Unisol 25 mg/ml oral solution for calves

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Enrofloxacin

Διαθέσιμο από:

Vetpharma Animal Health, S.L.

Φαρμακολογική κατηγορία (ATC):

QJ01MA90

INN (Διεθνής Όνομα):

Enrofloxacin

Δοσολογία:

25 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Oral solution

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Cattle

Θεραπευτική περιοχή:

enrofloxacin

Θεραπευτικές ενδείξεις:

Antibacterial

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2009-07-10

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Unisol 25 mg/ml oral solution for calves [IE, IT]
UNISOL 25 mg/ml oral solution for calves [ES]
DORAFLOX 25 mg/ml oral solution for calves [BE]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin ..................................... 25.0
mg
EXCIPIENTS:
Qualitative composition of
excipients and other
constituents
Quantitative composition if that
information is essential for proper
administration of the veterinary medicinal
product
Benzyl Alcohol (E 1519)
14.0 mg
Potassium hydroxide
--
Hypromellose
--
Purified water
--
Aqueous, clear solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle (Pre-ruminant calves).
3.2.
INDICATIONS FOR USE FOR EACH TARGET SPECIES
In calves:
-
treatment of respiratory infections due to _ Pasteurella multocida_
and
_Mannheimia haemolytica._
-
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 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.
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.
During the period of rapid growth, enrofloxacin may affect articular
cartilage.
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, fluor