SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Kesium 400 mg / 100 mg Chewable tablets for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains: Active substances:

Amoxicillin (as amoxicillin trihydrate)	400.00 mg
Clavulanic acid (as potassium clavulanate)	100.00 mg

Excipients:

Qualitative composition of excipients and other constituents

Pig liver powder

Yeast

Crospovidone (type A)

Povidone K 25

Hypromellose

Microcrystalline cellulose

Silica colloidal anhydrous

Magnesium stearate

Oblong scored beige chewable tablet. The tablets can be divided into equal halves.

3. CLINICAL INFORMATION

3.1 Target species

Dogs

3.2 Indications for use for each target species

For the treatment of the following infections caused by β-lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid and where clinical experience and/or sensitivity testing indicates the veterinary medicinal product as the drug of choice:

- Skin infections (including superficial and deep pyodermas) associated with Staphylococcus spp.

- Urinary tract infections associated with Staphylococcus spp, Streptococcus spp, Escherichia coli and Proteus mirabilis.

- Respiratory tract infections associated with Staphylococcus spp, Streptococcus spp and Pasteurella spp.

- Digestive tract infections associated with Escherichia coli.

- Infections of the oral cavity (mucous membrane) associated with Pasteurella spp, Streptococcus spp and Escherichia coli.

3.3 Contraindications

Do not use in cases of hypersensitivity to penicillins, to other substances of the βlactam group or to any excipients.

Do not use in animals with serious dysfunction of the kidneys accompanied by anuria and oliguria.

Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas. Do not use in horses and ruminating animals.

Do not use where resistance to this combination is known to occur.

3.4 Special warnings

None

3.5 Special precautions for use

Special precautions for safe use in the target species:

Official, national and regional antimicrobial policies with respect to the use of broad- spectrum antibiotics should be taken into account.

Do not use in case of bacteria sensitive to narrow spectrum penicillins or to amoxicillin as single substance.

It is advised that upon initiating therapy appropriate sensitivity testing is performed and that therapy is continued only after susceptibility to the combination has been established.

Use of the veterinary medicinal product deviating from the instructions given in the

SPC may increase the prevalence of bacteria resistant to the

amoxicillin/clavulanate, and may decrease the effectiveness of treatment with betalactam antibiotics.

In animals with hepatic and renal dysfunction, the dosing regimen should be carefully evaluated and the use of the veterinary medicinal product based on a risk/benefit evaluation by the veterinary surgeon.

Caution is advised in the use in small herbivores other than those in the section 3.3.

The potential for allergic cross-reactions with other penicillin derivates and cephalosporins should be considered.

The chewable tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals.

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 cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.

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

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

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 with breathing are more serious symptoms and require urgent medical attention.

Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

3.6 Adverse events Dogs:

Very rare (<1 animal / 10,000 animals treated, including isolated reports ):

Gastrointestinal signs (e.g. diarrhoea or vomiting) 1 Allergic reaction (e.g. allergic skin reaction, anaphylaxis) 2

¹ Treatment may be discontinued depending on the severity of the undesirable effects and a benefit/risk evaluation by the veterinary surgeon.

² In these cases, administration should be discontinued, and a symptomatic treatment given.

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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3.7 Use during pregnancy, lactation or lay

Pregnancy and lactation:

Laboratory studies in rats and mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

In pregnant and lactating animals, use only according to the benefit/risk assessment by the responsible veterinarian.

3.8 Interaction with other medicinal products and other forms of interaction

Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action.

Penicillins may increase the effect of aminoglycosides.

3.9 Administration routes and dosage

Oral use.

The recommended dose of the veterinary medicinal product is 10 mg amoxicillin /2.5 mg clavulanic acid per kg body weight twice a day by the oral route in dogs, i.e. 1 tablet per 40 kg body weight every 12 h, according to the following table:

Body weight (kg)	Number of tablets twice daily
> 15 to 20	½
> 20 to 25	Use Kesium 250mg
> 25 to 40.0	1
> 40 to 60	1 ½
> 60 to 80	2

In refractory cases, the dose may be doubled to 20 mg of amoxicillin / 5 mg clavulanic acid/kg bodyweight twice daily, at the clinician’s discretion.

The chewable tablets are flavoured and are accepted by a majority of dogs. The chewable tablets can be administered directly into the mouth of the animals or added to a small quantity of food.

Duration of therapy

The majority of routine cases respond to 5 – 7 days of therapy.

In chronic cases, a longer case of therapy is recommended. In such circumstances overall treatment length must be at the clinician’s discretion, but should be long enough to ensure complete resolution of the bacterial disease.

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

3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)

In case of overdose diarrhoea, allergic reactions or further symptoms like central nervous excitation manifestations or cramps could appear. Symptomatic treatment should be initiated when necessary.

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.

3.12 Withdrawal periods

Not applicable

4. PHARMACOLOGICAL INFORMATION

4.1 ATCvet code:

QJ01CR02

4.2 Pharmacodynamics

Amoxicillin is a beta-lactam antibiotic and its structure contains the beta-lactam ring and thiazolidine ring common to all penicillins. Amoxicillin shows activity against susceptible Gram-positive bacteria and Gram-negative bacteria.

Beta-lactam antibiotics prevent the bacterial cell wall from forming by interfering with the final stage of peptidoglycan synthesis. They inhibit the activity of transpeptidase enzymes, which catalyse cross-linkage of the glycopeptide polymer units that form the cell wall. They exert a bactericidal action but cause lysis of growing cells only.

Clavulanic acid is one of the naturally occurring metabolites of the streptomycete Streptomyces clavuligerus. It has a structural similarity to the penicillin nucleus, including possession of a beta-lactam ring. Clavulanic acid is a beta-lactamase inhibitor acting initially competitively but ultimately irreversibly.

Clavulanic acid will penetrate the bacterial cell wall binding to both extracellular and intracellular beta- lactamases.

Amoxicillin is susceptible to breakdown by β-lactamase and therefore combination with an effective ß-lactamase inhibitor (clavulanic acid) extends the range of bacteria against which it is active to include β-lactamase producing species.

In vitro potentiated amoxicillin is active against a wide range of clinically important aerobic and anaerobic bacteria including:

Gram-positive:

Staphylococcus spp. (including β-lactamase producing strains) Streptococcus spp

Gram-negative:

Escherichia coli (including most β-lactamase producing strains)

Pasteurella spp

Proteus spp

Resistance is shown among Enterobacter spp, Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus. A trend in resistance of E. coli is reported.

4.3 Pharmacokinetics

After oral administration in dogs, amoxicillin and clavulanic acid are rapidly absorbed. Amoxicillin (pKa 2.8) has a relatively small apparent distribution volume, a low plasma protein binding (34% in dogs) and a short terminal half-life due to active tubular excretion via the kidneys. Following absorption the highest concentrations are found in the kidneys (urine) and the bile and then in liver, lungs, heart and spleen. The distribution of amoxicillin to the cerebrospinal fluid is low unless the meninges are inflamed.

Clavulanic acid (pKa 2.7) is also well-absorbed following oral administration. The penetration to the cerebrospinal fluid is poor. The plasma protein binding is approximately 25% and the elimination half-life is short. Clavulanic acid is mainly eliminated by renal excretion (unchanged in urine).

After single oral administration of 17 mg/kg amoxicillin and 4.3 mg/kg clavulanic acid in dogs:

- The maximal plasma concentration (Cmax) of amoxicillin (8.6 µg/mL) was observed 1.5 hour following administration.

- The maximal plasma concentration (Cmax) of clavulanic acid (4.9 µg/mL) was observed 54 minutes following administration.

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

Not applicable

5.2 Shelf life

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

Any divided tablet portions remaining after 12 hours should be discarded.

5.3 Special precautions for storage

Do not store above 25°C.

Divided tablets should be stored in the blister pack.

5.4 Nature and composition of immediate packaging

(PA-AL-PVC – aluminium heat sealed) containing 4 or 6 tablets per blister

Cardboard box with 1 blister of 6 tablets.

Cardboard box with 2 blisters of 6 tablets.

Cardboard box with 4 blisters of 6 tablets.

Cardboard box with 6 blisters of 6 tablets.

Cardboard box with 8 blisters of 6 tablets.

Cardboard box with 10 blisters of 6 tablets.

Cardboard box with 12 blisters of 6 tablets.

Cardboard box with 14 blisters of 6 tablets. Cardboard box with 16 blisters of 6 tablets.

Cardboard box with 40 blisters of 6 tablets. Cardboard box with 80 blisters of 6 tablets.

Cardboard box with 3 blisters of 4 tablets.

Cardboard box with 6 blisters of 4 tablets.

Cardboard box with 9 blisters of 4 tablets.

Cardboard box with 12 blisters of 4 tablets.

Cardboard box with 15 blisters of 4 tablets.

Cardboard box with 18 blisters of 4 tablets.

Cardboard box with 21 blisters of 4 tablets.

Cardboard box with 24 blisters of 4 tablets. Cardboard box with 60 blisters of 4 tablets.

Not all pack sizes may be marketed.

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

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.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

Ceva Sante Animale

7. MARKETING AUTHORISATION NUMBERS

Vm 14966/5074

Vm 14966/3073

8. DATE OF FIRST AUTHORISATION

5 October 2011

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

October 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.

Gavin Hall Approved: 30 October 2025