with anemia due to chronic kidney disease: The reconstituted solution can be administered subcutaneously or intravenously. In case of intravenous administration, the solution should be injected over approx. 2 minutes, e.g. in hemodialysis patients via the arterio-venous fistula at the end of dialysis. For non-hemodialysed patients, subcutaneous administration should always be preferred in order to avoid puncture of peripheral veins. In CKD patients, the aim of treatment is to reach a target Hb level of 10–12 g/dl. An Hb level of 12 g/dl should not be exceeded. If the rise in hemoglobin is greater than 2 g/dl (1.3 mmol/l) in 4 weeks, an appropriate dose reduction should be considered. In the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases, the weekly increase in Hb and the target Hb should be determined individually taking into account the clinical picture. Patients should be monitored closely to ensure that the lowest dose of Recormon is used to provide adequate control of the symptoms of anemia.

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