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Contra-indications, warnings, etc
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.
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.
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
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. Wash hands and contaminated skin immediately after handling the product.
Do not smoke, eat or drink while 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.
Use during pregnancy, lactation or lay
Doxycycline has a low affinity for forming complexes with calcium and studies have demonstrated that doxycycline scarcely affects skeleton formation. In the absence of specific studies the use of the product is not recommended during pregnancy or lactation.
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.
Adverse reactions (frequency and seriousness)
Tetracyclines may - in very rare cases - induce photosensitivity and allergic reactions. If suspected adverse reactions occur, treatment should be discontinued.
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.
Environmental Safety
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance to local requirements.
Withdrawal Periods
Pigs: Meat & Offal: 4 days
Meat & Offal: 3 days (at a dose rate of 10 mg/kg b.w.)
Meat & Offal: 9 days (at a dose rate of 20 mg/kg b.w.)
Eggs: Not for authorised use in laying birds producing eggs for human consumption.
Do not use within 4 weeks of onset of the laying period.