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POM-V Prescription Required

GalluDoxx 500 mg/g Powder for Use in Drinking Water/Milk for Calves, Chickens and Turkeys

Active ingredient: Doxycycline Hyclate

Form

Powder

Species

Cattle Chickens Turkeys

Manufacturer

Huvepharma NV

VMD MA No.

30282/4031

What it's used for

AN: 03160/2024 & 03161/2024 Chickens (broilers, breeders, replacement pullets) and turkeys: For the treatment of: - Ornithosis caused by Chlamydophila psit...

Full indications, dosage and side effects ↓
View official SPC (PDF)

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  1. 1

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Prescription required

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Clinical information

GalluDoxx 500 mg/g Powder for Use in Drinking Water/Milk for Calves, Chickens and Turkeys — SPC Details

Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.

AN: 03160/2024 & 03161/2024
Chickens (broilers, breeders, replacement pullets) and turkeys:
For the treatment of:
- Ornithosis caused by Chlamydophila psittaci
- Colibacillosis caused by E. coli in chickens and turkeys;
- Chronic Respiratory Disease caused by Mycoplasma gallisepticum in chickens and
turkeys.
Chickens (broilers, breeders, replacement pullets) and turkeys: In drinking water use.
Dosing:
Cattle (calves):
Doxycycline hyclate 5 mg per kg body weight, twice a day, equivalent to 10 mg of the
product per kg of animal body weight, twice a day, for 4-7 successive days.
Chickens (broilers, breeders, replacement pullets) and turkeys:
20 mg doxycycline hyclate per kg of body weight per day, corresponding to 40 mg of the
product per kg of animal body weight, for 4-7 consecutive days.
AN: 03160/2024 & 03161/2024
The exact daily amount of product should be calculated according to the following
formula, based on the recommended dose, and the number and weight of the animals
to be treated:
mg product / kg
body weight / day
x Mean body weight (kg) of
animals to be treated
Mean daily water consumption (litre) per animal
= .... mg product per
litre drinking water
To ensure a correct dosage body weight should be determined as accurately as
possible.
The uptake of medicated water is dependent on the clinical conditions of the animals. In
order to obtain the correct dosage, the concentration in drinking water may have to be
adjusted.
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 12 hours. Medicated drinking water should be freshly prepared every
12 hours. It is recommended to prepare a concentrated pre-solution - not exceeding 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. The water should be stirred until full dissolution of the
product is obtained. The solubility of doxycycline decreases at higher pH. Therefore the
product should not be used in hard alkaline water since precipitation might occur
depending on the product concentration. Delayed precipitation might also occur.
Milk replacer: The veterinary medicinal product must first be dissolved in warm water
before adding the milk powder - the maximal concentration to be used is 100 grams of
product per litre of water. The obtained milk replacer solution must be homogenised and
heated to feeding temperature prior to administration. The medicated milk replacer
should be freshly prepared prior to use, used immediately and be constantly stirred to
avoid sedimentation of the active substance.
If a concentration greater than 200 mg per litre of milk is required, animals should be
treated parenterally.
Sufficient access to the system of water supply should be available for the animals to be
treated to ensure adequate water consumption. No other source of drinking water
should be available during the medication period. At the end of treatment period the
water supply should be cleaned adequately to avoid the uptake of remaining quantities
in sub-therapeutic doses.
Do not use in cases of hypersensitivity to the active substance, to other tetracyclines or
to the excipient. Do not administer to animals with severe liver or kidney insufficiency.
Do not use when tetracycline resistance has been detected in the herd/flock due to the
potential for cross resistance.
Cattle (pre-ruminant calves), chickens (broilers, breeders, replacement pullets) and
turkeys:
Rare
(1 to 10 animals / 10 000
animals treated):
Photosensitivity
Allergic reaction
1
Treatment should be discontinued.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s)).
- common (more than 1 but less than 10 animals in 100 animals treated).
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated).
- rare (more than 1 but less than 10 animals in 10,000 animals treated).
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
AN: 03160/2024 & 03161/2024
either the marketing authorisation holder <or its local representative> or the national
competent authority via the national reporting system. See the package leaflet for
respective contact details.
The uptake of medication by animals can be altered as a consequence of illness. In
case of insufficient uptake of drinking water or medicated milk replacer, animals should
be treated parenterally. It is necessary to administer medicated milk to calves on an
individual basis.

Special precautions for safe use in the target species:
Due to variability (time, geographical) in susceptibility of bacteria for doxycycline,
bacteriological sampling and susceptibility testing of micro-organisms from diseased
animals on farm are highly recommended.
A high resistance rate of E. coli, isolated from chickens, against tetracyclines has been
documented. Therefore the product should be used for the treatment of infections
caused by
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.

Official, national and regional antimicrobial policies should be taken into account when
the product is used.
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.
Resistance to tetracyclines has also been reported in calf pathogens (Pasteurella spp.)
in some EU countries.
AN: 03160/2024 & 03161/2024
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
This product may cause contact dermatitis if contact is made with the eyes (powder or
solution), or if the product is inhaled. Take measures to avoid producing dust when
incorporating the product into water.
Avoid contact with skin and eyes when handling the product to prevent sensitisation and
contact dermatitis. People with known hypersensitivity to tetracyclines should avoid
contact with the veterinary medicinal product.
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 or a non-
disposable respirator to European Standard EN140 with a filter to EN143) 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.
Do not smoke, eat or drink while 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.
Special precautions for the protection of the environment:
Not applicable.
Do not use in conjunction with bactericidal antibiotics, such as penicillins and
cephalosporins.
Do not administer concurrently with feed overloaded with polyvalent cations such as
Ca
2+
, Mg
2+
, Zn
2+
and Fe
3+
because the formation of doxycycline complexes with these
cations is possible. Do not administer together with antacids, kaolin and iron
preparations. It is advised that the interval between administration of the product and
administration of products containing polyvalent cations should be 1-2 hours because
the latter limit the absorption of doxycycline.
Doxycycline increases the action of anticoagulants.
This veterinary medicinal product does not require any special temperature storage
conditions. After first opening keep the bag tightly closed in order to protect from
moisture.
Cattle (pre-ruminant calves): Meat and offal: 28 days
Turkeys: Meat and offal: 28 days
Chickens (broilers, breeders, replacement pullets): Meat and offal: 14 days
Not authorised for use in birds producing eggs for human consumption.

This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.

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