UNISOL 25 MG/ML ORAL SOLUTION FOR CALVES
Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Карактеристике производа
(SPC)
29-05-2015
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Активни састојак:
ENROFLOXACIN
Доступно од:
Universal Farma, S.L.
АТЦ код:
QJ01MA90
INN (Међународно име):
ENROFLOXACIN
Дозирање:
25 Mg/Ml
Фармацеутски облик:
Oral Solution
Тип рецептора:
POM
Терапеутска група:
Bovine
Терапеутска област:
Enrofloxacin
Терапеутске индикације:
Antibacterial
Статус ауторизације:
Authorised
Датум одобрења:
2009-07-10
Карактеристике производа
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Unisol 25 mg/ml oral solution for calves.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin....................................................... 25.0
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
Cattle (Pre-ruminant calves).
4.2 INDICATIONS FOR USE, SPECIFYING THE 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.
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 27/05/2015_
_CRN 7021093_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
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
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