OTOXOLAN EAR DROPS, SUSPENSION FOR DOGS

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE ACETATE PH. EUR. (EQUIVALENT TO DEXAMETHASONE)

Διαθέσιμο από:

Krka, d.d., Novo mesto

Φαρμακολογική κατηγορία (ATC):

QS02CA06

INN (Διεθνής Όνομα):

MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE ACETATE PH. EUR. (EQUIVALENT TO DEXAMETHASONE)

Δοσολογία:

3mg/10mg/1mg

Φαρμακοτεχνική μορφή:

Ear Drops Suspension

Τρόπος διάθεσης:

POM

Θεραπευτική ομάδα:

Canine

Θεραπευτική περιοχή:

Dexamethasone and antiinfectives

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2017-01-20

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Otoxolan ear drops, suspension for dogs
Marbofloxacin/Clotrimazole/Dexamethasone acetate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of suspension contains:
ACTIVE SUBSTANCES:
Marbofloxacin
3.0 mg
Clotrimazole
10.0 mg
Dexamethasone acetate
1.0 mg
(equivalent to Dexamethasone
0.9 mg)
EXCIPIENTS:
Propyl gallate (E310)
1.0 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ear drops, suspension.
Off yellow, opalescent, viscous 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 use in dogs suffering from perforation of the tympanic
membrane.
Do not use in cases of hypersensitivity to the active substances, to
other azole antifungal agents or to any other
fluoroquinolones or to any of the excipients.
Do not administer to pregnant or lactating bitches.
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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