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

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Enrofloxacin

Διαθέσιμο από:

Ecuphar NV

Φαρμακολογική κατηγορία (ATC):

QJ01MA90

INN (Διεθνής Όνομα):

Enrofloxacin

Φαρμακοτεχνική μορφή:

Concentrate for oral solution

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Ornamental Birds, Rabbits, Reptiles, Rodents

Θεραπευτική περιοχή:

Antimicrobial

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2017-06-01

Αρχείο Π.Χ.Π.

Revised: August 2022
AN: 01024/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
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.
Revised: August 2022
AN: 01024/2022
Page 2 of 6
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
a