Easotic

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

hydrocortisone aceponate / miconazole nitrate / gentamicin sulphate

MAH:

Virbac

ATC_code:

QS02CA03

INN:

hydrocortisone aceponate / miconazole nitrate / gentamicin sulphate

therapeutic_group:

Dogs

therapeutic_area:

Otologicals – Corticosteroids and anti-infectives in combination

therapeutic_indication:

Treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with bacteria susceptible to gentamicin and fungi susceptible to miconazole, in particular Malassezia pachydermatis.

authorization_status:

Authorised

authorization_date:

2008-11-20

PIL

18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET
:
EASOTIC EAR DROPS, SUSPENSION FOR DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE,
IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch
release:
VIRBAC
1
ère
avenue 2065 m L.I.D.
06516 Carros
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Easotic ear drops, suspension for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Hydrocortisone aceponate 1.11 mg/ml,
Miconazole as nitrate 15.1 mg/ml,
Gentamicin as sulphate 1,505 IU/ml.
4.
INDICATION(S)
Treatment of acute otitis externa, and acute exacerbation of recurrent
otitis externa associated with bacteria
susceptible to gentamicin and fungi susceptible to miconazole in
particular
_Malassezia pachydermatis_
.
5.
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substances or to
any of the excipients, to corticosteroids, to
other azole antifungal agents and to other aminoglycosides. If
hypersensitivity to any of the components
occurs, treatment should be discontinued and appropriate therapy
instituted.
Do not use if the eardrum is perforated.
Do not use concurrently with substances known to cause ototoxicity.
6.
ADVERSE REACTIONS
Mild to moderate redness of the ear was common (2.4% of treated dogs).
Papules were observed uncommonly
(less than 1% of treated dogs). In all cases, treatment with the
veterinary medicinal product was not
discontinued and all dogs recovered without any specific therapy.
In very rare cases, the use of the veterinary medicinal product has
been associated with hearing impairment
(partial hearing loss or deafness), usually temporary, and primarily
in geriatric dogs. In this case, treatment
should be stopped. See also “Special precautions for use in
animals”.
In very rare cases, Type-I Hypersensitivity reactions (facial
swelling, allergic pruritus) have been observed. If
this occurs, treatment should be stopped.
The frequency of adverse r

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Easotic ear drops, suspension for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Hydrocortisone aceponate
1.11 mg/ml
Miconazole as nitrate
15.1 mg/ml
Gentamicin as sulphate
1,505 IU/ml.
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ear drops, suspension.
A white suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of acute otitis externa, and acute exacerbation of recurrent
otitis externa associated with bacteria
susceptible to gentamicin and fungi susceptible to miconazole in
particular
_Malassezia pachydermatis_
.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients, to corticosteroids, to
other azole antifungal agents and to other aminoglycosides.
Do not use if the eardrum is perforated.
Do not use concurrently with substances known to cause ototoxicity.
Do not use in dogs with generalised demodecosis.
4.4
SPECIAL WARNINGS
Bacterial and fungal otitis is often secondary in nature and
appropriate diagnosis should be used to determine
the primary factors involved.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
If hypersensitivity to any of the components occurs, treatment should
be discontinued and appropriate therapy
instituted.
Use of the veterinary medicinal product should be based on
identification of infecting organisms and
susceptibility testing and take into account official and local
antimicrobial policies.
3
Use of the veterinary medicinal product deviating from the
instructions given in the SPC may increase the
prevalence of bacteria and fungi resistant to gentamicin and
miconazole respectively and may decrease the
effectiveness of treatment with aminoglycosides and azole antifungal
agents, due to the potential for
cross-resistance.
In case of parasitic otitis, an appropriate acaricidal treatment
sh