Tsefalen 500 mg Film-coated Tablets for Dogs

Composition

Each film-coated tablet contains:

Active substance:

Cefalexin 500 mg

(equivalent to cefalexin monohydrate 525.9 mg)

Excipient:

Orange coloured oblong film-coated tablets, with a break-line on one side. Engraved with GP4 on the other side.

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Pharmacological properties

4.1 ATCvet code: QJ01DB01

4.2 Pharmacodynamics

Cefalexin is a broad spectrum cephalosporin antibiotic with bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria.

Cefalexin is a semi-synthetic bactericidal broad spectrum antibiotic belonging to the cephalosporin group which acts by interfering with bacterial cell wall formation. This bactericidal activity is mediated by drug binding to bacterial enzymes known as penicillin binding proteins (PBPs). Such enzymes are located on the inner membrane of the cell wall and their transpeptidase activity is required for the terminal stages of assembling this essential structure of the bacterial cell. Inactivation of PBPs interferes with the cross-linkage of peptidoglycan chains necessary for bacterial cell wall strength and rigidity. The bactericidal effect of cefalexin is mainly "time dependent".

Cefalexin is resistant to the action of staphylococcal penicillinase and is therefore active against the strains of Staphylococcus aureus that are not sensitive 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.

The following micro-organisms have been shown to be susceptible to Cefalexin in vitro: Corynebacterium spp, Staphylococcus spp (including penicillin-resistant strains), Streptococcus spp, Escherichia coli, Moraxella spp, Pasteurella multocida.

MIC data collected for cefalexin in canine isolates from the European Union (EU) (Stegmann et al. 2006)

The three basic mechanisms of resistance to cephalosporins result from reduced permeability, enzymatic inactivation, or absence of specific penicillin-binding proteins.

4.3 Pharmacokinetics

Cefalexin is rapidly and almost completely absorbed in the gastrointestinal tract following oral administration. Cefalexin binds to a limited extent (10-20%) to plasma proteins. After oral administration of 15 mg/kg in tablets, peak blood concentration (Cmax=15 μg/ml) is usually reached between 1 and 2 hours (Tmax=90 min).

Bioavailability is nearly 100% of the administered dose (AUC 6279 μg min / ml). Cefalexin does not undergo biotransformation processes that are of pharmacokinetic significance.

The elimination half-life of cefalexin is about 1.5 hours (t1/2 = 90 min). Elimination of the microbiologically active form is almost entirely via the kidneys by tubular excretion and glomerular filtration.

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Target species

Dogs.

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Indications

For the treatment of infections of the respiratory system, urogenital system and skin, localised infections in soft tissue and gastrointestinal infections caused by cefalexin-sensitive bacteria.

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Dosage

Oral use.

The recommended dose is 15 mg of cefalexin per kg of body weight twice a day (i.e. equivalent to 1 tablet twice a day for a dog weighing 33 kg). In severe or acute conditions, the dose may be doubled to 30 mg/kg twice daily.

The following is a guide for the use of the veterinary medicinal product:

*Dose to be given twice per day

The veterinary medicinal product must be administered for a minimum of 5 days.

- 14 days in cases of urinary tract infection,

- At least 15 days in cases of superficial infectious dermatitis,

- At least 28 days in cases of deep infectious dermatitis.

Any increase in dose or duration of treatment should be accordingly to a benefit/risk assessment by the responsible veterinarian (e.g. chronic pyoderma).

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

The veterinary medicinal product can be given as whole tablets or crushed and added to food if necessary.

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Contraindications

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

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

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Adverse reactions

Dogs:

1 In cases of hypersensitivity reactions the treatment should be discontinued.

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:

Wherever possible, use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal and take into account official and local antimicrobial policies.

Deviating from the instructions given in the SPC when using the veterinary medicinal product may increase the prevalence of bacteria resistant to cefalexin and may also decrease the effectiveness of other beta-lactam antimicrobial treatments, due to the potential for cross-resistance. Therefore, deviation from the instructions must only be undertaken according to a risk/benefit assessment by the responsible veterinarian.

Do not administer in cases of known resistance to cephalosporin and penicillin.

As with other antibiotics which are excreted mainly by the kidneys, systemic accumulation may occur when renal function is impaired. In case of known renal insufficiency the dose should be reduced, and antimicrobials known to be nephrotoxic should not be administered concurrently.

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

Penicillins and cephalosporins may cause sensitisation (allergy) following injection, inhalation, ingestion, or skin contact. Sensitivity to penicillins may lead to cross sensitivity to cephalosporins 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 be in contact with such substances.

Handle this veterinary medicinal product with great care to avoid exposure, taking all recommended precautions. If you develop symptoms following exposure such as 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.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

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.

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Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Pregnancy and lactation:

Use only according to the benefit-risk assessment by the responsible veterinarian. Laboratory studies in rats and mice have not produced any evidence of teratogenic, foetotoxic, or maternotoxic effects.

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Interactions

In order to ensure efficacy, the veterinary medicinal product should not be used in combination with bacteriostatic antibiotics.

Concurrent use of first generation cephalosporins with polypeptide antibiotics, aminoglycosides or some diuretics such as furosemide can enhance nephrotoxicity risks.

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Overdose

Concerning acute toxicity, an LD50 > 0.5 g/kg has been recorded following oral administration in dogs. The administration of cefalexin has been shown to produce no serious side effects at several times the recommended dose rate.

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Special warnings

None.

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Withdrawal period

Not applicable.

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Incompatibilities

None known.

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Immediate packaging

Carton box containing 1 PVC/Aluminium blister pack of 12 tablets.

Carton box containing 3 PVC/Aluminium blister pack of 12 tablets, with a total of 36 tablets.

Carton box containing 9 PVC/Aluminium blister pack of 12 tablets, with a total of 108 tablets.

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special temperature conditions.

Return any halved tablet to the blister pack.

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Shelf life

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

Shell life afterfirst opening the immediate packaging: 48 hours.

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Disposal of unused product

Medicines should not be disposed of via wastewater or household waste.

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 58047/4000

8 DATE OF FIRST AUTHORISATION

08 November 2012

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

November 2024

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).

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Registration holder

Nextmune Italy S.R.L.

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