UNISOL 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS
Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Résumé des caractéristiques du produit
(SPC)
07-01-2017
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Ingrédients actifs:
ENROFLOXACIN
Disponible depuis:
Vetpharma Animal Health, S.L.
Code ATC:
QJ01MA90
DCI (Dénomination commune internationale):
ENROFLOXACIN
Dosage:
100 Mg/Ml
forme pharmaceutique:
Solution for Injection
Type d'ordonnance:
POM
Groupe thérapeutique:
Bovine, Porcine
Domaine thérapeutique:
Enrofloxacin
indications thérapeutiques:
Antibacterial
Statut de autorisation:
Authorised
Date de l'autorisation:
2011-05-06
Résumé des caractéristiques du produit
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Unisol 100 mg/ml solution for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Enrofloxacin
100.0 mg
EXCIPIENTS
Benzyl alcohol (E1519)
7.8 mg
Disodium edetate
10.0 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear slightly yellowish solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and pigs
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 23/12/2016_
_CRN 7025217_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE
Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of _Pasteurella multocida,_
_Mannheimia haemolytica _and _Mycoplasma _spp.
Treatment of acute severe mastitis caused by enrofloxacin susceptible strains of _Escherichia coli_.
Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of _Escherichia coli_.
Treatment of septicaemia caused by enrofloxacin susceptible strains of _Escherichia coli_.
Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of _Mycoplasma bovis _in
cattle less than 2 years old.
PIGS
Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of _Pasteurella multocida_,
_Mycoplasma _spp. and _Actinobacillus pleuropneumoniae_.
Treatment of infections of the urinary tract caused by enrofloxacin susceptible strains of _Escherichia coli._
Treatment of post-partum dysgalactiae syndrome, PDS (MMA syndrome) caused by enrofloxacin susceptible strains of
_Escherichia coli _and _Klebsiella _spp.
Treatment of infections of t
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