Soludox 500 mg/g Powder for Use in Drinking Water for Pigs and Chickens
Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Summary of Product characteristics
(SPC)
21-11-2012
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Active ingredient:
Doxycycline Hyclate
Available from:
Eurovet Animal Health BV
ATC code:
QJ01AA02
INN (International Name):
Doxycycline Hyclate
Authorization status:
Expired
Summary of Product characteristics
Revised: October 2012
AN: 00828/2012
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Soludox 500 mg/g powder for use in drinking water for pigs and chickens
_Soludox 433 mg/g powder for use in drinking water for pigs and chickens (France _
_only)_
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gram of powder contains:
ACTIVE SUBSTANCE:
Doxycycline hyclate 500 mg, corresponding to 433 mg doxycycline
_France: 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
Pigs and chickens (broiler, pullet, breeder).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs: For the treatment of the clinical signs associated with porcine respiratory
disease caused by _Actinobacillus pleuropneumoniae, Pasteurella multocida_, and
_Mycoplasma hyopneumoniae_ susceptible to doxycycline.
Chickens: Where clinical disease is present in the flock, to reduce mortality,
morbidity, and clinical signs and to reduce lesions due to Pasteurellosis caused by
_Pasteurella multocida _or to reduce morbidity and lesions in respiratory infections
caused by _Ornithobacterium rhinotracheale (ORT)_.
4.3 CONTRA-INDICATIONS
Do not use in case of hypersensitivity to the active substance or to any of excipients.
Do not use in animals with an impaired liver function.
4.4 SPECIAL WARNING FOR EACH TARGET SPECIES.
None.
Page 1 of 6
Revised: October 2012
AN: 00828/2012
4.5 SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Due to likely variability (time, geographical) in susceptibility of bacteria for
doxycycline, especially susceptibility of_ A. pleuropneumoniae _and_ O. _
_rhinotrache
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