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.

This product is an enzyme protein separated from healthy human urine or obtained from human kidney tissue culture. It consists of two parts with molecular weights of 33,000 (LMW-tcu-PA) and 54,000 (HMW-tcu-PA).

This product is white or off-white amorphous powder.

It 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 2500-10,000 units should be given intravenously before dripping. This product can also be prepared with 2 to 3 million units and then dripped intravenously, and the dripping should be completed in 45 to 90 minutes; 3 For peripheral arterial thrombosis, this product (concentration 2500 units/ml) is prepared with normal saline and injected into the blood clot at a rate of 4000 units/minute through the catheter. The catheter is clamped once every 2 hours; the dripping rate can be adjusted to 1000 units/minute until the blood clot dissolves; 4 Prevention and treatment of thrombosis after heart valve replacement surgery Thrombosis is one of the most common complications after heart valve surgery. This product can be used at 4400 units/kg body weight, and the dripping should be completed in 10 to 15 minutes after the preparation of normal saline. Then maintain it by intravenous drip at 4400 units/kg body weight/hour. Stop the medication when the valve function is normal; if the medication is still ineffective after 24 hours or a serious bleeding tendency occurs, the medication should be stopped; 5 Empyema or pericardial empyema is often treated with antibiotics and pus drainage. The drainage tube is often blocked by fibrin clots. At this time, 10,000 to 250,000 units of this product prepared with sterile water for injection (5,000 units/ml) can be injected into the chest cavity or pericardial cavity. It can not only keep the drainage tube unobstructed, but also prevent pleural or pericardial adhesion or pericardial constriction; 6. Ophthalmic application: Used to dissolve blood clots in the anterior chamber caused by intraocular hemorrhage. Disintegrate blood clots, which is conducive to surgical removal. The usual dosage is 5,000 units prepared with 2 ml of normal saline to flush the anterior chamber.

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 intra-tissue bleeding, with an incidence of 5% to 11%, 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 vascular recanalization, 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 few patients who have been treated with streptokinase have experienced bronchospasm, rash and fever after using this product. Gastrointestinal symptoms such as headache, heaviness of the head, loss of appetite, nausea, and vomiting may also occur.

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, abnormal blood coagulation, 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, active ulcer disease and severe liver disease.

Precautions for children: The safety and effectiveness of this product in children have not been reported. Precautions for pregnancy and lactation: It is forbidden to use for 10 days after pregnancy and delivery. Precautions for the elderly: The safety and effectiveness of this product in elderly patients have not been reported. However, it should be used with caution in patients aged ＞70 years old.

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 pentazoline. 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.

100,000 units

24 months