AUDENZ

Generic Name & Formulations:

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.

Company:

Vaccines

Vaccines:

Indications for: AUDENZ

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.

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:

History of a severe allergic reaction to any previous flu vaccine.

AUDENZ Warnings/Precautions:

Guillain-Barre syndrome within 6 weeks of previous flu vaccine. Immunosuppressed. Have epinephrine inj (1:1000) available. Pregnancy. Nursing mothers.

AUDENZ Classification:

Influenza vaccine.

AUDENZ Interactions:

Concomitant other vaccines: insufficient data (see full labeling). Immunosuppressants: may get suboptimal response.

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.

Generic Drug Availability:

How Supplied:

Single-dose prefilled syringes 0.5mL—10; Multi-dose vial 5mL (contains thimerosal)—10

AUDENZ Rx