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Institute for Vaccine Safety

Johns Hopkins Bloomberg School of Public Health

615 N. Wolfe Street

Room W5041

Baltimore, MD 21205

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Components of
Seasonal Influenza Vaccines 2013/14
Excipients Table
Allergens Table
Components Table
Components: Afluria-Flublok
Components: Fluzone all formulas
     

Proprietary Name

Flucelvax FluLaval FluLaval Quad Flumist Quad Fluvirin

Manufacturers

Novartis GlaxoSmithKline GlaxoSmithKline MedImmune, Wyeth Novartis

Viability

Inactivated

Inactivated

Inactivated

Live

Inactivated

Approved Ages

18 years and older

3 years and older

3 years and older

2-49 years

4 years and older

Pediatric Dose

NA

≥3 years: 0.5 mL

≥3 years: 0.5 mL

≥2 yrs: 0.2 mL

≥2 yrs: 0.2 mL

Adult Dose

0.5 mL

0.5 mL

0.5 mL

0.5 mL

0.5 mL

Route

Intramuscular

Intramuscular

Intramuscular

Nasal

Intramuscular

Dose form

Solution

Solution

Solution

Solution

Solution

Appearance

Slightly opalescent

Translucent to whitish opalescent

Translucent to whitish opalescent

Colorless to pale yellow liquid; clear to slightly cloudy

Slightly opalescent

Concentration (per 0.5 mL)

A/Brisbane/10/2010 (H1N1), an A/California/7/2009-like virus, 15 mcg

A/Texas/50/2012, NYMC X-223A (H3N2) (an A/Victoria/361/2011-like virus), 15 mcg

B/Massachusetts/2/2012, 15 mcg

A/California/7/2009 NYMC X-179A (H1N1), 15 mcg

A/Texas/50/2012 NYMC X-223A (H3N2), an A/Victoria/361/2011-like virus, 15 mcg

B/Massachusetts/2/2012 NYMC BX-51B, 15 mcg

A/California/7/2009 NYMC X-179A (H1N1), 15 mcg

A/Texas/50/2012 NYMC X-223A (H3N2), an A/Victoria/361/2011-like virus, 15 mcg

B/Massachusetts/2/2012 NYMC BX-51B, 15 mcg

B/Brisbane/60/2008, 15 mcg

Each 0.2 mL dose contains 106.5-7.5 FFUs of each:

A/California/7/2009, (H1N1)

A/Texas/50/2012 (H3N2), an A/Victoria/361/2011-like virus

B/Massachusetts/2/2012, B/Yamagata/16/88 lineage

B/Brisbane/60/2008, B/Victoria/2/87 lineage

 

A/Christchurch/16/2010, NIB-74 (H1N1), an A/California/7/2009-like virus, 15 mcg

A/Texas/50/2012, NYMC X-223 (H3N2), an A/Victoria/361/2011-like virus, 15 mcg

B/Massachusetts/2/2012, 15 mcg

Excipients (per 0.5 mL dose)

May contain residual amounts of:

MDCK cell protein, ≤8.4 mcg

Protein other than HA, ≤ 120 mcg

MDCK cell DNA, ≤ 10 ng

Polysorbate 80, ≤ 1125 mcg

CTAB, ≤ 13.5 mcg

Beta-propiolactone, ≤0.5 mcg

Thimerosal, <25 mcg mercury

May contain residual amounts of:

Egg proteins, residual

Sodium deoxycholate, ≤50 mcg

Formaldehyde, ≤25 mcg

Thimerosal, <25 mcg mercury

α-tocopheryl hydrogen succinate, ≤320 mcg

Polysorbate 80, ≤887 mcg

May contain residual amounts of:

Egg proteins, residual

Sodium deoxycholate, ≤50 mcg

Formaldehyde, ≤25 mcg

[per 0.2 mL dose]

Monosodium glutamate, 0.188 mg

Gelatin (hydrolyzed procine), 2.00 mg

Arginine, 2.42 mg

Sucrose, 13.68 mg

Dibasic potassium phosphate, 2.26 mg

Monobasic potassium phosphate, 0.96 mg

Gentamicin sulfate,  <0.015 mcg/mL

Ovalbumin, ≤0.24 mcg

EDTA, <0.37 mcg

Thimerosal, single-dose: ≤1 mcg mercury; multi-dose: 25 mcg of mercury

May contain residual amounts of:

Egg proteins, residual

 Polymyxin, ≤3.75 mcg

 Neomycin, ≤2.5 mcg

 Betapropiolactone, ≤0.5 ng

Nonylphenol ethoxylate, ≤0.015% w/v

Adjuvant

None

None

None

None

None

Allergens

Betapropiolactone, ≤ 0.5 mcg

Tip caps of the pre-filled syringes may contain natural rubber latex

May contain residual amounts of:

Egg proteins, residual

Sodium deoxycholate, ≤50 mcg

Formaldehyde, ≤25 mcg

Thimerosal, 25 mcg mercury

May contain residual amounts of:

Egg proteins, residual

Sodium deoxycholate, ≤50 mcg

Formaldehyde, ≤25 mcg

Thimerosal, 25 mcg mercury

Gentamicin sulfate, <0.015 mcg/mL

Gelatin (hydrolyzed porcine), 2.00 mg

Egg proteins (≤0.24 mcg ovalbumin)

May contain residual amounts of:

Egg proteins, residual

Sodium deoxycholate, ≤50 mcg

Formaldehyde, ≤25 mcg

Thimerosal, 25 mcg mercury

Preservatives

None

Thimerosal, 25 mcg mercury

Thimerosal, 25 mcg mercury

No preservatives

Single-dose: ≤1 mcg mercury

Multi-dose: Thimerosal, 25 mcg of mercury

Media

Madin Darby Canine Kidney (MDCK)

Allantoic fluid of embryonated hen eggs

Allantoic fluid of embryonated hen eggs

Specific pathogen-free (SPF) embryonated eggs

Allantoic fluid of embryonated hen eggs

Packaging

Prefilled single-dose (0.5 mL) syringe in package of 10

5 mL (10-dose) multi-dose vial

5 mL (10-dose) multi-dose vial)

10 pre-filled, single-use sprayers

Prefilled single-dose (0.5 mL) syringe

5 mL (10-dose) multi-dose vial

Routine Storage

2 to 8 C (36-46 F)

Do not freeze

2 to 8 C (36-46 F)

Do not freeze

2 to 8 C (36-46 F)

Do not freeze

2 to 8 C (36-46 F)

Do not freeze

2 to 8 C (36-46 F)

Do not freeze

Package Insert date

July 2013

Aug 2013

Aug 2013

Aug 2013

Feb 2013

This page was last updated on October 18, 2013

2014 Institute for Vaccine Safety