Fluzone Intradermal
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Questions & Answers
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Fluzone® Intradermal is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine.
Fluzone Intradermal is approved for use in persons 18 through 64 years of age.
History
There is currently no drug history available for this drug.
Other Information
Fluzone Intradermal (Influenza Vaccine) for intradermal injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a "split virus". The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone Intradermal process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration.
Fluzone Intradermal is a clear, slightly opalescent suspension for injection.
Neither antibiotics nor preservative are used in the manufacture of Fluzone Intradermal.
The Fluzone Intradermal microinjection system is not made with natural rubber latex.
Fluzone Intradermal is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2014-2015 influenza season: A/California/07/2009 X-179A (H1N1), A/Texas/50/2012 X-223A (H3N2), and B/Massachusetts/02/2012 (B Yamagata lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2.
| Quantity (per dose) |
|
|---|---|
| Ingredient | Fluzone Intradermal 0.1 mL Dose |
|
|
| Active Substance: Split influenza virus, inactivated strains*: | 27 mcg HA total |
| A (H1N1) | 9 mcg HA |
| A (H3N2) | 9 mcg HA |
| B | 9 mcg HA |
| Other: | |
| Sodium phosphate-buffered isotonic sodium chloride solution | QS† to appropriate volume |
| Formaldehyde | ≤20 mcg |
| Octylphenol ethoxylate | ≤50 mcg |
| Gelatin | None |
| Preservative | None |
Sources
Fluzone Intradermal Manufacturers
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Sanofi Pasteur Inc.
![Fluzone Intradermal (Influenza A Virus A/california/7/2009 X-179a (H1n1) Antigen (Formaldehyde Inactivated), Influenza A Virus A/texas/50/2012 X-223a (H3n2) Antigen (Formaldehyde Inactivated), And Influenza B Virus B/massachusetts/2/2012 Bx-51b Antigen (Formaldehyde Inactivated)) Injection, Suspension [Sanofi Pasteur Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Fluzone Intradermal | Sanofi Pasteur Inc.
For intradermal use only 2.1 Dose and ScheduleFluzone Intradermal should be administered as a single 0.1 mL injection by the intradermal route in adults 18 through 64 years of age.
2.2 AdministrationInspect Fluzone Intradermal visually for particulate matter and/or discoloration prior to administration. If either of these conditions exist, the vaccine should not be administered.
The preferred site of injection is the skin in the region of the deltoid.
Fluzone Intradermal should not be combined through reconstitution or mixed with any other vaccine.
Gently shake the microinjection system before administering the vaccine.
1. Remove Needle Cap
Remove the needle cap from the microinjection system.
2. Hold Microinjection System Between Thumb and Middle Finger
Hold the system by placing the thumb and middle finger only on the finger pads, the index finger remains free. Do not place fingers on the windows.
3. Insert Needle Rapidly and Perpendicular to the Skin
Insert the needle perpendicular to the skin, in the region of the deltoid, in a short, quick movement.
4. Inject Using the Index Finger
Once the needle has been inserted, maintain light pressure on the surface of the skin and inject using the index finger to push on the plunger. Do not aspirate. Once the intradermal vaccine has been administered, a wheal may be visible at the injection site.
5. Remove Needle from Skin and Activate Needle Shield by Pushing Firmly on Plunger
Remove the needle from the skin. Direct the needle away from you and others. With the same hand, push very firmly with the thumb on the plunger to activate the needle shield. You will hear a click when the shield extends to cover the needle.
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