Clavucill 500 mg – 400 mg amoxicillin/ 100 mg clavulanic acid , 10 tablets

CLAVUCILL 500 MG

Active substances:
Amoxicillin (as amoxicillin trihydrate)

Clavulanic acid (as potassium clavulanate)

Excipients:

Erythrosine (E127) 0.05 mg.

COMPOSITION:
Clavucill 500 mg – 400 mg amoxicillin / 100 mg clavulanic acid.

INDICATION(S)

Dogs:

Treatment of infections caused by microorganisms sensitive to the combination of amoxicillin/clavulanic acid, in particular:

– Dermatitis (superficial and deep pyoderma), caused by Staphylococcus

(pseudo)intermedius.

– Urinary tract infections caused by E. Coli.

– Respiratory tract infections caused by Streptococcus spp.

– Enteritis caused by E. coli.

CONTRAINDICATIONS

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

– Do not use in case of severe renal dysfunction accompanied by anuria and oliguria.

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

ADVERSE REACTIONS

Gastrointestinal disorders (diarrhea, vomiting) may occur after administration of the product. Treatment may be discontinued depending on the severity of the adverse effects and an assessment of the benefit/risk ratio by the veterinarian.

Very rarely, allergic reactions may occur regardless of the dose, such as skin reactions or even anaphylactic shock. In these cases, therapy should be stopped immediately and symptomatic treatment should be instituted.

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

– very common (more than 1 in 10 animals displaying adverse reactions during treatment)

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

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

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

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

If you notice any serious reactions or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

TARGET SPECIES

Dogs.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Oral use.

Dosage: The recommended dose is 10 mg amoxicillin/2.5 mg clavulanic acid/kg body weight (= 12.5 mg of combined active substances) twice

daily, orally in dogs and cats, i.e. 1 tablet/4 kg body weight every 12 h.

Body weight (kg) Number of tablets (twice/day)

(1.0 – 2.0)                     1/2

1(2.1 – 4.0)                   1

(4.1-6.0)                      1 1/2

(6.1- 8.0)                      2

> 8 Tablets of 250 or 500 mg are used

In the case of complicated infections, especially respiratory infections, a better cure rate is obtained by doubling the dose, i.e. 25 mg of combined active substances/kg body weight, twice a day.

In case of complicated infections, especially respiratory infections, a better cure rate is obtained by doubling the dose, i.e. 25 mg of active substance combination/kg body weight, twice daily.

Duration of treatment:

In most cases, 5 to 7 days of treatment are sufficient.

Chronic or refractory infections require a longer period of antibacterial treatment.

The duration of treatment is established by the veterinarian, and should be long enough to ensure complete bacteriological cure.

To ensure correct dosage, body weight should be determined as accurately as possible to avoid underdosing of the product.

RECOMMENDATIONS ON CORRECT ADMINISTRATION
Do not use in case of known resistance to the combination of active substances.

Official, national and regional antimicrobial policies regarding the use of broad-spectrum antibiotics should be taken into account.
Do not use in bacteria susceptible to narrow-spectrum penicillins or amoxicillin as a single agent.
Whenever possible, the product should only be used based on susceptibility testing.
Use of the product deviating from the instructions in the SPC may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid and may decrease the effectiveness of treatment with 13-lactam antibiotics due to the potential for cross-resistance.
In animals with hepatic and/or renal impairment, the dosage regimen should be carefully evaluated.