domingo, 20 de novembro de 2011

Quality Assurance (QA) Group and Treatment Investigational New Drug

The human menopausal gonadotropin. Contraindications to the use of drugs: pregnancy and lactation, cysts or increase the size of the ovaries liked not associated with c-IOM polycystic ovarian metrorahiyi uncertain etiology, tumor of the uterus, ovaries or breasts. Method of production of drugs: lyophilized powder for making Mr injection of 75 IU FSH and 75 IU LH vial., Lyophillisate for Mr injection of 150 IU in vial. Indications for use drugs: female infertility with hypo-or normohonadotropnoyu liked failure - follicular growth stimulation, controlled ovarian hyperstimulation for induction of multiple follicular liked during assisted reproductive technology (ART), fertilization in vitro, and intraplazmatychniy sperm injection. Pharmacotherapeutic group: G03GA05 - gonadotropin. Contraindications to the use of drugs: pregnancy, increase or ovarian cysts not related to c-IOM polycystic ovarian gynecological bleeding of unknown origin, ovarian carcinoma, uterine or breast cancer, tumors of the hypothalamus or pituitary gland; hypersensitivity to the drug; cases of effective responses response to treatment can develop, for example through: the primary pathology of ovarian defects of genital organs liked with pregnancy; fibroyidni tumors of the uterus incompatible with pregnancy liked . Side effects and complications in the use of drugs: local reactions, increasing t °, joint pain, can not exclude the possibility of ovarian hyperstimulation, arterial thromboembolism, pregnancy loss rate due to her miscarriage or spontaneous abortion is not much different from frequency observed among women with liked reproductive disorders, women with tubal pathology may develop a history of ectopic pregnancy. Method of production of drugs: lyophilized powder for making Mr injection of 75 IU in vial., Lyophillisate for Mr injection of 75 IU, 150 IU in vial. Dosing and Administration of drugs: injected V / m or subcutaneously, the duration of treatment in each case depends on individual patient characteristics (level of estradiol and ultrasound data) in order to stimulate growth of follicles dose selected individually, depending on ovarian response liked adjusted after the ultrasound and blood estrogen levels, with inflated drug doses observed single or double-headed growth Acute Lymphoblastic Leukemia treatment, usually starting with a dose of 75-150 IU / day in the absence of ovarian response dose gradually increasing to register increase in estrogen blood or follicular growth, this dose is kept until the concentration reaches preovulyatornoho estrogen levels, the rapid increase in estrogen levels at the beginning of stimulation dose should be reduced, for ovulation induction in 1-2 days after the last injection administered once SFHE 5000 -10 000 IU lHH (in / liked Side effects and complications in the use of drugs: nausea and vomiting, endocrine and gynecological status - ovarian hyperstimulation, which clinically appears after appointment to ovulation, human chorionic gonadotropin (lHH), which can lead to the formation of large ovarian cysts, ascites, hidrotoraksu, oliguria, arterial hypotension, thromboembolic phenomena, AR and immune reaction - hypersensitivity reactions (t ° increase of the body, skin rash), the formation of a / t, which leads to inefficiency of therapy; locally - swelling, pain, itching in the place of others' injections. Indications for use drugs: to stimulate follicular development and ovulation in women with hypothalamic-pituitary dysfunction against a background of liked or amenorrhea; to stimulate the development of many follicles in patients who require superovulation for auxiliary reproduction techniques (including c-m polycystic ovaries - PCOS) women who were sensitive to treatment Clomifenum citrate; stimulation of multiple follicles in patients who are in the application of superovulation and Urinary Output reproductive technologies, together with the drug progestin hormone (LH) to stimulate follicular development in women with severe LH and FSH deficiency. Contraindications to the use of drugs: hypersensitivity to the drug, high levels of follicle stimulating hormone in primary ovarian failure, thyroid gland and adrenal glands at the stage of decompensation, infertility is not associated with ovarian dysfunction, metrorahiya, bleeding unclear etiology, pituitary tumor, cancer ovarian, uterine or breast cancer, ovarian increase (only with-m polycystic ovaries), pregnancy, lactation.

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