Unisol 0.5% w/v Oral Solution for Piglets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Enrofloxacin

Saatavilla:

UNIVERSAL FARMA, S.L

ATC-koodi:

QJ01MA90

INN (Kansainvälinen yleisnimi):

Enrofloxacin

Valtuutuksen tilan:

Expired

Valmisteyhteenveto

Revised: January 2011
AN: 01273/2010
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
UNISOL 0.5% oral solution for piglets [IE]
UNISOL 0.5% w/v oral solution for piglets [UK]
UNISOL 5 mg/ml oral solution for piglets [ES, DE, PL]
LANFLOX 0.5% oral solution for piglets [NL, HU, RO, SK]
LANFLOX 5 mg/ml oral solution for piglets [CZ, PT]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin.....................................5.0
mg
EXCIPIENTS:
Benzyl Alcohol (E 1519)................14.0
mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
Ready to use aqueous clear, oral solution.
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Piglets
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In piglets (up to 10 kg):
-
treatment of gastro-intestinal infection due to _Escherichia coli_.
To be used where clinical experience and/or sensitivity testing
indicates
enrofloxacin as the drug of choice.
4.3.
CONTRAINDICATIONS
Do not use in cases of confirmed, or suspected, resistance to
quinolones.
Do not use in cases of hypersensitivity to the active substance.
Do not use in case of disturbances in growth of cartilage and/or
during injury of
locomotory system particularly on functionally loaded joints or due to
body weight
loaded joints.
Page 1 of 5
Revised: January 2011
AN: 01273/2010
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5.
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Do not use for prophylaxis.
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.
Wherever possible, fluoroquinolones should be used based on
susceptibility
testing.
Use of the product deviating from instructions given in the SPC may
increase the prevalence of bacteria resistant to fluoroquinolones and
may