Mitaban® amitraz

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

AMITRAZ (UNII: 33IAH5017S) (AMITRAZ - UNII:33IAH5017S)

থেকে পাওয়া:

Zoetis Inc.

INN (International Name):

amitraz

রচনা:

amitraz 0.18 g in 1 mL

প্রশাসন রুট:

TOPICAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION

থেরাপিউটিক ইঙ্গিত:

MITABAN (amitraz) is indicated for treatment of generalized demodicosis (Demodex canis) in dogs. Current data do not support use for treatment of localized demodicosis or scabies. - Fertility impairment studies have not been conducted in the canine with MITABAN (amitraz). It is not known whether MITABAN may cause impairment of fertility in dogs. - Reproduction studies during pregnancy have not been conducted with MITABAN. It is not known whether MITABAN may harm the embryo or fetus. - The safety of MITABAN has not been established for dogs less than four months of age.

পণ্য সারাংশ:

MITABAN Liquid Concentrate (amitraz) is available in cartons of 6–10.6 mL bottles.

অনুমোদন অবস্থা:

New Animal Drug Application

পণ্য বৈশিষ্ট্য

MITABAN- AMITRAZ LIQUID
ZOETIS INC.
----------
MITABAN
AMITRAZ
Liquid Concentrate
FOR TOPICAL USE ON DOGS
FOR USE IN ANIMALS ONLY
CAUTION: Federal (USA) law restricts this drug to use by or on the
order of a licensed veterinarian.
WARNING
Animal safety studies conducted in the dog and other species suggest
amitraz may alter the
animal's ability to maintain homeostasis. Animals treated with MITABAN
(amitraz) should not be
subjected to stress for a period of at least 24 hours posttreatment.
Adverse reactions including
three fatalities were reported during the clinical studies. In excess
of 1100 dogs with generalized
demodicosis were topically treated with MITABAN.
DESCRIPTION
MITABAN (amitraz) Liquid Concentrate contains 19.9% N'-(2,4
dimethylphenyl)-N-[[(2,4-
dimethylphenyl)imino]methyl]-N-methylmethanimidamide (w/w), and also
xylol, propylene oxide, and a
blend of alkyl benzene sulfonates and exthoxylated polyethers.
Amitraz, a diamide, is pale yellow, has a
melting point of 86° to 87° C, is not hygroscopic, is stable to
heating, soluble in most organic solvents,
and sparingly soluble in water.
CLINICAL PHARMACOLOGY
Amitraz is hydrolyzed to 2,4-dimethyl-formanilide and
N-(2,4-dimethylphenyl)-N'-methylformamidine;
these metabolites are further metabolized to 2,4-dimethylaniline and
ultimately to 4-amino-3-
methylbenzoic acid, which was the principal metabolite in the urine
and liver.
Radiolabeled amitraz was administered to beagles as a single oral
treatment at a level of 4 mg/kg. Peak
blood levels were reached between 1.5 and 6 hours posttreatment; the
half-life was approximately 12
hours during the initial 48 hours. Radioactivity was extremely low in
whole blood and plasma at 72
(0.05-0.06 ppm) and 96 (0.03- 0.06 ppm) hours. The organs having
residues at levels greater than
plasma concentrations at 96 hours included: liver, skin, eyes, bile,
kidney, medulla, cerebrum, lungs,
gonads, fat, thyroid, spleen, and large intestine. The main metabolite
isolated from these tissues was
identified as 4-amino-3-methylbenz