Revised: May 2016
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
DFV DOXIVET 200 mg/ml, solution for use in drinking water for pigs and chickens.
ES: DFV DOXYCYCLINE 200 mg/ml, solution for use in drinking water for pigs and
IT: Doxycycline DFV 200 mg/ml, solution for use in drinking water for pigs and chickens
SE: Doxycycline Divasa-Farmavic 200 mg/ml lösning för användning I dricksvatten
DK: Doxycycline Divasa-Farmavic Vet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition for 1 ml:
Doxycycline hyclate 230 mg
Equivalent to 200 mg doxycycline base
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for use in drinking water
Clear yellow-brown solution.
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
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals with an impaired liver function.
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4.4 Special warnings for each target species
4.5 Special precautions for use
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
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 should be avoided. Wear impermeable gloves (e.g. rubber or latex) 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.
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 (less than 1 animal in 10,000, including isolated
reports) - 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 doxycycline.
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 cephalosporins.
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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
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 tetracyclines.
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 (0.054 ml 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 (0.043 ml 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 (0.087 ml 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:
..... ml product/ kg body
weight / day x mean body weight (kg) of
animals to be treated
.... ml product per l
drinking water mean daily water consumption (l) per animal
at the previous day
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 animals. In
order to obtain the correct dosage the concentration of doxycycline has to be adjusted
accordingly. The use of suitably calibrated equipment is recommended if part containers
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. Solubility of the product is pH dependent and it may precipitate if it is
mixed in hard alkaline drinking water. During the treatment period animals should not have
access to other water sources than the medicated water.
Weight can also be used to measure the product quantity to be added in drinking water. In
this case the density correction should be used, according to the following formula:
Amount to be added in
drinking water (g/L) = amount to be added in drinking water (ml/L) x
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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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 period(s)
- 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 consumption.
Do not use within 4 weeks of onset of the laying period
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Antiinfectives for systemic use, antibacterials for systemic
use, tetracycline, doxycycline
ATCvet code: QJ01AA02
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 polycyclic
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, MycoplasmataFor
Ornithobacterium rhinotracheale results demonstrate a great variation from high to low
susceptibility, depending on the geographical region where isolates came from.
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.
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
5.2 Pharmacokinetic particulars
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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 approximately 21%.
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 faeces.
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
6.3 Shelf life
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 after dilution in
6.4. Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Nature of container:
HDPE container with tamper-evident aluminium seal and HDPE screw cap.
1 litre and 5 litres.
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
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Any unused veterinary medicinal product or waste materials derived from such veterinary
medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Ctra. Sant Hipòlit, km 71
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION
12 July 2011
10. DATE OF REVISION OF THE TEXT
PROHIBITION OF SALE, SUPPLY AND/OR USE
26 May 2016
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