ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Easotic, ear drops suspension, for dogs
2.
Active substances:
Hydrocortisone aceponate
1.11 mg/ ml
Miconazole as nitrate
15.1 mg/ ml
Gentamicin as sulphate
1505 IU/ ml
Excipients:
For a full list of excipients, see section 6.1.
3.
Ear drops suspension.
A white suspension.
4.
Dogs.
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 substance 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.
Bacterial and fungal otitis is often secondary in nature and appropriate diagnosis should be used to
determine the primary factors involved.
If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate
therapy instituted.
2/20
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 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 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.
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.
The use of auricular preparations may be associated with hearing impairment, usually temporary, and
primarily in geriatric dogs. If this occurs, treatment should be stopped. See section 4.5 of the SPC.
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 risk-benefit assessment by the responsible veterinarian.
Compatibility with ear cleaners has not been demonstrated.
Auricular use. One ml contains 1.11 mg hydrocortisone aceponate, 15.1 mg miconazole (as nitrate)
and 1505 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.
Shake the bottle thoroughly before first administration and prime the pump.
The recommended dosage is 1 ml of the veterinary medicinal product per infected ear once a day for
five consecutive days.
3/20
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.
ins
/ ear / day for 5 days
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 product as presented allows treating a dog suffering from bilateral otitis. The veterinary
medicinal product should be used at room temperature (i.e. do not instill cold product).
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.
4.11 Withdrawalperiod
Not applicable.
5.
Pharmacotherapeutic group: Otologicals – Corticosteroids and anti-infectives in combination
ATCvet code: QS02CA03
5.1 Pharmacodynamic properties
The veterinary medicinal product is a fixed combination of three active substances (corticosteroid,
antifungal and antibiotic):
Hydrocortisone aceponate
belongs to the diesters class of the glucocorticosteroids with a potent
intrinsic glucocorticoid activity which means a relief of both inflammation and pruritus leading to
an improvement of clinical signs observed in otitis externa.
4/20
Miconazole nitrate is
a synthetic imidazole derivative with a pronounced antifungal activity.
Miconazole selectively inhibits the synthesis of ergosterol, which is an essential component of the
membrane of yeasts and fungi including
Malassezia pachydermatis
. Mechanisms of resistance to
azoles consist of either failure in antifungal accumulation or modification of target enzyme. No
standardised
in-vitro
susceptibility breakpoints have been defined for miconazole; however, using
the method by Diagnostics Pasteur, no resistant strains were found.
Gentamicin sulphate
is an aminoglycoside bactericidal antibiotic which acts by inhibiting
protein synthesis. Its spectrum of activity includes Gram-positive and Gram-negative bacteria,
such as the following pathogenic organisms isolated from the ears of dogs:
Staphylococcus
intermedius
,
Streptococcus
spp.,
Pseudomonas aeruginosa
,
Proteus mirabilis, Escherichia coli,
etc…
The in-vitro activity of gentamicin against pathogens isolated from clinical cases of canine otitis
externa in EU field trials between 2004 and 2007 was:
MIC50 (µg/ml) MIC90 (µg/ml)
Range of MIC
(µg/ml)
N
Staphylococcus
spp 0.125
0.5
0.031-16
122
Streptococcus
spp 2
8
0.06-8
23
Pseudomonas
spp 0.25
4
0.031-4
30
Escherichia coli
0.125
2
0.031-2
8
Proteus
spp
0.5
Between 1 and 16
0.06-16
16
MIC- minimum inhibitory concentration
Since many bacterial strains may be involved in otitis externa in dogs, the mechanisms of resistance
can vary. The bacterial resistance phenotypes to gentamicin are mainly based on three mechanisms:
enzymatic modification of aminoglucosides, failure of intracellular penetration of the active substance
and alteration of the aminoglycoside target.
Cross-resistance is mainly linked with efflux pumps which confer resistance to
β
-lactams, quinolones
and tetracyclines depending on the specificity of the pump with its substrate.
Co-resistance has been described, i.e. gentamicin resistance genes are found to be physically linked to
other antimicrobial resistance genes that are transferred between pathogens due to transferable genetic
elements such as plasmids, integrons and transposons.
16 µg/ml) were low: 2.4 and 13% of
Staphylococcus
spp.
(among 122 strains) and
Proteus
spp. (among 16 strains) respectively. All the other bacteria species
(e.g.
Streptococcus
spp,
Pseudomonas
spp,
Escherichia coli
) were fully susceptible to gentamicin.
≥
5.2 Pharmacokinetic particulars
After application of the veterinary medicinal product into the ear canal, absorption of miconazole and
gentamicin through the skin is negligible.
Hydrocortisone aceponate belongs to the diesters class of glucocorticosteroids. The diesters are
lipophilic components ensuring an enhanced penetration into the skin associated with low systemic
bioavailability
.
The diesters are transformed inside the skin structures in C17 monoester responsible
for the potency of the therapeutic class. In laboratory animals, hydrocortisone aceponate is eliminated
the same way as hydrocortisone (other name for endogenous cortisol) through urine and faeces.
5/20
Resistant bacteria isolated from canine otitis before treatment against gentamicin (determined
according to CLSI guideline breakpoint
6.
6.1 List of excipients
Liquid paraffin.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 10 days.
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Multidose container composed of two extruded parts, one external white polypropylene rigid tube and
one internal (ethylene-methacrylic acid)-zinc copolymer (Surlyn) flexible pouch containing a steel
ball, closed with a 1 ml dosing airless pump equipped with a flexible atraumatic cannula and covered
by a plastic cap.
Box containing 1 multidose container (the content of 10 ml is equivalent to 10 doses).
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
VIRBAC S.A.
1
ère
avenue 2065 m L.I.D.
06516 Carros
FRANCE
Tel. 0033/4.92.08.73.00
Fax. 0033/4.92.08.73.48
E-mail. dar@virbac.fr
8.
EU/2/08/085/001
9.
20/11/2008
6/20
20/11/2008
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (EMEA)
http://www.emea.europa.eu
/.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
7/20
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE
B.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION REGARDING SUPPLY OR USE
C.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
D.
STATEMENT OF THE MRLs
8/20
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
VIRBAC S.A.
1
ère
avenue 2065 m L.I.D.
06516 Carros
FRANCE
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
D. STATEMENT OF THE MRLs
Not applicable.
9/20
ANNEX III
LABELLING AND PACKAGE LEAFLET
10/20
A. LABELLING
11/20
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
CARTON BOX OF 1 MULTIDOSE CONTAINER OF 10 DOSES
1.
Easotic, ear drops suspension for dogs
Hydrocortisone aceponate - Miconazole – Gentamicin
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Hydrocortisone aceponate
1.11 mg/ml
Miconazole as nitrate
15.1 mg/ml
Gentamicin as sulphate
1505 IU/ml
3.
Ear drops suspension.
4.
PACKAGE SIZE
10 ml (10 doses).
5.
Dogs
6.
INDICATIONS
Treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa.
7.
METHOD AND ROUTE OF ADMINISTRATION
For auricular use only.
Shake the bottle thoroughly before first administration and prime the pump.
Read the package leaflet before use.
8.
9.
SPECIAL WARNINGS, IF NECESSARY
Read the package leaflet before use.
12/20
10. EXPIRY DATE
EXP {month/year}
Once opened use within 10 days.
11. SPECIAL STORAGE CONDITIONS
Not applicable
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only - to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
VIRBAC S.A.
1
ère
avenue 2065 m L.I.D.
06516 Carros
FRANCE
16. MARKETING AUTHORISATION NUMBER
EU/2/08/085/001
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
13/20
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
MULTIDOSE CONTAINER LABEL
1.
Easotic, ear drops suspension for dogs
Hydrocortisone aceponate - Miconazole – Gentamicin
2.
QUANTITY OF THE ACTIVE SUBSTANCE
Hydrocortisone aceponate
1.11 mg/ml
Miconazole as nitrate
15.1 mg/ml
Gentamicin as sulphate
1505 IU/ml
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
10 ml (10 doses).
4.
ROUTE OF ADMINISTRATION
Auricular use.
5.
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
Once opened use within 10 days.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
14/20
B. PACKAGE LEAFLET
15/20
PACKAGE LEAFLET
Easotic, ear drops suspension for dogs
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
VIRBAC S.A.
1
ère
avenue 2065 m L.I.D.
06516 Carros
FRANCE
2.
Easotic, ear drops suspension for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Hydrocortisone aceponate
1.11 mg/ml
Miconazole as nitrate
15.1 mg/ml
Gentamicin as sulphate
1505 IU/ml
4.
INDICATIONS
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.
Do not use in case of hypersensitivity to the active substance 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.
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.
The use of auricular preparations may be associated with hearing impairment, usually temporary, and
primarily in geriatric dogs. In this case, treatment should be stopped.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
16/20
7.
Dogs
8.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Auricular use. One ml contains 1.11 mg hydrocortisone aceponate, 15.1 mg miconazole (as nitrate)
and 1505 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.
Shake the bottle thoroughly before first administration and prime the pump.
The recommended dosage is 1 ml of the veterinary medicinal product per ear once a day for five
consecutive days.
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.
ins
/ ear / day for 5 days
9.
ADVICE ON CORRECT ADMINISTRATION
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 product as presented allows treating a dog suffering from bilateral otitis. The veterinary
medicinal product should be used at room temperature (i.e. do not instill cold product).
10. WITHDRAWAL PERIOD
Not applicable.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
Do not use after the expiry date, which is stated on the label.
Once opened use within 10 days.
17/20
12. SPECIAL WARNINGS
Bacterial and fungal otitis is often secondary in nature and appropriate diagnosis should be used to
determine the primary factors involved. 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.
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 risk-benefit assessment by the responsible veterinarian.
Compatibility with ear cleaners has not been demonstrated.
Warnings for the user:
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.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
WASTE MATERIALS, IF ANY
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should
help to protect the environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
11/2008
Detailed information on this product is available on the website of the European Medicines Agency
(EMEA)
http://www.emea.europa.eu
/.
15. OTHER INFORMATION
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.
België/Belgique/Belgien
VIRBAC BELGIUM S.A.
Rue de la station 17
B-1300 Wavre
Tel: 32 (0) 10 47 06 35
Luxembourg/Luxemburg
VIRBAC BELGIUM S.A.
Rue de la station 17
B-1300 Wavre
Tel: 32 (0) 10 47 06 35
18/20
Република България
ERGON MILANOVA
Lulin, 10 rue Orion Appt.1
BL-145 A Sofia
Tel: 359 282 591 04
Magyarország
VIRBAC MO. KK
Csibor u. 11/A
H-1021 Budapest
Tel.: 36 (1) 274 23 59
Česká republika
GS PARTNERS SRO
Porcernicka 96
CZ-108 03 Praha 10
Tel: 420 267 021 258
Malta
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Danmark
VIRBAC DANMARK A/S
Profilvej 1
6000 Kolding
Tlf. : + 45 75521244
Nederland
VIRBAC NEDERLAND BV
Hermesweg 15
NL-3771 ND-Barneveld
Tel: 31 (0) 342 427 100
Deutschland
VIRBAC TIERARZNEIMITTEL GMBH
West Rögen 20
D-23843 Bad Oldesloe
Tel: 49 (4531) 805 555
Norge
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Eesti
OÜ ZOOVETVARU
Pärnasalu 31
ET - 76505 Saue/Harjumaa, ESTONIA
Tel: + 372 6 709 006
Österreich
VIRBAC ÖSTERREICH GMBH
Hildebrandgasse 27
A-1180 Wien
Tel: 43 (0) 1 21 834 260
Ελλάδα
VIRBAC HELLAS A.E.
23 rd Klm National Road Athens-Lamia
GR-14565 Agios Stefanos (Athens)
Tel: 30 210 6219520
Polska
ANIMAL TRADE SP. Z.O.C.
Ul. Poleczki 47
P-02-822 Warszawa
Tel: 48 (22) 332 75 90/91
España
VIRBAC ESPAÑA, S.A.
C/Angel Guimera 179-181-
E-08950 - Esplugues de Llobregat (Barcelona)
Tel: 34 (93) 470 79 40
Portugal
VIRBAC DE PORTUGAL
LABORATÓRIOS LDA
P-2080 Almeirim
Tel: 351 243 570 500
France
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
România
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Ireland
C&M Veterinary Distributors Limited
IE-Limerick
Tel: 353 (61) 314 933
Slovenija
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Ísland
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Slovenská republika
ING. GOSCIKOVA
Schurmanova 15
SK-949 010 Nitra
Tel: 420 739 572 634
Italia
VIRBAC S.R.L.
Via dei Gracchi 30
I-20146 Milano
Tel: 39 02 48 53 541
Suomi/Finland
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
19/20
Κύpρος
VIRBAC HELLAS A.E.
23 rd Klm National Road Athens-Lamia
GR-14565 Agios Stefanos (Athens)
Tel: 30 210 6219520
Sverige
VIRBAC S.A.
1
ère
avenue 2065 m – L.I.D
F-06516 Carros
Tel: 33 (0) 4 92 08 73 00
Latvija
OÜ ZOOVETVARU
Pärnasalu 31
ET - 76505 Saue/Harjumaa, ESTONIA
Tel: + 372 6 709 006
United Kingdom
VIRBAC LTD
UK-Suffolk IP30 9 UP
Tel: 44 (0) 1359 243243
Lietuva
OÜ ZOOVETVARU
Pärnasalu 31
ET - 76505 Saue/Harjumaa, ESTONIA
Tel: + 372 6 709 006
20/20
Source: European Medicines Agency
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