Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
Milbemycin oxime (UNII: 0502PUN0GT) (Milbemycin oxime - UNII:0502PUN0GT)
Elanco US Inc.
Milbemycin oxime
Milbemycin oxime 1 mg in 1 mL
AURICULAR (OTIC)
PRESCRIPTION
MILBEMITE OTIC Solution is indicated for treatment of ear mite (Otodectes cynotis ) infestations in cats and kittens four weeks of age and older. Effectiveness is maintained throughout the life cycle of the ear mite.
MILBEMITE OTIC Solution is supplied in individual white polypropylene tubes, paired in a foil overlay pouch. The product is packaged in a box of 10 pouches of 2 tubes of 0.25 mL each. Product of Japan Manufactured for: Elanco US Inc. Greenfield, IN 46140, USA Approved by FDA under NADA # 141-163 Milbemite, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2022 Elanco or its affiliates Revision Date: May 2022 PA103718X Elanco TM
New Animal Drug Application
MILBEMITE- MILBEMYCIN OXIME SOLUTION ELANCO US INC. ---------- MILBEMITE™ OTIC SOLUTION (0.1% milbemycin oxime) CAUTION: U.S. Federal law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION: MILBEMITE OTIC Solution is available in plastic dispensing tubes. Each plastic tube contains 0.25 mL of MILBEMITE OTIC Solution as a 0.1% solution of milbemycin oxime. Milbemycin oxime consists of the oxime derivatives of 5-didehydromilbemycins in the ratio of approximately 80% A (C H NO , MW 555.71) and 20% A (C H NO , MW 541.68). INDICATIONS: MILBEMITE OTIC Solution is indicated for treatment of ear mite (_Otodectes cynotis_) infestations in cats and kittens four weeks of age and older. Effectiveness is maintained throughout the life cycle of the ear mite. HUMAN WARNINGS: Not for human use. Keep this and all drugs out of the reach of children. PRECAUTIONS: The safe use of MILBEMITE OTIC Solution in cats used for breeding purposes, during pregnancy, or in lactating queens, has not been evaluated. ADVERSE REACTIONS: No adverse reactions caused by MILBEMITE OTIC Solution have been reported in controlled effectiveness studies in adult cats and kittens (4 weeks of age). DOSAGE: MILBEMITE OTIC Solution should be administered topically into the external ear canal as the entire contents of a single-dose tube per ear. The volume delivered will be approximately 0.2 mL, with 0.05 mL residual volume remaining in dispensing tube. Repeat the treatment one time if necessary, based upon the ear mite life cycle and the response to treatment. 4 32 45 7 3 31 43 7 ADMINISTRATION: MILBEMITE OTIC Solution should be administered as one tube per ear as a single treatment. Each foil pouch contains two tubes of solution, one for each ear. Open the tube by pressing cap down firmly to break seal. Remove cap and check to be sure tip of tube is open. Squeeze the tube to administer the contents of one tube into each external ear canal. Massage the base of the ear for optimal distribution. In clinical field trials, ears read_full_document