About the vaccine (information for professionals)

General characteristics
CANCER AUTOVACCINE (PAHs) - the first national anti-tumor agent that is prepared from the patient's own tumor tissue and products of microbial synthesis (lectins) Bacillus subtilis B-7025. The purpose of PAHs is the individual patient's long-term induction of immune responses aimed at deterrence and prevention of tumor recurrence and metastases.

PAH is a yellowish liquid, which combines a modified puhlynoasotsiyovani antigens and cytotoxic lectins. Depending on the histogenesis of tumor it is composed of several antigens with molecular weights of 15 to 70 kd. It is not harmful, is not toxic, sterile, does not have anaphylactic properties, for its production does not use preservatives. PAHs standardized to protein (by the method of Lowry), its total rate of vaccination is 45-60 mg.

Ways cytotoxic lectins, PAHs and treatment of cancer patients are protected 15 patents of Ukraine.

State service of medical drugs and medical supplies of the Ministry of Health of Ukraine found that PAH meet domestic and international safety standards and allowed for broad clinical use in Ukraine (Certificate № 411/03-300200000 of 9 December 2003).


Efficacy of anticancer autovaccine in the treatment of cancer patients
In clinical trials, conducted at the Institute of Oncology AMS of Ukraine (1980-2003 biennium) and the Russian Cancer Research Center of RAMS (Moscow) found that the use of PAHs in the combined treatment of patients with gastric cancer, colorectal cancer and lung cancer significantly improves the performance 5 -year survival and improves quality of life of patients.
Mechanism of action
Antitumor and antimetastatic efficacy of PAH based on the activation of cell-specific effectors and nonspecific immune response, activation antyhenprezentuyuchyh cells; content cytokines, etc. Immunization PAHs leads to statistically significant increase in T-and B-activated lymphocytes (p <0.05) compared with their number for surgical intervention. Observed increase in the relative content of CD3 and CD4 lymphocyte subpopulations simultaneously with a decrease in the number of CD8, increased activity antyhenprezentuyuchyh cells. Immunization PAHs leads to a significant growth of production of interferon α-(1.5 times), interleukins 1 and 2, tumor necrosis factor, serum cytotoxicity.
Indications
AUTOVACCINE used in the postoperative period to enhance antitumor resistance of the organism, preventing recurrence and metastases, prolongation and improved quality of life in patients with solid tumors when combined or integrated treatments. CAV is used for the intended purpose and under medical supervision.
Method and application features
PAHs injected subcutaneously. In patients with early-stage disease, absence of metastases, the prescription can be effective without the use of CAV chemotherapy or radiation therapy for 10-14 days after surgery. In the case of the need for pre-or post-operative course chemotherapy, or radiation therapy input autovaccine begin at 18-21 days after their completion. The complete course consists of 5 injections - 3 injections at intervals of 7 days and revaktsynatsiy at 1 and 6 months after the last vaccination.
Contraindication
End-stage malignant disease, allergic diseases, phlebitis, expressed forms of leukocyte-and lymphopenia. In case of post-operational period of severe complications (purulent-septic, cardiovascular, etc.) on the use of PAH should be resolved in each case individually and may change terms of early immunization.
Side effects
In 25% of patients have transient nature of pyrogenic reactions (with fever to 37,5-37,8 ° C for 4-6 hours), which removed paracetamol. In 40% of patients noticed slight pain in the vaccine.
Product and storage conditions
Standard penitsilinovi vials containing 3.0 ml of sterile PAH (1 dose on the bottle). In packages of five vials for the entire course vaccinotherapy. The vaccine is stored in a freezer at a temperature from -18 to -20 ° C is not recommended to defrost and re-freezing. The vaccine is thawed immediately before entering the patient. Opening bottles and injection procedure carried out in strict adherence to the rules of asepsis. Expiration PAHs - 9 months, lectins for their production are suitable for use within 10 years. According to the decision of the State Service for Drugs and Medical Devices Ministry of Health of Ukraine Institute of Experimental Pathology, Oncology and Radiobiology. P.YE. Kavetsky HAH Ukraine is a developer and manufacturer of PAH, the drug produces on the order of specialized medical institutions in the form of standard contracts.