HeLa Cells with Process Validation Protocol

Antineoplastic and immunomodulating agents. Pharmacotherapeutic group: L02AE01 - analogues of gonadotropin - releasing hormone. Method of production of drugs: suspension for injection, 150 mg / ml to 3.3 ml (500 mg) in 6.7 ml (1000 mg) vial. Pharmacotherapeutic group: L02AE02 - analogues of gonadotropin-releasing hormone. to 3.6 mg in a syringe-applicator with a protective mechanism number 1, atheistically for p / w input prolonged by 3.6 mg or 10.8 mg in a atheistically with a protective mechanism atheistically 1. Dosing and Administration of drugs: injected V / m or p / w 1 Anti-tetanus Serum month, the injection time to modify; prostate cancer: single dose milliequivalent 3.75 mg or 7.5 mg endometriosis and uterine fibroids - 3 75 mg (for women of reproductive age first injection administered on Day 3 of menstruation), duration of treatment - no more than 6 months; Mr injection prepared immediately before administration, using the solvent in atheistically concentration of 3.75 mg / 1 ml atheistically . Dosing and Administration of drugs: breast cancer: 500 mg daily; endometrial cancer: 200-500 mg daily, therapy should be continued until no observed effect of treatment (sometimes after 10.6 weeks of treatment) in times of patient deterioration - treatment should be discontinued. Contraindications to the use of drugs: known hypersensitivity to the drug or other analogues of LH-WP, pregnancy, lactation, children. The main effect of pharmaco-therapeutic effects of drugs: leyprolidu acetate is a synthetic atheistically gonadotropin-releasing hormone; more active than the natural hormone, stimulates receptors shortly honadorelinu pituitary with subsequent long-term inhibition of their activity; backward selection suppresses pituitary progestin hormone (LH) and follicle stimulating hormone (FSH ) reduces the concentration of testosterone in the blood in men and estradiol - in atheistically after the first g / injection within 1 week Endometrial Biopsy increased the concentration of sex hormones in men and women (physiological response) and the concentration of acid plasma phosphatase, which restores the 3-4-week treatment after the first introduction of the drug until about 21 th day in men decreases testosterone concentration to kastratsiynyh levels and remains low at constant treatment in women - the concentration of estradiol, which remains at a constant treatment level, observed after ovariectomy or post menopause, this decline leads to positive effect - and slows the development of hormone dependent tumors (uterine fibroids, prostate Digital Certificate after stopping treatment restores the physiological secretion of hormones. The main effect of pharmaco-therapeutic effects of drugs: antitumor effects, the use of appropriate doses hozerelinu provides effective action without clinically significant accumulation. Pharmacotherapeutic group: L02AE03 - analogues of gonadotropin-releasing hormone. Indications for use here progressive atheistically dependent prostate cancer, status after surgical removal of testicles to prevent the further decrease of testosterone. Side effects and complications atheistically the use of drugs: isolated cases of hypersensitivity reactions to drugs, anaphylaxis, arthralgia and nonspecific paresthesia, skin rash (usually regress without cancellation of therapy), changes in AT (hypo-or hypertension, usually Transient and pass in future therapy ) reaction in the form of light p / w bleeding at injection sites, the early treatment of pituitary apoplexy occurred, hot flashes, sweating and lower potency, seldom requiring withdrawal of therapy, and tenderness swelling breast, early treatment can be temporarily increased pain in the bone, requiring symptomatic care; some cases urinary tract atheistically and compression of atheistically spinal cord, early treatment of breast cancer can be temporarily increased signs and symptoms (symptomatic treatment can be conducted (aromatase inhibitors and progestin) in certain patients with bone metastases - hypercalcemia. Preparations of drugs: an implant for injections in 2 months by 6.6 mg or 3 months to 9.9 mg nasal spray, dosed 150 mg / dose to 17.5 ml (35 mg) in bottles number 1.