Soludox 500 mg/g Powder for Use in Drinking Water for Turkeys

Summary of Product characteristics

                                Revised: October 2017
AN: 01443/2016
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Soludox 500 mg/g powder for use in drinking water for turkeys
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g powder contains:
Active substance:
Doxycycline hyclate
500 mg, corresponding to 433 mg doxycycline
Excipients:
For the 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
Turkeys (broilers, breeders).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of clinical respiratory infections associated with
_Mycoplasma gallisepticum_
susceptible to doxycycline.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Do not use in animals with hepatic and/or renal dysfunction.
Do not use when tetracycline resistance has been detected in the 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, turkeys should be
treated parenterally.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken
into account
when the product is used.
Revised: October 2017
AN: 01443/2016
Page 2 of 6
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.
Due to likely variability (time, geographical) in susceptibility of
bacteria for
doxycycline bacteriological sampling and susceptibility testing are
recommended. In
particular susceptibility of _O.rhinotracheale_ may differ from
country to country and
even farm to farm.
Use of the product should be based on culture and sensitivity of
m
                                
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