Enrotron 25 mg/ml orale oplossing voor runderen

Country: Netherlands

Language: Dutch

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

Active ingredient:

ENROFLOXACINE

Available from:

aniMedica GmbH

ATC code:

QJ01MA90

INN (International Name):

ENROFLOXACINE

Pharmaceutical form:

Concentraat voor drank

Composition:

ENROFLOXACINE 25 mg/ml,

Administration route:

Oraal gebruik

Prescription type:

Uitsluitend door dierenartsen te gebruiken

Therapeutic group:

Kalveren

Therapeutic area:

Enrofloxacin

Product summary:

Wachttermijn: Kalveren Vlees 7 dagen

Authorization status:

NL/V/0165/002

Authorization date:

2013-03-19

Summary of Product characteristics

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