| Application: | Internal Medicine |
|---|---|
| Usage Mode: | for Injection |
| Suitable for: | Elderly, Children, Adult |
| State: | Liquid |
| Shape: | Powder |
| Type: | Biological Products |
| Samples: |
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| Customization: |
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Indications:
Cefotaxime is indicated in the treatment of the following severe infections when known or thought very likely to be caused by bacteria that are susceptible to cefotaxime :
- Bacterial pneumonia
- Complicated infections of the urinary tract including pyelonephritis
- Severe skin and soft tissue infections
- Genital infections, including gonorrhoea
- Intra-abdominal infections (such as peritonitis)
- Bacterial meningitis
- Endocarditis
- Borreliosis
Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
Perioperative prophylaxis. For surgical operations with increased risk of infections with anaerobic pathogens, e.g. colorectal surgery, a combination with an appropriate drug with activity against anaerobes is recommended.
Dosage and Administration:
Cefotaxime may be administered by intravenous bolus injection or intravenous infusion or by intramuscular injection after reconstitution of the solution.
Dosage and mode of administration should be determined by the severity of the infection, susceptibility of the causative organism and the patient's condition. Therapy may be started before the result of microbiological tests are known.
Storage instructions:
This medicinal product does not require any special temperature storage conditions.
Keep the vials in the outer carton in order to protect from light.
| Testing terms | Standards | Results |
| Clarity of solution | Clarified | Clarified |
| Particulate matter | Not detected | Not detected |
| Sub-visible particles | ≥10um,≤6000Particles/Bottle ≥25um,≤600Particles/Bottle |
107.7 Particles/Bottle 10.9 Particles/Bottle |
| Acidity | 4.5~6.5 | 5.51 |
| Loss on drying | ≤3.0% | 1.60% |
| Single impurity | ≤6.0% | 0.44% |
| Total of impurities | ≤10.0% | 1.44% |
| Bacterial endotoxins | Not more than 0.20EU per mg of cefotaxime. | <0.20EU/mg |
| Uniformity of dosage units |
AV≤15.0 | 6.16 |
| Sterility | Complies | Complies |
| Assay | 90.0%-115.0% | 98.27% |
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