Urokinase for injection

Short Description:

The product is mainly used for thrombolytic therapy of thromboembolic diseases. These include acute generalized pulmonary embolism, coronary artery embolism and myocardial infarction within 6-12 hours of chest pain, acute cerebrovascular embolism with symptoms shorter than 3-6 hours, retinal artery embolism and other peripheral artery embolism symptoms of severe skeletal vein thrombosis.?It is also used to prevent thrombosis after prosthetic heart valve surgery, and to keep vascular cannulation and thoracic and pericardial drainage tubes unobstructed. Thrombolytic efficacy requires subsequent heparin anticoagulation to maintain.


Product Detail

Product Tags

Urokinase for injection

Source

Fresh human urine

Definition

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.

Pharmacopoeia standard

CP

Character

A?white or almost-white?lyophilized mass?or powder.

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.

Test

Acidity or alkalinity pH value should be 6.0~7.0
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

Assay

The potency is not less than?85.0%?and not more than 120.0% of the?stated potency.

Storage

The sealed container should be protected from light?and stored at a temperature of not exceeding 10℃.

Specification

??500,000units

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.


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