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Questions & Answers
Side Effects & Adverse Reactions
Warnings
For external use only. Flammable, keep away from fire or flame.
Do not use with electrocautery procedures, or in/near eyes.
Stop use if irritation or redness develops.
If irritating condition persists for more than 72 hours, consult a physician.
Keep out of reach of children. If swallowed, seek medical attention and/or contact a Poison Control Center immediately.
Do not use with electrocautery procedures, or in/near eyes.
Stop use if irritation or redness develops.
If irritating condition persists for more than 72 hours, consult a physician.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Fluzone® Quadrivalent is an inactivated quadrivalent influenza virus vaccine indicated for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
Fluzone Quadrivalent is approved for use in persons 6 months of age and older.
Use
For preparation of the skin prior to injection
History
There is currently no drug history available for this drug.
Other Information
Fluzone Quadrivalent (Influenza Virus Vaccine) for intramuscular injection is an inactivated influenza virus 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 Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation.
Fluzone Quadrivalent suspension for injection is clear and slightly opalescent in color.
Neither antibiotics nor preservative are used in the manufacture of Fluzone Quadrivalent.
The Fluzone Quadrivalent prefilled syringe and vial presentations are not made with natural rubber latex.
Fluzone Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain 60 micrograms (mcg) HA per 0.5 mL dose in the recommended ratio of 15 mcg HA of each of the following four influenza strains recommended for the 2013-2014 influenza season: A/California/07/2009 X-179A (H1N1), A/Texas/50/2012 X-223A (H3N2) (an A/Victoria/361/2011-like virus), B/Massachusetts/02/2012 (B Yamagata lineage), and B/Brisbane/60/2008 (B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 6.
Ingredient | Quantity (per dose) |
|
---|---|---|
Fluzone Quadrivalent 0.25 mL Dose |
Fluzone Quadrivalent 0.5 mL Dose |
|
|
||
Active Substance: Split influenza virus, inactivated strains*: | 30 mcg HA total | 60 mcg HA total |
A (H1N1) | 7.5 mcg HA | 15 mcg HA |
A (H3N2) | 7.5 mcg HA | 15 mcg HA |
B/(Victoria lineage) | 7.5 mcg HA | 15 mcg HA |
B/(Yamagata lineage) | 7.5 mcg HA | 15 mcg HA |
Other: | ||
Sodium phosphate-buffered isotonic sodium chloride solution | QS† to appropriate volume | QS† to appropriate volume |
Formaldehyde | ≤50 mcg | ≤100 mcg |
Octylphenol ethoxylate | ≤125 mcg | ≤250 mcg |
Preservative | None | None |
Sources
Medical Provider Single Use Ez Flu Shot 2013-2014 Manufacturers
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Medchem Manufacturing Inc. Dba Enovachem
Medical Provider Single Use Ez Flu Shot 2013-2014 | Medchem Manufacturing Inc. Dba Enovachem
For intramuscular use only 2.1 Dose and ScheduleThe dose and schedule for Fluzone Quadrivalent are presented in Table 1.
Table 1: Dose and Schedule for Fluzone Quadrivalent Age Dose Schedule "-" Indicates information is not applicable * 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 6 months through 35 months One or two doses*, 0.25 mL each If 2 doses, administer at least 4 weeks apart 36 months through 8 years One or two doses*, 0.5 mL each If 2 doses, administer at least 4 weeks apart 9 years and older One dose, 0.5 mL - 2.2 AdministrationInspect Fluzone Quadrivalent visually for particulate matter and/or discoloration prior to administration. If any of these defects or conditions exist, the vaccine should not be administered.
Before administering a dose of vaccine, shake the prefilled syringe or single-dose vial. Withdraw the vaccine using a sterile needle and syringe.
The preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in persons 12 months through 35 months of age, or the deltoid muscle in persons ≥36 months of age. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.
Do not administer this product intravenously, intradermally, or subcutaneously.
Fluzone Quadrivalent vaccine should not be combined through reconstitution or mixed with any other vaccine.
Directions
Prepare site by wiping vigorously
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Medchem Manufacturing Inc. Dba Enovachem
Medical Provider Single Use Ez Flu Shot 2013-2014 | Medchem Manufacturing Inc. Dba Enovachem
2.1 Preparation for AdministrationShake the syringe vigorously before administering the vaccine and shake the multidose vial preparation each time before withdrawing a dose of vaccine.
Inspect FLUVIRIN® syringes and multidose vials visually for particulate matter and/or discoloration prior to administration [see DESCRIPTION (11)]. If either of these conditions exists, the vaccine should not be administered.
Between uses, return the multidose vial to the recommended storage conditions between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen.
A separate sterile syringe and needle must be used for each injection to prevent transmission of infectious agents from one person to another. Needles should be disposed of properly and not recapped.
It is recommended that small syringes (0.5 mL or 1 mL) should be used to minimize any product loss.
For intramuscular use only.
2.2 Recommended Dose and ScheduleThe dose and schedule for Fluvirin is presented in Table 1.
TABLE 1 Fluvirin Dose and Schedulea 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.
"-" indicates information is not applicable
Age Dose Schedule 4 years through 8 years One or two doses a, 0.5 mL each If 2 doses, administer at least 1 month apart 9 years and older One dose, 0.5 mL -In children, the needle size may range from 7/8 to 1¼ inches, depending on the size of the child's deltoid muscle, and should be of sufficient length to penetrate the muscle tissue. The anterolateral thigh can be used, but the needle should be longer, usually 1 inch.
In adults, a needle of ≥1 inch is preferred because needles <1 inch might be of insufficient length to penetrate muscle tissue in certain adults. The preferred site for intramuscular injection is the deltoid muscle of the upper arm. The vaccine should not be injected in the gluteal region or areas where there may be a major nerve trunk.
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