Easotic
hydrocortisone aceponate, miconazole nitrate, gentamicin sulfate
Marketing authorisation holder and manufacturer responsible for batch release: VIRBAC
1ère avenue 2065 m LID 06516 Carros
FRANCE
Easotic ear drops, suspension for dogs
Hydrocortisone aceponate 1.11 mg/ml, Miconazole as nitrate 15.1 mg/ml, Gentamicin as sulphate 1,505 IU/ml.
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.
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.
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), primarily in geriatric dogs.
Based on post-marketing safety experience, hearing improvement was observed in most dogs with
deafness/loss of hearing and complete recovery was confirmed in 70% of cases with an adequate follow-up.
Among dogs with full recovery, improvement has been rapidly seen. Recovery has been observed as
early as one week after onset of signs, the majority of dogs recovering within one month; in a minority of reports, the deafness lasted for up to two months.
If deafness or partial hearing loss occurs, 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 reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reaction(s))
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Dogs.
Auricular use. One ml contains 1.11 mg hydrocortisone aceponate, 15.1 mg miconazole (as nitrate) and 1,505 IU gentamicin (as sulphate).
It is recommended that the external ear canal should be cleaned and dried before treatment and excess hair around the treatment area be cut.
The recommended dosage is 1 ml of the veterinary medicinal product per ear once a day for five consecutive days.
[Multi-dose container:]
Shake the bottle thoroughly before first administration and prime the pump by pressing it.
Introduce the atraumatic canula in the ear canal. Administer one dose (1 ml) of the product in each affected ear. This dose is adequately delivered by one pump activation. The airless pump allows the product to be administered whatever the position of the bottle is.
1 dose / ear / day for 5 days
Whatever the size Whatever the position
The product as presented allows treating a dog suffering from bilateral otitis.
[Single-dose container:]
To administer one dose (1 ml) of the product in the affected ear:
Take out one pipette from the box. Shake the pipette thoroughly before use.
To open: hold up the pipette upright and break the top of the cannula.
Introduce the atraumatic cannula in the ear canal. Squeeze gently but firmly in the middle of the body of the pipette.
After application, the base of the ear may be massaged briefly and gently to allow the preparation to penetrate to the lower part of the ear canal.
The veterinary medicinal product should be used at room temperature (i.e. do not instil cold product).
Not applicable.
Keep out of the sight and reach of children. Do not store above 25 °C.
Do not use this veterinary medicinal product after the expiry date, which is stated on the label. Shelf life after first opening the multi-dose container: 10 days.
Special warnings:
Bacterial and fungal otitis is often secondary in nature and appropriate diagnosis should be used to determine the primary factors involved.
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.
Use of the veterinary medicinal product deviating from the instructions given in the summary of product characteristics 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 should be implemented.
Before the veterinary medicinal product is applied, the external auditory canal must be examined thoroughly to ensure that the ear drum is not perforated in order to avoid the risk of transmission of the
infection to the middle ear and to prevent damage to the cochlear and vestibular apparatus.
Gentamicin is known to be associated with ototoxicity when administered by the systemic route at higher doses.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental skin contact, it is recommended to wash thoroughly with water.
Avoid contact with eyes. In case of accidental contact, rinse with abundant quantities of water. In case of eye irritation, seek medical advice.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Systemic absorption of hydrocortisone aceponate, gentamicin sulphate and miconazole nitrate being
negligible, it is unlikely for teratogenic, foetotoxic or maternotoxic effects to occur at the recommended dosage in dogs.
Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction: Compatibility with ear cleaners has not been demonstrated.
Overdose (symptoms, emergency procedures, antidotes):
At 3 and 5 times the recommended dose, no local or general adverse reactions were observed with the exception of some dogs showing erythema and papulae in the ear canal.
In dogs treated at the therapeutic dose for ten consecutive days, serum cortisol levels decreased from
five days onward and returned to normal values within ten days after the end of treatment. However, serum cortisol response levels post ACTH stimulation remained in the normal range during the extended
treatment period, indicating a preserved adrenal function.
Incompatibilities:
Do not mix with other veterinary medicinal products.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
Detailed information on this product is available on the website of the European Medicines Agency (/).
The veterinary medicinal product is a fixed combination of three active substances: antibiotic, antifungal and corticosteroid.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
VIRBAC BELGIUM NV
Esperantolaan 4 BE-3001 Leuven
Tél/Tel : +32-(0)16 387 260
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Prancūzija
Tel: +33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Франция
Teл: +33-(0)4 92 08 73 00
VIRBAC BELGIUM NV
Esperantolaan 4 BE-3001 Leuven
Belgique / Belgien
Tél/Tel: +32-(0)16 387 260
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Francie
Tel: +33-(0)4 92 08 73 00
VIRBAC HUNGARY KFT
Szent Istvàn krt.11.II/21. HU-1055 Budapest
Tel: +36703387177
VIRBAC Danmark A/S
Profilvej 1
DK-6000 Kolding Tlf: +45 75521244
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Franza
Tel: + 33-(0)4 92 08 73 00
VIRBAC Tierarzneimittel GmbH
Rögen 20
DE-23843 Bad Oldesloe Tel: +49-(4531) 805 111
VIRBAC Nederland BV
Hermesweg 15
NL-3771 ND-Barneveld Tel : +31-(0)342 427 127
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Prantsusmaa
Tel: +33-(0)4 92 08 73 00
VIRBAC Danmark A/S
Profilvej 1
DK-6000 Kolding Danmark
Tel: + 45 75521244
VIRBAC HELLAS Α.Ε.
13o χλμ Ε.Ο. Αθηνών - Λαμίας
EL-14452, Μεταμόρφωση Τηλ: +30 2106219520
VIRBAC Österreich GmbH
Hildebrandgasse 27 A-1180 Wien
Tel: +43-(0)1 21 834 260
VIRBAC ESPAÑA SA
Angel Guimerá 179-181
ES-08950 Esplugues de Llobregat (Barcelona) Tel. : + 34-(0)93 470 79 40
VIRBAC Sp. z o.o.
ul. Puławska 314
PL 02-819 Warszawa
Tel.: + 48 22 855 40 46
France VIRBAC France 13e rue LID
FR-06517 Carros
Tél : +33 805 05 55 55
VIRBAC de Portugal Laboratórios LDA R.do Centro Empresarial
Ed13-Piso 1- Esc.3
Quinta da Beloura PT-2710-693 Sintra
Tel: + 351 219 245 020
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros Francuska
Tel: + 33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros Franţa
Tel: + 33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065m LID FR-06516 Carros
France
Tel: + 33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Francija
Tel : + 33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros Frakkland
Sími: + 33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Francúzsko
Tel: + 33-(0)4 92 08 73 00
VIRBAC SRL
Via Ettore Bugatti, 15 IT-20142 Milano
Tel: + 39 02 40 92 47 1
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Puh/Tel : + 33-(0)4 92 08 73 00
VIRBAC HELLAS Α.Ε.
13o χλμ Ε.Ο. Αθηνών - Λαμίας
EL-14452, Μεταμόρφωση Τηλ.: +30 2106219520
VIRBAC Danmark A/S Filial Sverige
c/o Incognito AB Box 1027
SE-171 21 Solna
Tel: +45 75521244
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Francjia
Tel: +33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065m LID FR-06516 Carros France
Tel: + 33-(0)4 92 08 73 00