
| - | - | - |
|---|---|---|
| Product Group | : | Antibacterials |
| Pharmaceutical Form | : | Injection Suspension |
| Active Ingredient | : | Cefquinome sulfate |
| Target Type | : | Cattle, Calf |
| Package Form | : | 50 ml and 100 ml vials |
COMPOSITION
It is whitish or cream-colored, ready-to-use suspension containing cefquinom sulfate equivalent to 25 mg cefquinom per ml.
PHARMACOLOGICAL PROPERTIES
Cefovil Suspension for Injection is an antibiotic formulation containing a broad-spectrum, bactericidal cephalosporin antibiotic from the fourth generation of cephalosporins. Like other cephalosporins, it exerts its bactericidal effect by inhibiting transpeptidase enzymes involved in cell wall biosynthesis, thereby disrupting cell wall synthesis. It is effective against many bacteria, including Gram-positive and Gram-negative bacteria.
The main bacteria susceptible to Cefquinome are: Salmonella spp., Streptococcus spp., Staphylococcus spp., Pasteurella spp., E. coli, Bacillus spp., Fusabacterium spp., Corynebacterium spp., A. pyogenes, Citrobacter spp., Clostridium spp. It has been found to be effective against many Gram-negative and Gram-positive bacteria such as Haemophilus somnus, Klebsiella spp., Bacteroides spp., Proteus spp., and Prevotella spp.
In studies conducted, the MIC90 values of bacteria against cefquinome were: E. coli 0.391 µg/ml, Salmonella spp. 0.195 µg/ml, Klebsiella spp. 0.391 µg/ml, Serratia spp. 0.391 µg/ml, Enterobacter spp. 0.781 µg/ml, Citrobacter spp. 0.195 µg/ml, Proteus spp. 0.195 µg/ml, and Pseudomonas aeruginosa 25 µg/ml.
When Cefovil is administered intramuscularly at 10 mg/kg to calves, the pharmacokinetic data show Cmax = 4.5 µg/ml, Tmax = 2 hours, and AUC = 24.0 mgh/lt. Cefquinome binds minimally to plasma proteins. The drug is excreted unchanged via the urinary tract.
AREA OF USE/INDICATIONS
It is indicated for the treatment of respiratory tract infections (especially penicillin-resistant bacteria) caused by bacteria susceptible to cefquinome, foot infections (fork rot, pododermatitis), as well as calf septicemia caused by E. coli, acute mastitis infections and secondary infections accompanying viral diseases in cattle and calves.
USAGE AND DOSAGE
Pharmacological Dose: 1 mg/kg body weight is administered intramuscularly for cattle and calves.
Practical Dose: 1 ml/25 kg body weight Cefovil is administered for 3-5 days with 24 hours intervals.
For the treatment of E. coli-induced septicemia in newborn calves, a dose of 2 ml/25 kg body weight (twice the normal dose) is recommended.
For mastitis treatment, a dose of 1 ml/25 kg body weight should be administered twice, 24 hours apart.
The suspension should be homogenized by shaking the bottle vigorously before use.
SPECIAL CLINICAL INFORMATION AND SPECIAL WARNINGS FOR TARGET SPECIES
Laboratory studies have shown no embryotoxic or teratogenic effects in rats and rabbits.
ADVERSE EFFECTS
After intramuscular administration, the injection site may experience tenderness, pain, and temporary swelling. The swelling observed has been reported to resolve within one to two weeks. Betalactams have side effects ranging from mild allergies to death in susceptible animals.
DRUG INTERACTIONS
Cephalosporin derivatives exhibit synergistic effects with aminoglycoside antibiotics. They should not be used in combination with bacteriostatic antibiotics.
SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE
Cefovil Injectable Suspension has no undesirable side effects at the recommended doses and duration of use. The toxicity of cefquinome is very low. It has been reported that even 10 times the normal dose is tolerated in target species.
WITHDRAWAL PERIODS
Meat: 5 days.
Milk: 1 day (2 milkings).
CONTRAINDICATIONS
It should not be used in animals sensitive to beta-lactam antibiotics, as they are also sensitive to cephalosporins in this group. IM administration may cause pain and suffering. It should not be used in animals with severe renal impairment.
GENERAL WARNINGS
Consult a veterinarian before use and if any unexpected effects occur. Keep out of reach of children.
PRECAUTIONS TO BE TAKEN BY THE ADMINISTRATOR AND WARNINGS FOR VETERINARY SURGEON
Avoid contact with the product and wash your hands after use. Individuals known to be sensitive to penicillins and cephalosporins should avoid contact with the product. If sensitive people experience symptoms such as swelling of the face, eyes, or lips, or difficulty breathing following exposure to the medication by mouth, skin, or inhalation, immediate medical attention is required. In such cases, consult a doctor and show the medication and label.
STORAGE CONDITIONS AND SHELF LIFE
It should be stored in the original packages, protected from light, and below 25°C, without being placed in the refrigerator or freezer. The shelf life is 2 years.
DISPOSAL AFTER USE AND WARNINGS FOR NON-TARGET SPECIES
Used or remaining product should be disposed of according to the relevant regulations.
COMMERCIAL PRESENTATION FORM
50 ml and 100 ml colorless glass vials with cardboard boxes.
PLACE AND CONDITIONS OF SALE
It is sold in pharmacies and veterinary clinics with a veterinarian’s prescription. (VHP)
APPROVAL DATE OF LEAFLET: 26.12.2006
MARKETING AUTHORIZATION DATE AND NO: 09.11.2006 – 017/0009
NAME AND ADDRESS OF MARKETING AUTHORIZATION HOLDER
VİLSAN Veteriner İlaçları Tic. Ve San. A.Ş.
Balıkhisar Mah. Balıkhisar Köyiçi Küme Evleri No: 765A Akyurt/Ankara – Turkiye
MANUFACTURER COMPANY
VİLSAN Veteriner İlaçları Tic. Ve San. A.Ş.
Balıkhisar Mah. Balıkhisar Köyiçi Küme Evleri No: 765A Akyurt/Ankara – Turkiye
Made in Turkiye