ALFAXAN- alfaxalone injection, solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

ALFAXALONE (UNII: BD07M97B2A) (ALFAXALONE - UNII:BD07M97B2A)

から入手可能:

Jurox Pty. Limited

INN（国際名）:

ALFAXALONE

構図:

ALFAXALONE 10 mg in 1 mL

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION

適応症:

INDICATIONS ALFAXAN is indicated for the induction and maintenance of anesthesia and for induction of anesthesia followed by maintenance with an inhalant anesthetic, in cats and dogs. CONTRAINDICATIONS: ALFAXAN is contraindicated in cats and dogs with a known sensitivity to alfaxalone or its components, or when general anesthesia and/or sedation are contraindicated. DRUG ABUSE AND DEPENDENCE: Controlled Substance: ALFAXAN contains alfaxalone, a neurosteroid anesthetic and a class IV controlled substance. Abuse: Alfaxalone is a central nervous system depressant that acts on GABA receptor associated chloride channels, similar to the mechanism of action of Schedule IV sedatives such as benzodiazepines (diazepam and midazolam), barbiturates (phenobarbital and methohexital) and fospropofol. In a drug discrimination behavioral test in rats, the effects of alfaxalone were recognized as similar to those of midazolam. These biochemical and behavioral data suggest that alfaxalone has an abuse potential similar to oth

製品概要:

HOW SUPPLIED: ALFAXAN is supplied in 10 mL single-use vials containing 10 mg alfaxalone per mL. NDC 49480-001-01 - 10 mL vial.

認証ステータス:

New Animal Drug Application

製品の特徴

ALFAXAN- ALFAXALONE INJECTION, SOLUTION
JUROX PTY. LIMITED
----------
ALFAXAN SPL
NADA 141-342, Approved by FDA
FOR ANIMAL USE ONLY
ALFAXAN® CIV
(ALFAXALONE 10 MG/ML)
INTRAVENOUS INJECTABLE ANESTHETIC FOR USE IN CATS AND DOGS
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
DESCRIPTION
ALFAXAN (alfaxalone) is a neuroactive steroid molecule with properties
of a general anesthetic.
Alfaxalone is chemically described as 3-α-hydroxy-5-α-pregnane-11,
20-dione, and has a molecular
weight 332.5. The primary mechanism for the anesthetic action of
alfaxalone is modulation of neuronal
cell membrane chloride ion transport, induced by binding of alfaxalone
to GABA (gamma-
aminobutyric acid) cell surface receptors.
INDICATIONS
ALFAXAN is indicated for the induction and maintenance of anesthesia
and for induction of anesthesia
followed by maintenance with an inhalant anesthetic, in cats and dogs.
DOSAGE AND ADMINISTRATION
Administer by intravenous injection only. For induction, administer
ALFAXAN over approximately 60
seconds or until clinical signs show the onset of anesthesia,
titrating administration against the response
of the patient. Rapid administration of ALFAXAN may be associated with
an increased incidence of
cardiorespiratory depression or apnea. Apnea can occur following
induction or after the administration
of maintenance boluses of ALFAXAN. The use of preanesthetics may
reduce the ALFAXAN induction
dose. The choice and the amount of phenothiazine, alpha
-adrenoreceptor agonist, benzodiazepine or
opioid will influence the response of the patient to an induction dose
of ALFAXAN.
WHEN USING ALFAXAN, PATIENTS SHOULD BE CONTINUOUSLY MONITORED, AND
FACILITIES FOR THE
MAINTENANCE OF A PATENT AIRWAY, ARTIFICIAL VENTILATION, AND OXYGEN
SUPPLEMENTATION MUST BE
IMMEDIATELY AVAILABLE.
ALFAXAN does not contain an antimicrobial preservative. Do not use if
contamination is suspected.
Strict aseptic techniques must be maintained because the vehicle is
capable of supporting the rap