Enrocare 100 mg/ml Solution for Injection for Cattle and Pigs

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Enrofloxacin

Dostopno od:

Emdoka bvba

Koda artikla:

QJ01MA90

INN (mednarodno ime):

Enrofloxacin

Odmerek:

100 milligram(s)/millilitre

Farmacevtska oblika:

Solution for injection

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtsko območje:

enrofloxacin

Status dovoljenje:

Authorised

Datum dovoljenje:

2013-09-27

Lastnosti izdelka

Health Products Regulatory Authority
27 February 2019
CRN008W34
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrocare 100 mg/ml Solution for Injection for Cattle and Pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the solution for injection contains:
ACTIVE SUBSTANCE:MG
Enrofloxacin 100
EXCIPIENTS:
Butyl alcohol as antimicrobial preservative 30
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, light yellow, sterile, aqueous solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
Pigs weighing more than 25kg.
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 the alimentary tract caused by enrofloxacin
susceptible strains of _Escherichia coli_.
Treatment of septicaemia caused by enrofloxacin susceptible strains of
_Escherichia coli_.
4.3 CONTRAINDICATIONS
Do not use in cases of resistance against other fluoroquinolones, due