Indication

Active immunity against influenza viruses

Proprietary Name

Fluvirin

Fluzone

FluLaval

Flumist

Manufacturers

Novartis

sanofi pasteur

MedImmune, Wyeth

Viability

Inactivated

Inactivated

Inactivated

Live

Dose

0.5 mL

0.5 mL

0.2 mL (0.1 mL per nostril)

Route

Intramuscular

Intramuscular

Nasal

Dose form

Solution

Solution

Solution

Appearance

Slightly opalescent

Clear and 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), an A/Brisbane/10/2007-like strain, 15 mcg

B/Florida/4/2006, 15 mcg

A/Brisbane/59/ 2007(H1N1), 15 mcg

A/Uruguay/716/2007 ( A/Brisbane/10/2007-like strain (H3N2), 15 mcg

B/Florida/4/2006, 15 mcg

A/Brisbane/59/2007 (H1N1)-like virus (A/Brisbane/59/2007 IVR-148), 15 mcg

A/Brisbane/10/2007 (H3N2)-like virus (A/Uruguay/716/2007 NYMC X-175C), 15 mcg

B/Florida/4/2006-like virus (B/Brisbane/3/2007), 15 mcg

A/Brisbane/59/2007 (H1N1)-like virus (A/Brisbane/59/2007 IVR-148), 15 mcg

A/Brisbane/10/2007 (H3N2)-like virus (A/Uruguay/716/2007 NYMC X-175C), 15 mcg

B/Florida/4/2006-like virus (B/Brisbane/3/2007), 15 mcg

Each 0.2 mL dose contains 10^6.5-7.5 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/Florida/4/2006

Preservatives

Single-dose prefilled syringe: preservative free

Mulit-dose vial: Thimerosal, 25 mcg

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)

None

Adjuvant

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

Ovalbumin, ≤0.1 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

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

Beta-propiolactone, <25 nanograms

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

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

 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

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

FREEZE

≤ -15° C (5° F)

updated Mar 09