Vials. Vial contains streptokinase 1 500 000 IU.
PHARMACODYNAMICS. Rotakinase - fibrinolytic agent containing streptokinase, enzymatic protein produced from group C p-hemolytic streptococcus culture with molecular weight about 50.000 daltons. At interaction with plasminogene (profibrinolysine) it forms a complex that activates a transition of blood plasminogen or blood clot in plasmine (fibrinolysine) - proteolytic enzyme dissolving the fibrin fibers in blood clots and thrombus. This causes the degradation of fibrinogene and plasma proteins, including coagulation factors. It dissolves thrombus through action both on their surface and from inside. PHARMACOKINETICS. T1/2 after intravenous injection of 1 500 000 IU - 1 h, streptokinase - plasminogene complex - about 23 min. It biotransformes in liver by hydrolyze. It eliminated through kidneys in small quantities. Clearance is delayed at liver disease, but renal failure doesn't influence on it.
- acute myocardial infarction (during the first 12 h), refractory angina;
- pulmonary embolism;
artery thrombosis and thromboembolism (acute, subacute, chronic thrombosis of peripheral arteries, chronic obliterating endarteritis, arteriovenous shunt obliteration);
- occlusion of central retinal vessels with limitation to duration of less than 6-8 h (arteries),or less than 10 days (veins);
- artery thrombosis due to diagnostic or therapeutic procedures in children, vessel thrombosis at catheterization in newborn children;
- viscera vein thrombosis, deep veins thrombosis in the extremities (with limitation of
duration to less than 14 days) and in the pelvis;
- rethrombosis after vascular operation;
- thrombosis of hemodialysis shunt;
- thrombosis of prosthetic repair cardiac valve.
- surgical operation, trauma, biopsy, vessel puncture (subcluvian or jugular vein), cardiac tamponade, endotracheal intubation made during the last 10 days;
- coronary artery lesion, that can be at heavy arterial hypertension, hypertonic or diabetic retinopathy, stroke within 2 months or other cerebrovascular pathology, aneurism;
- bleeding or high risk of bleeding appearance (hemorrhagic diatheses, thrombocytopenia, heavy hepatic and/or renal failure, peptic ulcer in last 6 months, nonspecific ulcerative colitis, diverticulitis, menses, pregnancy, state after delivery, active tuberculosis, tumors, acute pancreatitis);
- risk of cardiac embolism, for example, at atrial fibrillation on the background of mitral valve damage and bacterial endocarditis;
- recent treatment with streptokinase (from 5 days to 6 months);
mitral heart disease with atrial fibrillation, septic endocarditis;
cancer of the brain and metastases in CNS.
Nonspecific protein reactions during Rotakinase administration: headache, nausea, fever, allergic reactions (in case of highly expressed allergic reaction it is recommended to administer corticosteroids), bleeding from the injection points, gums. Development of hypotension and arrhythmias. The possibility of embolism should be taken into account.
DOSAGE AND ADMINISTRATION:
It is directed for intravenous injection, and in some cases for intra-arterial or intra- coronary administration. At myocardial infarction (during the first 12 hours) it is prescribed intravenously in a dose 1 500 000 IU, dissolved in 100 ml of 0.9% sodium chloride solution or 5% glucoses solution. It is possible to use intra-coronary injection in a dose of250 000 - 300 000 IU during 30-60 min. At thrombosis of peripheral arteries and veins: in case of short-term thrombolisis - intravenously, in initial dose of 250 000 IU during 30 min, in supporting -1 500 000 lU/h during 6 h; in case of long-term thrombolisis - 250 000 IU intravenously during 30 min, then 1 000 000 lU/h in form of infusion, with duration from 12 h to 3-5 days. At thrombosis of deep vein, pulmonary artery thromboembolism and arterial occlusion - intravenously in a dose of 250 000 IU in 100- 300 ml of solvent during 30 min. The supporting treatment 100 000 IU Rotakinase every hour during 3 days. For dissolution of thrombosis in hemodialysis shunts 10 000 - 25 000 IU is introduced in clotted shunt. Children, including new bom children, at artery thrombosis - intravenously 1000-10000 lU/kg of body weight during 20-30 min, with further continuation (but not more than 5 days) of intravenous infusion of 1000 IU/kg/h.
1 vial with enclosed leaflet in carton box.