Revised: October 2012
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Soludox 500 mg/g powder for use in drinking water for pigs and chickens
Soludox 433 mg/g powder for use in drinking water for pigs and chickens (France
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gram of powder contains:
Doxycycline hyclate 500 mg, corresponding to 433 mg doxycycline
France: Doxycycline 433 mg, corresponding to 500 mg doxycycline hyclate
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for use in drinking water
Yellow crystalline powder
4 CLINICAL PARTICULARS
4.1 Target species
Pigs and chickens (broiler, pullet, breeder).
4.2 Indications for use, specifying the target species
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, and clinical signs and to reduce lesions due to Pasteurellosis caused by
Pasteurella multocida or to reduce morbidity and lesions in respiratory infections
caused by Ornithobacterium rhinotracheale (ORT).
Do not use in case of hypersensitivity to the active substance or to any of excipients.
Do not use in animals with an impaired liver function.
4.4 Special warning for each target species.
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4.5 Special precautions for use
i. Special precautions for use in animals
Due to likely variability (time, geographical) in susceptibility of bacteria for
doxycycline, especially susceptibility of A. pleuropneumoniae and O.
rhinotracheale 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 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.
ii. 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.
4.6 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.
Inform your veterinary surgeon if adverse reactions occur that are not stated.
4.7 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. No negative
effects were observed in poultry after the administration of therapeutic doses of
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Revised: October 2012
In the absence of specific studies the use of the product is not recommended during
pregnancy or lactation.
4.8 Interaction with other medicinal products and other forms of interaction
Do not combine with antibiotics that are bacteriocidal e.g. penicillins or
Absorption of doxycycline can be decreased in the presence of high quantities of
calcium, iron, magnesium or aluminium in the diet. Do not administered 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
Doxycycline increases the action of anticoagulants.
The solubility of the product is pH dependent and will precipitate if mixed in alkaline
Do not store the drinking water in metallic containers.
4.9 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 exact daily amount of product can be calculated. The following formula
can be used to calculate the concentration of the product in drinking water:
mg product / kg body
weight / day x Mean body weight (kg) of
animals to be treated = .... mg product per l
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 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
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Revised: October 2012
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 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 other water sources than the medicated
4.10 Overdose (symptoms, emergency procedures, antidotes)
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.
4.11 Withdrawal periods
- Meat and offal: 4 days
- Meat and offal: 3 days, following a dose rate of 10 mg/kg body weight for 4 days.
- Meat and offal: 12 days, following a dose rate of 20 mg/kg body weight for 4 days.
- Eggs: Not authorised for use in laying birds producing eggs for human
Do not use within 4 weeks of onset of the laying period
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Antibacterial - Tetracycline.
ATC vet code: QJ 01 AA 02
5.1 Pharmacodynamic properties
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. Especially cell-
division and the formation of the cell wall are impaired.
Doxycycline is a broad-spectrum antibiotic, active against a large number of Gram-
positive and Gram-negative, aerobe and anaerobe micro-organisms, Mycoplasmata,
Chlamydiae and Rickettsia.
For Ornithobacterium rhinotracheale results demonstrate a great variation from high
to low susceptibility, depending on the geographical region where isolates came
In pig pathogens resistance against doxycycline may also vary; especially
susceptibility figures of A. pleuropneumoniae may differ from country to country and
even farm to farm.
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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.
5.2 Pharmacokinetic properties
Doxycycline is absorbed in the stomach and the first part of the duodenum.
Compared to the older tetracyclines the absorption of doxycycline is less affected by
the presence of bivalent cations in food. Bioavailability in non-fasted pigs is
Following oral administration at a dose of 12.8 mg/kg body weight, steady state
concentrations during medication range between a C
min of 0.40 µg/ml in the early
morning to a C
max of 0.87 µg/ml in the late afternoon in pigs.
Following administration of doxycycline hyclate at an actual dose of 21 mg/kg body
weight to chickens mean plasma concentrations above 1 µg/ml were reached within
6 hours and lasted for 6 hours after cessation of medication. From 24 h up to 96 h
after start of treatment the doxycycline plasma concentrations exceeded 2 µg/ml.
Following administration of doxycycline hyclate at an actual dose of 10 mg/kg body
weight steady state plasma concentrations ranged from 0.75 to 0.93 µg/g between
12 and 96 hours after start of medication.
Because doxycycline is highly lipid soluble, it has a good tissue penetration.
Respiratory tract tissue: plasma ratios of 1.3 (healthy lungs), 1.9 (pneumonic lungs)
and 2.3 (nasal mucosa) have been reported for doxycycline. Plasma protein binding
is high (over 90%).
Doxycycline is scarcely metabolised. Doxycycline is primarily excreted with the
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Solubility of doxycycline is pH dependent. Precipitation will occur in an alkaline
solution. In the absence of compatibility studies, this product must not be mixed with
other veterinary medicinal products.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
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Revised: October 2012
Shelf-life after first opening the immediate packaging: 9 months
Shelf-life after dilution or reconstitution according to directions: After reconstitution
with water, any product remaining after 24 hours should be discarded.
6.4 Storage precautions
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.
6.5 Nature and composition of immediate packaging
The packs consists of one of the following laminates:
Polyester / polyethylene / aluminium / polyethylene and an inner layer
Polyester / polyethylene / aluminium and an inner layer of ionomer
Polyethylene terephtalic acid / aluminium / polyamide and an inner
layer of polyethylene.
Pack sizes of 100g, 250g, 500g, 1 kg and 10x 100g in a carton box
Not all pack sizes may be marketed.
6.6 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
7. MARKETING AUTHORISATION HOLDER
Eurovet Animal Health B.V.
5531 AE Bladel
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date: 8 September 2011
10. DATE OF REVISION OF THE TEXT
Date: October 2012
Approved by: 21/11/2012
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