FLOXACIN ENROFLOXACIN 10 % CONCENTRATE FOR ORAL SOLUTION
Country: Portugal
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
13-03-2012
Summary of Product characteristics
(SPC)
13-03-2012
Active ingredient:
enrofloxacin 100 MG
Available from:
Global Vet Health SL
ATC code:
QJ01MA90
Pharmaceutical form:
Oral solution
Therapeutic group:
enrofloxacin
Therapeutic area:
Chicken, Turkeys
Authorization date:
2011-02-23
Patient Information leaflet
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
LABEL - LEAFLET
FLOXACIN 100 mg/ml concentrate for oral solution for chickens and
turkeys
Enrofloxacin
National issue CZ: Přípravek s indikačním omezením
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION
HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER
RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder:
GLOBAL VET HEALTH SL
C/Capçanes
nº12-bajos
Polígono Agro-Reus
REUS 43206
Tarragona (SPAIN)
Manufacturer for the batch release:
SP VETERINARIA SA
Ctra Reus Vinyols km 4.1
Riudoms (43330)
Tarragona (SPAIN)
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
FLOXACIN Enrofloxacin 100 mg/ml concentrate
for oral solution for chickens and turkeys
3.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Composition per ml:
Active substance:
E
E
n
n
r
r
o
o
f
f
l
l
o
o
x
x
a
a
c
c
i
i
n
n
…
…
…
…
…
…
…
…
…
…
.
.
1
1
0
0
0
0
m
m
g
g
/
/
m
m
l
l
Excipients:
Benzyl alcohol ………….. 0.014 ml/ml
4.
PHARMACEUTICAL FORM
Concentrate for oral solution.
Clear yellow solution.
5.
TARGET SPECIES
Chickens and turkeys
6.
INDICATIONS
Treatment of infections in chickens and turkeys and mix and secondary infections associated
with virus, caused by Mycoplasma and gram-positive and gram-negative bacteria susceptible to
enrofloxacin.
Enrofloxacin should be used where clinical experience, supported where possible by sensitivity
testing of the causal organism, indicates enrofloxacin as
the drug of choice.
Resistance does occurs by mutation,
particularly with Pseudomonas _aeruginosa_ , _Klebsiella_ ,
_Acinetobacter _and _Enterococci_.
7.
CONTRAIN
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Summary of Product characteristics
_SUMMARY OF PRODUCT CHARACTERISTICS _
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
FLOXACIN 100 mg/ml concentrate for oral solution for chickens and
turkeys
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
E
E
n
n
r
r
o
o
f
f
l
l
o
o
x
x
a
a
c
c
i
i
n
n
…
…
…
…
…
…
…
…
…
…
.
.
1
1
0
0
0
0
m
m
g
g
/
/
m
m
l
l
Excipients:
Benzyl alcohol ………….. 0.014 ml/ml
F
F
o
o
r
r
a
a
f
f
u
u
l
l
l
l
l
l
i
i
s
s
t
t
o
o
f
f
e
e
x
x
c
c
i
i
p
p
i
i
e
e
n
n
t
t
s
s
,
,
s
s
e
e
e
e
s
s
e
e
c
c
t
t
i
i
o
o
n
n
6
6
.
.
1
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 in chickens and turkeys and mix and secondary infections associated
with virus, caused by Mycoplasma and gram-positive and gram-negative bacteria,
susceptible to
enrofloxacin
Enrofloxacin should be used where clinical experience, supported where possible by sensitivity
testing of the causal organism, indicates enrofloxacin as
the drug of choice.
Resistance does occurs by mutation,
particularly with _Pseudomonas aeruginosa_ , _Klebsiella _,
_Acinetobacter_ and_ Enterococci_.
4.3.
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active
substance.
Do not use in cases of confirmed resistance to quinolones,
as cross resistance may occur. Cross
resistance between fluoroquinolones is complete.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5.
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Official
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