NOROTIC EAR DROPS, SUSPENSION FOR DOGS

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE (AS DEXAMETHASONE ACETATE)

Dostopno od:

Norbrook Laboratories Limited

Koda artikla:

QS02CA06

INN (mednarodno ime):

MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE (AS DEXAMETHASONE ACETATE)

Odmerek:

10.0/3.0/1

Farmacevtska oblika:

Ear Drops Suspension

Tip zastaranja:

POM

Terapevtska skupina:

Canine

Terapevtsko območje:

Dexamethasone and antiinfectives

Terapevtske indikacije:

Antibacterial

Status dovoljenje:

Authorised

Datum dovoljenje:

2015-07-24

Lastnosti izdelka

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.
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