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It is introduced inside a carton box in 25 ml colourless glass bottles containing powder for injection and in 10 ml colourless glass bottles containing water for injection. |
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Each glass bottle in KLAVETSYLYN Solution Powder for Injection + Solvent contains Amoxycillin sodium equivalent to 2500 mg Amoxycillin base and Potassium clavulanate equivalent to 625 mg Clavulanic acid with a colour almost white or creamy white in crystal powder form and 10 ml apyrogen water for injection in glass bottle as solvent. In each ml of the 12 ml yellow-coloured, clear solution obtained after mixing of the solvent and powder, there is amoxycillin sodium equivalent to 208.3 mg amoxycillin base and potassium clavulanate equaivalent to 52.08 mg clavulanic acid. |
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KLAVETSYLYN Solution Powder for Injection and its Solvent is a drug having wide-spectrum and potent antibacterial activity based on the combination of amoxycillin which is a semisynthetic penicillin derivative and clavulanic acid. The active ingredient content is based on the combination of amoxycillin and clavulanic acid used in ratios of 4.1 or 80/20 % in different dosage forms. Amoxycillin exerts its effect by preventing chain synthesis by supressing the enzymes involved in the synthesis of the peptidoglycan chain in sensitive bacteria in the reproductive phase and thus by impairing cell wall synthesis. Clavulanic acid, on the other hand, makes bacteria sensitive to amoxycilline by irreversibly inhibiting the beta-lactamase enzyme that has rendered bacteria resistant.
Micro-organisms that the combination is effective against are as follows: Gram-positive bacteria such as Staphylococcus sp. (including those secreting beta-lactamase), Streptococcus sp., Corynebacterium sp., Clostridium sp., Bacillus anthracis, A.bovis and Peptostreptococci , strains of E. coli (including those strains secreting beta-lactamase), Salmonella sp., Bordetella bronchiseptica, Campylobacter sp., Klebsiella sp., Proteus sp., Pasteurella sp., Fusobacterium necrophorum, Bacteroides sp. (including those secreting beta-lactamase), and gram-negative bacteria like Moraxella sp., Actinobacillus lignierensi. The scientific approach that is taken as the basis of the development of the same combination is based on the reality of the acquisition of a potent synergistic effect of the bactericidal type especially on pathogen bacteria species that secrete beta-lactamase and that have developed resistance to penicillins through this enzyme via two antibacterial drugs used together under in vitro and in vivo conditions. Thus, while a wider antibacterial spectrum and a more rapidly developing potent antibacterial effect is maintained compared to amoxycilline alone, the emergence of strains resistant due to beta-lactamase can be prevented and cases of multiple resistance based on the indicated microorganisms can be easily broken.
When the KLAVETSYLYN Solution Powder for Injection and its Solvent is administered via intramuscular and subcutaneous routes, it is easily absorbed and distributed in all the fluid and tissue components of the whole body. In the half an hour following the injection it reaches peak values. Despite its accumulation in the liver and kidney at concentrations a couple of times higher than that in the blood, the amount of drug that passes through other soft tissues remains markedly low. The excretion kinetics of amoxycillin and clavulanic acid found in the combination are very close to each other. The drug which is generally administered as a single dose is excreted 80% via urine and 3-4% via feces in 24 hours.
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