Osurnia
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
13-05-2018
Charakterystyka produktu
(SPC)
13-05-2018
Sprawozdanie z oceny publicznego
(PAR)
15-08-2014
Składnik aktywny:
terbinafine / florfenicol / betamethasone acetate
Dostępny od:
Elanco Europe Ltd
Kod ATC:
QS02CA90
INN (International Nazwa):
terbinafine / florfenicol / betamethasone acetate
Grupa terapeutyczna:
Dogs
Dziedzina terapeutyczna:
Otologicals-corticosteroids and antiinfectives in combination
Wskazania:
Treatment of acute otitis externa
Status autoryzacji:
Authorised
Data autoryzacji:
2014-07-31
Ulotka dla pacjenta
B. PACKAGE LEAFLET
14
PACKAGE LEAFLET:
OSURNIA EAR GEL 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:
Elanco Europe Ltd., Lilly House, Priestley Road, Basingstoke, RG24
9NL, UNITED KINGDOM
Manufacturer responsible for batch release
:
Argenta Dundee Limited, Kinnoull Road, Dunsinane Industrial Estate,
Dundee DD2 3XR, UNITED
KINGDOM
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
OSURNIA ear gel for dogs
Terbinafine/florfenicol/betamethasone acetate
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One tube (1.2 g) contains 10 mg terbinafine, 10 mg florfenicol and 1
mg betamethasone acetate
Excipient: 1 mg butylhydroxytoluene (E 321)
Off-white to slightly yellow translucent gel.
4.
INDICATION(S)
For the treatment of acute otitis externa, and acute exacerbation of
recurrent otitis externa associated
with
_Staphylococcus pseudintermedius_
and
_Malassezia pachydermatis_
.
_ _
5.
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substances, to
other corticosteroids, or to any of the
excipients.
Do not use if the eardrum is perforated.
Do not use in dogs with generalised demodicosis (demodectic mange).
Do not use in pregnant or breeding animals.
6.
ADVERSE REACTIONS
Post authorisation experience indicates that very rare cases of
deafness or impaired hearing, usually
temporary, in dogs have been reported after use, mainly in elderly
animals.
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).
15
If you notice any side effects, even those not alre
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Charakterystyka produktu
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
OSURNIA ear gel for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
ACTIVE SUBSTANCES:
1 dose (1.2 g) contains:
Terbinafine:
10 mg
Florfenicol:
10 mg
Betamethasone acetate:
1 mg
equivalent to Betamethasone base
0.9 mg
EXCIPIENT:
Butylhydroxytoluene (E321):
1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ear gel.
Off-white to slightly yellow translucent gel.
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
_Staphylococcus pseudintermedius_
and
_Malassezia pachydermatis_
.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances, to
other corticosteroids or to any of the
excipients.
Do not use if the eardrum is perforated.
Do not use in dogs with generalised demodicosis.
Do not use in pregnant or breeding animals.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Clean the ears before the initial treatment is applied. Ear cleaning
should not be repeated until 21 days
after the second administration. In clinical trials, saline only was
used for ear cleaning.
Transient wetness of the inner and outer pinna can be observed. This
observation is attributed to
presence of product and is not of clinical concern. Bacterial and
fungal otitis is often secondary to
other conditions. Appropriate diagnosis should be used and therapy of
causative conditions should be
investigated before antimicrobial treatment is considered.
2
In animals with a history of chronic or recurrent otitis externa,
efficacy of the product may be affected
if the underlying causes of the condition such as allergy or
anatomical conformation of the ear are not
addressed.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
If hypersensitivity to any of the components occurs, the ear should be
thoroughly washed.
The safety of the product
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