December 1, 2015
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Influenza A H1N1 Monovalent Vaccine

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Influenza A H1N1 Monovalent Vaccine

Influenza A
(H1N1) Intramuscular Injection


Influenza A (H1N1) 2009 Monovalent Vaccine, for intramuscular injection, is a sterile, clear, colorless to slightly opalescent suspension with some sediment that resuspends upon shaking to form a homogeneous suspension. Influenza A (H1N1) 2009 Monovalent Vaccine is prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs. Following harvest, the virus is purified in a sucrose density gradient using a continuous flow zonal centrifuge. The purified virus is inactivated with beta-propiolactone, and the virus particles are disrupted using sodium taurodeoxycholate to produce a “split virion”. The disrupted virus is further purified and suspended in a phosphate buffered isotonic solution.

Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg hemagglutinin (HA) per 0.5 mL dose of influenza A/California/7/2009 (H1N1)v-like virus.

Thimerosal, a mercury derivative, is not used in the manufacturing process for the single dose presentations; therefore these products contain no preservative. The multi-dose presentation contains thimerosal, added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.

A single 0.5 mL dose of Influenza A (H1N1) 2009 Monovalent Vaccine contains sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (1.5 mcg). A single 0.25 mL dose of Influenza A (H1N1) 2009 Monovalent Vaccine contains half of these quantities. From the manufacturing process, each 0.5 mL dose may also contain residual amounts of sodium taurodeoxycholate ( ≤ 10 ppm), ovalbumin ( ≤ 1 mcg), neomycin sulfate ( ≤ 0.2 picograms [pg]), polymyxin B ( ≤ 0.03 pg), and beta-propiolactone ( < 25 nanograms).

The rubber tip cap and plunger used for the preservative-free, single-dose syringes and the rubber stoppers used for the multi-dose vial contain no latex.

Last reviewed on RxList: 11/30/2015
This monograph has been modified to include the generic and brand name in many instances.

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