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Afluria

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Afluria

Indications
Dosage
How Supplied

INDICATIONS

AFLURIA® is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. AFLURIA is approved for use in persons 5 years of age and older.

DOSAGE AND ADMINISTRATION

For intramuscular (IM) injection only, by needle and syringe (5 years of age and older) or by PharmaJet® Stratis Needle-Free Injection System (18 through 64 years of age). A single dose is 0.5 mL.

The dose and schedule for AFLURIA are presented in Table 1.

Table 1: AFLURIA Schedule

Age Schedule
5 years through 8 years One dose or two doses at least 1 month apart a
9 years and older One dose
a 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines.

Shake thoroughly and inspect visually before use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever suspension and container permit. If either of these conditions exists, the vaccine should not be administered.

May be administered by needle and syringe (5 years of age and older) or PharmaJet Stratis Needle-Free Injection System (18 through 64 years of age only).

When using the single-dose pre-filled syringe, shake the syringe thoroughly and administer the dose immediately.

When using the multi-dose vial, shake the vial thoroughly before withdrawing each dose, and administer the dose immediately.

  • Needle and Syringe: Draw up the exact dose using a separate sterile needle and syringe for each individual patient. It is recommended that small syringes (0.5 mL or 1 mL) be used to minimize any product loss.
  • PharmaJet Stratis Needle-Free Injection System: For instructions on withdrawal of a 0.5 mL dose and use of the PharmaJet Stratis Needle-Free Injection System, refer to the Instructions For Use for the PharmaJet Stratis Needle-Free Injection System.

The preferred site for intramuscular injection is the deltoid muscle of the upper arm.

Between uses, return the multi-dose vial to the recommended storage conditions between 2-8°C (36-46°F). Do not freeze. Discard if the vaccine has been frozen.

HOW SUPPLIED

Dosage Forms And Strengths

AFLURIA is a sterile suspension for intramuscular injection (see DESCRIPTION).

AFLURIA is supplied in two presentations:

  • 0.5 mL pre-filled syringe (single dose).
  • 5 mL multi-dose vial (ten 0.5 mL doses).

Each product presentation includes a package insert and the following components

Presentation Carton NDC Number Components
Pre-Filled Syringe 33332-014-01
  • Ten 0.5 mL single-dose syringes without needles [NDC 33332-014-02]
Multi-Dose Vial 33332-114-10
  • One 5 mL vial, which contains ten 0.5 mL doses [NDC 33332-114-11]

Storage And Handling

  • Store refrigerated at 2-8°C (36-46°F).
  • Do not freeze. Discard if product has been frozen.
  • Protect from light.
  • Do not use AFLURIA beyond the expiration date printed on the label.
  • Once the stopper of the multi-dose vial has been pierced the vial must be discarded within 28 days.

Manufactured by: bioCSL Pty Ltd., Parkville, Victoria, 3052, Australia, US License No. 1764. Distributed by: bioCSL Inc. 1020 First Avenue, King of Prussia, PA 19406, USA. Revised: August 2014

Last reviewed on RxList: 9/8/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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