Doxivet 200 mg/ml concentrate for oral solution
Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
13-10-2012
Summary of Product characteristics
(SPC)
13-10-2012
Active ingredient:
doxycycline hyclate 230 mg/ml
Available from:
DIVASA-FARMAVIC
ATC code:
QJ01AA02
Pharmaceutical form:
Oral solution
Therapeutic group:
doxycycline
Therapeutic area:
Chicken
Authorization date:
2012-02-17
Patient Information leaflet
1
PRODUCT LITERATURE
2
BOTTLE LABEL
DOXIVET 200 MG/ML,
SOLUTION FOR USE IN DRINKING WATER FOR BROILER BREEDERS .
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND
OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer for the batch release:
DIVASA-FARMAVIC S.A.
Ctra. Sant Hipòlit, km 71
08503 Gurb-Vic
Barcelona (Spain)
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DOXIVET 200 mg/ml, solution for use in drinking water for broiler breeders.
(Doxycycline as doxycycline hyclate)
IT / ES: DOXYCYCLINE DIVASA-FARMAVIC 200 mg/ml, solution for use in drinking water for
broiler breeders.
DK / SE: Doxivet vet, solution.
(Doxycycline as doxycycline hyclate)
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
1 ml of solution for use in drinking water contains 230 mg of doxycycline hyclate (equivalent to 200 mg
of doxycycline).
4.
INDICATIONS
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)_.
5.
CONTRAINDICATIONS
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.
6.
ADVERSE REACTIONS
Tetracyclines may - in very rare cases - induce photosensitivity and allergic reactions. If suspected
adverse reactions occur, treatment should be discontinued. If you notice any serious effects or other
effects not
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Summary of Product characteristics
1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DOXIVET 200 mg/ml, solution for use in drinking water for broiler breeders.
IT / ES: DOXYCYCLINE DIVASA-FARMAVIC 200 mg/ml, solution for use in drinking water for
broiler breeders.
DK / SE: Doxivet vet, concentrate for oral solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition for 1 ml:
ACTIVE SUBSTANCE:
Doxycycline hyclate
230 mg
Equivalent to 200 mg doxycycline base
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for use in drinking water
Clear yellow-brown solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Broiler breeders.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIE S
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
CONTRAINDICATIONS
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 WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
3
Due to likely variability (time, geographical) in susceptibility of bacteria for doxycycline, especially
susceptibility of _O. rhinotracheale _may differ from country to country and even farm to farm,
bacteriological sampling and susceptibility testing are recommended.
Use of
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