Aurimic Ear Drops and Cutaneous Suspension for Dogs and Cats

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Miconazole Nitrate, Polymyxin B Sulphate, Prednisolone Acetate

Verfügbar ab:

VetViva Richter GmbH

ATC-Code:

QS02CA01

INN (Internationale Bezeichnung):

Miconazole Nitrate, Polymyxin B Sulphate, Prednisolone Acetate

Darreichungsform:

Cutaneous/ear drops suspension

Verschreibungstyp:

POM-V - Prescription Only Medicine – Veterinarian

Therapiegruppe:

Cats, Dogs

Therapiebereich:

Antimicrobial; Anti Inflammatory; Antimycotic

Berechtigungsstatus:

Authorized

Berechtigungsdatum:

2015-03-05

Fachinformation

Revised: January 2023
AN: 02966/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Aurimic ear drops and cutaneous suspension for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml (40 drops) contains:
ACTIVE SUBSTANCES:
Miconazole nitrate
23.0 mg
(equivalent to 19.98 mg miconazole)
Prednisolone acetate5.0 mg
(equivalent to 4.48 mg prednisolone)
Polymyxin B sulfate
0.5293 mg
(equivalent to 5500 IU polymyxin B sulfate)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ear drops and cutaneous suspension
White suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of otitis externa and small localised superficial
skin infections in
dogs and cats caused by infections with the following miconazole and
polymyxin B
sensitive bacteria and fungi:
•
Gram-positive bacteria

_Staphylococcus_ spp.

_Streptococcus_ spp.
•
Gram-negative bacteria

_Pseudomonas_ spp.

_Escherichia_ _coli_
•
Fungi
Revised: January 2023
AN: 02966/2022
Page 2 of 6

_Malassezia_ _pachydermatis_

_Candida_ spp.

_Microsporum_ spp.

_Trichophyton_ spp.
Treatment of _Otodectes_ _cynotis_ (ear mites) infestations where
there is concurrent
infection with miconazole and polymyxin B sensitive pathogens.
4.3
CONTRAINDICATIONS
Do not use:

in cases of hypersensitivity to the active substances of the
veterinary medicinal
product, as well as to other corticosteroids, to other azole
antifungal agents, or
to any of the excipients

in animals with perforation of the tympanic membrane

in animals, where resistance of causative agents to polymyxin B and/or
miconazole is known

on the mammary glands of lactating bitches and queens
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Bacterial and fungal otitis is often secondary in nature. The
underlying cause should
be identified and treated.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in