SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cefaseptin 300 mg tablets for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One tablet contains:

Active substance:

cefalexin (as cefalexin monohydrate) 300 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Beige oblongtablet.

The tablet can be divided into equal halves and quarters.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

For the treatment of bacterial skin infections (including deep and superficial pyoderma) caused by organisms, including Staphylococcusspp.,susceptible to cefalexin.

For the treatment of urinary-tract infections (including nephritis and cystitis) caused by organisms, includingEscherichia coli,susceptible to cefalexin.

4.3 Contraindications

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

Do not use in the case of resistance to cephalosporins or penicillins.

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

4.4 Special warnings for each target species

None

4.5 Special precautions for use

Special precautions for use in animals

The need for systemic antibiotics compared with non-antibiotic alternatives for the treatment of superficial pyoderma should be carefully considered by the responsible veterinarian.

As with other antibiotics which are excreted mainly by the kidneys, systemic accumulation may occur in the body 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.

This product should not be used to treat puppies of less than 1 kg of bodyweight.

Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local epidemiological information.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to cefalexin and may decrease the effectiveness of treatment with other cephalosporins and penicillins, due to the potential for cross-resistance.

Official, national and regional antimicrobial policies should be taken into account when the product is used.

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

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporin and vice versa. Allergic reactions to these substances may occasionally be serious.

4.6 Adverse reactions (frequency and seriousness)

In very rare cases, nausea, vomiting and/or diarrhoea have been observed in some dogs after administration.

In rare cases hypersensitivity can occur.

In cases of hypersensitivity reactions the treatment should be stopped.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals )

- rare (more than 1 but less than 10 animals in 10,000 animals)

- very rare (less than 1 animal in 10,000 animals, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established in bitches during pregnancy and lactation. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

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 aminoglycoside antibiotics or some diuretics such as furosemide can enhance nephrotoxicity risks.

4.9 Amounts to be administered and administration route

For oral administration.

15 mg of cefalexin per kg of bodyweight twice daily (equivalent to 30 mg per kg of bodyweight per day) for a duration of:

- 14 days in case of urinary-tract infection

- at least 15 days in case of superficial bacterial infectionof the skin.

- at least 28 days in case of deep bacterial infection of the skin.

To ensure correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.

The product may be crushed or added to food if necessary.

In severe or acute conditions, except in cases of known renal insufficiency (see section 4.5), the dose may be doubled.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Trials performed on animals with up to 5 times the recommended twice daily dosage of 15 mg cefalexin/kg demonstrated that the product was well tolerated.

Adverse reactions that may occur at the recommended dose are expected in the case of overdose. In the event of overdose, treatment should be symptomatic.

4.11 Withdrawal period(s)

Not applicable

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterials for systemic use, first generation cephalosporins

ATCvet code: QJ01DB01

5.1 Pharmacodynamic properties

Cefalexin acts by inhibiting the nucleopeptide synthesis of the bacterial wall. Cephalosporins interfere with the enzymes of transpeptidation making it unable to cross-link the peptidoglycans of the bacterial cell wall. The glycan cross-linking is essential for the cell to build its cell wall. Inhibition of the biosynthesis results to a weakened cell wall, which eventually ruptures to osmotic pressure. The combined action results in cell lysis and filament formation.

Cefalexin is active against a wide range of Gram-positive (e.g. Staphylococcus spp.) and Gram-negative (e.g. Escherichia coli) aerobic bacteria.

The following breakpoints are recommended by the CLSI in dogs for E.coli and Staphylococcusspp:

MIC (µg/mL)	Interpretation
≤2	Sensitive
4	Intermediate
≥8	Resistant

Resistance to cefalexin can be due to one of the following mechanisms of resistance. Firstly, the production of cephalosporinases, that inactivate the antibiotic by hydrolysis of the β-lactam ring, is the most prevalent mechanism among Gram-negative bacteria. This resistance is transmitted by plasmid or chromosomally. Secondly, a decreased affinity of the PBPs (penicillin-binding proteins) for beta-lactam drugs is frequently involved for beta-lactam resistant Gram-positive bacteria. Lastly, efflux pumps, extruding the antibiotic from the bacterial cell, and structural changes in porins, reducing passive diffusion of the drug through the cell wall, may contribute to improve the resistant phenotype of a bacterium.

Well-known cross-resistance (involving the same resistance mechanism) exists between antibiotics belonging to the beta-lactam group due to structural similarities. It occurs with beta-lactamases enzymes, structural changes in porins or variations in efflux pumps. Co-resistance (different resistance mechanisms involved) has been described in E.coli due to a plasmid harbouring various resistance genes.

5.2 Pharmacokinetic particulars

After single oral administration of the recommended dosage of 15 mg of cefalexin per kg of bodyweight to Beagle dogs, plasma concentrations were observed within 30 minutes. The plasma peak was observed at 1.3 hour with a plasma concentration of 18.2 mg/ml.

The bioavailability of the active was over 90 %. Cefalexin was detected until 24 hours after the administration. The first urine specimen was collected within 2 to 12 hours with peak concentrations of cefalexin measured at 430 to 2758 mg/ml within 12 hours.

After repeated oral administration of the same dosage, twice a day for 7 days, plasma peaks occurred 2 hours later with a concentration of 20 mg/ml. Over the treatment period, concentrations were maintained above 1 mg/ml. The mean elimination half-life is 2 hours. Skin levels were around 5.8 to 6.6 mg/g, 2 hours after treatment.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate

Povidone K30

Croscarmellose sodium

Microcrystalline cellulose

Porcine liver powder

Yeast

Crospovidone

Sodium stearyl fumarate

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 48 hours.

6.4. Special precautions for storage

Store in the original package.

Return any part used tablet to the opened blister-pack.

6.5 Nature and composition of immediate packaging

PVC/aluminium/OPA – PVC blister

Cardboard box of 1 blister of 10 tablets

Cardboard box of 10 blisters of 10 tablets

Cardboard box of 25 blisters of 10 tablets

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Vetoquinol UK Ltd

Vetoquinol House

Great Slade

Buckingham Industrial Park

Buckingham

Buckinghamshire

MK18 1PA

8. MARKETING AUTHORISATION NUMBER

Vm 08007/4142

9. DATE OF FIRST AUTHORISATION

12 January 2016

10. DATE OF REVISION OF THE TEXT

March 2016

PROHIBITION OF SALE, SUPPLY AND/OR USE

Approved: 23 March 2016