SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Clavaseptin 750 mg palatable tablets for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active substances:

Amoxicillin (as amoxicillin trihydrate)……………….……………..………. 600 mg

Clavulanic acid (as potassium clavulanate, diluted)………………………...... 150 mg

Excipients

Iron oxide, brown (E172)………………………………….…..…….………….1.43 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablet.

Oblong, off -white to brownish speckled, scored tablets of about 24 mm. Tablet can be divided into four equal parts.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

In dogs: treatment or adjunctive treatment of periodontal infections caused by bacteria susceptible to amoxicillin in combination with clavulanic acid i.e. Pasteurella spp, Streptococcus spp and Escherichia coli.

4.3 Contraindications

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

Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas.

Do not administer to horses and ruminating animals.

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

Do not use in cases of known resistance to the combination of amoxicillin and clavulanic acid.

4.4 Special warnings for each target species

None

4.5 Special precautions for use

Special precautions for use in animals

In animals with impaired liver and kidney function, the use of the product should be subject to a benefit/risk evaluation by the veterinary surgeon and the posology evaluated carefully.

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

Use of the product should be based on susceptibility testing.

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

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid and may decrease the effectiveness of treatment with other β-lactam antibiotics, due to the potential for cross resistance.

Narrow spectrum antibacterial 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.

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

The 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 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.

Wash hands after handling the tablets.

Accidental ingestion of the product by a child may be harmful. To avoid accidental ingestion, particularly by a child, unused part-tablets should be returned to the open blister space and inserted back into the carton.

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

4.6 Adverse reactions (frequency and seriousness)

Vomiting and diarrhoea may be observed very rarely. Treatment may be discontinued depending on the severity of the undesirable effects and a benefit/risk evaluation by the veterinary surgeon.

Hypersensitivity reactions (allergic skin reactions, anaphylaxis) may be observed very rarely. In these cases, administration should be discontinued and a symptomatic treatment given.

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

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

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

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

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

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

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies in rats have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

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

4.8 Interaction with other medicinal products and other forms of interaction

The bactericidal activity of amoxicillin may be reduced by the simultaneous use of bacteriostatic substances such as macrolides, tetracyclines, sulfonamides and chloramphenicol.

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

For oral use.

To ensure the correct dosage, body weight should be determined as accurately as possible to avoid under-dosing.

The recommended dose of the 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 60 kg body weight every 12 h, according to the following table:

Bodyweight (kg)	Number of tablets twice daily
[ >20 - 30 ]	½
[ 30.1 - 45 ]	3/4
[ 45.1 - 60 ]	1
[60.1 - 75]	1 ¼
[75.1 - 90]	1 ½

In severe periodontal infections the dose may be doubled to 20 mg amoxicillin / 5 mg clavulanic acid/kg body weight twice daily.

Duration of treatment:

- 7 days for the treatment of periodontal infections in dogs.

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

At three times the recommended dose for a period of 28 days, diarrhoea was observed in dogs. In the event of an overdose symptomatic treatment is advised.

4.11 Withdrawal period(s)

Not applicable

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: antibacterials for systemic use; amoxicillin and betalactamase 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-lactamases which protects amoxicillin from inactivation by many β-lactamases.

Amoxicillin/clavulanate has a wide range of activity which includes β-lactamase producing strains of both Gram-positive and Gram-negative aerobes, facultative anaerobes and obligate anaerobes.

Specific veterinary clinical breakpoints have not been established. Human derived breakpoints (M100-S document) for amoxicillin/clavulanic acid are:

Organisms other than Staphylococci: sensitive: MIC < 8/4 µg/ml, resistant: MIC > 32/16 µg/ml

In dog periodontal infections in Europe (isolates of the year 2002 from France, Germany and Belgium) amoxicillin/clavulanic acid combination in a ratio 2/1 showed the following data on sensitivity:

Pasteurellaceae:	MIC90: 0.4/0.2 µg/ml,
Streptococcus spp.:	MIC90: 0.4/0.2 µg/ml,
Escherichia coli:	MIC90: 5.3/2.6 µg/ml,

Resistance to β-lactam antibiotics is mainly mediated by β-lactamases which hydrolyze antibiotics such as amoxicillin.

Susceptibility and resistance patterns can vary with geographical area and bacterial strain, and may change over time.

5.2 Pharmacokinetic particulars

After oral administration at the recommended dose in dogs, the absorption of amoxicillin and clavulanic acid is fast. The maximum plasma concentration of amoxicillin of 8.5 µg/ml is reached in 1.4 hours and the maximum plasma concentration of clavulanic acid of 0.9 µg/ml is reached in 0.9 hours. Half-life is 1 hour for both substances.

Elimination is also fast. 12 % of the amoxicillin and 17 % of clavulanic acid is excreted in the urine. The remainder is excreted as inactive metabolites.

After repeated oral administration of the recommended dose, there is no accumulation of amoxicillin or clavulanic acid and the steady state is reached rapidly after first administration.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Iron oxide, brown E172

Crospovidone

Povidone

Silicon dioxide

Microcrystalline cellulose

Liver aroma

Yeast

Magnesium stearate

Hypromellose

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life after first opening the immediate packaging: 48 hours.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions. Return any part of tablet to the opened blister- and use within 48 hours.

6.5 Nature and composition of immediate packaging

Aluminum (oPA/Alu/PE)/Aluminum blister with 10 tablets/blister

Cardboard box: Pack sizes of 10, 100, 250, and 600 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 Limited

Steadings Barn

Pury Hill Business Park

Nr Alderton

Towcester

Northamptonshire

NN12 7LS

8. MARKETING AUTHORISATION NUMBER

Vm 08007/4176

9. DATE OF FIRST AUTHORISATION

09 May 2022

10. DATE OF REVISION OF THE TEXT

May 2022

Approved 09 May 2022