CEPHACARE DOG CAT 50MG 100 TABLETS

CEPHACARE DOG CAT 50MG 100 TABLETS

Indications for use, specifying the target species

Treatment of infections of the respiratory tract, gastrointestinal tract, genitourinary tract, skin and localized soft tissue infections caused by bacteria sensitive to cephalexin.

Contraindications

Do not use in case of known hypersensitivity to the active substance, to other cephalosporins, to other beta-lactam substances or to any of the excipients.

Do not use in rabbits, gerbils, guinea pigs and hamsters.

Special warnings for each target species

None.

Special precautions for use

Special precautions for use in animals

The use of the veterinary medicinal product should be based on susceptibility testing, and official and local recommendations on the use of antimicrobials should be taken into account.

The use of the veterinary medicinal product in conditions other than those recommended in the data sheet may increase the prevalence of bacteria resistant to cephalexin and reduce the efficacy of treatment with penicillins, due to the appearance of cross-resistance.

In case of allergic reaction, treatment should be discontinued.

As with other antibiotics that are mainly eliminated by the kidneys, unnecessary accumulation in the body can occur in the case of renal failure. In cases of known renal insufficiency, the dose should be reduced, nephrotoxic antimicrobials should not be concomitantly administered and the veterinary medicinal product should only be used according to the benefit/risk assessment by the responsible veterinarian.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Penicillins and cephalosporins may cause hypersensitivity (allergy) after injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may cross-react with cephalosporin and vice versa. Allergic reactions to these substances can sometimes be severe. Do not handle this veterinary medicinal product if you are known to be sensitive or if you have been advised not to come into contact with such substances.

Handle this veterinary medicinal product with great care to avoid exposure, following all recommended precautions. If after exposure you develop symptoms such as a skin rash, see a doctor and show him this warning. Swelling of the face, lips or eyes or respiratory distress are serious symptoms that require urgent medical attention.

In case of accidental ingestion, consult a doctor immediately and show him the package leaflet or the label.

Wash hands after use.

Adverse reactions (frequency and seriousness)

Vomiting has occasionally been observed in dogs treated with cephalexin-containing medicinal products.

Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy or lactation in dogs. Use only in accordance with the benefit/risk assessment carried out by the responsible veterinarian.

Interaction with other medicinal products and other forms of interaction

The bactericidal activity of cephalosporins is reduced by concomitant administration of compounds with bacteriostatic action (macrolides, sulfonamides, and tetracyclines). Nephrotoxicity may increase when first-generation cephalosporins are combined with polypeptide antibiotics, aminoglycosides, and some diuretics (furosemide). The concomitant use of these active substances should be avoided.

Dosage and route of administration

Orally. A dose of 15 mg/kg twice daily is recommended, which may be doubled if necessary.

The veterinary drug has a tear mark on both sides. Half tablets can be used to deliver a more exact dose if necessary.

It is recommended to administer the treatment for five days. Any increase in dose or prolongation of treatment should be made according to the benefit/risk assessment made by the responsible veterinarian (eg in cases of chronic pyoderma).

The tablets can be added to food if necessary.

To avoid underdosing, body weight should be determined as accurately as possible.

It is recommended to use lower strength tablets in dogs that weigh little.

Overdose (symptoms, emergency procedures, antidotes), if applicable

It has been shown that the administration of cephalexin does not produce serious adverse reactions even with doses several times the recommended dose.

Timeouts

Not applicable.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibiotics for systemic use, other beta-lactam antibiotics, first-generation cephalosporins

ATCvet: QJ01DB01.

Pharmacodynamic properties

Cephalexin is a semisynthetic bactericidal antibiotic that belongs to the group of cephalosporins and acts by interfering with the formation of the bacterial cell wall.

Cephalexin is active against a wide range of gram-positive and gram-negative bacteria. The following microorganisms have been shown to be sensitive to cephalexin in vitro: Staphylococcus spp (including penicillin-resistant strains), Streptococcus spp, Corynebacterium spp, Pasteurella multocida, Escherichia coli, Micrococcus spp, Moraxella spp.

Cephalexin is resistant to the action of staphylococcal penicillinase and is therefore active against strains of Staphylococcus aureus that are not sensitive to penicillin (or related antibiotics such as ampicillin or amoxicillin) due to production of penicillinase.

Cephalexin is also active against most ampicillin-resistant strains of E. coli.

Pharmacokinetic data

Following oral administration, cephalexin is rapidly and almost completely absorbed. Peak plasma concentrations in dogs (Cmax= 17,49 µg/mL) are reached in approximately 1,5 hours (Tmax= 1,55). Cephalexin is excreted in the urine in high concentrations and has an elimination half-life (T1/2) of approximately 2,5–3 hours.

PHARMACEUTICAL DATA

List of excipients

Lactose monohydrate

potato starch

Magnesium stearate

beef flavor

Incompatibilities

Not applicable.

Period of validity

Shelf-life of the veterinary medicinal product packaged for sale: 36 months

The half tablets must be stored in the blister pack and used within 48 hours.

Special storage precautions

Do not store at temperatures above 25ºC.

Store in a dry place.

Keep the blister in the outer carton.

Nature and composition of the immediate packaging

The veterinary medicinal product is supplied in PVC / PE / PVDC / aluminum blisters of 10 tablets, in cardboard boxes containing 20, 100 or 250 tablets.

Not all formats may be marketed.

Special precautions for the disposal of unused veterinary medicinal product or, where appropriate, residues derived from its use.

Any unused veterinary medicinal product or residues derived from it must be disposed of in accordance with local regulations.