Enroxil 100 mg/ml Oral Solution for Chickens and Turkeys

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Viambatanisho vya kazi:

Enrofloxacin

Inapatikana kutoka:

Krka d.d., Novo Mesto

ATC kanuni:

QJ01MA90

INN (Jina la Kimataifa):

Enrofloxacin

Dawa fomu:

Oral solution

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Chickens, Turkeys

Eneo la matibabu:

Antimicrobial

Idhini hali ya:

Authorized

Idhini ya tarehe:

2005-09-09

Tabia za bidhaa

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