Soludox 500 mg/g powder for use in drinking water for pigs and chickens
Country: Italy
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
10-09-2013
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Active ingredient:
doxycycline hyclate 500 mg/g
Available from:
Eurovet Animal Health
ATC code:
QJ01AA02
Pharmaceutical form:
Powder for oral solution
Therapeutic group:
doxycycline
Therapeutic area:
Chicken Food, Pigs Food
Authorization date:
2011-08-25
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS,
LABELLING AND PACKAGE LEAFLET
2/19
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.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Due to likely variability (time, geographica
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