Enrotron 25 mg/ml orale oplossing voor runderen

البلد: هولندا

اللغة: الهولندية

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

العنصر النشط:

ENROFLOXACINE

متاح من:

aniMedica GmbH

ATC رمز:

QJ01MA90

INN (الاسم الدولي):

ENROFLOXACINE

الشكل الصيدلاني:

Concentraat voor drank

تركيب:

ENROFLOXACINE 25 mg/ml,

طريقة التعاطي:

Oraal gebruik

نوع الوصفة الطبية :

Uitsluitend door dierenartsen te gebruiken

المجموعة العلاجية:

Kalveren

المجال العلاجي:

Enrofloxacin

ملخص المنتج:

Wachttermijn: Kalveren Vlees 7 dagen

الوضع إذن:

NL/V/0165/002

تاريخ الترخيص:

2013-03-19

خصائص المنتج

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