Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
ATIPAMEZOLE HYDROCHLORIDE (UNII: 2W4279571X) (ATIPAMEZOLE - UNII:03N9U5JAF6)
Modern Veterinary Therapeutics LLC
INTRAMUSCULAR
PRESCRIPTION
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
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
Abbreviated New Animal Drug Application
REVERTIDINE- ATIPAMEZOLE HYDROCHLORIDE INJECTION, SOLUTION MODERN VETERINARY THERAPEUTICS LLC ---------- 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 Lugege kogu dokumenti