SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Kesium 200 mg / 50 mg Chewable tablets for dogs and cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains: Active substances:

Amoxicillin 200 mg

(as amoxicillin trihydrate)

(equivalent to 229.56 mg amoxicillin trihydrate)

Clavulanic acid 50 mg

(as potassium clavulanate)

(equivalent to 59.56 mg potassium clavulanate) 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

Clover-shaped scored beige tablet. The tablets can be divided into four equal parts.

3. CLINICAL INFORMATION

3.1 Target species

Dogs and cats

3.2 Indications for use for each target species

Dogs:

For the treatment of

- Skin infections (including deep and superficial pyoderma).

- Soft tissue infections (including anal sacculitis and abscesses).

- Urinary tract infections.

- Respiratory infections.

- Intestinal infections.

- Periodontal infections in addition to mechanical or surgical periodontal therapy.

Cats:

For the treatment of

- Skin infections (including superficial pyoderma).

- Soft tissue infections (including abscesses).

- Urinary tract infections.

- Respiratory infections.

- Intestinal infections.

- Periodontal infections in addition to mechanical or surgical periodontal therapy.

3.3 Contraindications

Do not use in rabbits, guinea pigs, hamsters, gerbils, chinchillas or other small herbivores.

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

Do not administer to horses or ruminating animals.

Do not use in animals with severe renal impairment with anuria or oliguria.

3.4 Special warnings

Cross-resistance has been shown between amoxicillin/clavulanic acid and other antibiotics belonging to the beta-lactam group. Use of the veterinary medicinal product should be carefully considered when susceptibility testing has shown resistance to other antimicrobials in the beta-lactam group because its effectiveness may be reduced.

When susceptibility testing has shown resistance to sole beta-lactam, but susceptibility to combination of amoxicillin/clavulanic acid has been confirmed, treatment with the veterinary medicinal product might nevertheless be considered.

Do not use in cases of suspected or confirmed methicillin resistant S. aureus (MRSA) and methicillin resistant S. pseudintermedius (MRSP) infections, as such isolates should be considered resistant to all beta-lactams including amoxicillin/clavulanic acid combinations.

The veterinary medicinal product has no effect against infections caused by Pseudomonas spp. due to its inherent resistance.

3.5 Special precautions for use

Special precautions for safe use in the target species:

Use of the product should be based on identification and susceptibility testing of the target pathogen(s).

If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at local/regional level.

Use of the product should be in accordance with official, national and regional antimicrobial policies.

An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.

Narrow spectrum antibiotic therapy with a lower risk of antimicrobial resistance selection should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.

Pharmacokinetic of the active substances in the target tissue might be considered as well.

The routine use of systemic antibiotics for intestinal infections is not recommended.

Oral treatment with antibiotics can result in disturbance of gastrointestinal flora, especially in case of long-term treatment.

In case of renal or hepatic insufficiency, the use of the veterinary medicinal product should be subject to a benefit-risk assessment by the responsible veterinarian.

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 can lead to cross-reactions with cephalosporins and vice versa. Allergic reactions caused by these substances may occasionally be serious.

People with known hypersensitivity to the active substance should avoid contact with the veterinary medicinal product. Wear gloves when handling this product to avoid skin contact.

If you develop symptoms such as a skin rash and persistent eye irritation after exposure to the veterinary medicinal product, seek medical advice immediately and show the package leaflet or label to the physician. Swelling of the face, lips, or eyes, or difficulty breathing are more serious symptoms that require urgent medical attention.

Wash hands after use.

To prevent children from accessing the veterinary medicinal product, only the required number of tablets should be removed from the blister pack and only when required.

Store any unused portion of the tablet in the opened blister pack and return it into the carton immediately after use. The carton should be stored out of the sight and reach of children. In case of accidental ingestion, 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.

3.6 Adverse events Dogs and cats:

Common (1 to 10 animals / 100 animals treated):	gastrointestinal disorder1 (e.g. vomiting, diarrhoea)
Uncommon (1 to 10 animals / 1 000 animals treated):	hypersalivation anorexia1, 2, lethargy
Very rare (<1 animal / 10 000 animals treated, including isolated reports):	hypersensitivity reaction3 (e.g. allergic skin reaction, anaphylaxis)

¹ Depending on the severity of the adverse event treatment should be discontinued and symptomatic treatment initiated based on the benefit-risk assessment by the responsible veterinarian.

² Very rare (<1 animal / 10 000 animals treated, including isolated reports) in cats. ³ May be serious. Immediate discontinuation of the veterinary medicinal product is required. Countermeasures to be taken in case of an allergic reaction:

- anaphylaxis: administer epinephrine (adrenaline) and glucocorticoids.

- allergic skin reactions: administer antihistamines and/or glucocorticoids.

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

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

Pregnancy and lactation:

In laboratory studies (rat, mouse), signs of embryotoxicity or teratogenicity could only be detected at high doses.

Use only according to the benefit-risk assessment by the responsible veterinarian.

3.8 Interaction with other medicinal products and other forms of interaction

The bactericidal effect of amoxicillin may be inhibited by the concomitant use of bacteriostatic antimicrobials.

Penicillins may increase the effect of aminoglycosides.

3.9 Administration routes and dosage

Oral use.

Dosage: 10 mg amoxicillin and 2.5 mg clavulanic acid/kg body weight every 12 hours.

In refractory respiratory tract infections, the dose can be doubled to 20 mg amoxicillin and 5 mg clavulanic acid/kg body weight every 12 hours and the treatment can be prolonged for up to 10 days.

Dosing instructions:

Body weight (kg)	Number of tablets every 12 hours (10 mg amoxicillin and 2.5 mg clavulanic acid/kg body weight)
>2.6 to 5	¼
> 5.0 to 10	½
> 10.0 to 15	¾
> 15.0 to 20	1
> 20.0 to 25	1 ¼
> 25.0 to 30	1 ½
> 30.0 to 35	1 ¾
> 35.0 to 40	2

Duration of treatment:

In most of the cases, a treatment duration of 5 to 7 days is sufficient.

For chronic cases, a longer course of therapy may be required.

Based on clinical trials, the following treatment durations are recommended:

Chronic skin infections, 10–20 days. Chronic cystitis, 10–28 days.

Instructions for use:

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

Instruction on how to divide the tablet:

Put the tablet on an even surface, with its scored side facing down (convex face up). With the tip of the forefinger, exert slight vertical pressure on the middle of the tablet to break it along its width into halves. Then, in order to obtain quarters, exert slight pressure on the middle of one half with the forefinger to break it into two parts.

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

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

Doses up to 40 mg amoxicillin and 10 mg clavulanic acid/kg and 60 mg amoxicillin and 15 mg clavulanic acid/kg administered twice daily for 5 days were tolerated well in young dogs and young cats respectively.

No adverse events associated with overdoses other than those listed in section 3.6 were detected in the respective studies (for information on symptomatic treatment see also section on adverse events).

Due to the neurotoxicity of penicillins, overdosing might result in central nervous system symptoms and convulsions. In these cases, treatment with the veterinary medicinal product should be discontinued immediately and symptomatic treatment should be initiated.

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

The veterinary medicinal product is an association of amoxicillin and clavulanic acid. Amoxicillin inhibits the cross-linking of the peptidoglycan layer through a selective and irreversible blockage of various enzymes involved in this process (primarily transpeptidases) and thus prevents the formation of an intact bacterial cell wall. This results in an osmotic imbalance that particularly affects bacteria in the logarithmic phase of growth which ultimately leads to bacterial cell lysis. The effect is therefore bactericidal and related to the time the susceptible organisms are exposed to supraminimum inhibitory concentrations. Clavulanic acid has a similar structure to betalactam antibiotics such as amoxicillin.

It has a weak antibacterial effect but, compared to amoxicillin, has a higher affinity for beta-lactamases, enzymes produced by Gram-positive and Gram-negative bacteria which inactivate beta-lactam antibiotics through the hydrolytic cleavage of their betalactam ring. When administered simultaneously with amoxicillin, clavulanic acid rapidly, progressively and irreversibly inactivates the beta-lactamases by forming a stable molecule-enzyme complex. This prevents inactivation of amoxicillin by betalactamases and, as a result, the spectrum of amoxicillin is broadened to include strains that have acquired resistance through secretion of plasmid-derived penicillinase, and strains that are naturally resistant through the production of chromosomally mediated beta-lactamases.

Other mechanisms of resistance to beta-lactams include the modification of the antibiotic target site (penicillin-binding proteins), efflux pumps and changes in the permeability of the outer membrane.

4.3 Pharmacokinetics

After oral administration in dogs and cats, 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. In dogs , bioavailability is 60-70%. 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. Amoxicillin is excreted mainly by the kidneys (unchanged in the urine).

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 13 mg/kg amoxicillin and 3.15 mg/kg clavulanic acid in cats:

- The time to reach maximum concentration of amoxicillin (Tmax) ranged from 1 to 3 hours, with a maximum concentration (Cmax) between 5.2 to 16.3 µg/mL. The mean elimination half-life (T1/2) was between 1.1 and 1.8 hours.

- The Cmax of clavulanic acid ranged from 2.2 to 6.4 µg/mL, the Tmax from

0.5 to 1.7 hours, and the T1/2 from 0.5 to 0.7 hour.

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

- The Tmax of amoxicillin ranged from 0.75 to 3 hours, with a Cmax between

4.2 to 14.3 µg/mL. The T1/2 was between 1.3 and 2 hours.

- The Cmax of clavulanic acid ranged from 0.6 to 8.2 µg/mL, the Tmax from

0.75 to 1.5 hours, and the T1/2 from 0.4 to 0.7 hour.

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 36 hours should be discarded

5.3 Special precautions for storage

Do not store above 25°C.

Store in a dry place.

Divided tablets should be stored in the blister pack.

5.4 Nature and composition of immediate packaging

(PA-AL-PVC – aluminium heat sealed blister) containing 8 tablets per blister

Cardboard box with 1 blister of 8 tablets

Cardboard box with 2 blisters of 8 tablets

Cardboard box with 4 blisters of 8 tablets

Cardboard box with 6 blisters of 8 tablets

Cardboard box with 8 blisters of 8 tablets

Cardboard box with 10 blisters of 8 tablets

Cardboard box with 12 blisters of 8 tablets

Cardboard box with 30 blisters of 8 tablets Cardboard box with 60 blisters of 8 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

8 rue de Logrono

33500 Libourne

7. MARKETING AUTHORISATION NUMBER

Vm 14966/5072

Vm 14966/3071

8. DATE OF FIRST AUTHORISATION

05 October 2011

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

September 2026

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: 21 October 2026