ENRODEXIL 100 mg/ml solution for injection for cattle and pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enrofloxacin

Available from:

Industrial Veterinaria, S.A.

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 group:

Cattle, Pigs

Therapeutic area:

enrofloxacin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2012-06-28

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
ENRODEXIL 100 mg/ml solution for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for injection.
Clear slightly yellowish solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and pigs.
Each 1 ml solution contains:
ACTIVE SUBSTANCE:
Enrofloxacin
100.0 mg
EXCIPIENTS:
Benzyl alcohol (E 1519)
7.8
mg
Disodium edetate
10.0
mg
For the full list of excipients, see section 6.1.
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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 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 trac