Issued July 2016
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
ORNICURE 150 mg/g, powder for use in drinking water for racing pigeons and
ornamental birds (all CMS except FR)
ORNICURE, powder for use in drinking water for racing pigeons and ornamental
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Per 1 gram
Doxycycline hyclate 150.0 mg, equivalent to 130.0 mg of doxycycline base
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for use in drinking water.
A fine, light yellow to yellow powder.
4. CLINICAL PARTICULARS
4.1 Target species
Racing pigeons and ornamental birds, particularly Psittaciformes (e.g. African grey
parrots, Goffin's cockatoos, cockatiels)
4.2 Indications for use, specifying the target species
Treatment of infections caused by micro-organisms susceptible to doxycycline:
Chlamydophila psittaci, Pasteurella multocida, Mycoplasma spp.
Do not use in case of hypersensitivity to tetracyclines.
4.4 Special warnings for each target species
The uptake of medicated drinking water by animals can be altered as a consequence
of illness and should be monitored carefully. In case of insufficient uptake of water, it
is advised to administer doxycycline directly into the crop or to medicate parenterally.
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Doxycycline (re)absorption may be reduced when birds are given grit. It is therefore
recommended to suppress grit and mineral additives during the treatment in pigeons
and to limit calcium to a maximum content of 0.7% in pelleted feed in parrots.
4.5 Special precautions for use
Special precautions for use in animals
Due to variability (time, geographical) in the susceptibility of bacteria to doxycycline,
bacteriological sampling and susceptibility testing of micro-organisms originating from
diseased animals are strongly recommended.
Medication should be combined with good management practices, e.g. good hygiene
and ventilation and, as far as applicable, appropriate stocking density.
Use of the product deviating from the instructions given in the SPC/product literature
may increase the prevalence of bacteria resistant to doxycycline due to the potential
for cross resistance and may decrease the effectiveness of the treatment.
Use of the product should take into account official and local antimicrobial policies.
Avoid administration in oxidized drinking equipment.
See section 4.10 for additional warnings.
Toxic concentrations might also be reached in birds housed in hot, outdoor climates
where water consumption is increased. Birds undergoing treatment should be
monitored for signs of doxycycline toxicosis, including lethargy, inappetance,
inactivity, and passing yellow or green urine. Doxycycline toxicosis caused hepatic
damage and dysfunction that may result in high plasma AST, lactate dehydrogenase,
and bile acids. Doxycycline treatment should be discontinued and general supportive
care started if doxycycline toxicosis is suspected.
The quality of the drinking water may influence the bioavailability of the product. See
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
People with a possible allergy to tetracyclines are advised not to handle this product.
Avoid direct skin contact with the drug and inhalation of dust particles during the
preparation and administration of the medicated drinking water to prevent
sensitisation and contact dermatitis.
It is recommended to wear impermeable gloves (e.g. rubber or latex) and an
appropriate dust mask (disposable half-mask respirator conforming to European
Standard EN 149 (FFP2) or a nondisposable respirator to European Standard EN
140 with a filter to EN 143) during the preparation and the administration of the
solution. 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.
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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
In case of accidental ingestion, seek medical attention.
4.6 Adverse reactions (frequency and seriousness)
As for all tetracyclines, on rare occasions allergic reactions and photosensitivity may
occur. Intestinal flora may be affected if treatment is prolonged (> 10 days), and this
may result in digestive disturbance. If suspected adverse reactions occur, treatment
should be discontinued.
A slight weight loss may occur.
4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during the
reproduction period, i.e., the time period from mating until the end of feeding the
progeny. During this time period the use of the product is not recommended.
4.8 Interaction with other medicinal products and other forms of interaction
Concurrent administration of doxycycline with any divalent cations (e.g. Ca, FE, Mg,
Al, divalent ions of antacids) should be avoided as this may lead to decreased
Doxycycline may enhance the effect of anticoagulants.
Do not administer together with kaolin, iron preparations and antacids.
Do not use in conjunction with bactericidal antibiotics, such as penicillins,
cephalosporins and beta-lactam antibiotics due to antagonism of the mode of action.
4.9 Amounts to be administered and administration route
For oral use.
To be administered in drinking water.
- Treatment of infections due to Chlamydophyla psittaci susceptible to doxycycline:
46 mg doxycycline hyclate/kg bodyweight for at least 30 days
- Treatment of infections due to other pathogens susceptible to doxycycline
(Pasteurella multocida, Mycoplasma spp): 20 mg doxycycline hyclate/kg
bodyweight for 5 days
The medicated drinking water can also be administered directly into the crop (once
Ornamental birds, particularly Psittaciformes (e.g. African grey parrots,
Goffin's cockatoos, cockatiels):
For the treatment of infections due to Chlamydophyla psittaci susceptible to
doxycycline, the drinking water should be medicated in:
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African grey parrots:
at a dose of 800 mg doxycycline hyclate/L drinking water ad libitum for 42 days or
54 mg doxycycline hyclate/kg bodyweight;
at a dose of 400 mg doxycycline hyclate/L drinking water ad libitum for 42 days or 24
mg doxycycline hyclate/kg bodyweight;
at a dose of 400 mg doxycycline hyclate/L drinking water ad libitum (or 40 mg
doxycycline hyclate/kg bodyweight via feeding tube into the crop) for 30 days.
Owing to physiological and pharmacokinetic differences between the wide range of
species for which this product is indicated, the dose rates above are for guidance
only. Depending upon the species of animal and the infection to be treated,
alternative doses may be appropriate using an evidence-based approach. However,
any change in dosing regimen should be based on a benefit:risk assessment by the
responsible veterinarian, as tolerance at higher doses has not been investigated.
The exact daily amount of the product can be calculated using the following formula
... mg product/kg
bodyweight/day* mean bodyweight
(kg) of birds to be
treated = ... mg product per L drinking
Mean daily water uptake (L) per bird
* 10 mg doxycycline hyclate/kg bodyweight is equivalent to 67 mg product/kg
To ensure a correct dosage, the body weight should be determined as accurately as
The uptake of medicated drinking water depends on the clinical condition of the birds.
To obtain the correct dosage the concentration in the drinking water may have to be
The medicated drinking water is a clear, colourless to yellow solution.
The maximal solubility of the product in soft/hard water at 20°C is around 390 g/L and
in soft/hard water at 5°C around 190 g/L.
Warning: The solubility of the product depends on the pH-value; in hard alkaline
water the product can precipitate. Water with a hardness of > 19.2°d and a pH-value
of > 8.1 is not suitable for dissolving this product.
The use of suitably calibrated weighing equipment is recommended if parts of the
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
replaced every 24 hours.
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No other source of drinking water should be available during the medication period.
Racing pigeons should be kept in the pigeon loft during treatment.
The water supply system should be cleaned appropriately after the end of the
medication period to avoid intake of sub-therapeutic amounts of the active substance.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Gastrointestinal effects. Ornamental birds and racing pigeons can regurgitate after
administration of high dosages.
In Goffin's cockatoos at a dose of 30 mg doxycycline hyclate/kg bodyweight changes
in plasma biochemical analyses suggest mild hepatic damage which disappears
7 days after the end of the treatment.
4.11 Withdrawal period(s)
Not authorised for use in birds intended for human consumption. Not authorised for
use in birds producing eggs for human consumption.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: antibacterial for systemic use, tetracyclines.
ATCvet code: QJ01 AA 02.
5.1 Pharmacodynamic properties
Doxycycline is a semi-synthetic tetracycline derivative.
In vitro doxycycline is primarily a bacteriostatic drug. It exerts its action by inhibiting
the protein synthesis of the bacterial cell. Doxycycline specifically binds on the
receptors of the 30S ribosomal subunits, causing the access of aminoacetyl-tRNA to
the receptor location of the RNA-ribosomal complex to be disturbed.
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.
Based on bibliographic references: Chlamydophyla psittaci (2013) and Mycoplasma
spp ( 2008) demonstrated to be highly susceptible. Pasteurella multocida results
(2014) demonstrated a great variability from high to low susceptibility, depending on
the geographical region where isolates came from.
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.
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5.2 Pharmacokinetic particulars
The following data are based on bibliographic source:
In general, doxycycline is quite rapidly absorbed from the gastrointestinal tract,
widely distributed in the organism, not metabolised to any significant extent and
excreted mostly via the faeces.
It was shown that doxycycline was well absorbed from the gastrointestinal tract of the
pigeons after an oral dosage of 60 mg/kg b.w. A maximum plasma concentration of
8.1 μg/mL was reached 6 hours after administration and a plasma half-life of 11.3 h
At a daily oral dosage of 30 mg doxycycline/kg b.w. divided into 2 equal doses over a
time period of 14 days, mean peak-values in the plasma of 2.4 μg/mL and mean
trough-values in the plasma of 1.8 μg/mL were measured”.
A distribution volume of 1.3-1.4 L/kg was identified in pigeons.
In the liver, a high accumulation (values 8-26 µg/g) was noted 2 h after the last
administration, and was slightly reduced after 7 h (single values 7 to 17 µg/g).
For the lung, concentrations significantly higher than in plasma were measured
(average plasma levels =1.8 µg/mL after 2 h and 1.4 µg/mL after 6h), although the
maximal concentration and the variability is substantially less than in the liver (3-7
µg/g after 2 h and 2 to 4 µg/g after 7 h).
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Citric acid, anhydrous
Sodium dihydrogen citrate, anhydrous
In the absence of compatibility studies, this veterinary medicinal 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
Shelf life after first opening the 4 g sachet: use immediately. Do not store.
Shelf life after first opening the 200 g bag: 1 month
Shelf life after dilution or reconstitution according to directions: 24 hours
6.4 Special precautions for storage
This veterinary medicinal product does not require any special temperature storage
Tightly reclose the 200 g bag after opening in order to protect from light.
Following reconstitution, the medicated solutions should be protected from direct
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6.5 Nature and composition of immediate packaging
Carton box with 8 single-use aluminium foil sachets, containing 4 g powder each.
Each sachet contains 600 mg of doxycycline hyclate.
Polypropylene jar with screw cap containing a bag of 200 g powder.
Scew cap: HDPE
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 product should be disposed of in accordance with local
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION
28 July 2016
10. DATE OF REVISION OF THE TEXT
Approved: 28 July 2016
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