CLARO OTIC SOLUTION (- florfenicol, terbinafine, mometasone furoate solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

FLORFENICOL (UNII: 9J97307Y1H) (FLORFENICOL - UNII:9J97307Y1H), TERBINAFINE (UNII: G7RIW8S0XP) (TERBINAFINE - UNII:G7RIW8S0XP), MOMETASONE FUROATE (UNII: 04201GDN4R) (MOMETASONE - UNII:8HR4QJ6DW8)

제공처:

Bayer HealthCare, LLC Animal Health Division

관리 경로:

AURICULAR (OTIC)

처방전 유형:

PRESCRIPTION

치료 징후:

CLARO® is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis ) and bacteria (Staphylococcus pseudintermedius ). Do not use in dogs with known tympanic membrane perforation (see PRECAUTIONS ). CLARO® is contraindicated in dogs with known or suspected hypersensitivity to florfenicol, terbinafine hydrochloride, or mometasone furoate.

제품 요약:

CLARO® solution is supplied in a single-use dropperette in a blister. Each dropperette contains one 1 mL dose. CLARO® is available in cartons of two, ten, or twenty dropperettes. Bayer, the Bayer Cross and CLARO are registered trademarks of Bayer. ©2018 Bayer Manufactured for Bayer HealthCare LLC Animal Health Division P.O. Box 390, Shawnee Mission, Kansas 66201 USA Made in Germany NADA 141-440, Approved by FDA. February, 2018 86384450 LV1802

승인 상태:

New Animal Drug Application

제품 특성 요약

CLARO OTIC SOLUTION- (FLORFENICOL, TERBINAFINE, MOMETASONE FUROATE)
SOLUTION
BAYER HEALTHCARE, LLC ANIMAL HEALTH DIVISION
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CLARO
(FLORFENICOL, TERBINAFINE, MOMETASONE FUROATE)
OTIC SOLUTION
Antibacterial, antifungal, and anti-inflammatory
For Otic Use in Dogs Only
CAUTION:
Federal (U.S.A.) law restricts this drug to use by or on the order of
a licensed veterinarian.
DESCRIPTION:
CLARO contains 16.6 mg/mL florfenicol, 14.8 mg/mL terbinafine
(equivalent to 16.6 mg/mL
terbinafine hydrochloride) and 2.2 mg/mL mometasone furoate.
Inactive ingredients include purified water, propylene carbonate,
propylene glycol, ethyl alcohol, and
polyethylene glycol.
INDICATIONS:
CLARO is indicated for the treatment of otitis externa in dogs
associated with susceptible strains of
yeast (_Malassezia pachydermatis_) and bacteria (_Staphylococcus
pseudintermedius_).
DOSAGE AND ADMINISTRATION:
SHAKE BEFORE USE.
CLARO SHOULD BE ADMINISTERED BY VETERINARY PERSONNEL.
Administer one dose (1 dropperette) per affected ear. The duration of
effect should last 30 days.
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Clean and dry the external ear canal before administering the product.
Verify the tympanic membrane is intact prior to administration.
Remove single dose dropperette from the package.
While holding the dropperette in an upright position, remove the cap
from the dropperette.
Turn the cap over and push the other end of the cap onto the tip of
the dropperette.
Twist the cap to break the seal and then remove cap from the
dropperette.
Screw the applicator nozzle onto the dropperette.
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10.
Cleaning the ear after dosing may affect product effectiveness.
CONTRAINDICATIONS:
Do not use in dogs with known tympanic membrane perforation (see
PRECAUTIONS).
CLARO is contraindicated in dogs with known or suspected
hypersensitivity to florfenicol,
terbinafine hydrochloride, or mometasone furoate.
WARNINGS:
Human Warnings: Not for use in humans. Keep this and all drugs out of
reach of children. In case of
accidental ingestion by humans, contact a physi