Target species
Clavudale 40 mg/10 mg - Cats and dogs.
Clavudale 200 mg/50 mg and 400 mg/100 mg - Dogs
Indications for use
For the treatment of bacterial infections susceptible to amoxicillin in combination with clavulanic acid where clinical experience and/or sensitivity testing indicates the veterinary medicinal product as the drug of choice.
Uses include:
Skin infections (including deep and superficial pyodermas) associated with Staphylococcus spp. and Streptococcus spp.;
Infections of the oral cavity (mucous membrane) associated with Clostridium spp., Trueperella spp. (previously Corynebacterium spp.), Staphylococcus spp., Streptococcus spp., Bacteroides spp. and Pasteurella spp.;
Urinary tract infections associated with Staphylococcus spp., Streptococcus spp., Escherichia coli and Proteus mirabilis;
Respiratory tract infections associated with Staphylococcus spp., Streptococcus spp. and Pasteurella spp.;
Gastrointestinal infections associated with Escherichia coli and Proteus mirabilis.
Contraindications
Do not use in rabbits, guinea pigs, hamsters and gerbils.
Do not use in cases of hypersensitivity to the active substances, substances of the β-lactam group or any of the excipients.
Do not use in animals with either oliguria or anuria associated with renal dysfunction.
Do not use in cases of known resistance to the combination of amoxicillin and clavulanic acid.
Special precautions for use in animals
In animals with hepatic and renal dysfunction, the dosing regimen should be carefully evaluated.
Use of the veterinary medicinal product should be based on susceptibility testing and should take into account official national and regional policies with respect to the use of broad spectrum antibiotics. Do not use in cases of bacteria sensitive to narrow spectrum penicillins or to amoxicillin as a single substance. Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to amoxicillin and clavulanic acid, and may decrease the effectiveness of treatment with other β-lactam antibiotics, due to the potential for cross-resistance.
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 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 package leaflet or label to the physician. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
- Wash hands after use.
- In order to avoid any accidental ingestion, store tablets out of reach of animals.
Other precautions:
Caution is advised on the use of the veterinary medicinal product in small herbivores other than those listed in Contraindications.
Adverse reactions
Dogs:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Vomitinga , Diarrhoeaa |
Undetermined frequency (cannot be estimated from the available data) | Blood dyscrasia, Colitis Anaphylaxis, Allergic skin reaction |
a Mild. In these cases, discontinue administration and give symptomatic therapy.
Cats:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Vomitinga |
Undetermined frequency (cannot be estimated from the available data) | Blood dyscrasia, Colitis, Diarrhoeaa Allergic skin reaction, Anaphylaxis |
a Mild. In these cases, discontinue administration and give symptomatic therapy.
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. See the package leaflet for respective contact details.
Use during pregnancy and lactation
Laboratory studies in rats and mice have not produced any evidence of teratogenic or foetotoxic effects. No studies have been conducted in pregnant or lactating dogs or cats. Use only according to the benefit/risk assessment by the responsible veterinarian.
Interactions
Bacteriostatic antibiotics (e.g. 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
For oral administration only. The dosage rate is 10 mg amoxicillin/2.5 mg clavulanic acid/kg body weight twice daily. The tablets may be added to a little food.
To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
The following table is intended as a guide to dispensing the veterinary medicinal product at the standard dose rate of 10 mg amoxicillin/2.5 mg clavulanic acid/kg body weight twice daily.
Clavudale 40 mg/10 mg tablets for cats and dogs - dosage table: |
Body weight (kg) | Number of tablets twice daily |
1 to ≤ 2 | ½ |
> 2 to ≤ 4 | 1 |
> 4 to ≤ 6 | 1½ |
> 6 to ≤ 8 | 2 |
Clavudale 200 mg/50 mg tablets for dogs - dosage table: |
Body weight (kg) | Number of tablets twice daily |
> 8 to ≤ 10 | ½ |
> 10 to ≤ 20 | 1 |
> 20 to ≤ 30 | 1½ |
> 30 to ≤ 40 | 2 |
Clavudale 400 mg/100 mg tablets for dogs - dosage table: |
Body weight (kg) | Number of tablets twice daily |
> 30 to ≤ 40 | 1 |
> 40 to ≤ 60 | 1½ |
> 60 to ≤ 80 | 2 |
In refractory cases the dose may be doubled to 20 mg amoxicillin/5 mg clavulanic acid/kg body weight twice daily.
Duration of therapy:
Routine cases involving all indications: The majority of routine cases respond to between 5 and 7 days of therapy. Lack of effect after 5-7 days of treatment necessitates renewed examination.
Chronic or refractory cases: In chronic cases, longer courses of antibacterial therapy may be required. In such circumstances, overall treatment length is at the clinician’s discretion, but must be long enough to ensure complete resolution of the bacterial disease.
Overdose
Mild gastrointestinal symptoms (diarrhoea and vomiting) may occur more frequently after overdose of the veterinary medicinal product.