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.

Urokinase

Urokinase for injection is a white or off-white amorphous powder, composed of two substances with molecular weights of 33,000 and 54,000 respectively. It is soluble in water, and the urokinase activity per milligram of enzyme protein should be no less than 70,000 international units.

This 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 in 10 minutes at a rate of 90 ml/hour; then continuously intravenously dripped for 2 hours or 12 hours at a rate of 4400 units per hour. 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. For myocardial infarction, it is recommended to prepare with saline and drip continuously into the coronary artery at a rate of 6000 units/minute for 2 hours. Heparin 2500-10000 units should be given intravenously before dripping. It is also possible to prepare 2-3 million units of this product and drip it intravenously for 45 to 90 minutes. 3. Peripheral arterial thrombosis: Prepare this product (concentration 2500 units/ml) with normal saline and inject the blood clot at a rate of 4000 units/min through the catheter. Clamp the catheter once every 2 hours; the drip rate can be adjusted to 1000 units/min 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 dripped in 10 to 15 minutes after preparation of normal saline. Then maintain 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 units to 250,000 units of this product prepared with sterile water for injection (5000 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: It is used to dissolve blood clots in the anterior chamber caused by intraocular hemorrhage. It disintegrates the blood clots and facilitates surgical removal. The usual dosage is 5000 units 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 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°C to 10°C. The prepared injection solution should be used within 8 hours at room temperature (25°C); it can be stored in a refrigerator (2°C to 5°C) for 48 hours.

1.5 million units

Jilin Aodong--Taonan Pharnalentical Company Ltd

• Founded in:

  1998-02-06

• Address:

  No. 2999, Xingye Road, Taonan Economic Development Zone, Jilin Province

• Tax NO.:

  912208007022438244

• Registered Funds:

  70.170757 million yuan

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