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Product information - Pigs and Chickens
Summary of Product Characteristic
Use during pregnancy and lactation Overdose
Because doxycycline is highly lipid soluble, Qualitative and quantitative composition
Doxycycline has a low affinity for forming it has a good tissue penetration. Respiratory 1 g of powder contains: Active substance: recommended dose resulted in no clinical signs tract tissue: plasma ratios of 1.3 (healthy lungs), Doxycycline hyclate 500 mg, corresponding to demonstrated that doxycycline scarcely affects that could be attributed to treatment. Poultry 1.9 (pneumonic lungs) and 2.3 (nasal mucosa) skeleton formation. No negative effects were tolerate double overdoses of doxycycline (40 have been reported for doxycycline. Plasma For a full list of excipients, see Excipients.
observed in poultry after the administration of mg/kg body weight) without any clinical effect.
protein binding is high (over 90%). Doxycycline Pharmaceutical form
Withdrawal periods
is scarcely metabolised. Doxycycline is primarily Powder for use in drinking water. Yellow In the absence of specific studies the use of the product is not recommended during pregnancy Chickens: Meat and offal - 3 days, following a Pharmaceutical particulars
Clinical particulars
dose rate of 10 mg/kg body weight for 4 days.
Meat and offal - 12 days, following a dose rate Pigs and chickens (broiler, pullet, breeder).
Do not combine with antibiotics that are bacteriocidal, e.g. penicillins or cephalosporins.
Eggs: Not authorised for use in laying birds Solubility of doxycycline is pH dependent. Pigs: For the treatment of the clinical signs
Absorption of doxycycline can be decreased in producing eggs for human consumption. Do not Precipitation will occur in an alkaline solution. associated with porcine respiratory disease the presence of high quantities of calcium, iron, use within 4 weeks of onset of the laying period In the absence of compatibility studies, this caused by Actinobacillus pleuropneumoniae, magnesium or aluminium in the diet. Do not Pharmacological particulars
product must not be mixed with other veterinary administer together with antacids, kaolin or iron Pharmacotherapeutic group: Antibacterial, hyopneumoniae susceptible to doxycycline.
Chickens: Where clinical disease is present
It is advised that the interval between the Shelf life of the veterinary medicinal product as in the flock, to reduce mortality, morbidity, and administration of other products containing clinical signs and to reduce lesions due to polyvalent cations should be 1-2 hours because Shelf life after first opening the immediate Pasteurellosis caused by Pasteurella multocida they limit the absorption of tetracyclines.
tetracycline antibiotics. These antibiotics have or to reduce morbidity and lesions in respiratory a broad-spectrum of antimicrobial activity, Shelf life after dilution or reconstitution according sharing the same basic structure of polycyclic to directions: After reconstitution with water, The solubility of the product is pH dependent any product remaining after 24 hours should be and will precipitate if mixed in alkaline solution.
Doxycycline is primarily a bacteriostatic drug. Do not use in case of hypersensitivity to the Do not store the drinking water in metallic It exerts its action by inhibiting the protein active substance or to any of the excipients.
synthesis of the bacterial cell. Inhibition of This veterinary medicinal product does not Do not use in animals with an impaired liver Amounts to be administered and administration bacterial protein synthesis results in disturbance require any special storage conditions. Keep the of all functions necessary for the life of bacteria. bag tightly closed after first opening in order to Special precautions for use in animals Administration orally with the drinking water.
Cell-division and the formation of the cell wall in protect from moisture. Keep out of the reach Due to likely variability (time, geographical), The recommended dose in pigs is: 12.5 mg
susceptibility of bacteria to doxycycline doxycycline hyclate (25 mg product) per kg Doxycycline is a broad-spectrum antibiotic, (especially susceptibility of A. pleuropneumoniae body weight per day for 4 consecutive days. If active against a large number of gram-positive and O. rhinotracheale) may differ from country to no improvement in clinical signs is seen within and 10x100g in a carton box. Formed from a country and even farm to farm, bacteriological this time, the diagnosis should be reviewed and micro-organisms, Mycoplasmata, Chlamydiae polyester/polyethylene/aluminium/polyethylene treatment changed. In case of severe infections or a polyester/polyethylene/aluminium/ionomer the medication period may be prolonged for a For Ornithobacterium rhinotracheale results laminate. Not all pack sizes may be marketed.
be based on culture and sensitivity of micro- maximum of 8 consecutive days as determined demonstrate a great variation from high to low organisms from diseased cases on the farm. If by the attending veterinary surgeon.
susceptibility, depending on the geographical Any unused veterinary medicinal product or this is not possible, therapy should be based The recommended dose in chickens is: 10
waste materials derived from such veterinary on local (regional, farm level) epidemiological mg doxycycline hyclate (20 mg product) per kg In pig pathogens resistance against doxycycline medicinal products should be disposed of in information about susceptibility of the target body weight per day for 3-4 consecutive days may also vary; susceptibility figures of A. in case of infections caused by P. multocida pleuropneumoniae in particular may differ from Marketing authorisation holder (if different
As eradication of the target pathogens may not and 20 mg doxycycline hyclate (40 mg product) country to country and even farm to farm.
from distributor)
be achieved, medication should therefore be per kg body weight per day for 3-4 consecutive Eurovet Animal Health BV, Handelsweg 25, 5531 combined with good management practices, days in case of infections caused by O. micro-organisms against tetracyclines in general e.g. good hygiene, proper ventilation, no have been reported: decreased accumulation Marketing authorisation number
Based on the dose to be used, and the number of tetracyclines (decreased permeability of the Special precautions to be taken by the person and weight of the animals to be treated, bacterial cell wall and active efflux), protein Date of the first authorisation or date of
administering the veterinary medicinal product the exact daily amount of product can be protection of the bacterial ribosome, enzymatic calculated. The following formula can be used inactivation of the antibiotic and rRNA mutations If you know you are allergic to the tetracycline to calculate the concentration of the product in (preventing the tetracycline binding to ribosome). Date of revision of the text
class of antibiotics, special care should be taken Tetracycline resistance is usually acquired by when handling this product or the medicated means of plasmids or other mobile elements Any other information
mg product/kg body weight per day x mean solution. During preparation and administration body weight (kg) of animals to be treated For animal treatment only. To be supplied only ________________________________________ of the medicated drinking water, skin contact Mean daily water consumption (l) per animal drinking water resistance between tetracyclines has also been with the product and inhalation of dust particles described. Due to the greater liposolubility and Manufacturing authorisation holder responsible should be avoided. Wear impermeable gloves greater facility to pass through cell membranes for batch release: Eurovet Animal Health (e.g. rubber or latex) and an appropriate dust (in comparison to tetracycline), doxycycline mask (e.g. disposable half-mask respirator possible. The uptake of medicated drinking retains a certain degree of efficacy against conforming to European Standard EN149) when water depends on the clinical condition of the microorganisms with acquired resistance to Legal category
pigs/chickens. In order to obtain the correct In the event of eye or skin contact, rinse the Significant changes
affected area with large amounts of clean water has to be adjusted accordingly. The use of Doxycycline is absorbed in the stomach and the GTIN (Global Trade Item No)
and if irritation occurs, seek medical attention. suitably calibrated weighing equipment is first part of the duodenum. Compared to the Soludox 500 mg/g Powder for Use in Drinking Wash hands and contaminated skin immediately recommended if part packs are used. The daily older tetracyclines the absorption of doxycycline after handling the product. If you develop amount is to be added to the drinking water is less affected by the presence of bivalent symptoms following exposure such as skin rash, such that all medication will be consumed in cations in food. Bioavailability in non-fasted pigs you should seek medical advice and show this 24 hours. Medicated drinking water should warning to the physician. Swelling of the face, be refreshed or replaced every 24 hours. It Following oral administration at a dose of 12.8 lips or eyes, or difficulty with breathing are more is recommended to prepare a concentrated mg/kg body weight, steady state concentrations serious symptoms and require urgent medical pre-solution, approximately 100 grams product during medication range between a Cmin of per litre drinking water, and to dilute this further 0.40 µg/ml in the early morning to a Cmax of Do not smoke, eat or drink while handling the to therapeutic concentrations if required. 0.87 µg/ml in the late afternoon in pigs.
Alternatively, the concentrated solution can Following administration of doxycycline hyclate Take measures to avoid producing dust when be used in a proportional water medicator. at an actual dose of 21 mg/kg body weight to incorporating the product into water.
Solubility of the product is pH dependent and chickens mean plasma concentrations above 1 Avoid direct contact with skin and eyes when it may precipitate if it is mixed in hard alkaline µg/ml were reached within 6 hours and lasted handling the product to prevent sensitisation drinking water. Use at minimum concentrations for 6 hours after cessation of medication. From of 200 mg powder per litre drinking water in 24 hours up to 96 hours after start of treatment areas with hard alkaline drinking water (hardness Tetracyclines may, in very rare cases, induce above 10.2°d and pH more than 8.1). During photosensitivity and allergic reactions. If Following administration of doxycycline hyclate suspected adverse reactions occur, treatment have access to other water sources than the at an actual dose of 10 mg/kg body weight should be discontinued. Inform your veterinary steady-state plasma concentrations ranged from surgeon if adverse reactions occur that are not 0.75 to 0.93 µg/g between 12 and 96 hours

Source: http://www.dechra.dk/files//dechra/Downloads/Pharma/SPCs%20Global/SPC%20Sheet%20-%20Soludox%20(pigs%20and%20chickens).pdf