Urokinase for injection

The main ingredient of this product is urokinase. Excipients: human serum albumin, dextran 20, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride.

This product is white or off-white freeze-dried block or powder.

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 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 dripping 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 severe 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. This 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 the 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 clinic is bleeding tendency. The most common is local hematoma after injection or puncture. The second is intra-tissue 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. The incidence is as high as 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 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: Animal experiments show that this product, 1000 times the human dose, has no damage to the reproductive capacity and fetus of female mice and rats. There are no reports of carcinogenicity in long-term use. There are no reports of the use of this product in pregnant women with a strict control group. Therefore, unless this product is urgently needed, pregnant women should not use it. There are no reports on whether this product can be excreted from breast milk. Therefore, lactating women should use this product with caution. Precautions for the elderly: The safety and effectiveness of this product in elderly patients have not been reported. However, people over 70 years old should use it with caution.

Keep in a dark place and sealed at a temperature below 10℃.

100,000 units

24 months.

Tianjin Biochemical Pharmaceutical Co., Ltd.

• Founded in:

  1980-09-19

• Address:

  No. 269, Huanhe South Road, Tianjin Pilot Free Trade Zone (Airport Economic Zone)

• Tax NO.:

  91120116103294558X

• Registered Funds:

  303.3028 million yuan

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