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Contra-indications, warnings, etc
Do not use in cases 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 in small herbivores. Do not administer to those listed above under Contraindications.
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.
Adverse reactions (frequency and seriousness)
Vomiting and diarrhoea may be observed very rarely. 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 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).
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 only according 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.
User warnings
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
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.