Instruction for use: Urokinase medac

Dosage form: Lyophilizate for the preparation of a solution for infusions

Active substance: Urokinasum

ATX

B01AD04 Urokinase

Pharmacological group

Fibrinolytics

The nosological classification (ICD-10)

I26 Pulmonary embolism: Recurrent thromboembolism of the pulmonary artery; Recurrent pulmonary embolism; Thromboembolism of the branches of the pulmonary artery; Thromboembolism of the lungs; Thromboembolism of the pulmonary artery (PE); Thrombosis of the pulmonary artery; Thromboembolism; Thromboembolism of the pulmonary artery; Thromboembolism; Pulmonary embolism; Thromboembolism of the pulmonary artery and its branches; Thromboembolism of pulmonary vessels; Embolism of the lung; Embolism of the pulmonary artery; Acute massive thromboembolism of the pulmonary artery

I73.8 Other specified peripheral vascular disease: Syndrome of intermittent claudication; endarteritis obliterans; acrocyanosis; vasoconstriction; occlusive disease; Intermittent claudication; Disorders of vascular innervation; Spasm of peripheral arteries; Arterial angiopathy; Venous insufficiency and its complications; Spasm of peripheral vessels; The spasm of coronary vessels; endarteritis; cooling stop; Occlusal disorders of peripheral circulation; Peripheral vascular occlusion

I74.9 Embolism and thrombosis of unspecified arteries: Arterial embolism; Arterial thrombosis; Acute arterial thromboembolism; Acute vascular occlusion; Acute occlusion of arteries; Acute arterial thrombosis; Acute thrombosis; Acute thrombosis of peripheral arteries; Thrombosis; Thrombosis in the extracorporeal circulation; Thrombosis of peripheral arteries; Peripheral vascular thrombosis; Shunttromboz; Embolism; Embolism of peripheral arteries; Occlusive Arterial Disease

I82 Embolism and thrombosis of other veins: Recurrent venous thrombosis; Postoperative thrombosis; Venous thrombosis; Acute venous thromboembolism; Recurrent vein thrombosis; Venous thrombosis; Thrombosis of veins of internal organs; Venous thrombosis; Deep vein thrombosis; Thrombosis of blood vessels; Vascular thrombosis; Thrombosis of veins; Deep vein thrombosis; Thromboembolic diseases; Thromboembolism of veins; Severe venous thrombosis; Embolism; Embolism of veins; Thromboembolic complications

Z49.1 Aids that include extracorporeal dialysis: hemodialysis; Chronic hemodialysis; Extracorporeal circulation; Thrombosis of hemodialysis shunt

Composition

Lyophilizate for solution for infusion 1 bottle

active substance: Urokinase 10000 IU; 50000 IU; 100,000 IU; 500,000 IU

Auxiliary substances: human serum albumin; Sodium hydrophosphate dodecahydrate; Sodium dihydrogen phosphate dihydrate

The free space in the vial is filled with nitrogen to create an inert atmosphere

Pharmachologic effect

Mode of action - Fibrinolytic.

Dosing and Administration

Powder with active substance is diluted immediately before administration with the applied IV, intracoronary by drop or stream infusion.

The required dose is selected individually. Therefore, the following diagrams should be used as a general guide for dose selection. Depending on the clinical picture, the dose may be increased. As a rule, an increase in thrombin time 3-5 times in relation to the norm is considered optimal to achieve an adequate effect. Also, standard blood coagulability parameters should be monitored in order to select the dosage based on them.

Deep vein thrombosis. The initial dose is 4400 IU / kg, for patients with high risk - 150,000 IU for 10-20 minutes; A maintenance dose of 100,000 IU / h, for patients with an increased risk of 40000-60000 IU for 2-3 days.

If the desired effect cannot be achieved after 72 hours, the dose can be increased individually in each case.

Severe pulmonary embolism. The initial dose is 4400 IU / kg for 10-20 min; The maintenance dose is 4400 IU / kg / h for 12 hours.

If the desired effect cannot be achieved after 24 hours, the dose can be increased individually in each case.

Occlusion of peripheral vessels: 4000 IU / min (240,000 IU / h) is infused into the intraarterial catheter in the first 2-4 hours or until the anterograde flow of blood (permeability) is restored, then 1000-2000 IU / min. Infusion should be discontinued after the completion of the thrombus lysis, if the arteriography shows no further progress, or after 48 hours after the start of the infusion.

Blocking fibrin clots of hemodialysis shunts. For use in lysis of thrombi in arteriovenous shunts, the drug is dissolved in 2-3 ml of saline to produce a solution with a concentration of 5000 to 25000 IU / ml. The solution is introduced into both branches of the arteriovenous shunt. If necessary, the administration is repeated after 30-45 minutes. The total time of application should not exceed 2 hours.

To prevent the re-formation of clots after the application of urokinase, treatment with heparin and oral anticoagulants in usual doses with the control of the standard coagulogram parameters should be started.

Preparation of the drug solution

Before use, the preparation should be dissolved in water for injection in accordance with the following scheme: 10000 IU vial - use 2 ml of a solvent; 50000 IU - 2 ml of solvent; 100,000 IU - 2 ml of solvent; 500000 IU - 10 ml of solvent. After that, it can be diluted to the required concentration of 0.9% solution of sodium chloride or 5 or 10% glucose solution.

The solution should be used immediately after preparation.

Release form

Lyophilizate for solution for infusion. For 10,000 IU, 50000 IU, 100,000 IU or 500,000 IU in a vial of colorless glass (Type I EF). The bottle is sealed with a cork made of butyl rubber and crimped with an aluminum cap with a polymer protective cover. 1 bottle of the drug is placed in a cardboard box.

Manufacturer

The owner of the registration certificate: medak GmbH, Teatralstrasse 6, 22880 Wedel, Germany.

Claims from consumers and complaints on the quality of the drug should be sent to the address of the manufacturer's representative in the Russian Federation.

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Urokinase medac

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Urokinase medañ

3 years.

Do not use after the expiry date printed on the package.