ENROX 100 MG/ML ORAL SOLUTION
Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Produktets egenskaber
(SPC)
17-04-2015
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Aktiv bestanddel:
ENROFLOXACIN
Tilgængelig fra:
Krka, d.d., Novo mesto
ATC-kode:
QJ01MA90
INN (International Name):
ENROFLOXACIN
Dosering:
100 Mg/Ml
Lægemiddelform:
Oral Solution
Recept type:
POM
Terapeutisk gruppe:
Fowl - Chicken, Fowl - Turkey
Terapeutisk område:
Enrofloxacin
Terapeutiske indikationer:
Antibacterial
Autorisation status:
Authorised
Autorisation dato:
2008-06-20
Produktets egenskaber
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrox 100 mg/ml oral solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Oral solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (broilers, broiler breeders, replacement chickens), turkeys.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections caused by the following bacteria susceptible to enrofloxacin:
CHICKENS
_Mycoplasma gallisepticum,_
_Mycoplasma synoviae,_
_Avibacterium paragallinarum,_
_Pasteurella multocida,_
_Escherichia coli._
TURKEYS
_Mycoplasma gallisepticum,_
_Mycoplasma synoviae,_
_Pasteurella multocida,_
_Escherichia coli._
4.3 CONTRAINDICATIONS
Do not use for prophylaxis.
Do not use when resistance / cross-resistance to (fluoro)quinolones is known to occur in the flock
intended for treatment.
Do not use in poultry producing eggs for human consumption.
Do not use in aquatic poultry.
Do not use in infections caused by _Streptococcus _spp., because of only marginal susceptibility to enrofloxacin.
ACTIVE SUBSTANCE
1 ml of oral solution contains:
Enrofloxacin
100 mg.
EXCIPIENTS
Benzyl alcohol
14 mg.
For the full list of excipients, see section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 02/04/2015_
_CRN 7020279_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatment of _Mycoplasma _spp. infections may not eradicate the organism.
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 c
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