ALFAXAN MULTIDOSE IDX- alfaxalone solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Jurox Pty. Limited

Calea de administrare:

INTRAMUSCULAR

Tip de prescriptie medicala:

PRESCRIPTION

Indicații terapeutice:

ALFAXAN MULTIDOSE IDX is indicated as a sedative and anesthetic in multiple minor species*. More specifically, ALFAXAN MULTIDOSE IDX is indicated for the following: - For sedation and anesthesia in captive reptiles, excluding any food‑producing species** - For sedation and anesthesia in captive amphibians, excluding any food‑producing species** - For sedation and anesthesia in ornamental fish, including species used in research such as the zebrafish - For sedation and anesthesia in captive species and pet birds in the orders Psittaciformes, Passeriformes, and Columbiformes, excluding any food‑producing species** - For sedation and anesthesia in non‑human primates - For sedation and anesthesia in captive rodents - For sedation and anesthesia in captive mustelids - For sedation and anesthesia in captive marsupials - For induction of anesthesia and immobilization in captive minor species ungulates, excluding any food‑producing species** Use only when there is reasonable certainty that the treated animal will not be consumed by humans or food‑producing animals. *    The term “minor species” means animals other than humans that are not major species. “Major species” means cattle, horses, swine, chickens, turkeys, dogs and cats. ** As used on this label, a “food‑producing minor species” is considered to be a minor species of which some members are bred, cultured, farmed, ranched, hunted, caught, trapped or otherwise harvested for the purpose of having the animals or edible products of the animals commercially distributed for consumption by humans or food‑producing animals in the United States. ALFAXAN MULTIDOSE IDX is contraindicated in animals with a known sensitivity to ALFAXAN MULTIDOSE IDX or its components, or when general anesthesia and/or sedation are contraindicated. Do not use in any minor species animal that may become eligible for consumption by humans or food‑producing animals. Controlled substance : ALFAXAN MULTIDOSE IDX 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 other Schedule IV sedatives. Physical dependence : There are no data that assess the ability of alfaxalone to induce physical dependence. However, alfaxalone has a mechanism of action similar to the benzodiazepines and can block the behavioral responses associated with precipitated benzodiazepine withdrawal. Therefore, it is likely that alfaxalone can also produce physical dependence and withdrawal signs similar to that produced by the benzodiazepines. Psychological dependence : The ability of alfaxalone to produce psychological dependence is unknown because there are no data on the rewarding properties of the drug from animal self-administration studies or from human abuse potential studies.

Rezumat produs:

ALFAXAN MULTIDOSE IDX is supplied in 10 and 20 mL multiple-dose vials containing 10 mg alfaxalone per mL. 

Statutul autorizaţiei:

Legally Marketed Unapproved New Animal Drugs for Minor Species

Caracteristicilor produsului

ALFAXAN MULTIDOSE IDX- ALFAXALONE SOLUTION
JUROX PTY. LIMITED
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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ALFAXAN MULTIDOSE IDX
FOR ANIMAL USE ONLY
ALFAXAN® MULTIDOSE IDX CIV
(ALFAXALONE) 10 MG/ML INJECTABLE SOLUTION
FOR USE AS AN INJECTABLE SEDATIVE AND ANESTHETIC IN MULTIPLE NON FOOD-
PRODUCING MINOR SPECIES.
CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF
A
LICENSED VETERINARIAN.
LEGAL STATUS: IN ORDER TO BE LEGALLY MARKETED, A NEW ANIMAL DRUG
INTENDED
FOR A MINOR SPECIES MUST BE APPROVED, CONDITIONALLY APPROVED, OR
INDEXED BY
THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS INDEXED—MIF
900-031.
EXTRA-LABEL USE IS PROHIBITED.
THIS PRODUCT IS NOT TO BE USED IN ANIMALS FOR USE AS FOOD FOR HUMANS
OR FOOD-
PRODUCING ANIMALS.
DESCRIPTION
ALFAXAN MULTIDOSE IDX contains alfaxalone, 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 of
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. THIS PRODUCT
CONTAINS THE
FOLLOWING PRESERVATIVES: CHLOROCRESOL (0.1% W/V), BENZETHONIUM
CHLORIDE
(0.02% W/V) AND ETHANOL (15% W/V).
INDICATIONS
ALFAXAN MULTIDOSE IDX is indicated as a sedative and anesthetic in
multiple minor
species*. More specifically, ALFAXAN MULTIDOSE IDX is indicated for
the following:
For sedation and anesthesia in captive reptiles, excluding any
food‑producing
species**
For sedation and anesthesia in captive amphibians, excluding any
food‑producing
species**
For sedation and anesthesia in ornamental fish, including species used
in research
such as the zebrafish
A
For sedation and anesthesia in captive species and p