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Haematopoietic agent (Anemia, neutropenia)

NANOKINE

DESCRIPTION

 

 

NANOKINE is produced from raw high purity materials erythropoietin (EPO). Material EPO is produced by recombinant DNA techniques on ovarian cell lines marsupial cheeks of China (Chinese Hamster ovary, CHO). EPO gene coding for the protein was transferred into CHO cells (no gene EPO). CHO cell lines were cultured EPO gene in specific environments to produce EPO.

Erythropoietin alfa is recombinant human erythropoietin, contains 165 amino acids. Recombinant human erythropoietin and erythropoietin  (rHu EPO) completely natural sequence similarity and amino acid sequences oligosaccharide is very similar in structure carbon hydrate. Molecular group is more glycosylated. Erythropoietin has biological effects and immunology as endogenous erythropoietin and activity of 100,000 IU to 1 mg hormone.

NANOKINE is supplied in sterile, white, lyophilized powder. The reconstituted preparation with 1 ml solvent (containing 0.9% benzyl alcohol) results in a clear, colorless solution.

NANOKINE is supplied as an injectable solution in vials and prefilled syringes.  Injectable solution is sterile, clear, and colorless.

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 

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