Therapeutic Epoetin Zeta antibody from the biosimilar Silapo® commercial drug.
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|API type||Glycoprotein hormone|
|Pharmacotherapeutic group||Other antianaemic preparations, erythropoietin|
|Target of antibody||Erythropoietin cell surface receptors|
|General function||Epoetin zeta is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF)|
(Mechanism of action; Source EMA document)
|Epoetin zeta is a biosimilar medicinal product. Erythropoietin (EPO) is a glycoprotein hormone produced primarily by the kidney in response to hypoxia and is the key regulator of RBC production. EPO is involved in all phases of erythroid development, and has its principal effect at the level of erythroid precursors. After EPO binds to its cell surface receptor, it activates signal transduction pathways that interfere with apoptosis and stimulates erythroid cell proliferation. Recombinant human EPO (epoetin zeta), expressed in Chinese hamster ovary cells, has a 165 amino acid sequence identical to that of human urinary EPO; the 2 are indistinguishable on the basis of functional assays. The apparent molecular weight of erythropoietin is 32 000 to 40 000 dalton|
|Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)||After single doses (20 000 to 160 000 IU subcutaneously) of epoetin alfa, a dose-dependent response was observed for the pharmacodynamic markers investigated including: reticulocytes, RBCs, and haemoglobin.|
|Original license holder||Stada Arzneimittel AG|
|Marketing authorisation numbers||EU/1/07/432/001- EU/1/07/432/047|
|Marketing authorisation holder||STADA Arzneimittel AG
D-61118 Bad Vilbel
|Name of the manufacturer of the biological active substance||Norbitec GmbH Pinnauallee 4 D-25436 Uetersen Germany|
|Name and address of the manufacturer(s) responsible for batch release||STADA Arzneimittel AG Stadastrasse 2-18 D-61118 Bad Vilbel Germany|
|Max shelf life||30 months|
|Storage conditions||2°C – 8°C|
|List of excipients||Disodium phosphate dihydrate, Sodium dihydrogen phosphate dihydrate, Sodium chloride, Calcium chloride dihydrate, Polysorbate 20, Glycine, Leucine, Isoleucine ,Threonine, Glutamic acid, Phenylalanine, Sodium hydroxide (pH adjuster), Hydrochloric acid (pH adjuster).
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