Instruction For Use

Instruction for use GA-40.
Georgia – registration: № R- 014514, № R-015768.

GA-40 is a complex of peptides, obtained from the ecologically pure plant material. GA-40 contains biochemically purified standardized combination of plant origin natural peptides.


Composition
Acting substance: 1 mg of GA-40.
Supplement substances: 45 mg sodium chloride,
13,5 mg potassium dihidrophosphate, pH 7,4


Form of Production
GA-40 is produced in the form of a lyophilized powder. The packing box contains 5 vials. Each vial contains 1 mg lyophilized powder of GA-40.


Pharmacological Group and Classification Code
Immunomodulator – code: LO3A; antineoblastic - code: L01C.


Pharmacological Properties
Preclinical and clinical trials show that the drug GA-40 is an immunomodulator and belongs to immunocorrectors of immunorehabilitation type. The drug GA-40 is characterized by direct anti-tumor and indirect mediated by immunity anti-tumor action.


GA-40 possesses selective action. Unlike to chemical preparations GA-40 does not damage normal cells that define its safety action on any tissues and organs of the organism. GA-40 interacts with membrane DR receptors of death on the surface of the tumor cells and kills them by promoting apoptosis (programmed cellular death).


GA-40 causes normalization of p53, p21 functions and blocking of glutathione system of a tumor.


GA-40 causes activation of anti-tumor systems of immunity. GA-40 interacts with the specific membrane receptors located on a surface of mononuclear cells of immunity (monocytes, macrophages). As a result changes appear in the structure of phosphatidylserine and activation of Ca2 +- of independent protein kinase C from a class of new or atypical and tyrosine protein kinases - Ca (PKCε), Ca2 +-dependent on protein kinases +Ca (PKCα,) and the tyrosine protein kinases. Protein kinases way leads (TPK) to activation of a transcription factor of NF-kB and its translocation in a nucleus. Activation of NF-kB is expressed in increase of production of a factor of necrosis of a tumor (TNF-α), interferon - ү (INF-ү), activating the expression of specific genes. The mechanism of action of GA-40 is the cornerstone of the processes of activation of cells of immunity possessing ability to destroy cancer cells: natural killer cells (NK-cell), T-cytotoxic cells, macrophages and neutrophils.


Anti-tumoral action of GA-40 is also caused by its anti-angiogenesis property. GA-40 inhibits the release of vascular epithelial cell growth factor (VEGF) by cancer cells. GA-40 inhibits the development of new blood vessels or the process of neovascularization in malignant neoplasm’s and metastases, and practically prevents the spread of metastases in the body via blood circulatory system. GA-40 shows the expressed antioxidant and cytoprotector activity (neutralization of free radicals) that is especially important for the treatment of cancer patients by traditional methods and in the period of preventive treatment. Increase in a liver GA-40 causes the decrease in serotonin, lactic and piruvat acids, xanthine, uric acid, hydrogen peroxide and oxygen with two unpaired electrons and hydrogen with one unpaired electron. The latter ones are free radicals, high amount of which can be observed in the bodies of patients with malignant tumors, especially after radiotherapy and chemotherapy.


GA-40 has immunocorrective properties that make a correction of the immune status of the organism and restore the quantitative and functional indicators T and B of immune cellular systems i.e. T-helper cells, T-cytotoxic cells, T-killers (NK-cells), macrophages and granulocytes. It regulates the correlation of T-helper and T-suppressor cells. It also regulates the indicators of immunoglobulin’s, stimulates the production of cytokines, including the tumor necrosis factor (TNF-a) and interferon’s (INF).


GA-40 restores the functional activity of stem haemopoietic cells too, normalizing the content of leukocytes, erythrocytes, neutrophils, thrombocytes, lymphocytes and other blood forming elements.

GA-40 provides for normalization of the blood biochemical indicators – total protein, albumin, globulin, urea nitrogen, creatinine, bilirubin,glucose, as well as certain enzymes such as alanine-aminotransferase (ALT), aspartate-aminotransferase (AST), γ-glutamine-transpeptidase (γ-GP) and alkaline phosphatase. The preparation renders a positive influence on the dynamic contents in the bloodstream of carcinoembryonic antigens (CEA), alpha-fetoprotein (AFP), prostate-specific antigen (PSA), as well as the blood contents in mineral compounds of sodium, calcium, potassium and others.


Indications GA-40 is applied to:
* Malignant tumors

GA-40 treatment opens the following therapeutic possibilities: Treatment of cancer of all types and all stages offering a considerable chance of recovery even for patients in advanced stages who have exhausted all standard treatments. GA -40 reduces and decreases the rate of growth of the tumor cells, and results in the regression of tumor and metastases, considerably lessens the pain and increases the activity and life span of the patients.


It can be applied before and after surgical intervention in the preparation of planned surgical operations (the decrease of immunological indications is a direct contra-indication of surgical intervention), for rapid post-surgical recovery processes and for decreasing the risk of the initiation of progressive growth of hidden metastases mostly caused by the surgical removal of the initial tumor of the main localization and also for the inhibition of the processes of the arising and spreading of new metastases. Preparatory long-term GA-40 immunotherapy or combined with radio or chemotherapy in patients with a rapidly growing tumor to render inoperable tumors operable.


Application of GA-40 during and after radiation and/or chemotherapy increases the effect of contra-tumor treatment of oncological patients, considerably increasing the anti-carcinogenic effects, and what is most essential, the combined treatment decreases the toxic influence of chemical and radial therapy on the organism, which for its part causes serious complications and the necessity of interruption of treatment of oncological patients.


It may also be used:
· For leucosis - acute myeloid leukemia (AML) and chronic myeloid leukemia (CML) monotherapy or as an adjuvant therapy.
· For the treatment of benign tumors (fibroid, mioma, adenoma, cystose, etc.).
· During infection-inflammatory processes (pneumonia lobularis, bronchopneumonia, pulmonary tuberculosis, liver disorders (cirrhosis, hepatitis-C), chronic banal prostatitis etc.)
· Nontoxic preventive treatment for patients at risk (genetic predisposition coupled with environmental challenges), and those with precancerous lesions.
· For prophylaxis. It is recommended for persons above 40-50 age to carry out a course of treatment twice a year, to allow us to get rid of senile non-specific diseases, to reduce the risk of oncological diseases and to create a state of the organism in which susceptibility to virus and other infectious diseases is reduced to a minimum.

DOSAGE AND METHOD OF APPLICATION

​Each vial contains 1 mg GA-40 without violation hermetic. Add to each vial 5 ml water for injection, shake gently to disperse. GA-40 is injected intramuscularly or subcutaneously. One GA-40 injection dose is 100 mkg per each 50 kg of body weight accordingly 0.5 ml per each 50 kg of body weight (0.5 ml / 1-50 kg of body weight; 1 ml /50-100 kg of body weight; 1.5 ml / 100-150 of body weight). One course of treatment 20 days consists of 40 injections. Injection is recommended every 12 hours. Treatment period should last until full remission of an existing tumor or other diseases. It should consist of no less than 7 courses with time interval of 10 –14 days. As prevention (TasP) or prophylaxis (PrEP) the standard course of GA-40 therapy may be given at intervals of 2-4 months in this case one course of treatment 20 days consists of 20 injection.

​SIDE EFFECTS

In therapeutic dosage is non-toxic, no side effects, it is possible to reveal hypersensitivity towards the components.

​CONTRAINDICATIONS

It is not revealed.

​PREGNANCY AND BREAST-FEEDING

Ga-40 is used during pregnancy and lactation with no contraindications.

REFERENCES TO "WITHDRAWAL SYNDROME" RISK DEVELOPMENT

​The drug does not have the "withdrawal syndrome".

​SPECIAL INSTRUCTIONS

​Does not affect the ability to drive or work with machines.

OVERDOSE

​Ga-40, a 40-fold therapeutic dose is completely safe for the body.

​DRUG INTERACTIONS

​Compatible with all the drugs that are used in the above-mentioned diseases.

CONDITION AND TERM OF STORAGE

​It should be stored in a place protected from light at a temperature from  +10 to 20°C.

SHELF LIFE

​1 month after opening. 2 years unopened.

​PHARMACY ISSUING RULE

​Obtained with a prescription.

Medical & Biological Scientific - Research Center“ALEXIS” LTD

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