Epoetin zeta

Therapeutic Epoetin Zeta antibody from the biosimilar Silapo® commercial drug.

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EPO receptor
Biosimilar
,
Glycoprotein hormone
Silapo®
40000 IU/mL
5000 IU
-80°C
08/2022
409,00 
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Silapo® / Epoetin zeta Biosimilar Drug

Drug nameSilapo®
INNEpoetin zeta
API typeGlycoprotein hormone
Pharmacotherapeutic group
Other antianaemic preparations, erythropoietin
ATC code
B03XA01
Target of antibody
Erythropoietin cell surface receptors
General functionEpoetin zeta is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF)
Short description
Pharmacodynamic properties
(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

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany
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 releaseSTADA 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).
Contains phenylalanine.
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