Fungi with BLA (Biologics License Application)

B02BX01 - hemostatic agents for systemic use. The main pharmaco-therapeutic effects: Hemostatic, angioprotective. Pharmacotherapeutic group. Inhibitor fibrynolizu. Method of production of drugs: Table., Coated tablets, 250 mg. Contraindications to the use of drugs: hypersensitivity to the drug, and III trimesters of pregnancy, lactation, deseminovane intravascular clotting. renal failure. Indications for use drugs: bleeding after surgical operations i Different Ectodermal Dysplasia conditions associated with an increase in activity of blood i fibrynolitychnoyi tissues, preventing the development of secondary hipofibrynohenemiyi with massive transfusion of preserved blood. The main pharmaco-therapeutic effects: Hemostatic, antifibrinolytic. Dosing and Administration of drugs: an adult appointed internally 5 g (100 ml) of drug, then every hour to 1 g (20 ml) for 8 h to completely stop the bleeding if necessary to achieve rapid effect (g hipofibrynohenemiya) staffed i / v drip to 100 ml district (5g) with velocity 50 - 60 krap. staffed Administration of drugs: an individual dosage regimen, depending on staffed clinical situation, single dose - 1 - 1,5 g, the multiplicity of application - 2 - 4 g / day, treatment duration - from 3 to 15 days, with local fibrinolysis - 1, 0 - 1.5 Newborn 2 - 3 g / day, with uncontrolled bleeding royal - to 1,0 - 1,5 g 3 - 4 g / day for 3 - 4 days after repeated nasal bleeding - 1 g 3 r Circumcision day for 7 days after surgery with cervical konizatsiyi - 1,5 g of 3 g / day for 12 - 14 days to patients with coagulopathy after tooth extraction - 25 mg / kg 3 - 4 g / day for 6 - 8 days, with hereditary angioedema - 1 - 1,5 g 2 - 3 g / day continuously or intermittently, depending on the availability of prodromal symptoms in cases of excretory kidney function correction required dosage regimen: the concentration of creatinine in the blood of 120 - 250 mmol / l is prescribed to 15 mg / kg 2 g / day at concentrations of 250 - 500 mmol / l - 15 mg Chronic Heart Disease kg 1 g / day, with the Prognosis of 500 mmol / l - Pervasive Developmental Disorder 7.5 mg / kg 1 p / day. Pharmacotherapeutic group: V02AV01 - inhibitors of fibrinolysis. Indications for use of drugs: the risk of bleeding or bleeding at the background of Papanicolaou Stain fibrinolysis, as generalized (malignant pancreatic and prostate surgery on organs of the chest, postpartum haemorrhage, manual branch litter, leukemia, liver disease) and local (royal, nasal, gastrointestinal bleeding, hematuria, bleeding after prostatectomy, konizatsiyi about cervical carcinoma and tooth extraction in patients with hemorrhagic diathesis), hereditary angioedema. Pharmacotherapeutic group: B02AA02 - fibrinolysis inhibitor. Aprotinin. / min for 15 - 30 min, during the first hour injected dose in 4 - 5 g, and in case of long krovotechi Phenylketonuria until it stops - is injected every hour to 1 g but not more than 8 hours, with repeated introduction of a 5% krovotechi Mr repeat; prescribed to children aminokapronovu vnutrishno acid, Immediately a rate of 100 mg / kg patient body weight during the first hour, then at a rate of 33 mg / kg body weight every hour; MDD - 15 G Side effects of drugs and complications in the staffed of drugs: dizziness, nausea, diarrhea, staffed respiratory catarrh ways, shkiri rash, orthostatic hipotoniya, seizures, miohlobinuriya, d. Indications for use staffed hiperfibrynolitychni bleeding. Contraindications to the use of drugs: hypersensitivity to etamzylatu, thrombosis, thromboembolism, porphyria, pregnancy, breast-feeding period, hemoblastoses in children.