NorOtic Ear Drops, Suspension for Dogs

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Clotrimazole ; Marbofloxacin; Dexamethasone

Mevcut itibaren:

Norbrook Laboratories (Ireland) Limited

ATC kodu:

QS02CA06

INN (International Adı):

Clotrimazole ; Marbofloxacin; Dexamethasone

Doz:

3, 10, 0.9 milligram(s)/millilitre

Farmasötik formu:

Ear drops, suspension

Reçete türü:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapötik alanı:

dexamethasone and antiinfectives

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2015-07-24

Ürün özellikleri

Health Products Regulatory Authority
27 February 2019
CRN008TS7
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
NorOtic Ear Drops, Suspension for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
​
ACTIVE SUBSTANCES:
​
​
Marbofloxacin
​
3.0 mg
​
Clotrimazole
​
10.0 mg
​
Dexamethasone
​
0.9 mg
​
(equivalent to dexamethasone acetate
​
1.0 mg)
​
​
​
EXCIPIENTS
​
​
Propyl gallate (E310)
​
1.0 mg
For the 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 of isolated
bacteria.
4.3 CONTRAINDICATIONS
Do not use in dogs suffering from perforation of the tympanic
membrane.
Do not use in case of hypersensitivity to the active substances or to
any of the excipients. See section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The external ear canal should be meticulously cleaned and dried before
treatment.
Bacterial and fungal otitis is often secondary in nature. The
underlying cause should be identified and treated.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
For external use only. Auricular use.
Avoid contact with eyes in animals. In case of accidental contact,
rinse thoroughly with water.
Health Products Regulatory Authority
27 February 2019
CRN008TS7
Page 2 of 4
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 t