Alfaxan® Product Specification

Features and Benefits of Alfaxan

Alfaxan is a 1% [10mg/mL] aqueous solution of alfaxalone in hydropropyl-beta-cyclodextrin [HP-β-CD]. The solution has a pH of 6.05-7.0 and does not contain a preservative. It is a clear, colorless, sterile solution for injection, presented in 10 mL, single use vials. Alfaxan should be stored in the outer carton at room temperature, avoiding freezing. Once a vial has been opened, vial contents should be drawn into sterile syringes; each syringe should be prepared for a single patient use only. Any unused, unpreserved Alfaxan should be discarded within six hours of initially broaching the vial. Alfaxan Multidose may be retained and used within 28 days of initially broaching the vial.

When Alfaxan is administered as recommended, the following will be observed.

Smooth Induction

No Pain

No pain on injection18

Rapid

Rapid onset of anesthesia19

No tissue irritation

No tissue irritation if inadvertently given peri-vascularly21

Excellent Muscle Relaxation

Excellent muscle relaxation1920

Cardio-pulmonary function

Minimal disruption to cardio-pulmonary function or vascular system parameters1920

Stress Free Recovery

Stree-free recovery192022

Wide Safety Margin

Alfaxan has a wide safety margin, with animals receiving significant overdoses (20 mg/kg dogs; 25 mg/kg cats) requiring only ventilation to allow recovery with no residual effects.1920

Rapid Elimination

Alfaxan is rapidly eliminated from the body23 and is registered for use as an anesthetic maintenance agent.  Studies have shown that repeated, supra-clinical doses of Alfaxan administered IV at 10 mg/kg dogs (5X)24 and 25 mg/kg cats (5X)25 every 48 hours for three doses did not result in any deleterious effects. It can be used with confidence repeatedly over consecutive days

Registered for Maintenance

Alfaxan is also registered for use as a maintenance anesthetic agent and produces clinically acceptable anesthetic quality and hemodynamic values when used for maintenance.26

Compatible

Alfaxan is compatible with routine premedicant medications.16172728

When using Alfaxan

When using Alfaxan patients should be continuously monitored and facilities for the maintenance of a patient airway, artificial ventilation and oxygen supplementation must be immediately available.

Adverse Reactions

Adverse Reactions:  The primary side effects of alfaxalone are respiratory depression (apnea, bradypnea, hypoxia) and cardiovascular derangements (hypertension, hypotension, tachycardia, bradycardia).  Other adverse reactions observed in clinical studies include hypothermia, emesis, unacceptable anesthesia quality, lack of effectiveness, vocalization, paddling and muscle tremors.

Appropriate analgesia should be provided for painful procedures.