OTOXOLAN EAR DROPS, SUSPENSION FOR DOGS

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

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

제공처:

Krka, d.d., Novo mesto

ATC 코드:

QS02CA06

INN (국제 이름):

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

복용량:

3mg/10mg/1mg

약제 형태:

Ear Drops Suspension

처방전 유형:

POM

치료 그룹:

Canine

치료 영역:

Dexamethasone and antiinfectives

승인 상태:

Authorised

승인 날짜:

2017-01-20

제품 특성 요약

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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