Ceporex 180 mg/ml Suspension for Injection for Cattle, Cats and Dogs

Composition

Each ml contains:

Active substance:

Cefalexin 180 mg

(equivalent to 191.3 mg cefalexin sodium)

Excipients:

A white to off-white suspension.

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Pharmacological properties

4.1 ATCvet code: QJ01DB01.

4.2 Pharmacodynamics

Cefalexin is a semi-synthetic bactericidal antibiotic belonging to the cefalosporin group which acts by interference with bacterial cell wall formation.

Cefalexin is resistant to the action of staphylococcal penicillinase and is therefore active against the strains of Staphylococcus aureus that are insensitive to penicillin (or related antibiotics such as ampicillin or amoxycillin) because of production of penicillinase.

Cefalexin is also active against the majority of ampicillin-resistant E. coli.

4.3 Pharmacokinetics

Cefalexin is rapidly absorbed after injection. Peak blood concentrations are generally achieved within one hour of administration. Cefalexin is excreted in the urine in high concentration.

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Target species

Cattle, cats and dogs.

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Indications

The veterinary medicinal product is indicated for antibiotic therapy in cattle, cats and dogs. Cefalexin is a broad spectrum cefalosporin antibiotic with bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria.

The following micro-organisms have been shown to be sensitive to cefalexin in vitro:

Staphylococcus spp. (including penicillin-resistant strains)

Streptococcus spp.

Actinomyces bovis

Corynebacterium spp.

Haemophilus spp.

Pasteurella spp.

Erysipelothrix rhusiopathiae

Escherichia coli

Clostridium spp.

Proteus spp.

Salmonella spp.

Micrococcus spp.

Fusobacterium spp.

Moraxella spp.

Peptostreptococcus spp.

Actinobacillus lignieresi

Peptococcus spp.

When susceptible organisms are present, the veterinary medicinal product is indicated in the treatment of infections of the respiratory tract, urogenital tract, the skin and localised infections in soft tissues in dogs and cats. In dogs it may also be effective in the treatment of infections of the gastrointestinal tract.

Trials have shown the product to be of particular value in treating metritis, foot infections, wounds and abscesses and in the treatment of septicaemic mastitis to supplement intramammary therapy in cattle.

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Dosage

Before withdrawal of a dose the vial should be shaken to resuspend the contents.

This veterinary medicinal product does not contain an antimicrobial preservative. Use a dry needle and syringe. Swab the septum before removing each dose.

To ensure a correct dosage, body weight should be determined as accurately as possible.

Cats and dogs: Subcutaneous use or intramuscular use.

The recommended dose is 10 mg/kg once daily for up to 5 days. Any variation should be at the prescribing veterinary surgeon’s discretion, e.g. in severe or acute conditions. After administration massage the injection site.

The following is intended as a guide:

Cattle: Intramuscular use.

The recommended dose for cattle is 7 mg/kg (1 ml/25 kg) once daily for up to 5 days.

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Contraindications

Do not use in cases of hypersensitivity to cefalexin.

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Adverse reactions

Cattle, cats and dogs:

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Not suitable for intravenous or intrathecal administration.

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

Cephalosporins may cause sensitisation (allergy) following injection, inhalation, ingestion or skin contact. Sensitivity to penicillin may lead to cross sensitivity to cephalosporin and vice versa. Allergic reactions to these substances may occasionally be serious.

Do not handle this veterinary medicinal product if you know you are sensitised, or if you have been advised not to work with such preparations.

Handle this veterinary medicinal product with great care to avoid exposure, taking all recommended precautions.

Wash hands after use.

If you develop symptoms following exposure such as a skin rash you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty breathing are more serious symptoms and require urgent medical attention.

Care should be taken to avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Special precautions for the protection of the environment:

Not applicable.

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Use during pregnancy, lactation or lay

None.

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Interactions

Concurrent use of cephalosporins with potentially nephrotoxic substances (e.g. aminoglycosides, polymyxin antibiotics) or diuretic substances (e.g. furosemide) may increase possible nephrotoxic effects. Also see section 3.4.

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Overdose

Administration of cefalexin at up to twice the recommended dose in cattle and at up to three times the recommended dose in dogs and cats does not produce any adverse effects.

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Special warnings

As with other antibiotics which are excreted mainly by the kidneys, unnecessary accumulation may occur in the body when renal function is impaired. In cases of known renal insufficiency the dose should be reduced.

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Withdrawal period

Cattle:

Meat and offal: 19 days.

Milk: Zero hours.

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Incompatibilities

In the presence of water, hydrolysis of cefalexin occurs. It is important, therefore, that a dry syringe is used when extracting suspension for injection to avoid contaminating the remaining contents of the vial with drops of water.

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Immediate packaging

Colourless, multidose 100 ml Type I or Type II glass vial, sealed with a bromobutyl rubber closure and an aluminium cap with tear-off lid.

Pack size:

Cardboard box containing 1 x 100 ml vial.

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Storage

Do not store above 30 °C.

Keep the vial in the outer carton in order to protect from light.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after first opening the immediate packaging: 28 days.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 06376/4127

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

8 DATE OF FIRST AUTHORISATION

23 December 1992

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

September 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved: 22 October 2025

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Registration holder

Intervet International B.V.

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