Aurizon Ear Drops, Suspension

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: VMD (Veterinary Medicines Directorate)

Aktif bileşen:

Clotrimazole, Dexamethasone, Marbofloxacin

Mevcut itibaren:

Vetoquinol UK Ltd

ATC kodu:

QS02CA06

INN (International Adı):

Clotrimazole, Dexamethasone, Marbofloxacin

Farmasötik formu:

Ear drops, suspension

Reçete türü:

POM-V - Prescription Only Medicine – Veterinarian

Terapötik grubu:

Dogs

Terapötik alanı:

Antimicrobial

Yetkilendirme durumu:

Authorized

Yetkilendirme tarihi:

2001-07-19

Ürün özellikleri

Revised: September 2018
AN: 00594/2018
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AURIZON ear drops, suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of AURIZON contains:
ACTIVE SUBSTANCES:
Marbofloxacin
3.0 mg
Clotrimazole
10.0 mg
Dexamethasone acetate
1.0 mg
(equivalent to dexamethasone
0.9 mg)
EXCIPIENTS:
Propyl galate (E310)
1.0 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ear drops, suspension
Homogenous beige to yellow oily suspension
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Dogs
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of otitis externa of both bacterial_ _and_ _fungal origin
respectively due to
bacteria
sensitive
to
marbofloxacin,
and
fungi
especially
_Malassezia _
_pachydermatis _sensitive to clotrimazole.
The product should be used based on susceptibility testing.
4.3.
CONTRAINDICATIONS
Do not administer to dogs suffering from perforation of the tympanic
membrane.
Do not administer to dogs with known hypersensitivity to any of the
ingredients.
Do not administer to pregnant or lactating bitches.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: September 2018
AN: 00594/2018
Page 2 of 5
4.5.
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Heavy reliance on a single class of antibiotic may result in the
induction of resistance in a bacterial population. It is prudent to
reserve the fluoroquinolones for the treatment of clinical conditions
which have responded poorly, or are expected to respond poorly, to
other classes of antibiotics.
Before
treating
with
the
product,
the
integrity
of
the
tympanic
membrane must be verified.
The external ear canal should be meticulously cleaned and dried
before treatment.
ii)
Special precautions to be taken by the person administering the
medicinal products to animals
Wash hands carefully after applying the product.
Avoid contact with eyes. If splashed in the eye, rinse with copious
amounts of water.
Persons with known hypersens