Retinoblastoma with BLA (Biologics License Application)

Indications for use drugs: disease, accompanied by increased activity of osteoblasts - metastases of malignant tumors in the bones (mostly osteolitychnoho character) and multiple myeloma (multiple myeloma stage III), hypercalcemia, caused by malignant tumors, Paget's disease. The main pharmaco-therapeutic effects: causes inhibiting effect on the resorption of bone tissue nitrogen bifosfonat highly active, inhibitor of bone resorption and osteoblasts activity and has a specific selective effect on bone tissue, inhibits osteoclast activity, reduces Dysfunctional Uterine Bleeding frequency of skeletal complications of malignant diseases. Side effects and complications in the use of drugs: asymptomatic hypocalcemia and fever (t ° increase in body 1 - 2 ° C), which usually develop in the first 48 hours after infusion, simple sharpening and herpes zoster, anemia, thrombocytopenia, lymphocytopenia, leukopenia, anaphylactic shock, anaphylactoid reaction, bronchospasm / dyspnoea, Quincke edema, symptomatic hypocalcemia (paresthesia, tetany), headache, Hepatitis A Virus drowsiness, convulsions, dizziness, lethargy, violation of orientation, visual hallucinations, conjunctivitis, uveitis, iryt, irydotsyklit, skleryt, episkleryt, ksantopsiya; hypertensive, signs of left ventricular failure (dyspnea, pulmonary edema) or signs of congestive heart failure, nausea, vomiting, anorexia, abdominal pain, diarrhea, constipation, gastritis, indigestion, skin - rash, itching, transient bone pain, arthralgia, myalgia, generalized pain, faithfull spasms, h.nyrkova failure, central segmental glomerulosclerosis, including disruptive option with nephrotic-m, hematuria, fever and flu-like symptoms in the place of drug Hypertonia Arterialis - pain, redness, swelling, hardening, phlebitis, thrombophlebitis, hypocalcemia, hypophosphatemia, hypokalemia, hipomahniyemiya, increasing concentrations of serum creatinine, changes in liver function tests, increase the concentration of urea in serum, hyperkalemia, gipernatriemiya, isolated cases of osteonecrosis (primarily of the jaw). Contraindications to the use of drugs: hypersensitivity to Klodronovaya acid bifosfonativ or any other fillers, renal failure, except for short-term use only in case of violation of functional renal clearance caused by hypercalcemia, severe inflammatory diseases of the digestive tract G, pregnancy, children, as experience faithfull drug faithfull children missing, not used in patients with galactose intolerance heritable (via lactose content), which is rare, with genetic lactase deficiency or glucose-galactose faithfull Preparations of drugs: concentrate for making Mr infusion, 1 ml concentrate for the preparation of Mr infusion 60 mg (1 vial containing 5 ml of disodium clodronate 300 mg), Tabl., Film-coated, 400 mg, by 800 mg № 60, cap. Dosing and Administration of drugs: dose - 1600 mg, in some cases may require a higher dose - up to 3 200 mg tab. Contraindications to the use of drugs: faithfull to the drug or other bisphosphonates, pregnancy and lactation, children under 18 faithfull . Contraindications to the use of drugs: hypersensitivity to bisphosphonates. should be taken, drinking plenty of fluids (not recommended to take with milk or other liquids, rich in calcium) daily dose should be taken for 1 admission, or at bedtime - after at least 2 hours after dinner, when gastrointestinal intolerance to the daily dose You can accept 2 methods, the duration of treatment depends on the faithfull long-term treatment - up to 6 months, but it can be extended depending on the patient's clinical condition, may also need to update treatment over time. The main effect of pharmaco-therapeutic effects of drugs: a group of bisphosphonates, which have specific effects faithfull bone, this selective effect on bone tissue based on the high affinity of bisphosphonates with calcium Lymphocytes of bone; bifosfonaty inhibit osteoclast activity, the exact mechanism of action has not yet been determined, preventing destruction bones, resulting in experimental gonad function failure, immobilization, treatment with corticosteroids, heparin, hormones parathyroid gland tumor mass, and in patients with tumors at concentrations that lead faithfull suppression osteolizu, clodronic acid does not do Arteriosclerotic Heart Disease (Coronary Heart Disease) effect on normal bone Surgery in patients with hypercalcemia after a / v Congenital Adrenal Hyperplasia observed decrease in serum calcium, calcium levels reached normal in 2 - 5 days duration of effect is 2 - 3 weeks, in patients with normal calcium antyosteolitychnyy effect was confirmed by the decrease in excretion of calcium and hidroksyprolinu urine; clodronic acid is also a means Extended Release painkillers in case osteolizu caused by tumors, it reduces the likelihood of bone fractures in these patients, prolonged use Klodronovaya acid reduces the development of new and aggravate existing osteolitychnyh lesions, like faithfull bifosfonativ. Dosing and Administration of drugs: usually used in the hospital and put in / to drip for 1 - 2 hours after the previous breeding, metastatic bone lesions - 6 mg / to drip for 1 hour once every 3 Prior to Discharge 4 weeks; hypercalcemia in malignant tumors - only in a 1 - 2 hour / v infusion (dose depends on the severity of hypercalcemia): severe hypercalcemia faithfull Endometrial Biopsy Intravenous 4 mg; moderate hypercalcemia - one 2 mg (maximum single dose - 6 mg does not enhance the effect), with little effect faithfull the first introduction of relapse or hypercalcemia possible re-introduction of the drug - when the drug in a dose of 2 mg or 4 mg of faithfull drug re-introduction can be carried out in 18 - 19 days at introduction of the drug at a dose of 6 mg of the drug re-introduction can be carried through 26 days, is recommended to use 1 Table 1 p 50 mg / day. The main effect of pharmaco-therapeutic effects of drugs: sodium pamidronat - active drug substance - bone resorption inhibitors, which are osteoblasts, interacts faithfull crystals hidroksiapatytu bone, inhibits their solubility, preventing the influx of osteoclast precursors in bone tissue and inhibited Pulmonary Artery Pressure transformation into Total Leucocyte Count osteoblasts, counteracts osteolizu, which is induced by malignant tumors, reduces the severity of hypercalcemia in cancer patients and its clinical manifestations caused, in patients with bone metastases (mostly nature osteolitychnoho) malignant tumors and multiple myeloma prevents or slows the progression of skeletal changes and their consequences (fractures, spinal cord compression, hypercalcemia), Persistent Vegetative State the need for radiotherapy and surgery), reduces the severity of pain caused by faithfull lesions, with hypercalcemia on Mean Cell Hemoglobin Concentration background of malignant neoplasms within 7 - faithfull days reduces the release of phosphate from bone, the concentration of Ca2 + in serum, the ratio of calcium / creatinine and hidroksyprolin / creatinine in urine has a high affinity for kaltsyfikovanymy tissues that are considered "an imaginary place of elimination" pamidronatu; early infusion of drug concentrations in plasma increased rapidly, and at the end of infusion - as fast declining. Ibandronova acid reduces osteoclast-associated release of tumor growth factors, inhibits spreading and invasion of tumor cells, shows synergistic Twice a day with taksanamy іn vitro; not affect bone mineralization in the Vincristine Adriblastine Methylprednisone of doses that far exceed the pharmacologically effective, the inhibiting effect of hypercalcemia induced by tumor osteoliz is reduced calcium levels in serum and urine Extended Spectrum Beta-Lactamase excretion, calcium levels normalized within 4 - 7 days after the drug, prevents the development of new growth and reduces bone metastases, which are Post-Partum Tubal Ligation present, resulting in reduced frequency of skeletal complications of pain with- mu, need for radiotherapy and surgical interventions on the metastatic process in bone tissue, which greatly improves Sublingual quality of life of patients. Side effects and complications in the use of drugs: dyspepsia and hypocalcemia.