| - | - | - |
|---|---|---|
| Product Group | : | Antibacterials |
| Pharmaceutical Form | : | Suspension for Injection |
| Active Ingredient | : | Cefalexin Monohydrate |
| Target Species | : | Cattle, Cat, Dog |
| Package Form | : | 100 ml |
For Veterinary Use Only
For Veterinary Use Only
Suspension for Injection
Veterinary Systemic Antibacterial
COMPOSITION
It is cream-pale pink in color and contains Cephalexin monohydrate equivalent to 180 mg Cephalexin base per ml.
PHARMACOLOGICAL PROPERTIES
Cephalexin is a first-generation broad-spectrum cephalosporin that is active against Gram (+) and some Gram (-) bacteria. It is bactericidal. It shows this effect by inhibiting mucopeptide synthesis in the bacterial cell wall. Like other beta-lactam antibiotics, it also shows its effect by inhibiting enzymes such as carboxypeptidase, transpeptidase, and endopeptidase, which are located in the bacterial cytoplasm and are responsible for bacterial cell wall synthesis. The main bacterial species it is effective on: Staphylococcus sp. (including penicillinase-producing strains), Streptococcus sp., Escherichia coli, Corynebacterium sp., Pasteurella multocida, Proteus sp., Microciccus sp., Erysipelothrix rusiopathiae, Clostridium sp., Salmonella sp., Moraxella sp., Actinobacillus lignierese, Actinomyces bovis, Haemophilus sp., Fusobacterium sp., Peptostreptococcus sp. and Peptococcus sp.
Following intramuscular administration, it is rapidly absorbed from the injection site and reaches a maximum plasma concentration of 9.8 mg/ml within 1 hour. A two-hour inhibitory concentration is sufficient for the bactericidal effect of cephalexin to be seen. Its concentration in plasma drops rapidly and falls below minimum limits after 12 hours. This rapid concentration decrease prevents the antibiotic from accumulating in the blood-breast barrier and leaving residues in milk. After cephalexin is metabolized, most of it is excreted in urine and some in feces.
AREA OF USE/INDICATIONS
It is used for the treatment of respiratory, digestive and urogenital system infections, foot rot, interdigital infections, septicemia, skin and soft tissue infections caused by Gram (+) and Gram (-) microorganisms sensitive to cephalexin, as a complementary treatment to intramammary treatment in metritis and septicemic mastitis in cattle, cats and dogs.
USAGE AND DOSAGE
It is applied subcutaneously or intramuscularly in cattle, cats and dogs. The syringe to be used must be dry and sterile.
Pharmacological dose;
For cattle: 7 mg/kg body weight/day,
For cats and dogs: 10 mg/kg body weight/day.
Practical dose;
For cattle: 1 ml/25 kg body weight
For cat and dog: 0.25 ml/4.5 kg body weight. Shake well before use.
Administer once a day and continue for 5 days. When the amount given exceeds 10 ml, the injection should be divided in half. The injection site should be massaged following the application.
SPECIAL CLINICAL INFORMATION AND SPECIAL WARNINGS FOR TARGET SPECIES
It is recommended to use with an appropriate intramammary antibiotic in septicemic mastitis. Dosage should be adjusted in animals with liver and kidney failure.
UNDESIRED EFFECTS
In sensitive animals, respiratory distress, swelling of the tongue, redness of the mucous membranes and skin, and itching may be observed. Diarrhea, mucus in the stool or bleeding may be observed. In intramuscular administration, a temporary, local, mild tissue reaction may occur at the injection site. Anaphylactic reactions may occur in allergic animals.
DRUG INTERACTIONS
It should not be used with tetracyclines, phenicols and macrolides. It may have a synergistic effect when used with penicillins. There is cross-sensitivity with other cephalosporins.
SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE
Depending on the high dose and the prolonged duration, neurotoxic and nephrotoxic effects, abdominal cramps, dizziness and muscle spasms may occur. It may cause skin rash and fever at the injection site. Symptoms return to normal when the application is stopped.
WITHDRAWAL PERIODS
Meat: 4 days
Milk: 0 days
CONTRAINDICATIONS
It should not be used intravenously or intratracheally. It should not be used in animals that are hypersensitive to cephalosporins. It should not be used in animals with severe renal impairment.
Use during pregnancy: Cephalosporins are known to cross the placenta, but studies in pregnant mice and rats have not found any teratogenic effects on the fetus.
GENERAL WARNINGS
Consult a veterinarian before use and if an unexpected effect is observed. Keep out of reach of children and away from foodstuffs. Do not purchase or use products with damaged packaging.
PRECAUTIONS TO BE TAKEN BY THE ADMINISTRATOR AND WARNINGS FOR VETERINARY SURGEON
Penicillins and cephalosporins can cause serious allergic reactions by injection, inhalation, ingestion or skin contact. Therefore, hypersensitive individuals should not come into contact with the product. If reactions such as itching occur after contact, a physician should be consulted for medical intervention. Swelling of the face, lips and tongue and shortness of breath are symptoms that require urgent medical attention.
STORAGE CONDITIONS AND SHELF LIFE
It should be stored in the original packaging, away from direct sunlight, at 8°C-25°C. Shelf life is 2 years.
COMMERCIAL PRESENTATION FORMS
It is presented in 100 ml colorless, type II glass vials with box.
PLACE AND CONDITIONS OF SALE
Sold with Veterinary Surgeon’s prescription in pharmacies and veterinary surgeries (VSP).
APPROVAL DATE OF PACKAGE INSERT: 10.08.2021
MARKETING AUTHORIZATION DATE AND NO: 13.12.2011- 025/0018
MARKETING AUTHORIZATION HOLDER
Pİ FARMA İLAÇ SAN. VE TİC. A.Ş.
Malıköy Başkent OSB Mah. 26. Cad. No:34/A Sincan/Ankara-Türkiye
MANUFACTURER COMPANY
FDN İLAÇ SAN. VE TİC. LTD. ŞTİ.
Büyükkayacık OSB Mah. İnsu Sokak No:3 Selçuklu/Konya-Türkiye
Made in Turkiye
