DFV Doxivet 200 mg/ml, Solution for Use in Drinking Water for Pigs and Chickens

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Doxycycline Hyclate

Saatavilla:

Divasa - Farmavic S.A

ATC-koodi:

QJ01AA02

INN (Kansainvälinen yleisnimi):

Doxycycline Hyclate

Lääkemuoto:

Solution for use in drinking water

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Chickens, Pigs

Terapeuttinen alue:

Antimicrobial

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

2011-07-12

Valmisteyhteenveto

Revised: May 2016
AN: 01226/2015
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DFV DOXIVET 200 mg/ml, solution for use in drinking water for pigs and
chickens.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition for 1 ml:
ACTIVE SUBSTANCE:
Doxycycline hyclate
230 mg
Equivalent to 200 mg doxycycline base
EXCIPIENTS:
For the 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
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
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the 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
Revised: May 2016
AN: 01226/2015
Page 2 of 6
Due to likely variability (time, geographical) in susceptibility of
bacteria for doxycycline,
especially susceptibility of _A. pleuropneumoniae _and _O.
rhinotracheale _may differ from
country to country and even farm to farm, bacteriological sampling and
susceptibility
testing are recommended.
Use of the product should be based on culture and sensitivity of
micro-organisms from
diseased cases on farm. If this is not possible, therapy should be
based on local (regional,
farm level) epidemiological information about susceptibility of the