|
Indication |
Active immunity against influenza viruses |
|
Proprietary Name |
Afluria |
Agriflu |
Fluvirin
|
Fluzone |
Fluarix |
FluLaval |
Flumist |
|
Manufacturers |
CSL Limited |
Novartis |
Novartis |
sanofi pasteur |
GlaxoSmithKline |
GlaxoSmithKline |
MedImmune,
Wyeth |
|
Viability |
Inactivated
|
Inactivated |
Inactivated
|
Inactivated |
Inactivated |
Inactivated |
Live |
|
Dose |
0.5 mL |
0.5mL |
0.5 mL |
0.5 mL |
0.5 mL |
0.5 mL |
0.2 mL (0.1 mL per nostril) |
|
Recommended Age |
18 years and older |
18 years and older |
4 years and older |
6 months and older |
18 years and older |
18 years and older |
2-49 years old |
|
Route |
Intramuscular
|
Intramuscular |
Intramuscular
|
Intramuscular |
Intramuscular |
Intramuscular |
Nasal |
|
Dose form |
|
|
Solution |
Solution |
|
|
Solution |
|
Appearance |
Colorless to slightly opalescent |
Clear |
Slightly opalescent |
Clear and slightly opalescent |
Colorless to slightly opalescent |
Colorless to slightly opalescent |
Colorless to pale yellow liquid; clear to
slightly cloudy |
|
Concentration (per 0.5 mL) |
A/Brisbane/59/2007 (H1N1), 15 mcg
A/Uruguay/716/2007 (H3N2), 15 mcg
B/Brisbane/60/2008, 15 mcg
|
A/Brisbane/59/2007 (H1N1), 15 mcg
A/Uruguay/716/2007 (H3N2), 15 mcg
B/Brisbane/60/2008, 15 mcg
|
A/Brisbane/59/ 2007(H1N1), 15
mcg
A/Uruguay/716/2007 (H3N2), 15 mcg
B/Brisbane/60/2008, 15 mcg
|
A/Brisbane/59/ 2007(H1N1), 15
mcg
A/Uruguay/716/2007 (H3N2), 15 mcg
B/Brisbane/60/2008, 15 mcg
|
A/Brisbane/59/ 2007(H1N1), 15
mcg
A/Uruguay/716/2007 (H3N2), 15 mcg
B/Brisbane/60/2008, 15 mcg
|
A/Brisbane/59/ 2007(H1N1), 15
mcg
A/Uruguay/716/2007 (H3N2), 15 mcg
B/Brisbane/60/2008, 15 mcg
|
Each 0.2 mL dose contains 106.5-7.5
FFUs of each:
A/South Dakota/6/2007 (H1N1)
(A/Brisbane/59/2007-like)
A/Uruguay/716/2007 (H3N2)
(A/Brisbane/10/2007-like)
B/Brisbane/60/2008
|
|
Preservatives |
Single-dose prefilled syringe: preservative free
Mulit-dose vial:
Thimerosal, 24.5 mcg of mercury
|
No preservatives
|
Thimerosal, single-dose syringe contains trace
amounts
Thimerosal, multidose vials, 25 mcg |
5 mL vial contains
Thimerosal, 25 mcg
No Preservative in prefilled syringes or single
dose vial |
Thimerosal,
≤1 mcg mercury (trace amount) |
Thimerosal, 25 mcg |
None |
|
Adjuvant |
None |
|
None |
None |
|
|
None |
|
Excipients |
Sodium chloride, 4.1 mg
Monobasic sodium phosphate,
80 mcg
Diasic sodium phosphate, 300
mcg
Monobasic potassium
phosphate, 20 mcg
Potassium chloride, 20 mcg
Calcium chloride, 1.5 mcg
|
|
Phosphate- buffered saline,
≤1 mcg Polymyxin,
≤3.75 mcg Neomycin,
≤2.5 mcg |
Gelatin, 0.05%
Residual formaldehyde, ≤
100 mcg
Formaldehyde, ≤.02% Sucrose,
≤2.0%
|
Octoxynol-10 (TRITON® X-100), ≤0.120 mg
α-tocopheryl
hydrogen succinate, ≤0.1 mg
Polysorbate 80 (Tween 80), ≤0.380 mg |
Formaldehyde, ≤25 mcg |
Monosodium glutamate, 0.188 mg
Hydrolyzed porcine gelatin, 2.00 mg
Arginine, 2.42 mg
Sucrose, 13.68 mg
Dibasic potassium phosphate, 2.26 mg
Monosodium phosphate, 0.96 mg
|
|
Allergens |
May contain residual amounts
of:
Sodium taurodeoxycholate, ≤
10 ppm
Ovalbumin, ≤ 1 mcg
Neomycin sulfate, ≤ 0.2 pg
Polymyxin B, ≤ 0.03 pg
Betapropiolactone, <25
nanograms
|
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
|
Egg proteins, residual
Neomycin and polymyxin B added during production
but undetectable in the final product |
Egg proteins, residual
Gelatin, 0.05% as a stabilizer
|
Egg
proteins, residual
Tip
cap and rubber stopper contain dry natural latex
rubber |
Egg
proteins, residual
Sodium deoxycholate, ≤50mcg |
Gentamicin sulfate, <0.015 mcg/mL
Gelatin (hydrolyzed porcine), 2.00 mg
Egg proteins |
|
Media |
Allantoic fluid of embryonated
chicken eggs
|
Allantoic fluid of embryonated
chicken eggs
|
Extraembryonic (allantoic) fluids of chicken
embryo |
Extraembryonic (allantoic) fluids of chicken
embryo |
Embryonated chicken eggs |
|
Specific pathogen-free (SPF) embryonated hen
eggs |
|
Packaging |
Prefilled single-dose (0.5 mL) syringe
5 mL
multi-dose vial |
Single-dose (0.5mL)
pre-filled syringe in package of 10 pre-filled
syringes per carton without needles
|
Prefilled single-dose (0.5 mL) syringe
10-dose vial |
Prefilled syringe (0.25 and 0.5 mL)
10-dose and
Single-dose vial |
Prefilled syringe |
5 mL
multi-dose vial |
10 pre-filled, single-use sprayers |
|
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 |
|
updated Nov 2009 |
