Baytril Piglet Doser 0.5% Oral Solution

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Enrofloxacin

Available from:

Elanco Europe Ltd

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Pharmaceutical form:

Oral solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

1993-11-11

Summary of Product characteristics

Revised: September 2023
AN: 03529/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Baytril Piglet Doser 0.5% Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE CONSTITUENTS
MG PER ML
Enrofloxacin
5.0
RELEVANT CONSTITUENTS OF THE
EXCIPIENTS
Benzyl Alcohol
14.0
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral solution.
Clear aqueous solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Piglets
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is for use in the treatment of diseases of the respiratory
and
alimentary tracts of bacterial or mycoplasmal origin (e.g.
pasteurellosis,
mycoplasmosis, coli-bacillosis, coli-septicaemia and salmonellosis),
and
multifactorial diseases such as atrophic rhinitis and enzootic
pneumonia,
where clinical experience, supported where possible by sensitivity
testing
of the causal organism, indicates enrofloxacin as the drug of choice.
4.3
CONTRAINDICATIONS
Should not be used for prophylaxis.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known
Revised: September 2023
AN: 03529/2022
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
I)
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.
II)
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
MEDICINAL PRODUCT TO ANIMALS
Enrofloxacin may cause hypersensitivity (allergic reactions). People
with
known hypersensitivity to fluoroquinolone