Enrotron 100 mg/ml Solution for injection for cattle, sheep, goats and pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enrofloxacin

Available from:

aniMedica GmbH

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

enrofloxacin

Authorization status:

Authorised

Authorization date:

2012-04-20

Summary of Product characteristics

Enrotron 100 mg/ml
1 von 17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrotron 100 mg/ml Solution for injection for cattle, sheep, goats and
pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Enrofloxacin
100.0 mg
EXCIPIENTS
1-Butanol
30.0 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, slightly yellowish to yellowish orange solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
Sheep
Goats
Pigs
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.
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_
.
Enrotron 100 mg/ml
2 von 17
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
_Escherichia