NOROTIC EAR DROPS, SUSPENSION FOR DOGS

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE (AS DEXAMETHASONE ACETATE)

Διαθέσιμο από:

Norbrook Laboratories Limited

Φαρμακολογική κατηγορία (ATC):

QS02CA06

INN (Διεθνής Όνομα):

MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE (AS DEXAMETHASONE ACETATE)

Δοσολογία:

10.0/3.0/1

Φαρμακοτεχνική μορφή:

Ear Drops Suspension

Τρόπος διάθεσης:

POM

Θεραπευτική ομάδα:

Canine

Θεραπευτική περιοχή:

Dexamethasone and antiinfectives

Θεραπευτικές ενδείξεις:

Antibacterial

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2015-07-24

Αρχείο Π.Χ.Π.

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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