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Influenza A H1N1 Monovalent Vaccine

"The Food and Drug Administration (FDA) recently approved the H1N1 vaccine as an injection and an intranasal spray made by CSL, Sanofi Pasteur, MedImmune and Novartis.

How are the H1N1 vaccines manufactured and are they saf"...

Influenza A H1N1 Monovalent Vaccine

Influenza A (H1N1) 2009
Monovalent Vaccine

DRUG DESCRIPTION

Influenza A (H1N1) 2009 Monovalent Vaccine, an inactivated influenza virus vaccine, for intramuscular use, is prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, polyethylene glycol p-isooctylphenyl ether (Triton® X-100), producing a “split virus”. The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution.

Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009 (H1N1) v-like virus per 0.5 mL dose. Gelatin 0.05% is added as a stabilizer. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg), polyethylene glycol p-isooctylphenyl ether (not more than 0.02%), and sucrose (not more than 2.0%).

There is no thimerosal used in the manufacturing process of the single-dose presentations of Influenza A (H1N1) 2009 Monovalent Vaccine. The multi-dose presentation of Influenza A (H1N1) 2009 Monovalent Vaccine contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose of the multidose presentation contains 25 mcg mercury.

Influenza A (H1N1) 2009 Monvalent Vaccine is a sterile clear to a slightly opalescent suspension.

Antibiotics are not used in the manufacture of Influenza A (H1N1) 2009 Monovalent Vaccine.

All presentations of Influenza A (H1N1) 2009 Monovalent Vaccine do not contain latex.

Last reviewed on RxList: 11/5/2009
This monograph has been modified to include the generic and brand name in many instances.

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