Fluzone® Intradermal Quadrivalent is indicated for active
immunization for the prevention of influenza disease caused by influenza A
subtype viruses and type B viruses contained in the vaccine. Fluzone
Intradermal Quadrivalent is approved for use in persons 18 through 64 years of
DOSAGE AND ADMINISTRATION
For intradermal use only
Dose And Schedule
Fluzone Intradermal Quadrivalent should be administered
as a single 0.1 mL injection by the intradermal route in adults 18 through 64
years of age.
Inspect Fluzone Intradermal Quadrivalent 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. Note: A potential way to make vaccination more efficient is to
have the patient place the hand of the arm being immunized on his/her hip, so
the arm bends at the elbow. This can help create a more accessible angle to the
skin in the deltoid region.
Fluzone Intradermal Quadrivalent should not be combined
through reconstitution or mixed with any other vaccine.
1. Gently shake the device and remove needle cap
To prepare for vaccination, gently shake the device and
remove needle cap before administering the vaccine.
2. Position the device in your hand between the thumb
and middle finger, keeping the index finger free
Hold the device by placing the thumb and middle finger on
the finger pads above device window. Keep the index finger free.
3. Gently pierce the skin over the deltoid region
Using light pressure, gently pierce the skin
perpendicular to the deltoid region.
4. Press the plunger to inject the vaccine
Using index finger, gently press the plunger to inject
the vaccine. Do not aspirate. When the plunger stops, vaccination is complete.
Note: Excessive pressure on the plunger may prematurely activate the needle
shield on the patient's arm. Because the vaccine is injected into the skin, a
wheal (superficial bump) and/or redness may be visible at the injection site.
5. Activate the needle shield and dispose
Remove the needle from the skin. Direct the needle away
from you and others. 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. Dispose the device in an appropriate container.
Dosage Forms And Strengths
Fluzone Intradermal Quadrivalent is a suspension for
Fluzone Intradermal Quadrivalent is supplied in a
single-dose prefilled microinjection system, 0.1 mL, for adults 18 through 64
years of age.
Single-dose prefilled microinjection system, 0.1 mL (NDC
49281-710-48) (not made with natural rubber latex). Supplied as package of 10
Storage And Handling
Store Fluzone Intradermal Quadrivalent refrigerated at 2°
to 8°C (35° to 46°F). DO NOT FREEZE. Discard if vaccine has been frozen.
Do not use after the expiration date shown on the label.
Manufactured by:Â Sanofi Pasteur Inc., Swiftwater PA
18370 USA. Revised: Jun 2016