Animal NDC 49480-003-01 Alfaxan Multidose Idx

Alfaxalone

Animal NDC Product Code 49480-003-01

Field Name Field Value
Animal NDC Code 49480-003-01
Proprietary Name Alfaxan Multidose Idx What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Alfaxalone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Jurox Pty. Limited
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Alfaxalone
Inactive Ingredient(s)
  • HYDROXYPROPYLBETADEX (0.58-0.68 MS) (1I96OHX6EK)
  • SODIUM CHLORIDE (451W47IQ8X)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (22ADO53M6F)
  • ALCOHOL (3K9958V90M)
  • BENZETHONIUM CHLORIDE (PH41D05744)
  • CHLOROCRESOL (36W53O7109)
  • POTASSIUM PHOSPHATE, MONOBASIC (4J9FJ0HL51)
  • HYDROCHLORIC ACID (QTT17582CB)
  • HYDROXYPROPYLBETADEX (0.58-0.68 MS) (1I96OHX6EK)
  • SODIUM CHLORIDE (451W47IQ8X)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (22ADO53M6F)
  • ALCOHOL (3K9958V90M)
  • BENZETHONIUM CHLORIDE (PH41D05744)
  • CHLOROCRESOL (36W53O7109)
  • POTASSIUM PHOSPHATE, MONOBASIC (4J9FJ0HL51)
  • HYDROCHLORIC ACID (QTT17582CB)
Marketing Category LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number MIF900031 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Alfaxan Multidose Idx Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

General Precautions

FOR ANIMAL USE ONLYAlfaxan® Multidose IDX CIV(alfaxalone) 10 mg/mL Injectable SolutionFor use as an injectable sedative and anesthetic in multiple nonfood-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

DESCRIPTIONALFAXAN 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 GABAA (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 & Usage

  • INDICATIONSALFAXAN 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 zebra fishFor 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 primatesFor sedation and anesthesia in captive rodentsFor sedation and anesthesia in captive mustelidsFor sedation and anesthesia in captive marsupialsFor 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.

Dosage & Administration

DOSAGE AND ADMINISTRATIONWhen administering ALFAXAN MULTIDOSE IDX by intravenous injection administer slowly to effect, titrating administration against the response of the patient. Rapid administration of ALFAXAN MULTIDOSE IDX may be associated with an increased incidence of cardiorespiratory depression or apnea. The use of preanesthetics may reduce the ALFAXAN MULTIDOSE IDX induction dose. The choice and the amount of phenothiazine, alpha₂‑ adrenoreceptor agonist, benzodiazepine or opioid will influence the response of the patient to an induction dose of ALFAXAN MULTIDOSE IDX.When using ALFAXAN MULTIDOSE IDX, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.ALFAXAN MULTIDOSE IDX contains preservatives. Use within 56 days of first puncture. Any unused ALFAXAN MULTIDOSE IDX remaining after 56 days should be discarded.The following tables outline the dosage and administration of ALFAXAN MULTIDOSE IDX for the indicated species by major group. The doses are representative of doses published in the literature. Veterinarians are advised to consult the published literature before use of the product (see List of References at end of product insert).








Drug Interactions

DRUG INTERACTIONSNo specific preanesthetic is either indicated or contraindicated with ALFAXAN MULTIDOSE IDX. The necessity for and choice of preanesthetic is left to the discretion of the veterinarian. Preanesthetic doses may be lower than the label directions for their use as a single medication. ALFAXAN MULTIDOSE IDX is compatible with benzodiazepines, opioids, alpha2‑agonists, and phenothiazines as commonly used in surgical practice.

Contraindications

CONTRAINDICATIONSALFAXAN 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.

Warnings

WARNINGSAnimal Safety: Rapid bolus administration or anesthetic overdose may cause cardiorespiratory depression, including hypotension, apnea, hypoxia, or death. Arrhythmias may occur secondary to apnea and hypoxia. In cases of anesthetic overdose, stop ALFAXAN MULTIDOSE IDX administration and administer treatment as indicated by the patient’s clinical signs. Cardiovascular depression should be treated with plasma expanders, pressor agents, anti‑arrhythmic agents or other techniques as appropriate for the treatments of the clinical signsHuman safety: Not for human use. Keep out of the reach of children.ALFAXAN MULTIDOSE IDX should be managed to prevent the risk of diversion, through such measures as restriction of access and the use of drug accountability procedures appropriate to the clinical setting.Exercise caution to avoid accidental self‑injection. Overdose is likely to cause cardiorespiratory depression (such as hypotension, bradycardia and/ or apnea). Remove the individual from the source of exposure and seek medical attention. Respiratory depression should be treated by artificial ventilation and oxygen. Avoid contact of this product with skin, eyes, and clothes. In case of contact, eyes and skin should be liberally flushed with water for 15 minutes. Consult a physician if irritation persists. In the case of accidental human ingestion, seek medical advice immediately and show the package insert or the label to the physician.The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse reactions in users or to obtain a copy of the SDS for this product call 1‑844‑253‑2926.Note to physician: This product contains an injectable anesthetic.

Drug Abuse And Dependence

DRUG ABUSE AND DEPENDENCEControlled 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 inducephysical 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 benzodiazepinesPsychological 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.

Precautions

PRECAUTIONSAnalgesia during anesthesia: ALFAXAN MULTIDOSE IDX is not an analgesic and appropriate analgesia should be provided to the patient for painful procedures.Rapid arousal: Careful monitoring of the patient is necessary due to possibility of rapid arousal.Apnea: Apnea may occur following IV administration of an induction dose, maintenance dose or a dose administered during transition to inhalant maintenance anesthesia of ALFAXAN MULTIDOSE IDX, especially with higher doses and rapid administration. Endotracheal intubation, oxygen supplementation and intermittent positive pressure ventilation (IPPV) should be administered to treat apnea and associated hypoxemia in the appropriate species.Blood Pressure: ALFAXAN MULTIDOSE IDX can exacerbate the myocardial depressive and vasodilatory effects of inhalant anesthetics resulting in hypotension. Preanesthetics can potentiate the effect of ALFAXAN MULTIDOSE IDX resulting in more pronounced changes in blood pressure. Transient hypertension has also been observed with ALFAXAN MULTIDOSE IDX administration, possibly due to elevated sympathetic activity in the patient. It is prudent to monitor blood pressure whenever possible.Body temperature: Steps should be taken to maintain the normal physiological temperature of the patient during anesthesia. Supplemental heat, appropriate for the species, should be provided to maintain acceptable core body temperature until full recovery.Breeding animals: Alfaxalone crosses the placenta, and as with other general anesthetic agents, the administration of ALFAXAN MULTIDOSE IDX may be associated with neonatal depression.Compromised or debilitated animals: Caution should be used in animals with cardiac, respiratory, renal or hepatic impairment, or in hypovolemic or debilitated animals and geriatric animals.

Adverse Reactions

ADVERSE REACTIONSSpecific adverse reactions described in the referenced literature are listed in the Dosage and Administration section of the product insert.To report adverse reactions or to obtain a copy of the SDS for this product call 1‑844‑253‑2926. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1‑888‑FDA‑VETS or online at http://www.fda.gov/reportanimalae.

Overdosage

OVERDOSERapid administration, accidental overdose, or relative overdose due to inadequate dose sparing of ALFAXAN MULTIDOSE IDX in the presence of preanesthetics may cause cardiopulmonary depression. Respiratory arrest (apnea) may be observed. In cases of respiratory depression, stop drug administration, establish a patent airway, and initiate assisted or controlled ventilation with pure oxygen. Cardiovascular depression should be treated with plasma expanders, pressor agents, antiarrhythmic agents or other techniques as appropriate for the observed abnormality.

Storage And Handling

STORAGE INFORMATION: Store at controlled room temperature 20°C ‑ 25°C (68° to 77°F) with excursions between 15° and 30°C (59° and 86°F). ALFAXAN MULTIDOSE IDX contains preservatives. The product can be used for 56 days after broaching the vial. Any unused ALFAXAN MULTIDOSE IDX remaining after 56 days should be discarded.

How Supplied

HOW SUPPLIED: ALFAXAN MULTIDOSE IDX is supplied in 10 mL and 20 mL multiple‑dose vials containing 10 mg alfaxalone per mL.

Other

Manufactured in Australia by Jurox Pty LimitedMarketed By:Jurox Inc.Kansas City, MO 64116Phone 1-844-253-2926Distributed by:Vedco, Inc.St. Joseph, MO 64507Alfaxan is a registered trademark of Jurox Pty Limited.US Patent # 7,897,586US Patent # 9,492,552

References

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