Enrofloxacin Krka 100 mg/ml oral solution for chickens and turkeys

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Enrofloxacin

Disponible depuis:

Krka, d.d., Novo mesto

Code ATC:

QJ01MA90

DCI (Dénomination commune internationale):

Enrofloxacin

Dosage:

100 milligram(s)/millilitre

forme pharmaceutique:

Oral solution

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Groupe thérapeutique:

Chickens, Turkeys

Domaine thérapeutique:

enrofloxacin

indications thérapeutiques:

Antibacterial

Statut de autorisation:

Authorised

Date de l'autorisation:

2013-06-14

Résumé des caractéristiques du produit

Health Products Regulatory Authority
03 July 2018
CRN000YPH
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrofloxacin Krka 100 mg/ml oral solution for chickens and turkeys
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of oral solution contains:
ACTIVE SUBSTANCE:
Enrofloxacin 100 mg
EXCIPIENTS:
Benzyl alcohol 14 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Clear, yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chicken and Turkey.
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._
Health Products Regulatory Authority
03 July 2018
CRN000YPH
Page 2 of 7
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 case of 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.
Whenever possible, fluoroquinolones should only be used based on
susceptibility
testing.
Use of the product deviating from the instructions given in the SPC
may increase the
prevalence of bacteria resistant to the fluoroquinolones and may
decrease the
effectiveness of treatment with other quinolones due to the potential
for cross
resistance.
Since en