SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

NL: Clavoral 250/62.5 mg tabletten voor honden

CZ: Clavubactin 250/62.5 mg tablety pro psi

ES: Clavubactin 250/62.5 mg comprimidos para perros

FR: Clavubactin 250/62.5 mg comprimés pour chiens

HU: Clavubactin 250/62.5 mg tabletta kutyák számára

IE: Clavubactin 250/62.5 mg tablets for dogs

IS: Clavubactin vet. 250/62.5 mg töflur fyrir hunda

IT: Clavubactin 250/62.5 mg compresse per cani

PL: Clavubactin vet. 250/62.5 mg tabletki dla psów

SK: Clavubactin 250/62.5 mg tablety pre psov

UK: Clavubactin 250/62.5 mg tablets for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active substances: quantity

Amoxicillin

(as amoxicillin trihydrate) 250 mg

Clavulanic acid

(as potassium clavulanate) 62.5 mg

Excipient(s):

Quinoline Yellow E104 0.3 mg

Titanium dioxide E171 0.5 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablets

Yellowish-white to light yellow round tablet with a cross shaped break mark on one side.

The tablets can be divided into four equal parts.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Treatment of infections in dogs caused by bacteria sensitive to amoxicillin in combination with clavulanic acid, particularly:

• Skin infections (including superficial and deep pyodermas) associated with Staphylococci (including beta-lactamase producing strains) and Streptococci.

• Urinary tract infections associated with Staphylococci (including beta-lactamase producing strains), Streptococci, Escherichia coli (including beta-lactamase producing strains), Fusobacterium necrophorum and Proteus spp.

• Respiratory tract infections associated with Staphylococci (including beta-lactamase producing strains), Streptococci and Pasteurellae.

• Gastrointestinal tract infections associated with Escherichia coli (including beta-lactamase producing strains) and Proteus spp.

• Infections of the oral cavity (mucous membrane) associated with Clostridia, Corynebacteria, Staphylococci (including beta-lactamase producing strains), Streptococci, Bacteroides spp (including beta-lactamase producing strains), Fusobacterium necrophorum and Pasteurellae.

4.3 Contraindications

Do not use in animals with known hypersensitivity to penicillin or other substances of the beta-lactam group or any of the excipients.

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

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

Do not use in case of known resistance to the combination.

4.4 Special warnings for each target species

None known.

4.5 Special precautions for use

Special precautions for use in animals

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

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 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 β-lactam antibiotics due to the potential for cross-resistance.

In animals with hepatic and renal failure, the dosing regimen should be carefully evaluated.

Caution is advised in the use in small herbivores other than those in the section 4.3.

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

4.6 Adverse reactions (frequency and seriousness)

Mild gastrointestinal symptoms (diarrhoea, nausea and vomiting) may occur after administration of the product.

Allergic reactions (skin reactions, anaphylaxia) may occasionally occur. In these cases, administration should be discontinued and a symptomatic treatment given.

4.7 Use during pregnancy, lactation or lay

Laboratory studies in rats and mice have not produced any evidence of teratogenic or fetotoxic effects. No studies have been conducted in the pregnant and lactating dogs. Use only according to the benefit/risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

Chloramphenicol, macrolides, sulfonamides, and tetracyclines may inhibit the antibacterial effects of penicillins.

The potential for allergic cross-reactivity with other penicillins should be considered.

Penicillins may increase the effect of aminoglycosides.

4.9 Amounts to be administered and administration route

Posology

For oral administration in dogs.

To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.

Dosage

The recommended dose is 12.5 mg of combined active substance (=10 mg amoxicillin and 2.5 mg clavulanic acid) per kg bodyweight, twice daily.

The following table is intended as a guide to dispensing the product at the standard dose rate of 12.5 mg of combined actives per kg bodyweight twice daily.

	Number of tablets twice daily
Bodyweight (kg)	amoxicilline 50 mg/ clavulanic acid 12.5 mg	amoxicilline 250 mg/ clavulanic acid 62.5 mg	amoxicilline 500 mg/ clavulanic acid 125 mg
1 – 1.25
1.25 – 2.5
2.5 – 3.75
3.75 – 5
5 – 6.25
6.25 - 12.5
12.5 - 18.75
18.75 - 25
25 - 31.25
31.25 - 37.5
37.5 - 50
50 – 62.5
62.5 - 75

In refractory cases of skin infections, a double dose is recommended (25 mg per kg bodyweight, twice daily).

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.

4.10 Overdose (symptoms, emergency procedures, antidotes)

Mild gastrointestinal symptoms (diarrhea, nausea and vomiting) may occur more frequently after overdose of the product.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterials for systemic use, amoxicillin and enzyme inhibitor.

ATCvet code: QJ01CR02

5.1 Pharmacodynamic properties

Amoxicillin is an aminobenzylpenicillin from the β-lactam penicillin family which prevents the bacterial cell wall formation by interfering with the final step of peptidoglycan synthesis.

Clavulanic acid is an irreversible inhibitor of intracellular and extracellular β-la