NOROTIC EAR DROPS, SUSPENSION FOR DOGS

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE (AS DEXAMETHASONE ACETATE)

제공처:

Norbrook Laboratories Limited

ATC 코드:

QS02CA06

INN (국제 이름):

MARBOFLOXACIN, CLOTRIMAZOLE, DEXAMETHASONE (AS DEXAMETHASONE ACETATE)

복용량:

10.0/3.0/1

약제 형태:

Ear Drops Suspension

처방전 유형:

POM

치료 그룹:

Canine

치료 영역:

Dexamethasone and antiinfectives

치료 징후:

Antibacterial

승인 상태:

Authorised

승인 날짜:

2015-07-24

제품 특성 요약

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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