REVERTIDINE- atipamezole hydrochloride injection, solution

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

ATIPAMEZOLE HYDROCHLORIDE (UNII: 2W4279571X) (ATIPAMEZOLE - UNII:03N9U5JAF6)

Доступно од:

Modern Veterinary Therapeutics LLC

Пут администрације:

INTRAMUSCULAR

Тип рецептора:

PRESCRIPTION

Терапеутске индикације:

INDICATIONS: REVERTIDINE is indicated for the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs. CONTRAINDICATIONS: Since atipamezole is always used concomitantly with dexmedetomidine or medetomidine, it should not be used in dogs with the following conditions: cardiac disease, respiratory disorders, liver or kidney diseases, dogs in shock, severely debilitated dogs, or dogs stressed due to extreme heat, cold or fatigue. Administration of atipamezole is contraindicated in dogs with a known hypersensitivity to the drug. HUMAN WARNINGS: Not for human use. Keep out of reach of children. Atipamezole hydrochloride can be absorbed and may cause irritation following direct exposure to skin, eyes, or mouth. In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. If irritation or other adverse reaction occurs (for example, increased heart r

Резиме производа:

HOW SUPPLIED: REVERTIDINE is supplied in 10-mL, multidose vials containing 5.0 mg of atipamezole hydrochloride per mL. Approved by FDA under ANADA # 200-624

Статус ауторизације:

Abbreviated New Animal Drug Application

Карактеристике производа

REVERTIDINE- ATIPAMEZOLE HYDROCHLORIDE INJECTION, SOLUTION
MODERN VETERINARY THERAPEUTICS LLC
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REVERTIDINE
REVERTIDINE
(ATIPAMEZOLE HYDROCHLORIDE)
Sterile Injectable Solution - 5.0 mg/mL
Dexmedetomidine and Medetomidine Reversing Agent
For intramuscular use in dogs only
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
DESCRIPTION: REVERTIDINE (atipamezole hydrochloride) is a synthetic α
-adrenergic
antagonist. The chemical name is
4-(2-ethyl-2,3-dihydro-1H-inden-2-yl)-1H-imidazole
hydrochloride. The molecular formula is C
H
N • HCl and structural formula is:
Each mL of REVERTIDINE contains 5.0 mg atipamezole hydrochloride, 1.0
mg
methylparaben (NF), 8.5 mg sodium chloride (USP), and water for
injection (USP).
INDICATIONS: REVERTIDINE is indicated for the reversal of the sedative
and analgesic
effects of dexmedetomidine hydrochloride, and medetomidine
hydrochloride in dogs.
DOSAGE AND ADMINISTRATION : REVERTIDINE is administered
intramuscularly (IM)
2
14
16
2
for reversal of sedation and analgesia regardless of the route used
for dexmedetomidine
or medetomidine. The atipamezole dose for the reversal of IV
dexmedetomidine or
medetomidine is 3750 mcg/m . The atipamezole dose for the reversal of
IM
dexmedetomidine or medetomidine is 5000 mcg/m .
The dosage of REVERTIDINE is calculated based on body surface area.
Use the following
tables to determine the correct injection volume or the correct
REVERTIDINE dosage on
the basis of kilograms of body weight.
NOTE THAT THE MCG/KG DOSAGE DECREASES AS BODY WEIGHT INCREASES.
CONTRAINDICATIONS: Since atipamezole is always used concomitantly with
dexmedetomidine or medetomidine, it should not be used in dogs with
the following
conditions: cardiac disease, respiratory disorders, liver or kidney
diseases, dogs in
shock, severely debilitated dogs, or dogs stressed due to extreme
heat, cold or fatigue.
Administration of atipamezole is contraindicated in dogs with a known
hypersensitivity to
the drug.
HUMAN WARNINGS: Not for