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DOSAGE AND ADMINISTRATION
For intramuscular (IM) injection only (0.5 mL).
Dose and Schedule
The dose and schedule for AFLURIA is presented in Table 1.
Table 1: AFLURIA Dose and Schedule
|5 years through 8 years||0.5 mL IM||One dose or two doses at least 1 month apart*|
|9 years and older||0.5 mL IM||One dose|
|*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.
When using a single-dose 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. 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.
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.
For intramuscular injection. The preferred site for intramuscular injection is the deltoid muscle of the upper arm.
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||33332-013-01||Ten 0.5 mL single-dose syringes without needles [NDC 33332-013-02]|
|Multi-Dose Vial||33332-113-10||One 5 mL vial, which contains ten 0.5 mL doses [NDC 33332-113-11]|
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: CSL Limited, Parkville, Victoria, 3052, Australia, US License No. 1764. Distributed by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Revised: July 2013.
Last reviewed on RxList: 11/25/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Afluria Information
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