Doxivet 500 mg/g, powder for use in drinking water for broiler breeders
Country: Netherlands
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/g
Available from:
DIVASA-FARMAVIC
ATC code:
QJ01AA02
Pharmaceutical form:
Powder for oral solution
Therapeutic group:
doxycycline
Therapeutic area:
Chicken
Authorization date:
2012-02-17
Patient Information leaflet
1
PRODUCT LITERATURE
2
CARTON BOX: 10 X 100 G – 50 X 100 G – 250 X 100 G
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DOXIVET 500 mg/g, Powder for use in Drinking Water for broiler breeders.
_Doxycycline hyclate _
_ _
IT/CZ: DOXYCYCLINE DIVASA-FARMAVIC 500 mg/g, oral powder for use in drinking water for
broiler breeders.
_Doxycycline hyclate _
DK/SW: Doxivet vet, oral powder for use in drinking water.
_Doxycycline hyclate _
_ _
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
1 g of powder contains 500 mg of doxycycline hyclate (equivalent to 433 mg doxycycline base).
3.
PHARMACEUTICAL FORM
Yellow to pale yellow powder for use in drinking water.
4.
PACKAGE SIZE
10 x 100 g
50 x 100 g
250 x 100 g
5.
TARGET SPECIES
Broiler breeders.
6.
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)_.
7.
METHOD AND ROUTE OF ADMINISTRATION
Administration route: In drinking water use.
Pasteurellosis: 10 mg doxycycline hyclate per kg bw / day for 3-4 days.
ORT: 20 mg doxycycline hyclate per kg bw / day for 3-4 days.
Read the package leaflet before use.
3
8.
WITHDRAWAL PERIOD
Meat and offal: 3 days in cases of 10 mg/kg bw for a maximum of 4 days.
Meat and offal: 12 days in cases of 20 mg/kg bw for a maximum of 4 days.
Eggs: Not authorised for use in laying birds producing
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Summary of Product characteristics
1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DOXIVET 500 mg/g, powder for use in drinking water for broiler breeders.
IT/CZ: DOXYCYCLINE DIVASA-FARMAVIC 500 mg/g, oral powder for use in drinking water for
broiler breeders.
DK/SE: Doxivet vet, oral powder for use in drinking water.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition for 1 g:
ACTIVE SUBSTANCE:
Doxycycline hyclate
500 mg
(equivalent to 433 mg doxycycline base)
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for use in drinking water
Yellow to pale yellow powder.
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
4.5.I SPECIAL PRECAUTIONS FOR USE IN ANIMALS
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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.
U
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