Enrotron 5 mg/ml orale oplossing voor varkens

国家: 荷兰

语言: 荷兰文

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

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下载 产品特点 (SPC)
24-12-2023
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13-12-2023

有效成分:

ENROFLOXACINE

可用日期:

aniMedica GmbH

ATC代码:

QJ01MA90

INN(国际名称):

ENROFLOXACINE

药物剂型:

Vloeistof voor oraal gebruik

组成:

ENROFLOXACINE 5 mg/ml,

给药途径:

Oraal gebruik

处方类型:

Uitsluitend door dierenartsen te gebruiken

治疗组:

Varkens

治疗领域:

Enrofloxacin

產品總結:

Wachttermijn: Varkens Vlees 7 dagen

授权状态:

NL/V/0165/001

授权日期:

2013-03-19

产品特点

                                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.
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 testing should be performed before treatment is
initiated.
Use of the veterinary medicinal product deviating from instructions
given in the SPC may increase the
prevalence of bac
                                
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