Aurimic ear drops and cutaneous suspension for dogs and cats

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Miconazole nitrate ; Prednisolone acetate; Polymyxin b sulfate

Διαθέσιμο από:

Richter Pharma AG

Φαρμακολογική κατηγορία (ATC):

QS02CA01

INN (Διεθνής Όνομα):

Miconazole nitrate ; Prednisolone acetate; Polymyxin b sulfate

Δοσολογία:

23.0, 5.0, 0.5293 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Ear drops, suspension

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Cats, Dogs

Θεραπευτική περιοχή:

prednisolone and antiinfectives

Θεραπευτικές ενδείξεις:

Antibacterial

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2015-03-13

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
04 October 2019
CRN008XW8
Page 1 of 5
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 acetate
​5.0 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.
_- Escherichiacoli_

Fungi
_- Malasseziapachydermatis_
_- Candida_ spp.
_- Microsporum_ spp.
_- Trichophyton_ spp.
Health Products Regulatory Authority
04 October 2019
CRN008XW8
Page 2 of 5
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 shoul