OTOXOLAN EAR DROPS, SUSPENSION FOR DOGS

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

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

متاح من:

Krka, d.d., Novo mesto

ATC رمز:

QS02CA06

INN (الاسم الدولي):

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

جرعة:

3mg/10mg/1mg

الشكل الصيدلاني:

Ear Drops Suspension

نوع الوصفة الطبية :

POM

المجموعة العلاجية:

Canine

المجال العلاجي:

Dexamethasone and antiinfectives

الوضع إذن:

Authorised

تاريخ الترخيص:

2017-01-20

خصائص المنتج

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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