VALEMAS 50 mg/ml solution for injection for cattle, sheep, goats, pigs, dogs and cats.
Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Svojstava lijeka
(SPC)
13-11-2019
Izvješće o ocjeni javnog
(PAR)
13-11-2019
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Pošalji zahtjev.
Aktivni sastojci:
Enrofloxacin
Dostupno od:
FATRO S.p.A.
ATC koda:
QJ01MA90
INN (International ime):
Enrofloxacin
Doziranje:
50 milligram(s)/millilitre
Farmaceutski oblik:
Solution for injection
Tip recepta:
POM: Prescription Only Medicine as defined in relevant national legislation
Područje terapije:
enrofloxacin
Status autorizacije:
Authorised
Datum autorizacije:
2019-06-07
Svojstava lijeka
Health Products Regulatory Authority
12 November 2019
CRN009969
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
VALEMAS 50 mg/ml solution for injection for cattle, sheep, goats,
pigs, dogs and cats.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin
50
mg
EXCIPIENT:
n-Butyl alcohol
30
mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, pale yellow to yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (calves), sheep, goats, pigs, dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Calves
Treatment of infections of the respiratory tract caused by
enrofloxacin susceptible strains of _Pasteurella multocida,
Mannheimia_
_haemolytica _and _Mycoplasma _spp.
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._
Sheep
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 mastitis caused by enrofloxacin susceptible strains of
_Staphylococcus aureus _and _Escherichia coli._
_ _
Goats
Treatment of infections of the respiratory tract caused by
enrofloxacin susceptible strains of _Pasteurella multocida _and
_Mannheimia haemolytica_.
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 mastitis caused by enrofloxacin susceptible strains of
_Staphylococcus aureus _and _Escherichi
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