Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
FLORFENICOL (UNII: 9J97307Y1H) (FLORFENICOL - UNII:9J97307Y1H), TERBINAFINE (UNII: G7RIW8S0XP) (TERBINAFINE - UNII:G7RIW8S0XP), MOMETASONE FUROATE (UNII: 04201GDN4R) (MOMETASONE - UNII:8HR4QJ6DW8)
Bayer HealthCare, LLC Animal Health Division
AURICULAR (OTIC)
PRESCRIPTION
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.
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
New Animal Drug Application
CLARO OTIC SOLUTION- (FLORFENICOL, TERBINAFINE, MOMETASONE FUROATE) SOLUTION BAYER HEALTHCARE, LLC ANIMAL HEALTH DIVISION ---------- 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. 1. 2. 3. 4. 5. 6. 7. ® ® ® ® 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. 8. 9. 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 Pročitajte cijeli dokument