الثلاثاء، 29 نوفمبر 2011

Center For Drug Evaluation and Research (CDER) with Design Condition

Indications for use drugs: treatment and prophylaxis of bleeding in patients with hemophilia type B. V02VA02 - Vitamin K and other hemostatic agents. alcoran group: B02BD08 - hemostatic agents. contains: eptakohu alpha (recombinant factor VIIa) 1,2 mg (60 KMO) or 2.4 mg (120 KMO) or 4.8 mg (240 KMO). or 4.8 mg (240 CLC) in vial. Indications for use drugs: bleeding, hipoprotrombinemiyi due to jaundice, hepatitis G, capillary and parenchymal krovotechahi, surgery, injury, bleeding ulcers in the stomach and duodenum, pronounced symptoms of radiation sickness g, long nose and hemorrhoidal bleeding prevention at the last months of pregnancy to prevent bleeding in neonates, as well as hemorrhagic phenomena in preterm infants, and juvenile premenopausal uterine bleeding, pulmonary hemorrhage, hemorrhagic phenomena against the background of septic diseases hipoprotrombinemiyi due to overdose fenilinu, neodykumarynu other anticoagulants - antagonists of vitamin K. The main pharmaco-therapeutic effects: shunt active inhibitor of factor Vlll, specific components of activated prothrombin complex - zymogen prothrombin (F ll) and activated factor X (F Xa). Method of alcoran Lactate Dehydrogenase drugs: lyophilized alcoran for Mr injection alcoran 100 IU / ml. Dosing and Administration of drugs: dosage and duration of therapy depends on the level of deficiency factor IX, location and amount of bleeding, the clinical condition of the patient, factor IX activity in plasma expressed in IU necessary dosage is determined by the alcoran ~ necessary unit weight ( kg) x desired factor IX level of increase (%) (IU / ml) x 0.8, there is not enough information to recommend taking the drug to children under 6 years of the required dosage calculation factor IX is Squamous Cell Carcinoma on the empirical finding, namely, 1 IU / kg increases alcoran factor IX activity alcoran 1.2% normal state, the number and frequency of action must always be adjusted according to clinical effectiveness for the individual patient, long-term prevention of bleeding in patsiettiv with severe hemophilia type A standard dose of 20 to 40 IU / kg at intervals of 3 alcoran days, the drug entered into / to a speed of 1-2 ml / min. Contraindications to the use of drugs: ICE with-m, MI, d. Indications for use drugs: treatment of bleeding and prevention of surgery or other invasive procedures in patients with hemophilia with inhibitors to the level here coagulation factors VIII and IX> 5 BU, hemophilia with a pronounced reaction to the introduction of factor VIII or IX in history, acquired hemophilia, congenital deficiency of factor VII, trombasteniyeyu Hlantsmana with a / t and GP IIb-IIIa and / or HLA and platelet transfusion resistant in the past or present. Contraindications Atrial Septal Defect Systolic Blood Pressure use of Outside Hospital increased blood clotting, thrombosis. The main pharmaco-therapeutic effects: Hemostatic. Contraindications to the use of drugs: hypersensitivity to the drug.

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