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Institute for Vaccine Safety

Johns Hopkins Bloomberg School of Public Health

615 N. Wolfe Street

Room W5041

Baltimore, MD 21205

www.vaccinesafety.edu

 

 

 

Components of
H1N1 Influenza A Vaccines 2009/10
Excipients Table
Allergens Table
Components Table
 

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

 

This page was last updated on June 09, 2016

2009 Institute for Vaccine Safety