ALFAXAN MULTIDOSE IDX: Product Information

ALFAXAN MULTIDOSE IDX- alfaxalone solution
Zoetis Inc.

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.

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 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

• 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 fish
• 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.

DOSAGE AND ADMINISTRATION

When 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).

REPTILES

Lizards

Snakes

Turtles and Tortoises

AMPHIBIANS

FISH

BIRDS

NON-HUMAN PRIMATES

RODENTS