Clavaseptin 750 mg Palatable Tablets for Dogs

Composition

Each tablet contains:

Active substances:

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

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

Excipients:

Oblong, off -white to brownish speckled, scored tablets of about 24 mm.

Tablet can be divided into four equal parts.

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Pharmacological properties

4.1 ATCvet code: QJ01CR02

4.2 Pharmacodynamics

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.

4.3 Pharmacokinetics

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.

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Target species

Dogs

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Indications

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.

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Dosage

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:

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.

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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.

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Adverse reactions

Dogs:

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.

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Warnings

Special precautions for safe use in the target species:

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 3.3.

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.

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

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

3. If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the package leaflet or the label to the physician. 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 veterinary medicinal 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.

Special precautions for the protection of the environment:

Not applicable.

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.

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

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.

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Interactions

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.

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Overdose

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.

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Special warnings

None

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Withdrawal period

Not applicable

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Incompatibilities

None known.

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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.

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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.

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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.

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Disposal of unused product

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.

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Additional information

Vm 08007/5010

8 DATE OF FIRST AUTHORISATION

09 May 2022

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

May 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.

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Registration holder

Vetoquinol UK Limited

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