ENROX 100 MG/ML ORAL SOLUTION
Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Svojstava lijeka
(SPC)
17-04-2015
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Aktivni sastojci:
ENROFLOXACIN
Dostupno od:
Krka, d.d., Novo mesto
ATC koda:
QJ01MA90
INN (International ime):
ENROFLOXACIN
Doziranje:
100 Mg/Ml
Farmaceutski oblik:
Oral Solution
Tip recepta:
POM
Terapijska grupa:
Fowl - Chicken, Fowl - Turkey
Područje terapije:
Enrofloxacin
Terapijske indikacije:
Antibacterial
Status autorizacije:
Authorised
Datum autorizacije:
2008-06-20
Svojstava lijeka
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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