NANOKINE
COMPOSITION
Each lyophilized powder vial contains: rHu EPO 2000 IU, 4000 IU, 10000IU
Each glass vial of 1 mL contains : rHu EPO 2000 IU, 4000 IU, 10000 IU
Each prefilled syringe of 0.5 mL contains :rHu EPO 2000 IU, 4000 IU, 10000 IU
THERAPEUTIC INDICATIONS
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:
• Treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis
• Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis.
-Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).
Administration route: SC or IV injection.
CONTRAINDICATIONS
NANOKINE should NOT be used for patients:
· Have uncontrolled hypertension.
· Develop pure red cell aplasia (PRCA) following treatment with erythropoietin
· Hypersensitivity to the active substance or to any of the excipients.
· Have surgery and cannot receive adequate antithrombotic prophylaxis for any reason.
· Have autologous blood predonation programmes
· Are scheduled for major elective orthopaedic surgery and not participating in an autologous blood predonation
· Suffer severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.
STORAGE, SHELF-LIFE AND PACKING UNITS
Storage: at 2°C - 8°C. Do not freeze. Protect from light.
Shelf life: 24 months from manufacturing date. Reconstituted solution is stable for 7 days at temperatures of 2°C - 8°C.
Packing units:
Box of 1 vial of lyophilized powder NANOKINE 2000 IU, 4000 IU, 10000 IU and 1 vial solvent (1 mL)
Box of 1,10 vial(s) of solution for injection NANOKINE 2000 IU, 4000 IU, 10000 IU (1 mL)
Box of 01, 06, 12 prefilled syringe(s) of solution for injection NANOKINE 2000 IU, 4000 IU, 10000 IU