Enrox 100 mg/ml oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enrofloxacin

Available from:

Krka, d.d., Novo mesto

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Chickens, Turkeys

Therapeutic area:

enrofloxacin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2008-06-20

Summary of Product characteristics

Health Products Regulatory Authority
25 July 2018
CRN000YPK
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrox 100 mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
1 ml of oral solution contains:
Enrofloxacin
100
mg.
EXCIPIENTS
Benzyl alcohol
14
mg.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (broilers, broiler breeders, replacement chickens), turkeys.
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,_
Health Products Regulatory Authority
25 July 2018
CRN000YPK
Page 2 of 6
_Mycoplasma synoviae,_
_Pasteurella multocida._
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 poultry producing eggs for human consumption.
Do not use in aquatic poultry.
Do not use in infections caused by _Streptococcus_ spp., because of
only marginal
susceptibility to enrofloxacin.
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