Clavaseptin 500 mg / 400mg amoxicillin (as trihydrate) and 100mg clavulanic acid / Palatable Tablets for Dogs / 1 blister – 10 tablets /

Clavaseptin 500 mg Palatable Tablets containing 400mg amoxicillin (as trihydrate) and 100mg clavulanic acid (as potassium salt). For use in dogs.

Excipient: Brown Iron Oxide (E172)

Uses

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.

In cats: treatment of skin infections (including wounds and abscesses) caused by bacteria susceptible to amoxicillin in combination with clavulanic acid i.e. Pasteurella spp, Staphylococcus spp, Streptococcus spp and Escherichia coli.

Dosage and administration

For oral administration.

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

The recommended dose of Clavaseptin Palatable Tablets is 10 mg amoxicillin/2.5mg clavulanic acid/kg twice daily by the oral route in dogs and cats.

In severe 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

– 7 to 14 days for the treatment of skin infections in cats (including wounds and abscesses). The clinical status of animals should be re-evaluated after 7 days and the treatment prolonged for a further 7 days if necessary.

Administration is made easier by the palatable nature of the tablet.

Contra-indications, warnings, etc

Do not use in case of 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 oliguaria.

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

Special precautions for use in animals

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

Caution is advised in the use of Clavaseptin in any other small pet (non food-producing) herbivores.

Use of the product should be based on susceptibility testing.

Inappropriate use of the product may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid and may decrease the effectiveness of treatment with other beta lactam antibiotics, due to the potential for cross resistance. Use of the product should take into account official and local antimicrobial policies. Do not use in cases of bacteria sensitive to narrow spectrum penicillins or to amoxicillin as a single substance.

Adverse reactions (frequency and seriousness)

Vomiting and diarrhoea may be observed. Treatment may be continued depending on the severity of the undesirable effect observed and a benefit/risk evaluation by the veterinary surgeon.

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

Use during pregnancy and lactation

The safety of the 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 the product only accordingly to the benefit/risk assessment by the responsible veterinarian.

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 pencillins should be considered. Penicillins may increase the effect of aminoglycosides.

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

At three times the recommended dose for a period of 28 days, a decrease in cholesterol values and episodes of vomiting were observed in cats and diarrhoea was observed in dogs. In the event of an overdose, symptomatic treatment is advised.

Operator warning

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

2. Handle this 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 doctor this warning. Swelling of the face, lips or eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.

Wash hands after handling the tablets

Pharmaceutical precautions

Do not store above 25°C. Store in the original package.

Return any halved tablet to the opened strip-pack and use within 16 hours.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.