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Indication
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Active immunity against
influenza viruses
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Proprietary Name
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Afluria
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Agriflu
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Fluarix
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FluLaval
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Flumist
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Fluvirin
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Fluzone/High-Dose/Intradermal
see recent changes
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Manufacturers
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CSL Limited
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Novartis
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GlaxoSmithKline
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GlaxoSmithKline
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MedImmune,
Wyeth
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Novartis
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sanofi pasteur
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Viability
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Inactivated
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Inactivated
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Inactivated
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Inactivated
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Live
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Inactivated
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Inactivated
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Approved Ages
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5 years and older
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18 years and older
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3 years and older
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18 year and older
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2-49 years
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4 years and older
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Fluzone:
≥ 6 mos
High-Dose:
≥ 65 yrs
Intradermal: 18-64 y
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Pediatric Dose
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0.5 mL
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NA
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3-8 yrs: 0.5 mL
≥9
years: 0.5 mL
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NA
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2-8 yrs: 0.2 mL (0.1 mL
per nostril)
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0.5 mL
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Fluzone:
6-35 mos: 0.25 mL
≥
3 yrs: 0.5 mL
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Adult Dose
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0.5 mL
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0.5 mL
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0.5 mL
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0.5 mL
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9-49 yrs: 0.2 mL (0.1 mL
per nostril)
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0.5 mL
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Fluzone: 0.5 mL
High-Dose (≥
65 yrs): 0.5 mL
Intradermal (18-64 yrs):
0.1 mL
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Route
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Intramuscular
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Intramuscular
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Intramuscular
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Intramuscular
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Nasal
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Intramuscular
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Intramuscular (except
Intradermal formula)
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Dose form
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Solution
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Solution
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Solution
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Solution
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Solution
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Solution
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Solution
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Appearance
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Colorless to slightly
opalescent
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Clear
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Colorless to slightly
opalescent
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Translucent to whitish
opalescent
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Colorless to pale yellow
liquid; clear to
slightly cloudy
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Slightly opalescent
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Clear and slightly
opalescent
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Concentration (per 0.5
mL)
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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
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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
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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
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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
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Each 0.2 mL dose
contains 106.5-7.5
FFUs of each:
A/California/7/2009,
(H1N1)
A/Perth/16/2009
(H3N2)
B/Brisbane/60/2008
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A/Christchurch/16/2010,
NIB-74 (H1N1), 15 mcg
A/Victoria/210/2009,
NYMC X-187 (H3N2),
15 mcg
B/Brisbane/60/2008, 15
mcg
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A/California/07/2009
X-179A (H1N1), 15 mcg*
A/Victoria/210/2009,
NYMC X-187 (H3N2),
15 mcg*
B/Brisbane/60/2008, 15
mcg*
* 60 mcg each in
High-Dose formula; 9 mcg
each in Intradermal
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Excipients
(per 0.5 mL dose)
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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
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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
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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
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May contain residual
amounts of:
Egg proteins, residual
Sodium deoxycholate, ≤50
mcg
Formaldehyde, ≤25 mcg
Thimerosal, 25 mcg
mercury
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[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
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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
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Gelatin, 0.05% (None in
High-Dose or Intradermal)
Formaldehyde, ≤100 mcg
in Fluzone and
High-Dose; ≤20 mcg
in Intradermal formula
Octylphenol Ethoxylate,
≤150 mcg (≤250 mcg in
high-Dose; ≤50 mcg in
Intradermal)
Sodium
phosphate-buffered
isotonic sodium chloride
solution, "quantity
sufficient to
appropriate volume"
Thimerosal, 25 mcg
mercury (none in
Pediatric, Single-dose
and High-Dose)
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Adjuvant
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None
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None
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None
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None
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None
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None
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None
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Allergens
|
May contain residual
amounts of:
Sodium taurodeoxycholate,
≤ 10 ppm
Ovalbumin, ≤1 mcg
Neomycin sulfate, ≤ 0.2
pg
Polymyxin B, ≤0.03 pg
Beta-propiolactone, <25
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
|
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
|
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% (None in
High-Dose or Intradermal)
Thimerosal, 25 mcg
mercury only in
multi-dose vial (none in
Pediatric, Single-dose,
High-Dose or Intradermal)
Latex, None in
Intradermal; Prefilled
syringe caps may contain
latex
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|
Preservatives
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Single-dose:
preservative free
Multi-dose: Thimerosal,
24.5 mcg of mercury
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No preservatives
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No preservatives
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Thimerosal, 25 mcg
mercury
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None
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Single-dose:
preservative free
Multi-dose: Thimerosal,
25 mcg of mercury
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Single-dose (all forms):
No preservatives
Multi-dose: Thimerosal,
25 mcg of mercury
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Media
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Allantoic fluid of
embryonated chicken eggs
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Allantoic fluid of
embryonated hen eggs
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Embryonated chicken eggs
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Allantoic
fluid of embryonated hen
eggs
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Specific pathogen-free
(SPF) embryonated eggs
|
Allantoic fluid of
embryonated hen eggs
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Allantoic fluid of
embryonated hen eggs
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Packaging
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10 prefilled single-dose
(0.5 mL) syringe
5 mL (10-dose)
multi-dose vial
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Prefilled single-dose
(0.5 mL) syringe in
package of 10
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Prefilled syringe (0.5
mL)
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5 mL (10-dose)
multi-dose vial
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10 pre-filled,
single-use sprayers
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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
High Dose: Prefilled
syringe
Intradermal: Prefilled
microinjection system
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Routine Storage
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2 to 8°
C (36-46°
F)
Do not freeze
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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
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Package Insert date
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Nov 2011
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Oct 2010
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April 2011
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June 2011
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May 2011
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May 2011
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Jan 2012
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updated Jan 2012
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click thumbnail to see
changes since
May 2011
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