Floxamax 100 mg/ml concentrate for oral solution for chickens and turkeys

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enrofloxacin

Available from:

SP Veterinaria, S.A.

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Chickens, Turkeys

Therapeutic area:

enrofloxacin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2008-03-07

Summary of Product characteristics

B.1. SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
FLOXAMAX 100 mg/ml concentrate for oral solution for chickens and
turkeys
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Enrofloxacin ……………. 100 mg
Excipients:
Benzyl alcohol (E1519)………….. 0.014 ml
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Concentrate for oral solution.
Clear yellow solution.
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Chickens and turkeys
4.2.
INDICATIONS FOR USE
Treatment
of
infections
caused
by
the
following
bacteria
susceptible
to
enrofloxacin:
CHICKENS
_Mycoplasma gallisepticum, _
_Mycoplasma synoviae, _
_Avibacterium paragallinarum, _
_Pasteurella multocida _
TURKEYS
_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.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatment of _Mycoplasma spp _infections may not eradicate the
organism.
4.5.
SPECIAL PRECAUTIONS FOR USE
i)
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.
Since enrofloxacin was first authorised for use in poultry, there has
been
widespread
reduction
in
susceptibility
of
_E. _
_coli _
to
fluoroquinolones
and
emergence of
resistant
organisms.
Resistance
has
also
been
reported
in
_Mycoplasma synoviae _in the EU.
Whenever
possible
fluoroquinolones
should
only
be
used
based
on
susceptibility testing.
Use of the product deviating from the instructions given by in the SPC
may
increase the prevalence of bacteria resistant to the fluoroquinolones
and may
decrease the effectiveness of treatment with other fluoroquinolo