Cladaxxa Chewable Tablets

For the treatment of infections caused by bacteria susceptible to amoxicillin and clavulanic acid including: skin disease (including deep and superficial pyodermas); soft tissue infections (abscesses and anal sacculitis); dental infections (e.g. gingivitis); urinary tract infections; respiratory disease (involving upper and lower respiratory tract); enteritis.
Dosage and administration
FOR ORAL ADMINISTRATION
Dosage rate and frequency: 10 mg amoxicillin and 2.5 mg clavulanic acid/kg body weight (i.e. 12.5 mg of combined active substances per kg bodyweight), twice daily (corresponding to 25 mg of combined active substances per kg per day).
Cats and Dogs:
Description: cats and dogs
Dogs:
Description: 400 100
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
Duration of therapy:
The majority of routine cases respond to between 5 and 7 days therapy. In chronic cases, a longer course 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.
If the animal does not accept the tablet from hand or bowl, then the tablets may be crumbled and added to a little food and fed immediately.
Adverse Reactions
Very rarely, hypersensitivity reactions to penicillins may occur in treated animals; in these cases, administration should be discontinued and a symptomatic treatment given.
Very rarely, gastro-intestinal disturbances (diarrhoea, vomiting, …) may occur after administration of the product. Treatment may be discontinued depending on the severity of the undesirable effects and a benefit/risk evaluation by the veterinary surgeon.
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
Laboratory studies in rats and mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The safety of the product has not been assessed in pregnant and lactating bitches and queens. In pregnant and lactating animals, use only according to the benefit/risk assessment by the responsible veterinarian.
Contra-indications, warnings, etc
Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas. Do not use in horses and ruminants.
Do not use in cases of serious dysfunction of the kidneys accompanied by anuria and oliguria.
Do not use in cases of hypersensitivity to penicillins or other substances of the ß-lactam group or to any excipients.
Do not use in cases of known resistance to the combination of amoxicillin and clavulanic acid.
Special warnings for each target species
This product is not indicated for cases involving Pseudomonas spp.
Special precautions for use in animals:
Whenever possible, the amoxicillin/clavulanic acid combination should only be used based on susceptibility testing.
Official, national and regional antimicrobial policies should be taken into account when the product is used.
Use of the product deviating from the instructions given in the package leaflet may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid and may decrease the effectiveness of treatment with other penicillins, due to the potential for cross-resistance.
A trend in resistance of E. coli is reported, including multidrug-resistant E. coli.
In animals with hepatic and renal dysfunction, the dosing regimen should be carefully evaluated and the use of the product based on a risk/benefit evaluation by the veterinary surgeon.
Caution is advised in the use in small herbivores other than those in section Contraindications.
The chewable 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 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 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.
To avoid accidental ingestion, particularly by a child, unused part-tablets should be returned to the open blister space, inserted back into the outer packaging and kept in a safe place out of the sight and reach of children.
Overdose (symptoms, emergency procedures, antidotes):
Mild gastrointestinal symptoms (diarrhoea, nausea and vomiting) may occur after overdose of the product and symptomatic treatment should be initiated when necessary.
Pharmaceutical precautions
Interaction with other medicinal products and other forms of interaction:
Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action. Penicillins may increase the effect of aminoglycosides.
List of excipients
Cellulose, microcrystalline Magnesium stearate Silica, colloidal anhydrous Sodium starch glycollate (type A) Issued: June 2021 AN: 00577/2020 Page 7 of 8 Dried autolyzed yeast Erythrosine aluminium lake, E127
Storage precautions
Keep out of the sight and reach of children. Do not store above 25 °C.
Store in the original package in order to protect from light and moisture.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the blister after {EXP}. The expiry date refers to the last day of that month.
Any unused half tablets should be returned to the blister pack and used within 12 hours.
Shelf Life
3 years
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Legal category
Legal category:POM-V
Packaging quantities
Cladaxxa 40 mg/10 mg & 200 mg/50 mg chewable tablets for cats and dogs - Blister contains 10 tablets. Carton contains 10, 20, 100 or 500 tablets.
Cladaxxa 400 mg/100 mg chewable tablets for dogs - Blister contains 6 tablets. Carton contains 12, 60 or 300 tablets.
Marketing Authorisation Holder (if different from distributor)

Pack of 100