Enrocare 25 mg/ml Oral Solution for Pet Rabbits, Rodents, Ornamental Birds and Reptiles

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Enrofloxacin

Verfügbar ab:

Ecuphar NV

ATC-Code:

QJ01MA90

INN (Internationale Bezeichnung):

Enrofloxacin

Dosierung:

25 milligram(s)/millilitre

Darreichungsform:

Oral solution

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiebereich:

enrofloxacin

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2017-05-26

Fachinformation

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrocare 25 mg/ml concentrate for oral solution for pet rabbits,
rodents, ornamental birds and reptiles.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin 25 mg
EXCIPIENT:
Benzyl Alcohol 14 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for Oral Solution
Clear Solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pet rabbits, rodents, ornamental birds and reptiles.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pet rabbits
Treatment of infections of the digestive and respiratory tracts caused
by enrofloxacin susceptible
strains of:
_Escherichia coli, Pasteurella multocida and Staphylococcus spp_
.
Treatment of skin and wound infections caused by enrofloxacin
susceptible strains of
_Staphylococcus _
_aureus_
.
Rodents, reptiles and ornamental birds
Treatment of infections of the digestive and respiratory tracts where
clinical experience, if possible,
supported by susceptibility testing of the causal organism, indicates
enrofloxacin as the substance of
choice.
4.3
CONTRAINDICATIONS
The product should not be used for prophylaxis.
Do not use in cases of confirmed or suspected resistance to
quinolones, since a high degree or cross
resistance between enrofloxacin and other quinolones exists.
Do not use in cases of hypersensitivity to fluoroquinolones or to any
of the excipients.
Do not use in animals that are epileptic or suffer from seizures since
enrofloxacin may cause CNS
stimulation.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Official and local antimicrobial policies should be taken into account
when the product is used.
Fluoroquinolones should be reserved for the treatment of clinical
conditions which have responded
poorly, or are expected to respond poorly, to other classes of
antimicrobials.
Whenever possible, fluoroquinolones should only be used based on
susceptibility testing.
Use of the product deviat