|
Indication |
Immunity against influenza disease caused by
panemic (H1N1) 2009 virus. |
|
Vaccine |
package insert |
package insert |
package insert |
package insert |
package insert |
|
Manufacturers |
CSL Limited |
Novartis |
sanofi pasteur |
GlaxoSmith
Kline |
MedImmune |
|
Viability |
Inactivated
|
Inactivated
|
Inactivated |
Inactivated
|
Live |
|
Dose |
0.5 mL |
0.5 mL |
0.5 mL
0.25mL for 6-35 mos |
0.5 mL |
0.2 mL (0.1 mL per nostril) |
|
Recommended Age |
18 years and older |
4 years and older |
6 months and older |
18 years and older |
2-49 years old |
|
Route |
Intramuscular
|
Intramuscular
|
Intramuscular |
Intramuscular
|
Nasal |
|
Dose form |
Suspension |
Suspension |
Suspension |
Suspension |
Suspension |
|
Appearance |
Colorless to slightly opalescent |
Slightly opalescent |
Clear to slightly opalescent |
Colorless to slightly opalescent |
Colorless to pale yellow liquid; clear to
slightly cloudy |
|
Concentration (per 0.5 mL) |
A/California/7/2009 (H1N1)v-like virus, 15 mcg
|
A/California/7/2009 (H1N1)v-like virus, 15 mcg |
A/California/7/2009 (H1N1)v-like virus, 15 mcg |
A/California/7/2009 (H1N1)v-like virus, 15 mcg
|
A/California/7/2009
(H1N1)v, Each 0.2 mL dose contains 106.5-7.5
FFUs |
|
Preservatives |
Single-dose: preservative free
Multi-dose: Thimerosal, 24.5 mcg mercury
|
Single-dose:
≤ 1 mcg mercury
Multi-dose: Thimerosal, 24.5 mcg mercury
|
Single-dose: no thimerosal
Multi-dose: Thimerosal, 25 mcg mercury
|
Multi-dose: Thimerosal, 25 mcg mercury
|
None |
|
Adjuvant |
None |
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 Ovalbumin, ≤ 1 mcg
Neomycin, ≤ 2.5 mcg
Beta-ropiolactone, ≤ 0.5 mcg
|
Gelatin, 0.05%
|
|
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
Gentamicin sulfate, <0.015 mcg/mL
|
|
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
nanograms
|
May contain residual amounts
of:
Ovalbumin, ≤1 mcg
Polymyxin, ≤3.75 mcg
Neomycin, ≤2.5 mcg
Beta-ropiolactone, ≤0.5 mcg
Nonylphenol ethoxylate, ≤0.015%w/v |
May contain residual amounts
of:
Egg proteins
Gelatin, 0.05% as a stabilizer
Formaldehyde, ≤100 mcg
Polyethylene glycol p-isooctylphenyl ether, ≤0.02%
Sucrose,
≤2.0% |
May contain residual amounts
of:
Ovalbumin, ≤1mcg
Formaldehyde, ≤25 mcg
Sodium deoxycholate,
≤50 mcg
|
Gentamicin sulfate, <0.015 mcg/mL
Gelatin (hydrolyzed porcine), 2.00 mg
Egg proteins
Arginine, 2.42 mg
|
|
Media |
Allantoic fluid of embryonated
chicken eggs
|
Allantoic fluid of embryonated
chicken eggs |
Allantoic fluid of embryonated
chicken eggs |
Allantoic fluid of embryonated
chicken eggs
|
Specific pathogen-free (SPF)eggs |
|
Packaging |
Prefilled single-dose (0.5 mL) syringe
5 mL
multi-dose vial |
Prefilled single-dose (0.5 mL) syringe
10-dose vial |
Prefilled syringe (0.25 and 0.5 mL)
10-dose and
Single-dose vial |
10-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 |
|
updated Nov 2009 |
