Do not use in known cases of hypersensitivity to tetracyclines or to any of the excipients.
Do not use in animals with an impaired liver function.
Do not use in animals with renal disorders.
Do not use when tetracycline resistance has been detected in the herd/flock due to the potential for cross resistance.
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 in animals
Official, national and regional antimicrobial policies should be taken into account when the product is used.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to doxycycline and may decrease the effectiveness of treatment with other tetracyclines due to the potential for cross-resistance.
Resistance to tetracyclines has also been reported in pig respiratory pathogens (A. pleuropneumoniae) in some European countries.
Due to likely variability (time, geographical) in susceptibility of bacteria for doxycycline bacteriological sampling and susceptibility testing are recommended. In particular susceptibility of A. pleuropneumoniae and O. rhinotracheale may differ from country to country and even farm to farm. Use of the product should be based on culture and sensitivity of micro-organisms from diseased cases on 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
This veterinary medicinal product may cause contact dermatitis and/or hypersensitivity reactions if contact is made with the skin or eyes (powder and solution), or if the powder is inhaled. People with known hypersensitivity to tetracyclines such as doxycycline should avoid contact with the veterinary medicinal 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.
During preparation and administration of the medicated drinking water, skin and eye 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 or a non-disposable respirator to European Standard EN140 with a filter to EN143) when reconstituting or administering 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.
Wash hands and contaminated skin immediately after handling the product.
Do not smoke, eat or drink while handling the veterinary medicinal product.
Adverse reactions (frequency and seriousness)
In Pig and chicken: Tetracyclines may in very rare cases induce photosensitivity and allergic reactions. If suspected adverse reactions occur, treatment should be discontinued.
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 the national competent authority via the national reporting system. See also the section “Contact details” of the package leaflet for contact details.
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.
Interactions with other medicinal products and other forms of interaction
In the absence of compatibility studies, this product must not be mixed with other veterinary medicinal products.
Do not combine with antibiotics that are bactericidal 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 concurrently with antacids, kaolin and iron preparations.
It is advised that the interval between the administration of the product and administration of other products containing polyvalent cations should be 1-2 hours because the latter limit the absorption of tetracyclines.
Doxycycline increases the action of anticoagulants.
The solubility of the product is pH dependent and will precipitate if mixed in alkaline solution.
Do not store the drinking water in metallic containers.
Withdrawal Periods
Pigs: Meat & Offal: 4 days
Chickens:
Meat & Offal: 3 days (following a dose rate of 10 mg/kg body weight for 4 days)
Meat & Offal: 9 days (following a dose rate of 20 mg/kg body weight for 4 days)
Eggs: Not for use in laying birds producing eggs for human consumption.
Do not use within 4 weeks before the start of the laying period.