|
Proprietary Name
|
Afluria
|
Agriflu
|
Fluarix
|
Flublock
|
Flucelvax
|
FluLaval
|
Flumist
|
Fluvirin
|
Fluzone
|
Fluzone High-Dose
|
Fluzone
Intradermal
|
|
Manufacturers
|
CSL Limited
|
Novartis
|
GlaxoSmithKline
|
Protein Sciences Corp
|
Novartis
|
GlaxoSmithKline
|
MedImmune,
Wyeth
|
Novartis
|
sanofi pasteur
|
sanofi pasteur
|
sanofi pasteur
|
|
Viability
|
Inactivated
|
Inactivated
|
Inactivated
|
|
|
Inactivated
|
Live
|
Inactivated
|
Inactivated
|
|
|
|
Approved
Ages
|
5 years* and older
|
18 years and older
|
3 years and older
|
18-49 yrs
|
18 yrs and older
|
18 year and older
|
2-49 years
|
4 years and older
|
6 mos and older
|
65 yrs and older
|
18-64 yrs
|
|
Pediatric Dose
|
5-8 yrs:
No prior flu vax: 2
doses ≥1 mth apart;
0.5 mL each
Prior flu vax: 1 dose;
0.5 mL
≥9
years: 0.5 mL
|
NA
|
3-<9 yrs:
No prior flu vax: 2
doses ≥1 mth apart;
0.5 mL each
Prior flu vax: 1 dose;
0.5 mL
≥9
years: 0.5 mL
|
NA
|
NA
|
NA
|
2-8 yrs:
No prior flu vax: 2
doses ≥1 mth apart;
0.2 mL each (0.1
mL per nostril)
Prior flu vax: 1 dose;
0.2 mL (0.1 mL per
nostril)
|
4-8 yrs:
No prior flu vax: 2
doses ≥1 mth apart;
0.5 mL each
Prior flu vax: 1 dose;
0.5 mL
|
6-35 mos: 0.25 mL
≥
3 yrs: 0.5 mL
|
NA
|
NA
|
|
Adult Dose
|
0.5 mL
|
0.5 mL
|
0.5 mL
|
0.5 mL
|
0.5 mL
|
0.5 mL
|
9-49 yrs: 0.2 mL (0.1 mL
per nostril)
|
0.5 mL
|
0.5 mL
|
0.5 mL
|
0.1 mL
|
|
Route
|
Intramuscular
|
Intramuscular
|
Intramuscular
|
Intramuscular
|
Intramuscular
|
Intramuscular
|
Nasal
|
Intramuscular
|
Intramuscular
|
Intramuscular
|
Intradermal
|
|
Dose form
|
Solution
|
Solution
|
Solution
|
Solution
|
Solution
|
Solution
|
Solution
|
Solution
|
Solution
|
Solution
|
Solution
|
|
Appearance
|
Colorless to slightly
opalescent
|
Clear
|
Colorless to slightly
opalescent
|
Clear and colorless
|
Slightly opalescent
|
Translucent to whitish
opalescent
|
Colorless to pale yellow
liquid; clear to
slightly cloudy
|
Slightly opalescent
|
Clear and slightly
opalescent
|
Clear and slightly
opalescent
|
Clear and slightly
opalescent
|
|
Concentration (per 0.5
mL)
|
A/California/7/2009,
NYMC X-181 (H1N1), 15
mcg
A/Victoria/361/2011
(H3N2), IVR-165, 15 mcg
B/Hubei-Wujiagang/
158/2009, NYMC BX-39 (a
B/Wisconsin/1/2010-like
strain), 15 mcg
|
A/California/7/2009,
NYMC X-181 (H1N1), 15
mcg
A/Victoria/210/2009,
NYMC X-187 (H3N2),
15 mcg
B/Brisbane/60/2008, 15
mcg
|
A/Christchurch/16/2010
NIB-74XP (H1N1) (an
A/California/7/2009-like
virus), 15 mcg
A/Victoria/361/2011
IVR-165 (H3N2), 15 mcg
B/Hubei-Wujiagang/
158/2009 NYMC BX-39 (a
B/Wisconsin /1/2010-like
virus), 15 mcg
|
A/California/7/2009
(H1N1), 15 mcg
A/Victoria/361/2011
(H3N2), 15 mcg
B/Wisconsin/1/2010, 15
mcg
|
A/Brisbane/10/2010
(H1N1) (an
A/California/7/2009-like
virus), 15 mcg
A/Victoria/361/2011
IVR-165 (H3N2), 15 mcg
B/Wisconsin/1/2010, 15
mcg
|
A/California/7/2009,
NYMC X-181 (H1N1), 15
mcg
A/Victoria/361/2011
IVR-165 (H3N2), 15 mcg
B/Hubei-Wujiagang/
158/2009 NYMC BX-39, 15
mcg
|
Each 0.2 mL dose
contains 106.5-7.5
FFUs of each:
A/California/7/2009,
(H1N1)
A/Victoria/361/2011
(H3N2)
B/Wisconsin/1/2010
|
A/Christchurch/16/2010,
NIB-74 (H1N1), 15 mcg
A/Victoria/361/2011,
IRV-165 (H3N2), 15 mcg
B/Hubei-Wujiagang/
158/2009, NYMC BX-39, 15
mcg
|
A/California/07/2009
X-179A (H1N1), 15 mcg
A/Victoria/361/2011,
NYMC X-187 (H3N2),
15 mcg
B/Texas/6/2011, 15 mcg
|
A/California/07/2009
(H1N1), 60 mcg
A/Victoria/261/2011,
(H3N2), 60 mcg
B/Texas/6/2011, 60 mcg
|
A/California/07/2009
X-179A (H1N1),
9 mcg
A/Victoria/210/2009,
NYMC X-187 (H3N2),
9 mcg
B/Brisbane/60/2008,
9 mcg
|
|
Excipients (per 0.5 mL dose)
|
Sodium chloride, 4.1 mg
Monobasic sodium
phosphate, 80 mcg
Dibasic sodium
phosphate, 300 mcg
Monobasic potassium
phosphate, 20 mcg
Potassium chloride, 20
mcg
Calcium chloride, 1.5
mcg
May contain residual
amounts of:
Sodium taurodeoxycholate,
≤ 10 ppm
Ovalbumin, ≤1 mcg
Neomycin sulfate, ≤ 3 ng
Polymyxin B, ≤0.5 ng
Beta-propiolactone, ≤2
ng
|
May contain residual
amounts of:
Egg proteins, <0.4 mcg
Formaldehyde, ≤10 mcg
Polysorbate 80, ≤50 mcg
CTAB, ≤12 mcg
Neomycin, ≤0.02 mcg
Kanamycin, ≤0.03 mcg
|
Octoxynol-10 (TRITON®
X-100), ≤0.085 mg
α-tocopheryl hydrogen
succinate, ≤0.1 mg
Polysorbate 80 (Tween
80), ≤0.415 mg
May contain residual
amounts of:
Hydrocortisone,
≤0.0016 mcg
Gentamicin sulfate,
≤0.15 mcg
Ovalbumin, ≤0.05 mcg
Formaldehyde, ≤5 mcg
Sodium deoxycholate, ≤50
mcg
|
Sodium chloride, 4.4 mg
Monobasic sodium
phosphate, 0.195 mcg)
Dibasic sodium
phosphate, 1.3 mg
Polysorbate 20
(Tween®20), 27.5 mcg
May also contain
residual amounts of:
Baculovirus and host
cell proteins, ≤ 28.5
mcg
Cellular DNA, ≤ 10 ng
Triton X-100, ≤ 100 mcg
|
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
Betapropiolactone, ≤ 0.5
mcg
|
May contain residual
amounts of:
Egg proteins, residual
Sodium deoxycholate, ≤50
mcg
Formaldehyde, ≤25 mcg
Thimerosal, <25 mcg
mercury
|
[per 0.2 mL dose]
Monosodium glutamate,
0.188 mg
Gelatin (hydrolyzed
porcine), 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
|
May contain residual
amounts of:
Ovalbumin,
≤1 mcg
Polymyxin, ≤3.75 mcg
Neomycin, ≤2.5 mcg
Betapropiolactone, ≤0.5
ng
Nonylphenol ethoxylate,
≤0.015% w/v
|
Gelatin, 0.05%
Formaldehyde, ≤100 mcg
Octylphenol Ethoxylate,
≤150 mcg
Sodium
phosphate-buffered
isotonic sodium chloride
solution, "quantity
sufficient to
appropriate volume"
Thimerosal, 25 mcg
mercury (none in
Pediatric Dose)
|
Formaldehyde, ≤100 mcg
Octylphenol Ethoxylate,
≤250 mcg
Sodium
phosphate-buffered
isotonic sodium chloride
solution, "quantity
sufficient to
appropriate volume"
|
Formaldehyde, ≤20
mcg
Octylphenol Ethoxylate,
≤50 mcg
Sodium
phosphate-buffered
isotonic sodium chloride
solution, "quantity
sufficient to
appropriate volume"
|
|
Adjuvant
|
None
|
None
|
None
|
None
|
|
None
|
None
|
None
|
None
|
None
|
None
|
|
Allergens
|
May contain residual
amounts of:
Sodium taurodeoxycholate,
≤ 10 ppm
Ovalbumin, ≤1 mcg
Neomycin sulfate, ≤3 ng
Polymyxin B, ≤0.5 ng
Beta-propiolactone, <2
ng
Thimerosal, 24.5 mcg of
mercury [from multi-dose
vial]
|
May contain residual
amounts of:
Egg proteins, <0.4 mcg
Formaldehyde, ≤10 mcg
Polysorbate 80, ≤50 mcg
CTAB, ≤12 mcg
Neomycin, ≤0.02 mcg
Kanamycin, ≤0.03 mcg
Latex, may be in syringe
tip cap
|
May contain residual
amounts of:
Hydrocortisone,
≤0.0016 mcg
Gentamicin sulfate,
≤0.15 mcg
Ovalbumin, ≤0.05 mcg
Formaldehyde, ≤5 mcg
Sodium deoxycholate, ≤50
mcg
Natural latex rubber in
tip cap of the prefilled
syringes
|
|
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
|
Gentamicin sulfate,
<0.015 mcg/mL
Gelatin (hydrolyzed
porcine), 2.00 mg
Egg proteins (≤0.24 mcg
ovalbumin)
|
May contain residual
amounts of:
Ovalbumin,
≤1 mcg
Polymyxin, ≤3.75 mcg
Neomycin, ≤2.5 mcg
Betapropiolactone, ≤0.5
ng
Nonylphenol ethoxylate,
≤0.15% w/v
|
Egg proteins, residual
Gelatin, 0.05%
Thimerosal, 25 mcg
mercury only in
multi-dose vial
|
Egg proteins, residual
|
Egg proteins, residual
|
|
Preservatives
|
Single-dose:
preservative free
Multi-dose: Thimerosal,
24.5 mcg of mercury
|
No preservatives
|
No preservatives
|
No preservatives
|
None
|
Thimerosal, 25 mcg
mercury
|
None
|
Single-dose:
≤ 0.1 mcg mercury
Multi-dose: Thimerosal,
25 mcg of mercury
|
Single-dose: No
preservatives
Multi-dose: Thimerosal,
25 mcg of mercury
|
None
|
None
|
|
Media
|
Allantoic fluid of
embryonated chicken eggs
|
Allantoic fluid of
embryonated hen eggs
|
Embryonated chicken eggs
|
Serum-free medium
composed of
chemically-defined
lipids, vitamins, amino
acids, and mineral salts
|
Madin Darby Canine
Kidney (MDCK)
|
Allantoic
fluid of embryonated hen
eggs
|
Specific pathogen-free
(SPF) embryonated eggs
|
Allantoic fluid of
embryonated hen eggs
|
Allantoic fluid of
embryonated hen eggs
|
Allantoic fluid of
embryonated hen eggs
|
Allantoic fluid of
embryonated hen eggs
|
|
Packaging
|
10 prefilled single-dose
(0.5 mL) syringe
5 mL (10-dose)
multi-dose vial
|
Prefilled single-dose
(0.5 mL) syringe in
package of 10
|
Prefilled syringe (0.5
mL)
|
Prefilled single-dose
(0.5 mL) syringe in
package of 10
|
Prefilled single-dose
(0.5 mL) syringe in
package of 10
|
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
|
FZ: Prefilled syringe
(0.25 and 0.5 mL),
Single-dose vial,
10-dose multi-vial
|
Prefilled syringe
|
Prefilled
microinjection system
|
|
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
|
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
|
2 to 8° C (36-46° F)
Do not freeze
|
|
Package
Insert date
|
April 2012
|
Oct 2010
|
May 2012
|
Dec 2012
|
2012
|
Jul 2012
|
Aug 2012
|
Jul 2012
|
Jun 2012
|
May 2012
|
May 2012
|
|
updated
April 2013
|
|
|
*
U.S.
ACIP recommends children
younger than 9 not
receive this vaccine
because of an increased
risk of febrile seizures
in children aged 6 mos -
4 yrs on the day of
vaccination to the day
after
|
|
|
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|
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|
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