"The U.S. Food and Drug Administration today approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu. The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is for use in peopl"...
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
|5 years through 8 years||One dose or two doses at least 1 month aparta|
|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 o f 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.
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||33332-015-01||Ten 0.5 mL single-dose syringes without needles [NDC 33332-015-02]|
|Multi-Dose Vial||33332-115-10||One 5 mL vial, which contains ten 0.5 mL doses [NDC 33332-115-11]|
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. Distributed by: bioCSL Inc. 1020 First Avenue, King of Prussia, PA 19406, USA. Revised: Apr 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/2/2015
Additional Afluria Information
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