ENROFLOXACIN KRKA 100 MG/ML ORAL SOLUTION FOR CHICKENS AND TURKEYS
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
26-05-2015
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Virkt innihaldsefni:
ENROFLOXACIN
Fáanlegur frá:
Krka, d.d., Novo mesto
ATC númer:
QJ01MA90
INN (Alþjóðlegt nafn):
ENROFLOXACIN
Skammtar:
100 Mg/Ml
Lyfjaform:
Infus/Pdr/Oral Soln
Gerð lyfseðils:
POM
Meðferðarhópur:
Fowl - Chicken, Fowl - Turkey
Lækningarsvæði:
Enrofloxacin
Ábendingar:
Antibacterial
Leyfisstaða:
Authorised
Leyfisdagur:
2013-06-14
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrofloxacin Krka 100 mg/ml oral solution for chickens and turkeys.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of oral solution contains:
ACTIVE SUBSTANCE:
Enrofloxacin 100 mg
EXCIPIENTS:
Benzyl alcohol 14 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Clear, yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chicken and Turkey.
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._
Turkey
_Mycoplasma gallisepticum,_
_Mycoplasma synoviae,_
_Pasteurella multocida,_
_Escherichia coli._
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 11/05/2015_
_CRN 7020381_
_page number: 1_
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 case of hypersensitivity to the active substance, other (fluoro)quinolones or to
any of the excipients.
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 classes of antimicrobials.
Whenever possible, fluoroquinoones should only be u
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