| Application: | Internal Medicine |
|---|---|
| Usage Mode: | For oral administration |
| Suitable for: | Elderly, Children, Adult |
| State: | Liquid |
| Shape: | Powder |
| Type: | Biological Products |
| Samples: |
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| Customization: |
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Indications:
Cefazolin 1g Powder for solution for injection/infusion is indicated for the treatment of the following infections caused by cefazolin-susceptible micro-organisms:
- skin and soft tissue infections
- bone and joint infections.
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.
The use of cefazolin should be limited to cases where parenteral treatment is needed.
Susceptibility of causative organism to the treatment should be tested (if possible), although therapy may be initiated before the results are available.
Dosage and Administration:
The dosage as well as the method of administration are dependent on the location and severity of the infection and on the clinical and bacteriological progress. Local therapeutic guidance should be taken into consideration.
Contraindications
Hypersensitivity to cefazolin sodium.
Patients with known hypersensitivity to cephalosporin antibiotics.
History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).
Storage instructions:
Store below 30°C.
Keep the vials in the outer carton in order to protect from light.
| Testing terms | Standards | Results |
| Shape | White to almost white, crystalline powder or solid, practically odorless. | Almost white crystalline powder. practically odorless |
| Specifie optical rotation | -10°~24° | -17.29° |
| Acidity | 4.0~6.0 | 4.81 |
| Water | ≤6.0% | 0.70% |
| Clarity of solution | Clarified | Clarified |
| Particulate matter | Not detected | Not detected |
| Bacterial endotoxins |
Not more than 0.15EU per mg of cefazolin | <0.15EU/mg |
| Uniformity of dosage units |
AV≤15.0 | 5.81 |
| Assay | 90.0%-115.0% | 100.1% |
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