Baytril 10% Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enrofloxacin

Available from:

Elanco GmbH

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

enrofloxacin

Authorization status:

Authorised

Authorization date:

1988-10-01

Summary of Product characteristics

Health Products Regulatory Authority
16 October 2020
CRN009PVY
Page 1 of 5
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. _
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.
Health Products Regulatory Authority
16 October 2020
CRN009PVY
Page 2 of 5
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 antimi