Urokinase for injection

This product directly acts on the endogenous fibrinolytic system, catalyzing the cleavage of plasminogen into plasmin, which can not only degrade fibrin clots, but also degrade fibrinogen, coagulation factor V and coagulation factor VIII in the blood circulation, thereby exerting a thrombolytic effect. This product has a fast onset and good effect on newly formed thrombi. This product can also increase the activity of vascular ADP enzyme, inhibit ADP-induced platelet aggregation, and prevent thrombosis. After intravenous infusion of this product, the activity of plasmin in the patient's body is significantly increased; after a few hours of drug withdrawal, the activity of plasmin returns to its original level. However, the decrease in plasma fibrin or fibrinogen levels and the increase in their degradation products can last for 12-24 hours. This product shows a significant correlation between the thrombolytic effect and the drug dose and the time window of administration. This product has very low toxicity, and the median lethal dose of intravenous injection in mice is greater than 1 million international units/kg body weight. There is also no obvious antigenicity, teratogenicity, carcinogenicity and mutagenicity. Allergic reactions are rarely reported in clinical applications. However, given that this drug increases plasmin activity and reduces unbound plasminogen and fibrin-bound plasminogen in the blood circulation, a serious risk of bleeding may occur.

An enzyme that activates plasminogen extracted from fresh human urine, a sterile lyophilized product with appropriate amounts of stabilizers and excipients.

The product is mainly used for thrombolytic therapy of thromboembolic diseases, including acute extensive pulmonary embolism, coronary artery embolism and myocardial infarction within 6-12 hours of chest pain, acute cerebral vascular embolism with symptoms shorter than 3-6 hours, retinal artery embolism and other patients with severe iliac-femoral vein thrombosis with peripheral arterial embolism symptoms. It is also used to prevent thrombosis after artificial heart valve surgery, maintain patency of vascular cannulation and chest and pericardial drainage tubes, etc. The efficacy of thrombolysis requires subsequent heparin anticoagulation to maintain.

This product should be prepared with sterile saline or 5% glucose solution for injection before use. 1 The initial dose for pulmonary embolism is 4400 units/kg body weight, prepared with saline or 5% glucose solution, and dripped at a rate of 90 ml/hour within 10 minutes; then continuously intravenously dripped at a rate of 4400 units per hour for 2 hours or 12 hours. In case of pulmonary embolism, it can also be prepared with 15,000 units of saline per kilogram of body weight and injected into the pulmonary artery; if necessary, the dose can be adjusted according to the situation, repeated once every 24 hours, and used up to three times; 2 Myocardial infarction is recommended to be prepared with saline and continuously dripped into the coronary artery at a rate of 6000 units/minute for 2 hours. Heparin 2500-10000 units should be given intravenously before dripping.

The most common adverse reaction of this product in clinical practice is bleeding tendency. The most common is local hematoma after injection or puncture. The second is intratissue bleeding, with an incidence of 5%-11%, which is mostly mild, and severe cases can cause cerebral hemorrhage. When this product is used for coronary artery recanalization and thrombolysis, atrial or ventricular arrhythmias often occur after blood vessels are recanalized, with an incidence of more than 70%. Close ECG monitoring is required. This product has low antigenicity, and no induced antibody production has been detected in vitro or intradermal injection. Therefore, the incidence of allergic reactions is extremely low. However, there are reports that a small number of patients who have been treated with streptokinase have developed bronchospasm, rash and fever after using this product.

This product is contraindicated in patients with the following conditions: acute visceral hemorrhage, acute intracranial hemorrhage, old cerebral infarction, intracranial or spinal cord surgery within the past two months, intracranial tumors, arteriovenous malformations or aneurysms, bleeding diathesis, and severe uncontrolled hypertension. Relative contraindications include prolonged cardiopulmonary resuscitation, severe hypertension, trauma within the past 4 weeks, surgery or tissue puncture within 3 weeks, pregnancy, 10 days after delivery, and active ulcer disease.

Precautions during pregnancy and lactation: Do not use during pregnancy or 10 days after delivery.

There is no report on the interaction between this product and other drugs. Since this product is a thrombolytic drug, it is not suitable to be used with drugs that affect platelet function, such as aspirin, indomethacin, and pentazocine. Heparin and oral anticoagulants should not be used simultaneously with high doses of this product to avoid increased risk of bleeding.

The lyophilized powder preparation is stored at 4℃～10℃. The prepared injection solution should be used within 8 hours at room temperature (25℃); it can be stored in a refrigerator (2℃～5℃) for 48 hours.

1.5 million units

Jiangxi HAORAN BIO-PHARMA Co., Ltd.

• Founded in:

  2008-02-22

• Address:

  No. 369, Youkou Road, High-tech Industrial Development Zone, Nanchang City, Jiangxi Province

• Tax NO.:

  913601066697940095

• Registered Funds:

  50 million yuan

• Website:

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