Wednesday, September 16, 2009

Package Insert: Influenza A (H1N1) 2009 Monovalent Vaccine (Novartis Vaccines and Diagnostics Limited)

Sarasota for Vaccination Choice Comment:
Read the fine print, the devil is in the details?

NOTE: This is one of three INJECTABLE H1N1 Vaccines approved by FDA on Sept. 15, 2009. FDA also approved one Intranasal vaccine.


Influenza A (H1N1) 2009 Monovalent Vaccine, a sterile suspension for intramuscular injection, is supplied in two presentations:
• Prefilled single dose syringe, 0.5-mL. Thimerosal, a mercury derivative used during manufacture, is removed by subsequent purification steps to a trace amount (≤ 1 mcg mercury per 0.5-mL dose) (3, 11)
• Multidose vial, 5-mL. Contains thimerosal, a mercury derivative (25 mcg mercury per 0.5-mL dose). Thimerosal is added as preservative. (3,11)

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