UNISOL 5 MG/ML ORAL SOLUTION FOR PIGLETS
Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Charakterystyka produktu
(SPC)
30-05-2024
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Składnik aktywny:
ENROFLOXACIN
Dostępny od:
Universal Farma, S.L.
Kod ATC:
QJ01MA90
INN (International Nazwa):
ENROFLOXACIN
Dawkowanie:
5 Mg/Ml
Forma farmaceutyczna:
Oral Solution
Typ recepty:
POM
Grupa terapeutyczna:
Porcine
Dziedzina terapeutyczna:
Enrofloxacin
Wskazania:
Antibacterial
Status autoryzacji:
Authorised
Data autoryzacji:
2009-07-10
Charakterystyka produktu
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
UNISOL 5 mg/ml oral solution for piglets.
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.
Aqueous, clear solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (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 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.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 30/07/2014_
_CRN 7017616_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
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 antimic
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