Enrotron 100 mg/ml solution for use in drinking water for chicken, turkeys and rabbits

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enrofloxacin

Available from:

aniMedica GmbH

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, Rabbits, Turkeys

Therapeutic area:

enrofloxacin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2013-06-21

Summary of Product characteristics

Health Products Regulatory Authority
22 August 2018
CRN008DKX
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrotron 100 mg/ml solution for use in drinking waterfor chicken,
turkeys and rabbits
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin 100.0 mg
EXCIPIENTS:
Benzyl alcohol (E-1519) 14.0 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
Chickens, turkeys, rabbits
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
22 August 2018
CRN008DKX
Page 2 of 7
_ _
RABBITS
For the treatment of 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 when resistance/cross-resistance to (fluoro)quinolones is
known to occur
in the flock intended for treatment.
Do not use in cases of known hypersensitivity to the active substance,
other
(fluoro)quinolones or to any of the excipients.
Do not use for prophylaxis.
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 poor