Powdox 500 mg/g powder for use in drinking water for pigs, chickens and turkeys 1kg.
Pigs (fattening pigs after weaning), chickens (broilers, broilers breeders) and turkeys (broilers, breeders).
Indications for use
Pigs (fattening pigs after weaning): treatment of clinical respiratory infections caused by Mycoplasma hyopneumoniae and Pasteurella multocida susceptible to doxycycline.
Chickens (broilers, broiler breeders) and turkeys (broilers, breeders): treatment of clinical respiratory infections associated with Mycoplasma gallisepticum susceptible to doxycycline.
Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in animals with hepatic dysfunction
Special warnings for each target species
The uptake of medication by animals can be altered as a consequence of illness. In case of insufficient uptake of drinking water, animals should be treated parenterally.
Special precautions for use
i. Special precautions for use in animals
Inappropriate use of the product may increase the prevalence of bacteria resistant to tetracycline due to the potential for cross resistance.
Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
The safety of the product has not been established in piglets before weaning.
Avoid administration in oxidized drinking equipment.
Do not use when tetracycline resistance has been detected in the herd/flock due to the potential for cross resistance
Due to variability (time, geographical) in susceptibility of bacteria for doxycycline, bacteriological sampling and susceptibility testing of micro-organisms from diseased birds on farm are highly recommended.
A high resistance rate of E.coli, isolated from chickens, against tetracyclines has been documented. Therefore the product should be used for the treatment of infections caused by E.coli only after susceptibility testing has been carried out.
As eradication of the target pathogens may not be achieved, medication should therefore be combined with good management practices, e.g. good hygiene, proper ventilation, no overstocking.
ii.Special precautions to be taken by the person administering the veterinary medicinal product to animals
During preparation and administration direct contact of the product with the skin, eyes and mucous membranes and inhalation of dust particles should be avoided.People with known hypersensitivity to tetracyclines should avoid contact with the veterinary medicinal product.
Wear protective gloves (e.g. rubber or latex), goggles and an appropriate dust mask (either a disposable half-mask respirator conforming to European Standard EN 149 or a non-disposable respirator to European Standard EN 140 with a filter to EN 143), when reconstituting or administering the solution. Wash exposed skin after preparation. In case of accidental projection into the eyes, rinse abundantly with water. Do not smoke, eat or drink when handling the product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Inflammation of the face, lips or eyes or respiratory difficulties are the most serious signs which require urgent medical attention.
As for all tetracyclines, on rare occasions allergic reactions and photosensitivity may occur. If suspected adverse reactions occur, treatment should be discontinued.
Use during pregnancy, lactation or lay
Laboratory studies in rats and rabbits have not produced any evidence of a teratogenic, foetotoxic, maternotoxic effects.
The safety of the product has not been established in pregnant or lactating sows. The use is not recommended during pregnancy and lactation.
Do not use in birds in lay and within 4 weeks before the onset of the laying period.
Do not administer concurrently with feed overloaded with polyvalent cations such as Ca2+, Mg2+, Zn2+ and Fe3+ because the formation of doxycycline complexes with these cations is possible. Do not administer together with antacids, kaolin and iron preparations as tetracyclines are bacteriostatic antimicrobials, do not administer in conjunction with bactericidal antibiotics like beta-lactames. It is advised that the interval between administration of other products containing polyvalent cations should be 1-2 hours because they limit the absorption of tetracycline.
Doxycycline increases the action of anticoagulants.
Amounts to be administered and administration route
To be administered in drinking water.
In pigs and chickens, 23.1 mg doxycycline hyclate per kg of body weight daily (equivalent to 40.0 mg product per kg of body weight), administered in the drinking water for 5 consecutive days.
In turkeys, 28.8 mg doxycycline hyclate per kg of body weight daily (equivalent to 50.0 mg product per kg of body weight), administered in the drinking water for 5 consecutive days.
To ensure a correct dosage body weight should be determined as accurately as possible. The uptake of medicated water is dependant on the clinical condition of the animals. In order to obtain the correct dosage, the concentration in drinking water may have to be adjusted.
The use of suitably calibrated weighing equipment is recommended if part packs are used. The daily amount is to be added to the drinking water such that all medication will be consumed in 24 hours. It is recommended to prepare a concentrated pre-solution and to dilute this further to therapeutic concentrations if required. Alternatively, the concentrated solution can be used in a proportional water medicator.
Medicated water should be refreshed every 24 hours. The medicated water should be the only source of drinking water, throughout the treatment period. The medicated water must not be prepared or stored in a metal container.
The maximum solubility of the product in water is 72 g/L. Solubility of the product is pH dependent and it will precipitate if it is mixed in an alkaline solution.
Based on the recommended dose, and the number and weight of the animals to be treated, the exact daily amount of the veterinary product should be calculated according to the following formula:
X g veterinary product/kg b.w./day
Mean body weight (kg) of number of animal to be treated
X g veterinary product per l drinking water
Mean daily water consumption (l) per animal
During the target animal tolerance study, no adverse effect was observed even at the fivefold therapeutic dose administered for two times the recommended duration in either target animal species.
If suspected toxic reactions do occur due to extreme overdose, the medication should be discontinued and appropriate symptomatic treatment should be initiated if necessary.
Pigs:Meat and offal:4 days
Chickens:Meat and offal:5 days
Turkeys:Meat and offal:12 days
Not permitted for use in laying birds producing eggs for human consumption
Pharmacotherapeutic group: Anti-infectives for systemic use, tetracyclines
ATCvet code: QJ01AA02
Citric acid anhydrous.
Doxycycline may form insoluble complexes with divalent ions, especially iron or calcium, zinc and magnesium
Shelf-life of the veterinary medicinal product as packaged for sale: 18 months
Shelf-life after first opening the immediate packaging: 3 months
Shelf-life after dilution or reconstitution according to directions: 24 hours
Special precautions for storage
Do not store above 25ºC
The veterinary medicinal product is packaged in thermosealed bags of 200 g and 1 kg. Bags are made of polyester, aluminium and polyethylene complex.
Not all pack sizes may be marketed.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements
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