Chanear

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Miconazole nitrate ; Prednisolone acetate; Polymyxin b sulfate

Verfügbar ab:

Chanelle Pharmaceuticals Manufacturing Limited

ATC-Code:

QS02CA01

INN (Internationale Bezeichnung):

Miconazole nitrate ; Prednisolone acetate; Polymyxin b sulfate

Darreichungsform:

Ear drops, suspension

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiebereich:

prednisolone and antiinfectives

Berechtigungsdatum:

2023-02-23

Fachinformation

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Chanear 23.0 mg/ml + 5.0 mg/ml + 5500 IU/ml ear drops, suspension for
cats and dogs.
_ _
Chanear ear drops, suspension for cats and dogs (FR)
Aurifence
23.0 mg/ml + 5.0 mg/ml + 5500 IU/ml ear drops, suspension for cats and
dogs. (BE, NL)
Orelin 23.0 mg/ml + 5.0 mg/ml + 5500 IU/ml ear drops, suspension for
cats and dogs. (IT)
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml 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
5500 IU
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS
Silica, Colloidal Anhydrous
Paraffin, liquid
White to off-white ear drops, suspension.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cats and dogs
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the treatment of otitis externa and small, localised, superficial
skin infections caused by mixed
infections with the following miconazole and polymixin B susceptible
bacteria and fungi:
−
Gram-positive bacteria:
_Staphylococcus_
spp. and
_Streptococcus_
spp.
−
Gram-negative bacteria:
_Pseudomonas_
spp. and
_Escherichia coli _
−
Fungi:
_Malassezia pachydermatis_
,
_Candida_
spp.,
_Microsporum_
spp. and
_Trichophyton _
spp.
Treatment of
_Otodectes cynotis_
(ear mites) infestations where there is concurrent infection with
bacteria and fungi susceptible to polymyxin B and miconazole.
3.3
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 cases of skin viral infection;
-
in cases of large skin lesions and of poorly healing or fresh wounds;
-
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.
3.4
SPECIAL WARNINGS
Bac