Enroxil 100 mg/ml Oral Solution for Chickens and Turkeys

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktívna zložka:

Enrofloxacin

Dostupné z:

Krka d.d., Novo Mesto

ATC kód:

QJ01MA90

INN (Medzinárodný Name):

Enrofloxacin

Forma lieku:

Oral solution

Typ predpisu:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutické skupiny:

Chickens, Turkeys

Terapeutické oblasti:

Antimicrobial

Stav Autorizácia:

Authorized

Dátum Autorizácia:

2005-09-09

Súhrn charakteristických

Revised: June 2018
AN: 00219/2018
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ENROXIL 100 mg/ml oral solution for chickens and turkeys.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
1 ml of oral solution contains: enrofloxacin 100 mg.
EXCIPIENT:
Benzyl alcohol 14 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
Clear, yellow solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
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._
TURKEY
_Mycoplasma gallisepticum,_
_Mycoplasma synoviae,_
_Pasteurella multocida._
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.
Infections caused by _Streptococcus _spp., because of only marginal
susceptibility to
enrofloxacin.
Do not use in other animals.
Revised: June 2018
AN: 00219/2018
Page 2 of 6
Do not use in case of hypersensitivity to the active substance, 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, fluoroquinolones should only be used based on
susceptibility
testing.
Use of the product deviating from the instructions given in the SPC
may increase the
prevalence of bacteria resistant to the fluoroquinolones and may
decrease the
effective