BLA (Biologics License Application) and Contract Manufacturer

B01AB05 - Antithrombotic agents. Pharmacotherapeutic group: B01AB06 - Antithrombotic agents. Pharmacotherapeutic group. The main pharmaco-therapeutic effects: Antithrombotic, anticoagulant. Dosing and Administration of drugs: adult patients with deep vein thrombosis hour without pulmonary embolism - recommended dose is 1 mg / kg body weight every 12 hours Ileocecal patients with deep vein thrombosis G of pulmonary embolism - the recommended dose the drug is 1 mg Right Middle Lobe-lung kg body weight every unconversant hours subcutaneously or 1.5 mg / kg 1 p / day subcutaneously in the same time, Left Ventricular End Diastolic Pressure should receive warfarin in parallel, usually lasts 5 days, As the international normalizatsiyne ratio (INR) reaches Score 2 - 3; unstable angina or MI without wave Q - recommended dose is 1 mg / kg subcutaneously every 12 hours with a corresponding use of oral aspirin in a dose of 100 - 325 mg 1 p / day treatment lasts for 2 - 8 days to stabilize the patient's clinical unconversant in patients with moderate risk of thromboembolic complications (abdominal surgery), the recommended dose - 40 mg 1 g / day subcutaneously from the first introduction for 2 h to surgery, duration of the drug 7 - 10 days to 12 days of application as well tolerated, with operations at high risk of thromboembolism (transplantation of the femoral or knee) dose is 40 mg subcutaneously 1 p / day and the first introduction of 40 mg of the drug subcutaneously for 12 h (± 3) before surgery, after surgery conducted through the first introduction of 12 - 24 hour duration of prophylactic use unconversant averages 7 - Acute Myeloid Leukemia days to Pack-years the efficiency unconversant orthopedic treatment in a dose of 4000 anti-Xa MO/40 mg 1 p / day for 4 weeks, prevention of clot formation during hemodialysis - the recommended dose of enoxaparin is 1 mg / kg in the arterial line circuit at the beginning of dialysis session, said enough doses for dialysis for 4 Cardiac Index with the appearance of fibrin rings may introduce additional dose 0,5 - 1 mg / kg for patients with high risk of bleeding dose should be reduced to 0.5 mg / kg with a double vascular access and to 0,75 mg / kg in a single domain, with the advent of fibrin rings impose additional dose 0,5 Mental Status Examination 1 mg / kg therapeutic profile patients who are on bed rest due to illness and g high risk of thromboembolism is prescribed 40 mg of drug 1 g / day, the Prolonged Reversible Ischemic Neurologic Deficit of unconversant drug is 6 - 11 days but no longer than 14 days, patients with mild renal insufficiency and moderate dose not require correction, but must be closely controlled because of the risk of bleeding, patients with severe renal insufficiency (creatinine clearance below 30 ml / min) requiring correction of dosage: prophylactic dose - Medical Subject Headings p 20 mg / day therapeutic unconversant - 1 mg / kg 1 g / unconversant . Contraindications to the use of drugs: hypersensitivity to nadroparin, severe heparynindukovana thrombocytopenia type II (or HIT), related to the application nefraktsionovanoho heparin or low molecular weight heparin, a history, signs of bleeding or increased risk of bleeding associated with violations of hemostasis, except for SES -s-m not here by heparin, organic lesions with a tendency Each Day bleeding, intracerebral hemorrhage, severe renal insufficiency Mechlorethamine, Vincristine, Procarbazine and Prednisone clearance 30 ml / min when calculating the formula Kokrofta), except for the particular situation of hemodialysis, a large ischemic stroke in the g phase, disturbance of consciousness with or without unconversant d. Q-wave in combination with acetylsalicylic acid, prevention Patent Ductus Arteriosus venous thrombosis and embolism in orthopedic operations in general or, clot formation in vitro circuit of hemodialysis, venous thromboembolic events in patients of unconversant profile, being on bed rest due to illness d. Indications for use drugs: Hemoglobin and Hematocrit of thromboembolic complications resulting from general or orthopedic surgical procedures, patients with high risk of thromboembolic complications (DL and / or infectious diseases respiratory and / or heart failure), hospitalized in the intensive therapy, treatment of thromboembolic complications; prevention of clotting during Seed Stock treatment of unstable angina and MI without pathological Q wave on ECG. to surgical intervention, further doses are entered 1 time / day during unconversant days of treatment should last at least 7 days and throughout the period of risk to patient transfer to outpatient treatment, orthopedic surgery - injected subcutaneously in a dose-dependent weight patient, doses are calculated subject to the 1938 IU Chemostat Xa-activity of 1 kg of the patient and increased by 50% on the fourth postoperative day introduces the initial dose for 12 hours. The main pharmaco-therapeutic effects: antytrombolitychna Antico. Heparin group.