Target species
Pigs.
Indications for use
Treatment of infections caused by bacteria sensitive to amoxicillin:
Pigs: Pleuropneumonia caused by Actinobacillus pleuropneumoniae; Meningitis caused by Streptococcus suis.
Contraindications
Do not use in animals with known hypersensitivity to penicillin and other substances of the β-lactam group.
Do not use in rabbits and rodents such as guinea pigs, hamsters or gerbils.
Special warnings for use in animals
Official, national and regional antimicrobial policies should be taken into account when the product is used. Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Use of the product deviating from the instructions given in this datasheet may increase the prevalence of bacterial resistance to amoxicillin and may decrease its effectiveness of treatment with amoxicillin, due to the potential for cross-resistance. The uptake of medication by pigs can be altered as a consequence of illness. In case of insufficient uptake of water, pigs should be treated parenterally. Do not use in animals with serious kidney malfunction including anuria and oliguria.
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-sensitivity 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. Do not smoke, eat or drink while handling the product. During preparation and administration of the medicated drinking water, skin contact with the product and inhalation of dust particles should be avoided. Wear gloves and an appropriate dust mask when applying the product. Wash hands and contaminated skin immediately after handling the product.
In the event of eye or skin contact, rinse the affected area with large amounts of clean water and if irritation occurs, seek medical attention.
If you develop symptoms following exposure such as skin rash, you should seek medical advice and show this warning to the physician. Swelling of the face, lips or eyes, or difficulty with breathing are more serious symptoms and require urgent medical attention.
Adverse reactions
Hypersensitivity reactions may occur, the severity varying from skin rash to anaphylactic shock. If suspected adverse reactions occur, treatment should be discontinued.
Use during pregnancy and lactation
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, embryotoxic or maternotoxic effect of amoxicillin. The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Interactions
The bactericidal effect of amoxicillin is counteracted by pharmaceuticals with a bacteriostatic effect.
Amounts to be administered and administration route
Pigs: The recommended daily dose is 16 mg amoxicillin trihydrate, corresponding to 14 mg amoxicillin, per kg of body weight, i.e. 20 mg of the product per kg of body weight equivalent to 1 gram product per 50 kg body weight per day. The product is to be administered in the drinking water for 3-5 consecutive days. In case of severe infections the medication period must be prolonged to 5 days as determined by the attending veterinary surgeon.
Bolus dosage: It is recommended to administer the product once a day via the drinking water for a limited period of time. Shut off the drinking water system for approximately two hours (shorter time in warm weather) until the time of medication. Sprinkle the calculated daily quantity of powder on the surface of 5-10 litres water. Mix thoroughly until the powder has dissolved. Mix this solution by stirring into the volume of drinking water that will be drunk within about 2-3 hours.
Continuous treatment: The table below shows the guidelines for administering the product, assuming consumption of 100 litres drinking water a day based on an estimated water consumption of 1 litre per 10 kg of body weight in pigs under 4 months and 0.66 litre per 10 kg of body weight in pigs over 4 months.
Pigs under 4 months: | 20 g powder/100 litres/day |
Pigs over 4 months: | 30 g powder/100 litres/day |
In the case of continuous treatment, the medicated water must be changed twice daily. Based on the dose to be used, and the number and weight of the animals to be treated, the exact daily amount of product can be calculated. The following formula can be used to calculate the concentration of the product in drinking water:
20 mg product/kg body weight/day x mean body weight (kg) of animals to be treated | | |
________________________________________________ | = | ___ mg product per litre drinking water |
Mean water consumption (l) per animal on previous day* | | |
* Prepare an amount of medicated water to be consumed within the next 12 hours. Any unused medicated water should be discarded after 12 hours, and fresh medicated water - for the next 12 hours - should be prepared.
To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing. The uptake of medicated water depends on the clinical condition of the animals. In order to obtain the correct dosage the concentration of amoxicillin has to be adjusted accordingly. The maximum concentration of the pre-diluted medicated water is approximately 8 grams of product per litre. The proportioner setting should be changed accordingly. Make sure the animals do not have access to non-medicated water during the period when the medicated water is given. Once all the medicated water has been drunk, turn the drinking water system back on. Discard any excess medicated water after 12 hours. The use of suitably calibrated scales is recommended for administering the calculated amount of the product.
Withdrawal period
Meat and offal: 2 days.