Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction 
Company name: Vétoquinol UK Ltd
Address: Vétoquinol House
Great Slade
Buckingham Industrial Park
Buckingham
MK18 1PA
Telephone: 01280 814500
Fax: 01280 825460
Email: office@vetoquinol.co.uk
Website: www.vetoquinol.co.uk
Presentation
Three tablet strengths are available: Clavaseptin 50mg Palatable Tablets containing 40mg Amoxicillin (as trihydrate) and 10mg Clavulanic Acid (as potassium salt). For use in cats and dogs.
Clavaseptin 250mg Palatable Tablets containing 200mg Amoxicillin (as trihydrate) and 50mg Clavulanic Acid (as potassium salt). For use in dogs.
Clavaseptin 500mg Palatable Tablets containing 400mg Amoxicillin (as trihydrate) and 100mg Clavulanic Acid (as potassium salt). For use in dogs.
Excipient: Brown Iron Oxide (E172)
Uses
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.
In cats: treatment of skin infections (including wounds and abscesses) caused by bacteria susceptible to amoxicillin in combination with clavulanic acid i.e. Pasteurella spp, Staphylococcus spp, Streptococcus spp and Escherichia coli.
Dosage and administration
The recommended dose of Clavaseptin Palatable Tablets is 10 mg amoxicillin/2.5mg clavulanic acid/kg twice daily by the oral route in dogs and cats according to the following table.
Bodyweight (kg)
| 50mg tablets 1 tablet per 5kg bodyweight every 12h
| 250mg tablets 1 tablet per 20kg body weight every 12h
| 500mg tablets 1 tablet per 40kg bodyweight every 12h
| [1.0-2.0]
| ½
|
|
| [2.1-4.0]
| 1
|
|
| [4.1-6.0]
| 1½
|
|
| [6.1-8.0]
| 2
|
|
| [8.1-10]
|
| ½
|
| [10.1-20]
|
| 1
|
| [20.1-30]
|
| 1½
|
| [30.1-40]
|
| 2
| 1
| [40.1-60]
|
|
| 1½
| [60.1-80]
|
|
| 2
|
Duration of treatment:
- 7 days for the treatment of periodontal infections in dogs
- 7 to 14 days for the treatment of skin infections in cats (including wounds and abscesses). The clinical status of animals should be re-evaluated after 7 days and the treatment prolonged for a further 7 days if necessary.
To ensure the correct dosage, bodyweight should be determined as accurately as possible to avoid under-dosing.
Administration is made easier by the palatable nature of the tablet.
Contra-indications, warnings, etc
Do not use in case of hypersensitivity to penicillins or other substances of the β-lactam group.
Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas.
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 of Clavaseptin in any other small pet (non food-producing) herbivores.
Use of the product should be based on susceptibility testing.
Inappropriate use of the product may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid. Use of the product should take into account official and local antimicrobial policies.
Adverse reactions (frequency and seriousness)
Vomiting and diarrhoea may be observed. 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. In these cases, administration should be discontinued and a symptomatic treatment given.
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 the product only accordingly 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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
Operator warning
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
Pharmaceutical precautions
Do not store above 25°C. Store in the original package.
Any unused product or waste material should be disposed of in accordance with national requirements.
Legal category
POM-V
Packaging Quantities
Clavaseptin 50mg Palatable Tablets: 10 and 50 blisters of 10 tablets
Clavaseptin 250mg Palatable Tablets: 10 and 25 blisters of 10 tablets
Clavaseptin 500mg Palatable Tablets: 10 blisters of 10 tablets.
Further information
Amoxicillin is an aminobenzylpenicillin from the β-lactam penicillin family which prevents the bacterial cell wall formation by interfering with the final step of peptidoglycan synthesis.
Clavulanic acid is an irreversible inhibitor of intracellular and extracellular β-lactamases which protects amoxicillin from inactivation by many β-lactamases.
Amoxicillin/clavulanate has a wide range of activity which includes β‑lactamase producing strains of both Gram-positive and Gram-negative aerobes, facultative anaerobes and obligate anaerobes.
Resistance to β-lactam antibiotics is mainly mediated by β-lactamases which hydrolyze antibiotics such as amoxicillin. It is mostly shown in Pseudomonadaceae (81.25%) and in Enterobacter spp. (55.5%).
After oral administration at the recommended dose in dogs and cats, the absorption of amoxicillin and clavulanic acid is fast. In dogs, the maximum plasma concentration of amoxicillin of 8.5 µg/ml is reached in 1.4 h and the maximum plasma concentration of clavulanic acid of 0.9 µg/ml is reached in 0.9h.
In cats, the maximum plasma concentration of amoxicillin of 6.6 µg/ml is reached in 1.8 h and the maximum plasma concentration of clavulanic acid of 3.7 µg/ml is reached in 0.75h. Elimination is also fast.
After repeated oral administration of the recommended dose in dogs and cats, there is no accumulation of amoxicillin or clavulanic acid and the steady state is reached rapidly after first administration.
Marketing authorisation number
Clavaseptin 50mg Palatable Tablets: Vm 08007/4113.
Clavaseptin 250mg Palatable Tablets: Vm 08007/4114.
Clavaseptin 500mg Palatable Tablets: Vm 08007/4115.
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