Enrotron 5 mg/ml oral solution for pigs

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Enrofloxacin

Tersedia dari:

aniMedica GmbH

Kode ATC:

QJ01MA90

INN (Nama Internasional):

Enrofloxacin

Dosis:

5 milligram(s)/millilitre

Bentuk farmasi:

Oral solution

Jenis Resep:

POM: Prescription Only Medicine as defined in relevant national legislation

Kelompok Terapi:

Pigs

Area terapi:

enrofloxacin

Indikasi Terapi:

Antibacterial

Status otorisasi:

Authorised

Tanggal Otorisasi:

2013-06-21

Karakteristik produk

Health Products Regulatory Authority
22 August 2018
CRN008DKX
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrotron 5 mg/ml oral solution for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin 5.0 mg
EXCIPIENTS:
Benzyl alcohol (E-1519) 14.0 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (piglets)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections of the respiratory and alimentary tract caused
by
enrofloxacin-sensitive microorganisms. In particular:

Treatment of neonatal diarrhoea and septicaemia caused by
enrofloxacin-sensitive _E. coli_

Treatment of respiratory infections caused by enrofloxacin-sensitive
_Pasteurella multocida_, _Mannheimia haemolytica_ and _Mycoplasma
_spp.

Enzootic pneumonia
To be used where clinical experience and/or sensitivity testing
indicates enrofloxacin
as the drug of choice.
Health Products Regulatory Authority
22 August 2018
CRN008DKX
Page 2 of 5
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, to
other
(fluoro)quinolones or to any of the excipients.
Do not use in cases of disturbances to the growth of cartilage and/or
during injury to
the locomotory system, particularly if functionally loaded or body
weight loaded
joints are affected.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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.
Do not use in case of confirmed or suspected resistance to quinolones,
since a high
degree of cross resistance between enrofloxacin and other quinolones
does exist.
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.
Susceptibility te