Amoxibactin Tablets are for the treatment of primary and secondary infections of the airways such as rhinitis, treatment of primary infections of the urogenital tract such as pyelonephritis, infections of the lower urinary tract, endometritis, and vaginitis as a result of mixed infections. They can also be used for the treatment of mastitis and the treatment of local skin infections.
Amoxibactin Tablets are white to off-white in colour with brown spots. They are round and convex with a cross-shaped breakline on one side for easy and accurate dosing.
Do not use in known cases of hypersensitivity to penicillin's or other substances of the β-lactam group of to any of the excipients.
Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas.
Do not use in animals with serious renal dysfunction accompanied by anuria or oliguria.
Special precautions for use in animals
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 which have been contraindicated in Contraindications. Due to the likely variability (time, geographical) in the occurrence of resistance of bacteria for amoxicillin, bacteriological sampling and susceptibility testing are recommended. Increased antimicrobial resistance are reported among E. Coli isolates including multidrug-resistant E. Coli. Special precautions should be taken when multi-drug resistance are suspected based on susceptibility testing. Whenever possible, the product should only be used based on susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to amoxicillin and may decrease the effectiveness of treatment with other β-lactam antimicrobials or other classes of antimicrobials due to the potential for cross resistance.
Official, national and regional antimicrobial policies should be taken into account when product is used.
The 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
Penicillin's 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 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.
Mild gastrointestinal symptoms (diarrhoea and vomiting) may occur very rarely (less than 1 animal in 10,000 animals treated, including isolated reports) after administration of the product. Hypersensitivity reactions (allergic skin reactions, anaphylaxis) may occur very rarely. 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, fetotoxic or maternotoxic effects. Use only in accordance with the benefit/risk assessment by the responsible veterinarian.
Chloramphenicol, macrolides, sulphonamides and tetracyclines may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action. 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 in dogs and cats.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
The recommended dose is 10 mg amoxicillin per kg body weight, twice daily for a minimum of 5 consecutive days. The majority of routine cases respond after between 5 and 7 days of therapy. If no improvement is observed after 5 to 7 days, the diagnosis should be re-assessed. In chronic or refractory cases, a longer course of therapy may be required.
Tablets can be divided into halves or quarters to ensure accurate dosing.
Place the tablet on a flat surface, with its scored side facing up and the convex (rounded) side facing the surface.
Halves: press down with your thumbs on both sides of the tablet.
Quarters: press down with your thumb in the middle of the tablet.
In case of overdose no other adverse reactions are known than those described in Adverse reactions.