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FILGRASTIM
FILGRASTIM KONCENTROVANÝ ROZTOK
KONZENTRIERTE FILGRASTIM-LÖSUNG
FILGRASTIM-LÖSUNG, KONZENTRIERTE
ROZTOK FILGRASTIMU, KONCENTROVANÝ
SOLUTION CONCENTRÉE DE FILGRASTIM
FILGRASTIM (SOLUTION CONCENTRÉE DE)
ROZTOK BÍLKOVINY, KTERÁ MÁ STEJNOU PRIMÁRNÍ STRUKTURU JAKO FAKTOR STIMULUJÍCÍ GRANULOCYTÁRNÍ KOLONIE AŽ NA JEDNU PŘIDANOU AMINOKYSELINU, N-KONCOVÝ METHIONIN (R-MET HU G-CSF)
SOLUTION OF A PROTEIN HAVING THE PRIMARY STRUCTURE OF THE 174-AMINO-ACID ISOFORM OF HUMAN GRANULOCYTE COLONY-STIMULATING FACTOR (HUG-CSF) PLUS 1 ADDITIONAL AMINO ACID, AN N-TERMINAL METHIONINE. IN CONTRAST TO ITS NATURAL COUNTERPART, THE PROTEIN IS NOT GLYCOSYLATED. HUG-CSF IS PRODUCED AND SECRETED BY ENDOTHELIAL CELLS, MONOCYTES AND OTHER IMMUNE CELLS. THE PROTEIN STIMULATES THE DIFFERENTIATION AND PROLIFERATION OF LEUCOCYTE STEM CELLS INTO MATURE GRANULOCYTE
SOLUTION OF A PROTEIN HAVING THE PRIMARY STRUCTURE OF THE GRANULOCYTE COLONY-STIMULATING FACTOR PLUS 1 ADDITIONAL AMINO ACID, AN N-TERMINAL METHIONINE (R-MET HU G-CSF). IN CONTRAST TO ITS NATURAL COUNTERPART, THE PROTEIN IS NOT GLYCOSYLATED. HUMAN G-CSF IS PRODUCED AND SECRETED BY ENDOTHELIUM, MONOCYTES AND OTHER IMMUNE CELLS. THE PROTEIN STIMULATES THE DIFFERENTIATION AND PROLIFERATION OF LEUCOCYTE STEM CELLS INTO MATURE GRANULOCYTES. CONTENT: MINIMUM 0.9 MG OF PROTEIN PER MILLILITRE. POTENCY: MINIMUM 0.9 × 108 IU PER MILLIGRAM OF PROTEIN
RECOMBINANT FORM OF HUMAN GRANULOCYTE COLONY-STIMULATING FACTOR (R-METHUG-CSF). IT IS A SINGLE CHAIN, 175 AMINO ACID NONGLYCOSYLATED POLYPEPTIDE PRODUCED BY ESCHERICHIA COLI BACTERIA TRANSFECTED WITH A GENE ENCODING A METHIONYL HUMAN GRANULOCYTE COLONY-STIMULATING FACTOR. WHEN PREPARED AS A DRUG SUBSTANCE, IT CONTAINS NLT 0.9 MG/ML OF FILGRASTIM. FORMULATION CONTAINS ONE OR MORE SUITABLE BUFFERING AND/OR STABILIZING AGENTS. THE PRESENCE OF HOST CELL DNA AND PROTEIN IN FILGRASTIM IS PROCESS-SPECIFIC. THE CAPABILITY OF THE PROCESS TO CLEAR HOST-DERIVED DNA AND PROTEIN REQUIRES VALIDATION AND IS DETERMINED BY VALIDATED METHODS. IT HAS A BIOLOGICAL POTENCY OF NLT 80% AND NMT 125% RELATIVE TO STANDARD ON A MASS-TO-MASS BASIS