Enrotron 25 mg/ml orale oplossing voor runderen

Negara: Belanda

Bahasa: Belanda

Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Bahan aktif:

ENROFLOXACINE

Tersedia dari:

aniMedica GmbH

Kode ATC:

QJ01MA90

INN (Nama Internasional):

ENROFLOXACINE

Bentuk farmasi:

Concentraat voor drank

Komposisi:

ENROFLOXACINE 25 mg/ml,

Rute administrasi :

Oraal gebruik

Jenis Resep:

Uitsluitend door dierenartsen te gebruiken

Kelompok Terapi:

Kalveren

Area terapi:

Enrofloxacin

Ringkasan produk:

Wachttermijn: Kalveren Vlees 7 dagen

Status otorisasi:

NL/V/0165/002

Tanggal Otorisasi:

2013-03-19

Karakteristik produk

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrotron 25 mg/ml oral solution for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin
25.0 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
Cattle (calves)
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 bovis._
To be used where clinical experience and/or sensitivity testing
indicates enrofloxacin as the drug of
choice.
4.3
CONTRAINDICATIONS
Do not use in case of confirmed or suspected resistance to quinolones,
since a high degree of cross
resistance between enrofloxacin and other (fluoro)quinolones does
exist.
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.
Do not use for prophylaxis.
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.
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.
Wherever possible, fluoroquinolones should be used based on
susceptibility testing.
Use of the veterinary medicinal product deviating from instructions
given in the SPC may in