Soludox 500 mg/g powder for use in drinking water for turkeys
Country: Hungary
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
13-10-2013
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Active ingredient:
doxycycline hyclate 500 mg/ml
Available from:
Eurovet Animal Health
ATC code:
QJ01AA02
Pharmaceutical form:
Powder for oral solution
Therapeutic group:
doxycycline
Therapeutic area:
Turkeys
Authorization date:
2012-05-07
Summary of Product characteristics
Issued: August 2012
AN: 01495/2011
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
_FR: Soludox 433 mg/g powder for use in drinking water for turkeys _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gram of powder contains:
ACTIVE SUBSTANCE:
Doxycycline hyclate
500 mg, corresponding to 433 mg doxycycline
_FR: Doxycycline _
_ _
_433 mg, corresponding to 500 mg doxycycline hyclate _
EXCIPIENTS:
For a 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
Turkeys: treatment of clinical respiratory infections associated with Mycoplasma
gallisepticum susceptible to doxycycline
4.3 CONTRA-INDICATIONS
Do not use in case of known hypersensitivity to the active substance or to any of the
excipients.
Do not use in animals with hepatic dysfunction.
4.4 SPECIAL WARNING 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
Inappropriate use of the product may increase the prevalence of bacteria resistant to
tetracycline due to the potential for cross resistance. Do not use when tetracycline
resistance has been detected in the herd/flock.
Issued: August 20
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