| Application: | Internal Medicine |
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| Usage Mode: | Injection |
| Suitable for: | Elderly, Children, Adult |
| State: | Liquid |
| Shape: | Injection |
| Type: | Biological Products |
| Samples: |
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| Customization: |
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Indications:
Antibacterial. Serious infections caused by susceptible Gram-positive organisms, staphylococci (both penicillinase- and non-penicillinase-producing), streptococci (except Streptococcus faecalis) and pneumococci. It is also indicated for the treatment of severe infections caused by susceptible anaerobic pathogens such as Bacteroides spp, Fusobacterium spp, Propionibacterium spp, Peptostreptococcus spp. and microaerophilic streptococci.
Clindamycin does not penetrate the blood/brain barrier in therapeutically effective quantities.
Dosage and Administration:
Posology
Adults:
Serious infections: 600mg-1.2g/day in two, three or four equal doses.
More severe infections: 1.2-2.7g/day in two, three or four equal doses.
Single I.M. injections of greater than 600mg are not recommended nor is administration of more than 1.2g in a single one-hour infusion.
Elderly: The half-life, volume of distribution and clearance, and extent of absorption after administration of clindamycin phosphate are not altered by increased age. Analysis of data from clinical studies has not revealed any age-related increase in toxicity. Dosage requirements in elderly patients should not be influenced, therefore, by age alone. See Precautions for other factors which should be taken into consideration.
Paediatric population (over 1 month of age):
Serious infections: 15-25mg/kg/day in three or four equal doses.
More severe infections: 25-40mg/kg/day in three or four equal doses. In severe infections it is recommended that children be given no less than 300mg/day regardless of body weight.
Method of administration
Parenteral (IM or IV administration).
Clindamycin Solution for Injection and Infusion should be used undiluted for IM administration.
Clindamycin Solution for Injection and Infusion must be diluted prior to I.V. administration and should be infused over at least 10-60 minutes.
Storage instructions:
Do not store above 25°C. Keep ampoules in the outer carton. Do not refrigerate or freeze. From a microbiological point of view, the product should be used immediately.
| Testing terms | Standards | Results |
| Appearance | Almost colourless solution. | Complies |
| pH | 5.5-7.0 | 6.4 |
| Bacterial endotoxins | <6 IU/mL | Complies |
| Extractable volume | Not less than 4.00 mL | Complies |
| Sterility | Sterile | Complies |
| Assay | 90.0%-120.0% | 98.3% |
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