Target species
Chicken (broiler, pullet, breeder), duck (broiler, breeder), turkey.
Indications for use
Treatment of infections in chickens, turkeys and ducks caused by bacteria susceptible to amoxicillin.
Contraindications
Do not use in the presence of ß-lactamase-producing bacteria.
Do not use in rabbits, guinea pigs, hamsters, gerbils or any other small herbivores.
Do not use in cases of hypersensitivity to penicillins or other substances from the beta-lactam group or to any of the excipients.
Do not use in ruminants or horses.
Special precautions 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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
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.
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact, which may occasionally be serious. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. In case of contact with eyes or skin, wash immediately with water. 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 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.
Adverse reactions
Penicillins and cephalosporins may cause hypersensitivity reactions which may occasionally be serious.
Use during pregnancy and lactation
Laboratory studies in rats have not produced any evidence of a teratogenic effect due to the administration of amoxicillin. Use only according to the benefit/risk assessment by the responsible veterinarian.
Interactions
The product should not be administered with antibiotics that have a bacteriostatic mode of action, such as tetracyclines, macrolides and sulphonamides.
Synergism occurs with ß-lactam antibiotics and aminoglycosides.
Amounts to be administered and administration route
For use in drinking water.
Chickens: The recommended dosage is 13.1 mg amoxicillin (equivalent to 18.8 mg veterinary medicinal product) per kg body weight daily for 3 consecutive days or in severe cases for 5 consecutive days.
Ducks: Recommended dosage is 17.4 mg amoxicillin (equivalent to 25 mg veterinary medicinal product) per kg body weight daily for 3 consecutive days.
Turkeys: Recommended dosage is 13.1-17.4 mg amoxicillin (equivalent to 18.8-25 mg veterinary medicinal product) per kg body weight daily for 3 consecutive days or in severe cases for 5 consecutive days.
Prepare the solution with fresh tap water immediately before use. Any unused medicated water should be discarded after 12 hours. In order to ensure consumption of the medicated water, animals should not have access to other water supplies whilst being treated. The following formula may be used to calculate the required concentration of product (in milligrams of product per litre drinking water):
___ mg product per kg body weight per day x mean body weight (kg) of animals to be treated | | |
_____________________________________________ | = | ___ mg product per litre drinking water |
Mean daily water consumption (litre) per animal | | |
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 birds. In order to obtain the correct dosage the concentration of amoxicillin has to be adjusted taking into account water intake. After the end of the medication period the water supply system should be cleaned appropriately to avoid intake of sub-therapeutic amounts of the active substance. Maximum solubility of the product in water of at least 10°C is approximately 6 g/l within 10 minutes. At lower temperatures (4°C), the maximum solubility is approximately 5 g/l within 10 minutes.
The calculated dose should be measured out with calibrated scales.
For stock solutions and when using a proportioner, take care not to exceed the maximum solubility which can be achieved under the given conditions. Adjust flow rate settings of the dosing pump according to concentration of the stock solution and water intake of the animals to be treated.
Withdrawal periods
Chickens (meat and offal): 1 day
Ducks (meat and offal): 9 days
Turkeys (meat and offal): 5 days
Not for use in birds producing or intended to produce eggs for human consumption. Do not use within 3 weeks of onset of laying.