Target species
Clavubactin 50/12.5 mg - cats and dogs
Clavubactin 250/62.5 mg and 500/125 mg - dogs
Indications for use
Treatment of infections in cats and dogs caused by bacteria sensitive to amoxicillin in combination with clavulanic acid, particularly:
- Skin infections (including superficial and deep pyodermas) associated with Staphylococci (including beta-lactamase producing strains) and Streptococci.
- Urinary tract infections associated with Staphylococci (including beta-lactamase producing strains), Streptococci, Escherichia coli (including beta-lactamase producing strains), Fusobacterium necrophorum and Proteus spp.
- Respiratory tract infections associated with Staphylococci (including beta-lactamase producing strains), Streptococci and Pasteurellae.
- Gastrointestinal tract infections associated with Escherichia coli (including beta-lactamase producing strains) and Proteus spp.
- Infections of the oral cavity (mucous membrane) associated with Clostridia, Corynebacteria, Staphylococci (including beta-lactamase producing strains), Streptococci, Bacteroides spp (including beta-lactamase producing strains), Fusobacterium necrophorum and Pasteurellae.
Contraindications
Do not use in animals with known hypersensitivity to penicillin or other substances of the beta-lactam group or any of the excipients.
Do not use in serious dysfunction of the kidneys accompanied by anuria and oliguria.
Do not use in rabbits, guinea pigs, hamsters, chinchillas and gerbils.
Do not use in case of known resistance to the combination.
Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken into account when the product is used.
Do not use in case of bacteria sensitive to narrow spectrum penicillins or to amoxicillin as single substance.
It is advised that upon initiating therapy appropriate sensitivity testing is performed and that therapy is continued only after susceptibility to the combination has been established.
Use of the product deviating from the instructions given in this datasheet may increase the prevalence of bacteria resistant to the amoxicillin/clavulanate, and may decrease the effectiveness of treatment with β-lactam antibiotics due to the potential for cross-resistance.
In animals with hepatic and renal failure, the dosing regimen should be carefully evaluated.
Caution is advised in the use in small herbivores other than those in Contraindications.
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 product if you know you are sensitised, or if you have been advised not to work with such preparations.
Handle this product with great care to avoid exposure, taking all recommended precautions.
If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning.
Swelling of the face, lips or eyes or difficulty with breathing, are more serious symptoms and require urgent medical attention.
Wash hands after use.
Adverse reactions
Mild gastrointestinal symptoms (diarrhoea, nausea and vomiting) may occur after administration of the product.
Allergic reactions (skin reactions, anaphylaxia) may occasionally occur. In these cases, administration should be discontinued and a symptomatic treatment given.
Use during pregnancy and lactation
Laboratory studies in rats and mice have not produced any evidence of teratogenic or fetotoxic effects. No studies have been conducted in the pregnant and lactating dogs and cats. Use only according to the benefit/risk assessment by the responsible veterinarian.
Interactions
Chloramphenicol, macrolides, sulfonamides, and tetracyclines may inhibit the antibacterial effects of penicillins.
The potential for allergic cross-reactivity with other penicillins should be considered.
Penicillins may increase the effect of aminoglycosides.
Amounts to be administered and administration route
Posology:
For oral administration in dogs and cats.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid under dosing.
Dosage:
The recommended dose is 12.5 mg of combined active substance (=10 mg amoxicillin and 2.5 mg clavulanic acid) per kg body weight, twice daily.
The following tables are intended as a guide to dispensing the product at the standard dose rate of 12.5 mg of combined actives per kg body weight twice daily.
Clavubactin 50/12.5 mg tablets for cats and dogs - dosage table: |
Body weight (kg) | Number of tablets twice daily |
1 - 1.25 | ¼ |
1.25 - 2.5 | ½ |
2.5 - 3.75 | ¾ |
3.75 - 5 | 1 |
5 - 6.25 | 1¼ |
Clavubactin 250/62.5 mg tablets for dogs - dosage table: |
Body weight (kg) | Number of tablets twice daily |
5 - 6.25 | ¼ |
6.25 - 12.5 | ½ |
12.5 - 18.75 | ¾ |
18.75 - 25 | 1 |
25 - 31.25 | 1¼ |
31.25 - 37.5 | 1½ |
Clavubactin 500/125 mg tablets for dogs - dosage table: |
Body weight (kg) | Number of tablets twice daily |
6.25 - 12.5 | ¼ |
18.75 - 25 | ½ |
37.5 - 50 | 1 |
50 - 62.5 | 1¼ |
62.5 - 75 | 1½ |
In refractory cases of skin infections, a double dose is recommended (25 mg per kg body weight, twice daily).
Duration of therapy:
The majority of routine cases respond to 5 – 7 days of therapy.
In chronic cases, a longer case of therapy is recommended. In such circumstances overall treatment length must be at the clinician’s discretion, but should be long enough to ensure complete resolution of the bacterial disease.
Overdose
Mild gastrointestinal signs (diarrhoea, nausea and vomiting) may occur more frequently after overdose of the product.