Revised: October 2017
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
Soludox 500 mg/g powder for use in drinking water for turkeys
FR: Soludox 433 mg/g powder for use in drinking water for turkeys
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g powder contains:
500 mg, corresponding to 433 mg doxycycline
433 mg, corresponding to 500 mg doxycycline hyclate
For the full list of excipients, see section 6.1.
Powder for use in drinking water.
Yellow crystalline powder.
Turkeys (broilers, breeders).
Indications for use, specifying the target species
Treatment of clinical respiratory infections associated with Mycoplasma
gallisepticum susceptible to doxycycline.
Do not use in cases of hypersensitivity to the active substance or to any of the
Do not use in animals with hepatic and/or renal dysfunction.
Do not use when tetracycline resistance has been detected in the 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, turkeys should be treated parenterally.
Special precautions for use
Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken into account
when the product is used.
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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 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.
Avoid administration in oxidised drinking equipment.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
This product may cause contact dermatitis and/or hypersensitivity reactions if contact
is made with the skin or eyes (powder and solution) or if the product is inhaled.
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
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 (frequency and seriousness)
As for all tetracyclines, on rare occasions (more than 1 but less than 10 animals in
10,000 animals) 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 or maternotoxic effect. Do not use in birds in lay and within 4
weeks before the start of the laying period.
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Interaction with other medicinal products and other forms of interaction
Do not administer in conjunction with bactericidal antibiotics such as beta-lactams as
tetracyclines are bacteriostatic antimicrobials. 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 or iron
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
Doxycycline increases the action of anticoagulants.
The solubility of the product is pH-dependent and it will precipitate out if mixed in
Amounts to be administered and administration route
Administer orally in the drinking water.
Dosage: 25 mg doxycycline corresponding to 29 mg doxycycline hyclate per kg of
body weight daily (equivalent to 58 mg product per kg of body weight), administered
in the drinking water for 5 consecutive days.
The product should be administered continuously in the drinking water during the
whole period of treatment. Based on the dosage to be used, and the number and
weight of the birds to be treated, the exact daily amount of product required can be
The following formula can be used to calculate the concentration of the product in drinking water:
58 mg product / kg
body weight / day
mean body weight (kg)
of birds to be treated
= .... mg product per l
mean daily water consumption (l) per bird
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 birds. 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 is to be added to the drinking
water such that all medication will be consumed within 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 birds should not
have access to water sources other than the medicated water.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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No adverse effects were observed after administration of doxycycline to turkeys at
the fivefold therapeutic dose for up to 10 days. If suspected toxic reactions do occur
due to extreme overdose, the medication should be discontinued and appropriate
symptomatic treatment should be initiated if necessary.
4.11 Withdrawal periods
Meat and offal: 12 days.
Not authorised for use in birds producing eggs for human consumption.
Pharmacotherapeutic group: Tetracyclines.
ATCvet code: QJ 01 AA 02.
Doxycycline belongs to the group of the tetracycline antibiotics. These antibiotics
have a broad spectrum of antimicrobial activity, sharing the same basic structure of
Doxycycline is primarily a bacteriostatic drug. It exerts its action by inhibiting the
protein synthesis of the bacterial cell. Inhibition of bacterial protein synthesis results
in disturbance of all functions necessary for the life of bacteria. In particular, cell-
division and the formation of the cell wall are impaired.
Doxycycline is a broad-spectrum antibiotic.
The MIC90 of doxycycline against Mycoplasma gallisepticum strains isolated in
France, Germany and Hungary (2003-2009) was reported 0.5 µg/ml. The resistance
rate of M. gallisepticum isolates against doxycycline is low.
Four resistance mechanisms acquired by microorganisms against tetracyclines in
general have been reported: Decreased accumulation of tetracyclines (decreased
permeability of the bacterial cell wall and active efflux), protein protection of the
bacterial ribosome, enzymatic inactivation of the antibiotic, and rRNA mutations
(preventing the tetracycline binding to ribosome). Tetracycline resistance is usually
acquired by means of plasmids or other mobile elements (e.g. conjugative
transposones). Cross-resistance between tetracyclines has also been described.
Due to the greater liposolubility and greater facility to pass through cell membranes
(in comparison to tetracycline), doxycycline retains a certain degree of efficacy
against microorganisms with acquired resistance to tetracyclines.
In general, doxycycline is quite rapidly and extensively absorbed from the
gastrointestinal tract, widely distributed in the organism, not metabolised to any
significant extent and excreted mostly via the faeces.
The harmacokinetics of doxycycline after single oral administration to turkeys is
characterised by a quite rapid and substantial absorption from the gastrointestinal
tract providing peak plasma concentrations between 1.5 to 7.5 hours depending on
age and the presence of food. The drug is widely distributed in the organism with Vd
values close to or greater than 1, and it exhibits an elimination half-life in turkeys of
7.9 to 10.8 hours. The protein binding ratio at therapeutic plasma concentrations is in
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the range of 70 to 85%. The bioavailability in turkeys may vary between 25 and 64%,
also depending on age and feeding. The presence of food in the gastrointestinal tract
determines a lower bioavailability compared to that obtained in the fasted state.
After continuous in-water administration of the product at dosages of 25 mg
doxycycline/kg in turkeys for 5 days, the average plasma concentrations over the
whole treatment period were reported 2.24±1.02 µg/ml in turkeys. PK/PD analysis of
AUC/MIC90 data resulted in >24 h values that meet the requirements for
List of excipients
In the absence of compatibility studies, this veterinary medicinal product must not be
mixed with other veterinary medicinal products.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 6 months.
Shelf life after dilution or reconstitution according to directions: 24 hours.
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Keep the bag tightly closed after first opening in order to protect from moisture.
Nature and composition of immediate packaging
Bags of 1 kg.
Sachets of 100 grams packed per 10 in a carton box.
1000 g bag: polyester, polyethylene, aluminium, polyethylene and an inner layer of
1000 g bag: polyethylene terephtalic acid, aluminium, polyamide and an inner layer
100 g sachet: polyester, polyethylene, aluminium and an inner layer of ionomer
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal
product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal products should be disposed of in accordance with local
MARKETING AUTHORISATION HOLDER
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Revised: October 2017
Eurovet Animal Health B.V.
5531 AE Bladel
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION
28 August 2012
DATE OF REVISION OF THE TEXT
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