| Customization: | Available |
|---|---|
| Application: | Internal Medicine |
| Usage Mode: | For external use |
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Indications:
Enoxaparin sodium injection is a low molecular weight heparin indicated for:
Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness
Inpatient treatment of acute DVT with or without pulmonary embolism
Outpatient treatment of acute DVT without pulmonary embolism
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction.
Treatment of acute ST-segment elevation myocardial infarction [STEMI] managed medically or with subsequent percutaneous coronary intervention [PCI]
Dosage and Administration:
Evaluate all patients for a bleeding disorder before starting enoxaparin sodium injection treatment, unless treatment is urgently needed.
Do not administer enoxaparin sodium injection by intramuscular injection.
Administer enoxaparin sodium injection by intravenous or subcutaneous injection only.
Storage instructions:
Store in a cool and dry place,below 25°C.
| Testing terms | Standards | Results |
| Character | A clear, colorless to pale yellow liquid. | A clear, faint yellow liquid. |
| pH | 5.5-7.5 | 6.7 |
| Clarity and color | Clear Colour: BY5 or better |
Clear <Y5 |
| Bacterial endotoxin | <0.01EU/AXaUSPU | <0.01EU/AXaUSPU |
| Filling volume | Should meet the requirement. | Complies |
| Free sulfate content | ≤0.12% | 0.02% |
| Sterlity | Should meet the requirement. | Complies |
| Particulate matter | ≥10um:not exceeding 6000 225μm:not exceeding 600 |
8vial 0/vial |
| Anti-factor Xa potency | 90.0%-110.0% of stated potency | 100.8% |
| Anti-factor lla potency | 20.0%~35.0% of Anti-factor Xa potency | 23.4% |
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