INSTRUCTION ON MEDICAL APPLICATION
0.5%, 1%, AND 3% SOLUTION OF GLUTOXIM FOR INJECTIONS
International unpatented name: Disodium salt of bis-(g -L-glutamyl)-L-cysteinyl-bis-glycine.
Active principle: glutoxim (Disodium salt of bis-(g -L-glutamyl)-L-cysteinyl-bis-glycine).
Additional compounds: isotonic sodium chloride solution.
Colorless transparent liquid.
"Glutoxim" is a chemically synthesized biologically active substance - hexapeptide (disodium salt of bis-(g -L-glutamyl)-L-cysteinyl-bis-glycine) with a sum formula (C20H32O16N6S2).
"Glutoxim" injection form is manufactured as a sterile solution for intramuscular, intravenous and subcutaneous use.
"Glutoxim" is related to a new class of medical agents - thiopoietins, which has a unique biological activity due to a modulating effect on intracellular processes of thiol metabolism that plays an important role in a genetic and metabolic processes' regulation in cells and tissues.
The basic mechanism of the drug biological and pharmacological efficacy is a regulable escalation of cells' redox state. New level of redox systems and dynamics of phosphorilating of key proteins of signal-transducing systems and transcriptional factors (NFkB and AP-1), first of all, in immunocompetent cells determinates immunomodulating and systemic cell-protective drug effects.
Glutoxim is capable to perform differentiated impact on normal (stimulation of differentiation and proliferation) and on transformed (induction of apoptosis, genetically programmed cell death) cells. Main immune and physiologic drug features are the following: high drug affinity to cells of central immunity organs and lymphoid tissue system; enhancement of bone marrow hemopoiesis - processes of erythropoiesis, lymphopoiesis and granulocyto-monocytopoiesis; phagocytosis system activation including immunodeficiency conditions; restoration of neutrophil, monocyte, lymphocyte counts in peripheral blood and tissue macrophage functional capacities.
Among Glutoxim immune biochemical properties the following should be underlined: drug stimulating effect on cascade mechanisms of phosphate modifications of main proteins of the signal-transducing systems; initiation of cytokine systems including endogenous production of IL-1, IL-6, TNF, IFN, erythropoietin, and reproduction of IL-2 effects through its receptor expression induction.
Glutoxim is related to a group of natural metabolites that determinates its metabolism characteristics by existing cell enzyme system. Biological availability after intramuscular, intravenous and subcutaneous injection exceeds 90%. There is a linear dependence between dose and drug concentration in blood plasma. Maximum drug concentration in plasma after an intravenous introduction is observed in 2-5 min., after an intramuscular introduction - in 7-10 min. As a natural compound of peptide origin Glutoxim is metabolized in organs and tissues being eliminated through kidneys.
Glutoxim is administered to adults as an agent for prophylaxis and treatment of secondary immunodeficient conditions induced by radiation, chemical and/or infectious factors; to restore inhibited immune reactions and suppressed bone marrow condition; to enhance body resistance to multifarious pathologic impacts such as infectious agents, chemical and/or physical factors (intoxication, radiation, etc.); as a hepatoprotective agent for acute and chronic viral (B and C) hepatitis eliminating chronic virus-carriage objective signs; to potentate antibacterial therapy effects for chronic obstructive lung diseases; to prevent postoperative suppurative complications.
Glutoxim introduction is contraindicated only in cases of individual intolerance.
Some patients may note an insignificant temperature raise (to 37.10C - 37.50C) and tenderness in a drug introduction site. If subjectively such tenderness is tolerated badly it's recommended administering Glutoxim along with 1-2 ml of 0.5% Novocain solution.
In 1.0-ml and 2.0-ml ampoules.
Glutoxim should be stored in a dry, shadowed place at +40 - +60C.
Prescribed by a medical doctor.
PharmaBAM Ltd., 47, Myasnitskaya str.,
For more references:
Dr. Giorgio Castello
Via A. Cecchi, 19/9
16129 – Genova (Italy)