Baytril 2.5% Oral Solution

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Nopērc to tagad

Lejuplādēt Produkta apraksts (SPC)
14-07-2023
Lejuplādēt DSU (DSU)
14-07-2023

Aktīvā sastāvdaļa:

Enrofloxacin

Pieejams no:

Elanco GmbH

ATĶ kods:

QJ01MA90

SNN (starptautisko nepatentēto nosaukumu):

Enrofloxacin

Deva:

2.5 percent weight/volume

Zāļu forma:

Oral solution

Receptes veids:

POM: Prescription Only Medicine as defined in relevant national legislation

Ārstniecības joma:

enrofloxacin

Autorizācija statuss:

Authorised

Autorizācija datums:

1988-10-01

Produkta apraksts

                                Health Products Regulatory Authority
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE VETERINARY MEDICINAL PRODUCT
Baytril 2.5% Oral Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Constituents
mg/ml
Enrofloxacin
25.0 ml
Relevant Constituents of the Excipients
Benzyl Alcohol
14.0
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Oral solution.
4
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Calves
Exotic Animals (small mammals, reptiles and avian species)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is for use in calves in the treatment of infections of the
alimentary and respiratory tracts of bacterial or
mycoplasmal origin (e.g. pasteurellosis, mycoplasmosis,
coli-bacilliosis and salmonellosis), where clinical experience
supported
where possible by sensitivity testing of the causal organism,
indicates enrofloxacin as the drug of choice.
The product may also be used in exotic animals (small mammals,
reptiles and avian species) for the treatment of bacterial
infections of the alimentary and respiratory tracts where clinical
experience, supported where possible by sensitivity testing of
the causal organism, indicates enrofloxacin as the drug of choice.
4.3
CONTRAINDICATIONS
The product should not be used for prophylaxis.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
EXOTIC ANIMALS: Consult the Technical Services Department of Bayer
prior to use.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
See 4.4
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, fluoroquinoones 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

                                
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