
| - | - | - |
|---|---|---|
| Product Group | : | Antibacterials |
| Pharmaceutical Form | : | Suspension for Injection |
| Active Ingredient | : | Cephalexin monohydrate |
| Target Animal | : | Cattle |
| Package Form | : | 100 and 250 ml glass vials |
COMPOSITION
It is whitish or cream-colored, ready-to-use suspension when it is shaked, containing cefalexin monohydrate equivalent to 150 mg cefalexin per ml.
PHARMACOLOGICAL PROPERTIES
CEVİLEX suspension for injection contains cefalexin, a first-generation cephalosporin antibiotic. The core structure of cephalosporins is formed by 7-aminocephalosporanic acid (7-ASA), a cephem derivative. Cefalexin exerts a bactericidal effect by inhibiting the final step in the synthesis of the peptidoglycan exchange in the bacterial cell wall (transpeptidase reaction) and activating autolytic enzymes, similar to penicillins. Cefalexin is effective against both gram-positive and gram-negative bacteria, especially gram-positive bacteria. Due to its resistance to beta-lactamases, it is particularly effective against penicillin-resistant strains of Staphylococcus aureus.
Cephalexin reaches peak plasma concentration within 30 minutes following intramuscular administration. It distributes to all tissues and organs. It passes into pleural fluid, synovial fluid, pericardial fluid, and urine at therapeutic concentrations. Its passage into the cerebrospinal fluid (CSF) is weak. Elimination occurs mainly through glomerular filtration via the kidneys.
AREA OF USE/INDICATIONS
It is used for the treatment of respiratory infections caused by cephalexin-sensitive bacteria in cattle. It is used to support intramammary administration in the treatment of infections caused by septicemia, fork rot, bone and joint diseases, and septicemic mastitis.
USAGE AND DOSAGE
Pharmacological Dose: 7.5 – 10 mg/kg body weight.
Practical Dose: 1 ml/15-20 kg body weight is administered intramusularly for 5 days.
administration can be repeated at 12 and 24 hour intervals, depending on the severity and course of the infection and the veterinarian's advice. Shake well before use.
ADVERSE EFFECTS
Adverse effects are negligible at the recommended doses. Nausea, vomiting, diarrhea, and allergic reactions may occur in animals that are hypersensitive to cephalosporins. Fever, skin rash, hemolytic anemia, and anaphylaxis may occur in animals allergic to cephalosporins. Intramuscular administration may cause reactions and pain.
DRUG INTERACTIONS
The use of cephalosporin derivatives together with aminoglycosides and other drugs that have undesirable effects on the kidneys (such as amphotericin B) may increase their effects on the kidneys. They should not be used together with bacteriostatic antibiotics.
SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE
Rarely, diarrhea and pain may occur in cats, and loss of appetite may occur in dogs. In such cases, the use of these drugs for therapeutic purposes should be discontinued.
WITHDRAWAL PERIODS
Meat: 4 days.
Milk: ‘0’ day.
CONTRAINDICATIONS
It should not be used in animals sensitive to beta-lactam antibiotics, as they are also sensitive to cephalosporins from this group. 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. It is not used in rabbits or hamsters. It should also not be used in snakes or web-footed animals (such as ducks and geese). Administration to horses may cause gastrointestinal disorders, including colitis.
COMMERCIAL PRESENTATION FORM
100 ml and 250 ml amber colored 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: 01.11.2011
MARKETING AUTHORIZATION DATE AND NO: 31.10.2011 – 024/0097
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