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Audenz Generic Name & Formulations
Legal Class
Rx
General Description
Influenza A (H5N1) inactivated, monovalent vaccine (adjuvanted); contains 7.5mcg hemagglutinin per 0.5mL dose; emulsion for IM inj; may contain trace amounts of polysorbate 80, cetyltrimethylammonium bromide, β-propiolactone; antibiotics- and preservative-free.
Pharmacological Class
Influenza vaccine.
How Supplied
Single-dose prefilled syringes 0.5mL—10; Multi-dose vial 5mL (contains thimerosal)—10
Manufacturer
Generic Availability
NO
Audenz Indications
Indications
Active immunization for the prevention of disease in individuals aged ≥6 months at increased risk of exposure to the influenza A H5N1 virus subtype contained in the vaccine.
Audenz Dosage and Administration
Adults and Children
<6mos: not established. Give by IM inj into the anterolateral thigh (6–11mos); in deltoid muscle of the upper arm (>12mos). ≥6mos: administer 2 doses (0.5mL each) at 21 days apart.
Audenz Contraindications
Contraindications
History of a severe allergic reaction to any previous flu vaccine.
Audenz Boxed Warnings
Not Applicable
Audenz Warnings/Precautions
Warnings/Precautions
Guillain-Barre syndrome within 6 weeks of previous flu vaccine. Immunosuppressed. Have epinephrine inj (1:1000) available. Pregnancy. Nursing mothers.
Audenz Pharmacokinetics
See Literature
Audenz Interactions
Interactions
Concomitant other vaccines: insufficient data (see full labeling). Immunosuppressants: may get suboptimal response.
Audenz Adverse Reactions
Adverse Reactions
Inj site pain, fatigue, headache, malaise, myalgia, arthralgia, nausea; in children also: tenderness, irritability, sleepiness, change in eating habits, fever, loss of appetite.
Audenz Clinical Trials
See Literature
Audenz Note
Not Applicable
Audenz Patient Counseling
See Literature
