May 25, 2017
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Afluria Quadrivalent

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Afluria Quadrivalent 2016

QUADRIVALENT, for Intramuscular Injection


AFLURIA QUADRIVALENT, Influenza 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. AFLURIA QUADRIVALENT 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 continuous flow zonal 230 centrifugation. 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.

AFLURIA QUADRIVALENT is standardized according to USPHS requirements for the 2016-2017 influenza season and is formulated to contain 60 mcg hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA for each of the four influenza strains recommended for the 2016-2017 Northern Hemisphere influenza season: A/California/7/2009 (H1N1), NYMC X-181, A/Hong Kong/4801/2014 (H3N2), NYMC X-263B, B/Phuket/3073/2013 and B/Brisbane/60/2008.

Thimerosal, a mercury derivative, is not used in the manufacturing process for the single dose presentation. This presentation does not contain 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 AFLURIA QUADRIVALENT 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 (0.5 mcg). From the manufacturing process, each 0.5 mL dose may also contain residual amounts of sodium taurodeoxycholate (≤ 10 ppm), ovalbumin (< 1 mcg), sucrose (< 10 mcg), neomycin sulfate (≤ 62 nanograms [ng]), polymyxin B (≤ 11 ng), and beta-propiolactone (≤ 1.5 ng).

The rubber tip cap and plunger used for the preservative-free, single-dose syringes and the rubber stoppers used for the multi-dose vial were not made with natural rubber latex.

Last reviewed on RxList: 10/19/2016
This monograph has been modified to include the generic and brand name in many instances.

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