CLAVUCILL 50 mg 100 TABLETS | ANTIBIOTIC FOR DOGS

CLAVUCILL

40 mg/10 mg TABLETS FOR DOGS AND CATS

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet (180 mg) contains:
– Active substances: Amoxicillin (as amoxicillin trihydrate) 40mg/tablet
Clavulanic acid (as potassium clavulanate) 10mg/tablet
– Excipients: Erythrosine (E127) 0,05mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
pill.
Uncoated tablet, 8 mm in diameter, pale pink, rounded, with a
groove on one of the faces.
4. CLINICAL DATA
4.1 Target species
Dogs and cats.
4.2 Indications for use, specifying the target species
Dogs and cats:
Treatment of infections caused by microorganisms sensitive to the combination of
amoxicillin/clavulanic acid, in particular:
– Dermatitis (superficial and deep pyoderma) caused by Staphylococcus intermedius
– Urinary tract infections caused by E. coli
– Respiratory tract infections caused by Streptococcus spp.
– Enteritis caused by E. coli

CLAVUCILL

4.3 Contraindications
– Do not use in animals with known hypersensitivity to penicillin or other substances in the
β-lactam group.
– Do not use in case of severe kidney dysfunction with anuria and oliguria
– Do not use on rabbits, guinea pigs, hamsters, chinchillas or gerbils.
4.4 Special warnings for each target species
Not applicable.
4.5 Special precautions for use

CLAVUCILL

i) Special precautions for use in animals
– Do not use in case of known resistance to the combination
– The official, national and regional regulations for the use of
broad spectrum antibiotics.
– Do not use on bacteria sensitive to narrow-spectrum penicillins or amoxicillin
one
– It is recommended to carry out sensitivity tests before starting the treatment and this only
must be continued, after it has been established, susceptibility to
combination.
– The use of the product in conditions other than the CPR instructions may increase
the prevalence of bacteria resistant to amoxicillin and clavulanic acid, and may
decrease the efficacy of treatment with other β-lactam antibiotics.
– In animals with renal or hepatic insufficiency, the dose must be adjusted.
– Caution is advised in use in small herbivores not listed in the
section 4.3
ii) Specific precautions to be taken by the person administering the medicinal product to
animals
After injection, inhalation, ingestion, or skin contact, penicillins and
Cephalosporins may cause a hypersensitivity (allergic) reaction. Allergy to
Penicillins can give rise to a cross-allergy with cephalosporins and vice versa.
Allergic reactions caused by these substances can sometimes be severe.
– People with known hypersensitivity to penicillins should avoid contact
with the veterinary drug.
– Use the product with care and take precautions to avoid exposure.
– If you have any reaction after using this product (for example, erythema)
Consult a doctor and show this warning or the packaging.
Swelling of the face, lips or eyes or difficulty breathing are the symptoms
Serious that require immediate medical attention.
– Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
– Hypersensitivity reactions may occur independent of dose, such as
skin reactions and anaphylaxis. In these cases, treatment should be discontinued.
immediately and symptomatic therapy should be initiated.
– Gastrointestinal disorders (diarrhea and vomiting,…) after administration of the
product.

CLAVUCILL

4.7 Use during pregnancy or lactation
Laboratory studies in mice have not produced any teratogenic or toxic effects.
for the fetus. No study was conducted in dogs and cats during gestation and
lactation.
Use the product only in accordance with the risk/benefit assessment performed by
the vet in charge.
4.8 Interaction with other medicinal products and other forms of interaction
Chloramphenicol, macrolides, sulfonamides and tetracyclines can inhibit the action
antibacterial of penicillins.

The potential for allergic cross-reaction with other penicillins must be considered.
Penicillins may increase the effect of aminoglycosides.
4.9 Amounts to be administered and administration route
Orally
Amount to manage: The recommended dose is 10mg amoxicillin/2,5mg acid
clavulanate per kg body weight (= 12,5 mg of the combination of active substances)
twice a day, orally in dogs and cats, 1 tablet per 4 kg of body weight every 12 hours.

In case of complicated infections, especially respiratory infections, it can be
double the dose to obtain a greater improvement in the case, up to 25 mg of the
combination of active substances per kg of body weight, twice a day.
Treatment duration:
In most cases, 5 to 7 days of treatment is sufficient.
For chronic and refractory infections, more treatment time may be necessary. He
treatment must be adjusted by the veterinarian and must be sufficient to ensure healing
total bacteriological.
To ensure correct dosing, body weight should be determined to the greatest
precision as possible to avoid underdosing.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Moderate gastrointestinal symptoms (vomiting and diarrhea) may occur more frequently
after overdose of the product.
4.11 Timeout
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: amoxicillin and enzyme inhibitor
ATC veterinary code: QJ01CR02.

Not all formats may be marketed.
6.6 Special precautions for disposal of the veterinary medicinal product not
used or, where appropriate, the residues derived from its use
Any unused veterinary medicinal product or residues derived from it must be
disposed of in accordance with local regulations.

6. 8. MARKETING AUTHORIZATION NUMBER
   2440 ESP
   9. DATE OF THE FIRST AUTHORIZATION / RENEWAL OF THE AUTHORIZATION
   January 26, 2012
   10 DATE OF REVISION OF THE TEXT
   January 26, 2012
   PROHIBITION OF THE SALE, DISPENSATION AND/OR USE
   Medicine subject to a veterinary prescription.

See technical sheet 

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