Target species
Dogs
Indications for use for each target species
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.
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.
Special warnings
None
Special precautions for use
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 'Contradictions'.
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.
Adverse reactions
Dogs:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Vomiting1, diarrhoea.1 Hypersensitivity reaction2 (allergic skin reactions2), anaphylaxis2 |
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.
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.
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 penicillins should be considered.
Penicillins may increase the effect of aminoglycosides.
Administration routes and doseage
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:
Bodyweight (kg) | Number of tablets twice daily |
[ >20 - 30 ] | ½ |
[ 30.1 - 45 ] | ¾ |
[ 45.1 - 60 ] | 1 |
[60.1 - 75] | 1 ¼ |
[75.1 - 90] | 1 ½ |
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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
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.
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.
Withdrawal periods
Not applicable