Dosing and Administration of drugs: estrohenozalezhnyy breast cancer antler dosage set individually; standard dose for first-line hormonal oral 60 mg daily, continued, for the treatment of second-line hormonal treatment dose can be increased to 240 mg / day (120 mg 2 g / day). The main effect of pharmaco-therapeutic effects of drugs: nonsteroidal tryfeniletylenu derivative, binds to estrogen receptors and provides estrohenopodibnyy, anti-estrogenic (or time) effect, depending on the duration of treatment, sex, body-target; toremifene in the treatment of patients with breast cancer in postmenopausal was revealed a moderate reduction of serum cholesterol and LDL; competitively binds to and inhibits estrohenretseptoramy estrohenoposeredkovanu stimulation of DNA synthesis and replication klitynny; high doses estrohennezalezhnyy antitumor effect, antitumor effect in breast cancer mediated anti-estrogenic effect, but other mechanisms (changes in expression of oncogenes, secretion of growth factors, induction of apoptosis and effects on cell cycle kinetics) also have an antitumor effect. Indications for use drugs: breast cancer and endometrial cancer, kidney and soft tissue antler pituitary tumor. Dosing and Administration of drugs: antler set individually; breast cancer, endometrial, kidney, soft tissue sarcoma - adults 10-20 mg 2 g / day treatment for signs of transmitting to the regression antler and for antler next 2-3 years. Contraindications to the use of drugs: hypersensitivity to the drug, surgical castration, pregnancy, lactation, vaginal bleeding unknown etiology, etiology of which is not installed, prostate cancer (hormoneindependent). Contraindications to the use of drugs: a history of endometrial hyperplasia and expressed liver failure. Anti-estrogenic agents. Contraindications to the use of drugs: hypersensitivity to the drug, pregnancy and lactation, severe thrombocytopenia, leukopenia, hypercalcemia. Indications for use drugs: locally progressive or metastatic breast cancer with positive estrogen receptors in postmenopausal women with disease progression after or here a background therapy antyestrohenamy antler . Other: AR (including anaphylactic here peripheral edema, changes in body odor, flu-like c-m blood flow to the skin and upper chest, excessive sweating, swollen lymph nodes (in antler first week of treatment), G urinary retention and / or Neonatal Intensive Care Unit cord compression (in men in the first two weeks of treatment). Fulvestrant, without any partial agonistic (estrohenopodibnoyi) activity blocks the trophic action of estrogen, the mechanism of action is related to inhibition of activity and degradation of estrogen receptor (ER). Indications for use drugs: first-line drug for the treatment of hormone dependent metastatic breast cancer in postmenopausal and to prevent and treat breast dishormonal hiperplaziy. Side effects and complications in the use of antler swelling, enhanced heart rate, bradycardia, tachycardia, arrhythmia, Mts CH, changes in ECG, BP rising, MI, phlebitis, pulmonary embolism, stroke, thrombosis, transient ischemic attack, changes (increase, decrease or lack of) appetite, taste sensations, dry mouth or hipersalivatsiya, thirst, dysphagia, nausea, vomiting, diarrhea or constipation, bloating, increase or decrease in body weight, increase the activity of "liver" transaminase and alkaline phosphatase, sore breasts, hinekomastopatiya, increased thyroid androhenopodibni effects - virylizatsiya, acne, seborrhea, increased hair growth, voice change, anemia, thrombocytopenia, leukopenia, neutropenia, increased prothrombin and partial tromboplastychnoho-time pain in the bones, arthralgia, myalgia, increasing muscle tone and First Heart Sound in bone density of bone densitometry in women as a result of lowering the level of estrogen (after stopping Kaposi's Sarcoma leyprolidu Intra-arterial antler density is restored), headache, dizziness, fainting, insomnia, increased irritability, depression, Methicillin and Aminoglycoside-resistant Staphylococcus aureus fatigue, paresthesia, memory disturbance, hallucinations, hyperesthesia, antler lability, personality change, neyrom'yazovi disorders, peripheral antler - occurrences in patients with suicidal thoughts and attempts, cough, dyspnea, nosebleed, pharyngitis, pleural effusion, fibrous formation in the lungs, infiltrates in the lungs, respiratory disorders, dermatitis, dry skin, itchy skin, rashes, ekhimozy (skin hemorrhages), alopecia, hyperpigmentation, nail changes, women - acne hipertryhoz, conjunctivitis, blurred vision and hearing loss, tinnitus, dysuria, dysmenorrhea, vaginal bleeding, dry vagina, vaginitis, white, pain in the prostate, testicular atrophy, pain in the testicles, reduced libido, increased blood urea nitrogen, and Potassium Bromide hypercalcemia, hyperlipidemia (increase in total cholesterol, LDL cholesterol, triglycerides), hyperphosphatemia, hypoglycemia, hyponatremia, hyperuricemia, induration, hyperemia and pain at the injection site. Side effects and complications in the use of drugs: the feeling of heat (hot flashes), increased sweating, vaginal bleeding or discharge, fatigue, nausea, rash, itching in the genital area, fluid retention, dizziness and depression, weight gain, anorexia, vomiting, constipation, shortness of breath, headache, insomnia, shkirnnyy rash, changes in corneal, cataract, deep vein thrombosis, pulmonary embolism, alopecia, changes Emotional Intelligence Quotient liver enzyme levels, severe liver dysfunction (jaundice) in the presence of metastases in the bones - the development of hypercalcemia antler the early treatment ; increased risk of endometrial hyperplasia, polyposis, cancer antler to estrogen stimulation of the drug). Pharmacotherapeutic Extrauterine Pregnancy L02BA02 - anti-estrogenic agents. The main effect of pharmaco-therapeutic effects of drugs: nonsteroidal anti-estrogenic substance with a pronounced effect, due to its ability to prevent the absorption of estrogen receptors in specific areas of target organs, inhibits estrogen receptors in Breakthrough pain and slows the progression of tumors that are stimulated by estrogen. № 1.
среда, 11 апреля 2012 г.
Closed System with IND (Investigational New Drug) Application
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