Baytril 10% Oral Solution

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Enrofloxacin

Disponible depuis:

Bayer Limited

Code ATC:

QJ01MA90

DCI (Dénomination commune internationale):

Enrofloxacin

Dosage:

10 milligram(s)/millilitre

forme pharmaceutique:

Oral solution

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Groupe thérapeutique:

Chickens, Rabbits, Turkeys

Domaine thérapeutique:

enrofloxacin

indications thérapeutiques:

Antibacterial

Statut de autorisation:

Authorised

Date de l'autorisation:

1988-10-01

Résumé des caractéristiques du produit

Health Products Regulatory Authority
02 July 2018
CRN000YJV
Page 1 of 7
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._
TURKEYS
_Mycoplasma gallisepticum,_
_Mycoplasma synoviae,_
_Pasteurella multocida. _
Health Products Regulatory Authority
02 July 2018
CRN000YJV
Page 2 of 7
RABBITS
For the treatment infectious diseases due to _Pasteurella multocida_
and bacterial
enteritis due to infection with _E.coli._
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