Target species
Pigs and chickens (broiler, pullet, breeder).
Indications for use
Pigs: For the treatment of the clinical signs associated with porcine respiratory disease caused by Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae susceptible to doxycycline.
Chickens: Where clinical disease is present in the flock, to reduce mortality, morbidity, clinical signs and to reduce lesions due to Pasteurellosis caused by Pasteurella multocida or to reduce morbidity and lesions due to respiratory infections caused by Ornithobacterium rhinotracheale (ORT).
Contraindications
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals with an impaired liver function.
Special precautions for use in animals
Due to likely variability (time, geographical), in susceptibility of bacteria to doxycycline, especially susceptibility of A. pleuropneumoniae and O. rhinotracheale which may differ from country to country and even farm to farm, bacteriological sampling and susceptibility testing are recommended. Use of the product should be based on the culture and sensitivity of micro-organisms from diseased cases on the farm. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
If you know you are allergic to the tetracycline class of antibiotics, special care should be taken when handling this product or the medicated solution. During preparation and administration of the medicated drinking water, skin contact with the product and inhalation of dust particles should be avoided. Wear impermeable gloves (e.g. rubber or latex) and an appropriate dust mask (e.g. disposable half-mask respirator conforming to European Standard EN149) when applying 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. Wash hands and contaminated skin immediately after handling the product. 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.
Do not smoke, eat or drink while handling the product.
Take measures to avoid producing dust when incorporating the product into water.
Avoid direct contact with skin and eyes when handling the product to prevent sensitisation and contact dermatitis.
Adverse reactions
Tetracyclines may, in very rare cases, induce photosensitivity and allergic reactions. If suspected adverse reactions occur, treatment should be discontinued. Inform your veterinary surgeon if adverse reactions occur that are not stated.
Use during pregnancy and lactation
Doxycycline has a low affinity for forming complexes with calcium and studies have demonstrated that doxycycline scarcely affects skeleton formation. No negative effects were observed in poultry after the administration of therapeutic doses of doxycycline.
In the absence of specific studies the use of the product is not recommended during pregnancy or lactation.
Interactions
Do not combine with antibiotics that are bacteriocidal, e.g. penicillins or cephalosporins.
Absorption of doxycycline can be decreased in the presence of high quantities of calcium, iron, magnesium or aluminium in the diet. Do not administer together with antacids, kaolin and iron preparations.
It is advised that the interval between the administration of other products containing polyvalent cations should be 1-2 hours because they limit the absorption of tetracyclines.
Doxycycline increases the action of anticoagulants.
The solubility of the product is pH dependent and it will precipitate if mixed in alkaline solution.
Do not store the drinking water in metallic containers.
Amounts to be administered and administration route
Administration orally with the drinking water.
The recommended dose in pigs is: 12.5 mg doxycycline hyclate (25 mg product) per kg body weight per day for 4 consecutive days. If no improvement in clinical signs is seen within this time, the diagnosis should be reviewed and treatment changed. In case of severe infections the medication period may be prolonged for a maximum of 8 consecutive days as determined by the attending veterinary surgeon.
The recommended dose in chickens is: 10 mg doxycycline hyclate (20 mg product) per kg body weight per day for 3-4 consecutive days in case of infections caused by P. multocida and 20 mg doxycycline hyclate (40 mg product) per kg body weight per day for 3-4 consecutive days in case of infections caused by O. rhinotracheale.
Based on the dose to be used, and the number and weight of the animals to be treated, the daily amount of product can be calculated. The following formula can be used to calculate the concentration of the product required in drinking water:
___ mg product/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 (l) per animal | | |
To ensure a correct dosage body weight should be determined as accurately as possible. The uptake of medicated drinking water depends on the clinical condition of the pigs/chickens. In order to obtain the correct dosage the concentration of doxycycline has to be adjusted accordingly. The use of suitably calibrated weighing equipment is recommended if part packs are used. The daily amount of product required is to be added to the drinking water such that all medication will be consumed in 24 hours. Medicated drinking water should be refreshed or replaced every 24 hours. It is recommended to prepare a concentrated pre-solution - approximately 100 grams product per litre drinking water - and to dilute this further to therapeutic concentrations if required. Alternatively, the concentrated solution can be used in a proportional water medicator. Solubility of the product is pH dependent and it may precipitate out if it is mixed in hard alkaline drinking water. Use at minimum concentrations of 200 mg powder per litre drinking water in areas with hard alkaline drinking water (hardness above 10.2°d and pH more than 8.1). During the treatment period animals should not have access to water sources other than the medicated water.
Overdose
Overdoses up to 1.6 times the label recommended dose resulted in no clinical signs that could be attributed to treatment. Poultry tolerate double overdoses of doxycycline (40 mg/kg body weight) without any clinical effect.
Withdrawal periods
Pigs: Meat and offal - 4 days.
Chickens: Meat and offal - 3 days, following a dose rate of 10 mg/kg body weight for 4 days.
Meat and offal - 9 days, following a dose rate of 20 mg/kg body weight for 4 days.
Not authorised for use in birds producing eggs for human consumption. Do not use within 4 weeks of onset of laying.