Target species
Chickens (broilers, pullets, breeders), ducks (broilers, breeders), turkeys.
Indications for use for each target species
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 warmings
None.
Special precautions for safe use in the target species
Use of the veterinary medicinal product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level.
Use of the veterinary medicinal product should be in accordance with official, national and regional antimicrobial policies.
Use of the veterinary medicinal product deviating from the instructions given in the SPC 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.
Personal protective equipment consisting of disposable half-mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard EN140 with a filter to EN143 should be worn when handling the veterinary medicinal product.
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 veterinary medicinal product if you know you are sensitized or if you have been advised not to work with such preparations. Handle this veterinary medicinal 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 physician 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.
Special precautions for the protection of the environment
Not applicable.
Adverse events
Chickens, ducks, turkeys:
Undetermined frequency (cannot be estimated from the available data) | Hypersensitivity reaction* |
* May occasionally be serious.
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, lactation or lay
Pregnancy and lactation:
Use only according to the benefit-risk assessment by the responsible veterinarian.
Laboratory studies in rats have not produced any evidence of teratogenic effects.
Interaction with other medicinal products and other forms of interaction
The veterinary medicinal 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.
Administration routes and dosage
In drinking water use.
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 to 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. Based on the recommended dose and the number and weight of animals to be treated, the exact daily concentration of the veterinary medicinal product should be calculated according to the following formula:
___ mg veterinary medicinal product / kg body weight day x avarege body weight (kg) of animals to be treated | | |
_____________________________________________ | = | ___ mg veterinary medicinal product per litre of drinking water |
avarege daily water intake (litre/animal) | | |
To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing. The intake of medicated water depends on the clinical condition of the animals. In order to obtain the correct dosage, the concentration of amoxicillin may need to be adjusted accordingly. 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 veterinary medicinal 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 use of suitably calibrated measuring equipment is recommended.
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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
None known.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable
Withdrawal periods
Chickens (meat and offal): 1 day
Ducks (meat and offal): 9 days
Turkeys (meat and offal): 5 days
Do not use within 3 weeks before the start of the laying period.
Not for use in birds producing eggs for human consumption.