Target species
Pigs.
Indications for use, specifying the target species
In pigs: Preventive treatment of respiratory diseases due to Streptococcus suis, limited to reducing mortality. The presence of the disease in the herd should be established before the preventive treatment.
Contraindications
Do not use in animals with serious kidney (accompanied by anuria and oliguria) and/or liver failure.
Do not used in animals with known hypersensitivity to betalactamins.
The use of the product is contraindicated when a resistance to amoxicillin is known.
Do not use in the presence of β-lactamase producing bacteria.
Do not administer to rabbits, guinea-pigs, hamsters or gerbils.
Special warnings for each target species
Animals with reduced feed intake and/or disturbed general condition have to be treated parenterally.
Special precautions for use
Special precautions for use in animals
Animals with distinctive clinical signs of streptococcosis require individual treatment.
Use of the veterinary medicinal product should be based on susceptibility testing and take into account official and local antimicrobial policies. Inappropriate use of the veterinary medicinal product may increase the prevalence of bacteria resistant to amoxicillin.
This drug premix is intended for the preparation of solid drug feed and cannot be used as is; the concentration of incorporation of the drug premix in solid feed must not be lower than 5 kg/ton.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
When feed is being prepared, avoid skin contact
Whilst handling the product, wear a mask, coveralls, protective goggles and gloves at all times.
Avoid inhalation of dust. Wear either a disposable half-mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard EN140 with a filter to EN143.
To rule out any risk of ingestion it is recommended not to eat, or drink while using the product and to wash the hands after use.
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 reaction to these substances may occasionally be serious.
1Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
2Handle this product with great care to avoid exposure taking all recommended precautions.
3If 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 in breathing are more serious symptoms and require urgent medical attention.
Adverse reactions (frequency and seriousness)
Gastrointestinal signs may sometimes be observed (diarrhea).
Penicillins may cause allergic reactions after the administration of the product. Allergic reactions to these substances may sometimes be severe (anaphylaxis).
Use during pregnancy, lactation or lay
Laboratory studies have not produced any evidence of teratogenic, embryotoxic or maternotoxic effects of amoxicillin. Nevertheless, no study was performed in the target species during pregnancy or lactation. Therefore, use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Do not administer together with bacteriostatic anti-infectious agents (tetracyclines, sulphonamids…).
Do not use simultaneously with neomycin as it prevents the absorption of oral penicillins.
Amounts to be administered and administration route
Premix for medicated feeding stuff.
20 mg of amoxicillin /kg body weight by day for 5 consecutive days, by oral route in feed.
For a feed intake of 40 g/kg, this dose regimen corresponds to 500 ppm in medicated feed. In order to respect the dose regimen and to take into account the real food intake, the incorporation rate can be increased, which leads to a higher concentration in food.
The product can be incorporated in pelleted feed preconditioned with steam for up to 15 minutes at a temperature not exceeding 78°C
Do not use in liquid feed.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Apart from allergic reactions, penicillins have minimal direct toxicity.
There is no antidote, in case of accidental overdosage, the treatment is symptomatic.
Withdrawal period(s)
Meat and offal: 5 days