| Application: | Internal Medicine |
|---|---|
| Usage Mode: | for Injection |
| Suitable for: | Elderly, Children, Adult |
| State: | Solid |
| Shape: | Powder |
| Type: | Circulatory System Drugs |
| Samples: |
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| Customization: |
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Indications:
As a drug to protect myocardial, Creatine Phosphate Sodium has better curative effect and reliable safety, which leads huge usage of this product all over the world. In cardio-surgery, it can be added into cardiopulmonary byass to protect myocardium. It also can be used to treat my ocardial metabolic abnormalities because of ischemia.
Dosage and Administration:
1.0g each time, 1-2 times every day by intravenous injection within 30-45 minutes. It is added into cardiopulmonary byass to protect myocardium and cardiopulmonary byass concentration is 10 mmol/L.
Precautions & Warning:
Blood pressure might decrease if more than 1.0g creatine phosphate is administered by intravenous injection at rapid injection speed. Large dose of this drug 5-10g/ day can cause high intake of phosphate sodium, which might affect calcium metabolism and secretion of stable state hormones.
This drug can't be used for patients who is allergic to creatine phosphate. Large dose of this drug 5-10g/ day can't be used for patients with chronic renal insufficiency.
Contra-indications:
There are no contraindications to the administration of creatine phosphate sodium.
Storage instructions:
Keep protected from light, stored in cool and dry condition (not more than 20°C). Keep out of the reach of children.
| Testing terms | Standards | Results |
| Characteristic | White or almost white powder or crystalline powder | White crystalline powder |
| pH | 8.0~9.0 | 8.4 |
| Solubility | Meet the requirements | Complies |
| Clarity and Colour of Solution | Meet the requirements | Complies |
| Related substance | Creatine≤0.75% Creatinine≤0.75% Other single impurity≤0.5% Total impurities≤2.0% |
0.095% 0.0077% 0.08% 0.25% |
| Water | Should be 20.0%-25.0% | 24.0% |
| Sterility | Should be sterile | Sterile |
| Bacterial Endotoxin | <0.15 EU/mg | <0.15 EU/mg |
| Particulate Matters | ≥10μm:≤6000/vial ≥25μm:≤600/vial |
97/ vial 28/vial |
| Assay | 90.0%-110.0% | 101.4% |
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