Unisol 5 mg/ml oral solution for piglets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enrofloxacin

Available from:

Vetpharma Animal Health, S.L.

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Pigs

Therapeutic area:

enrofloxacin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2009-07-10

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
UNISOL 5 mg/ml oral solution for piglets [ES, IE, PL, IT]
LANFLOX 0.5% oral solution for piglets [HU]
LANFLOX 5 mg/ml oral solution for piglets [PT]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin ................................................... 5.0
mg
EXCIPIENTS:
Oral solution. Aqueous, clear solution.
3.
CLINICAL INFORMATION
3.1.
TARGET SPECIES
Pigs (Piglets).
3.2.
INDICATIONS FOR USE FOR EACH 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.
3.3.
CONTRAINDICATIONS
Do not use when resistance / cross-resistance to (fluoro)quinolones is
known to occur in
the flock intended for treatment. Do not use in cases of known
hypersensitivity to the
active substance, other (fluoro)quinolones or to any of the
excipients.
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.
QUALITATIVE
COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT
INFORMATION IS ESSENTIAL
FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUC
t
_ _
Benzyl alcohol (E 1519)
14.0
mg
Potassium hydroxide
Hypromellose
Purified water
3.4.
SPECIAL WARNINGS
None.
3.5.
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
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 only be used based on
susceptibility testing.
Use of the product deviating from instructions given in the SPC may
increase the
prevalence of bacteria resist