Medical Provider Single Use Ez Flu Shot 2013-2014

Medical Provider Single Use Ez Flu Shot 2013-2014

Medical Provider Single Use Ez Flu Shot 2013-2014 Recall

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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.

Table 6: Fluzone Quadrivalent Ingredients
Ingredient Quantity
(per dose)
Fluzone Quadrivalent
0.25 mL Dose
Fluzone Quadrivalent
0.5 mL Dose
*
per United States Public Health Service (USPHS) requirement
Quantity Sufficient
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

Medical Provider Single Use Ez Flu Shot 2013-2014 Manufacturers


  • Medchem Manufacturing Inc. Dba Enovachem
    Medical Provider Single Use Ez Flu Shot 2013-2014 (Influenza A Virus A/christchurch/16/2010 Nib-74 (H1n1) Antigen (Propiolactone Inactivated), Influenza A Virus A/victoria/361/2011 Ivr-165 (H3n2) Antigen (Propiolactone Inactivated), Influenza B Virus B/hubei-wujiagang/158/2009 Bx-39 Antigen (Propiolactone Inactivated) And Isopropyl Alcohol) Kit [Medchem Manufacturing Inc. Dba Enovachem]
  • Medchem Manufacturing Inc. Dba Enovachem
    Medical Provider Single Use Ez Flu Shot 2013-2014 (Influenza A Virus A/christchurch/16/2010 Nib-74 (H1n1) Antigen (Propiolactone Inactivated), Influenza A Virus A/victoria/361/2011 Ivr-165 (H3n2) Antigen (Propiolactone Inactivated), Influenza B Virus B/hubei-wujiagang/158/2009 Bx-39 Antigen (Propiolactone Inactivated) And Isopropyl Alcohol) Kit [Medchem Manufacturing Inc. Dba Enovachem]

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