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

Summary of Product characteristics

                                Revised: May 2022
AN: 00111/2021 & 00883/2021
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
GalluDoxx 500 mg/g powder for use in drinking water/milk replacer for
calves, chickens
and turkeys
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
ACTIVE SUBSTANCE:
Doxycycline hyclate 500 mg (equivalent to 433 mg doxycycline)
EXCIPIENT:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for use in drinking water/milk replacer.
Yellowish powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (pre-ruminant calves)
Chickens (broilers, breeders, replacement pullets) and turkeys.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle (pre-ruminant calves)
For the treatment of:
- Pneumonia and shipping fever caused by _Pasteurella_ spp and
_Mannheimia _
_haemolytica _infections.
Chickens (broilers, breeders, replacement pullets) and turkeys
For the treatment of:
- Ornithosis caused by _Chlamydophila psittaci_ in turkeys;
- Colibacillosis caused by_ E. coli_ in chickens and turkeys;
- Chronic Respiratory Disease caused by _Mycoplasma gallisepticum _in
chickens and
turkeys.
Revised: May 2022
AN: 00111/2021 & 00883/2021
Page 2 of 8
4.3
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to tetracyclines or 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
4.4
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 or medicated milk
replacer, animals should
be treated parenterally. It is necessary to administer medicated milk
to calves on an
individual basis.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Due to variability (time, geographical) in susceptibility of bacteria
for doxycycline,
bacteriological sampling and susceptibility tes
                                
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