Urokinase for injection
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Urokinase for injection |
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Source |
Fresh human urine | |
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Definition
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Urokinase for injection is a sterile lyophilized powder of urokinase with suitable stabilizing agents and excipients. It has a potency of not less than 85.0% and not more than 120.0% of the labeled potency. | |
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Pharmacopoeia standard |
CP |
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Character |
A white or almost-white lyophilized mass or powder. | |
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Identification |
The clot forms within 30~45 seconds and lyses again within 15 minutes. | |
| The clot does not lyse within 2 hours in blank control. | ||
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Test |
Acidity or alkalinity | pH value should be 6.0～7.5 |
| Clarity and color of solution | The solution is clear and colorless（3000IU/ml） | |
| Loss on drying | ≤5.0% | |
| Bacterial endotoxin | ＜1.0EU/10000IU | |
| Content uniformity | ±15%（500,000units） | |
| Visible foreign matter | Conforms | |
| Insoluble particle | Conforms | |
| Sterile | Conforms | |
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Assay |
The potency is not less than 85.0% and not more than 120.0% of the stated potency. | |
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Storage |
The sealed container should be protected from light and stored at a temperature of not exceeding 10℃. | |
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Specification |
500,000units | |
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Category |
Thrombolytic agent. | |
Contraindication
The patients should not use this product with the following situations:acute visceral hemorrhage, acute intracranial hemorrhage, old cerebral infarction, intracranial or spinal surgery within the past two months, intracranial tumors, arteriovenous malformations or aneurysms, bleeding diatheses, and severe uncontrolled hypertension.
Relative contraindications include prolonged CPR, severe hypertension, trauma within the last 4 weeks, surgery or tissue puncture within 3 weeks, pregnancy, 10 days after delivery, and active peptic ulcer disease.
Notice
1.Before use this product, determine the hematocrit, platelet count, thrombin time (TT), prothrombin time (PT) and activated partial thromboplastin time (APTT). TT and APTT should less than a range of 2-fold extension
2.During medication period, patients’ reactions, such as pulse rate, temperature, respiratory rate, blood pressure, and bleeding tendency should be closely observed. Record at least every 4 hours. If allergic symptoms such as rash and urticaria are found, stop using it immediately.
3. For intravenous administration, one successful puncture is required to avoid local bleeding or hematoma.
4. For arterial puncture administration, at the end of administration, should press the puncture site for at least 30 minutes, and pressure bind with sterile bandages and dressings to avoid bleeding
5. The risk is increased by the use of this product under the following circumstances, it should be used with caution after weighing the pros and cons.
（1）Patients who have given birth within the last 10 days, undergone tissue biopsy, venipuncture, major surgery, and those with severe gastrointestinal bleeding.
（2）Patients with a high risk of left heart thrombosis, such as mitral stenosis with atrial fibrillation
（3）Patients with subacute bacterial endocarditis.
（4）Patients with bleeding tendency or coagulopathy secondary to liver or kidney disease.
（5）Pregnant women, patients with cerebrovascular disease, and patients with diabetic hemorrhagic retinopathy.
