MILBEMITE- milbemycin oxime solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

Milbemycin oxime (UNII: 0502PUN0GT) (Milbemycin oxime - UNII:0502PUN0GT)

זמין מ:

Elanco US Inc.

INN (שם בינלאומי):

Milbemycin oxime

הרכב:

Milbemycin oxime 1 mg in 1 mL

מסלול נתינה (של תרופות):

AURICULAR (OTIC)

סוג מרשם:

PRESCRIPTION

סממני תרפויטית:

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.

leaflet_short:

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

מצב אישור:

New Animal Drug Application

מאפייני מוצר

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