Target species
50mg & 62.5mg : Dogs and cats
250mg & 500mg: Dogs
Indications for use, specifying the target species
In dogs: treatment of infections caused by bacteria susceptible to amoxicillin in combination with clavulanic acid (including beta-lactamase producing strains), in particular:
• Skin infections (including deep and superficial pyodermas, wounds, abscesses) caused by Staphylococcus spp, Streptococcus spp and Pasteurella spp.
• Respiratory tract infections (sinusitis, rhino-tracheitis, bronchopneumonia) caused by Staphylococcus spp and E. coli.
• Infections of the oral cavity (mucous membranes) caused by Streptococcus spp, and Pasteurella spp.
• Urinary tract infections (nephritis, cystitis) caused by E. coli, Klebsiella spp and Proteus mirabilis.
• Digestive tract infections, especially gastroenteritis caused by E. coli.
In cats: treatment of infections caused by bacteria susceptible to amoxicillin in combination with clavulanic acid (including beta-lactamase producing strains), in particular:
• Skin infections (including deep and superficial pyodermas, wounds, abscesses) caused by Staphylococcus spp, Streptococcus spp and Pasteurella spp.
• Respiratory tract infections (sinusitis, rhino-tracheitis, bronchopneumonia) caused by Staphylococcus spp and E. coli.
• Infections of the oral cavity (mucous membranes) caused by Streptococcus spp, and Pasteurella spp.
• Urinary tract infections (nephritis, cystitis) caused by E. coli, Pasteurella spp, Klebsiella spp and Proteus mirabilis.
• Digestive tract infections, especially gastroenteritis caused by E. coli.
Contraindications
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 or other small herbivores.
Do not use in animals with serious dysfunction of the kidneys accompanied by anuria or oliguria.
Do not administer to horses and ruminating animals.
Special warnings
Cross-resistance has been shown between amoxicillin/clavulanic acid and β-lactam antibiotics. Use of the veterinary medicinal product should be carefully considered when susceptibility testing has shown resistance to β-lactam antibiotics because its effectiveness may be reduced.
Methicillin resistant S. aureus (MRSA) and methicillin resistant S. pseudintermedius (MRSP) have been isolated in cats and dogs with proportion of resistance that varies across EU countries.
Do not use in cases of known resistance to the combination of amoxicillin and clavulanic acid.
Do not use in cases of suspected or confirmed MRSA/MRSP infections, as isolates should be considered resistant to all β-lactam including amoxicillin/clavulanic acid combination.
High resistances (up to 100%) have been reported in E. coli isolates from skin and soft tissue infections in dogs.
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 veterinary medicinal product should be subject to a benefit/risk evaluation by the veterinary surgeon and the posology evaluated carefully.
Use of the veterinary medicinal product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at local/regional level.
Use of the veterinary medicinal product should be in accordance with official, national and regional antimicrobial policies. Aminopenicillins in combination with beta-lactamase inhibitors are in AMEG category „C”. An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach. Narrow spectrum antibiotic 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.
The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals.
The potential for allergic cross-reactivity with other penicillins should be considered.
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.
Do not handle this veterinary medicinal product if you know you are sensitised, or if you have been advised not to work with such veterinary medicinal preparations. Handle this veterinary medicinal product with great care to avoid exposure, taking all recommended precautions.
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 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 immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Dogs and cats.
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Vomiting1, Diarrhoea.1 Hypersensitivity reaction (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 its local representative or the national competent authority via the national reporting system.
Use during pregnancy, lactation or lay
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 in accordance with the 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. Penicillins may increase the effect of aminoglycosides.
Administration routes and dosage
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 and cats, every 12 h, according to the following tables:
Clavaseptin 50 mg Palatable tablets for dogs and cats:
Bodyweight (kg) | Number of tablets twice daily |
[ 1.0- 2.0 ] | ½ |
[ 2.1- 4.0 ] | 1 |
[ 4.1- 6.0 ] | 1 ½ |
[ 6.1- 8.0 ] | 2 |
Clavaseptin 62.5 mg Palatable tablets for dogs and cats:
Bodyweight (kg) | Number of tablets twice daily |
[ 1.0- 2.5 ] | ½ |
[ 2.6- 5.0 ] | 1 |
[ 5.1- 7.5 ] | 1 ½ |
[ 7.6 - 10.0 ] | 2 |
Clavaseptin 250 mg Palatable tablets for dogs:
Bodyweight (kg) | Number of tablets twice daily |
[ 8.1 - 10 ] | ½ |
[ 10.1- 20 ] | 1 |
[ 20.1- 30 ] | 1 ½ |
[ 30.1- 40 ] | 2 |
Clavaseptin 500 mg Palatable tablets for dogs:
Bodyweight (kg) | Number of tablets twice daily |
[ 30.1 - 40 ] | 1 |
[ 40.1 - 60 ] | 1 ½ |
[ 60.1 - 80 ] | 2 |
In severe cases, the dose can be doubled at the discretion of the responsible veterinarian.
Duration of the treatment:
For all indications, a treatment of 5 to 7 days is sufficient in the majority of cases.
For chronic or recurrent cases, it may be necessary to continue treatment for 2 to 4 weeks.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
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.
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