Baytril 10% Oral Solution

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Enrofloxacin

Saatavilla:

Bayer plc

ATC-koodi:

QJ01MA90

INN (Kansainvälinen yleisnimi):

Enrofloxacin

Lääkemuoto:

Solution for use in drinking water

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Chickens, Rabbits, Turkeys

Terapeuttinen alue:

Antimicrobial

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

1993-11-11

Valmisteyhteenveto

Revised: June 2018
AN: 00202/2018
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Baytril 10% Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of Baytril 10% Oral Solution contains:
ACTIVE SUBSTANCE
Enrofloxacin
100 mg;
EXCIPIENT(S)
Benzyl alcohol
14 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for use in drinking water.
Clear yellowish solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chicken, turkey and rabbit.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections caused by the following bacteria susceptible
to
enrofloxacin:
CHICKENS
_Mycoplasma gallisepticum,_
_Mycoplasma synoviae,_
_Avibacterium paragallinarum,_
_Pasteurella multocida,_
TURKEY
_Mycoplasma gallisepticum,_
_Mycoplasma synoviae,_
_Pasteurella multocida,_
RABBITS
For the treatment infectious diseases due to _Pasteurella multocida_
and
bacterial enteritis due to infection with _E.coli._
Page 1 of 7
Revised: June 2018
AN: 00202/2018
Enrofloxacin should be used where clinical experience, supported where
possible by sensitivity testing of the causal organism, indicates
enrofloxacin
as the active substance of choice.
4.3
CONTRAINDICATIONS
Do not use for prophylaxis.
Do not use when resistance/ cross-resistance to (fluoro)quinolones is
known
to occur in the flock intended for treatment.
Do not use in the case of known hypersensitivity to the active
substance,
other (fluoro)quinolones or to any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatment of _Mycoplasma spp_ infections may not eradicate the
organism.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Official and local antimicrobial policies should be taken into account
when the
product is used.
Fluoroquinolones should be reserved for the treatment of clinical
conditions
which have responded poorly, or are expected to respond poorly, to
other
classes of antimicrobials.
Since enrofloxacin was first authorised for use in poultry, there has
bee