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<Home> <Newsletter> <Third Issue> <Vaccine Safety> <Influenza A (H1N1) 2009 Monovalent Vaccines Descriptions and Ingredients>
VACCINE
SAFETY Influenza A (H1N1) 2009 Monovalent Vaccines Descriptions and Ingredients The Description and Ingredients information on this page is excerpted from the package inserts for each of the licensed Influenza A (H1N1) 2009 Monovalent Vaccines. Click on the below "Package Insert" links to view the complete original documentation provided by each manufacturer. INJECTIBLE VACCINES CSL Limited
The single-dose formulation is preservative-free; thimerosal, a mercury derivative, is not used in the manufacturing process for this formulation. The multi-dose formulation 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). From the manufacturing process, each 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. Package Insert - CSL Limited Influenza A (H1N1) 2009 Monovalent Vaccine Novartis Vaccines
and Diagnostics Limited The 0.5-mL prefilled syringe presentation is formulated without preservative. Thimerosal, a mercury derivative used during manufacturing, is removed by subsequent purification steps to a trace amount (<_ 1 mcg mercury per 0.5-mL dose). The 5-mL multidose vial formulation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5-mL dose from the multidose vial contains 25 mcg mercury. Each dose from the multidose vial or from the prefilled syringe may also contain residual amounts of egg proteins (<_ 1 mcg ovalbumin), polymyxin (<_ 3.75 mcg), neomycin (<_ 2.5 mcg), betapropiolactone (not more than 0.5 mcg) and nonylphenol ethoxylate (not more than 0.015% w/v). The multidose vial stopper and the syringe stopper/plunger do not contain latex. Package Insert - Novartis Vaccines and Diagnostics Limited Influenza A (H1N1) 2009 Monovalent Vaccine Sanofi Pasteur,
Inc. 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. 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. Package Insert - Sanofi Pasteur, Inc Influenza A (H1N1) 2009 Monovalent Vaccine INTRANASAL (NASAL SPRAY) MedImmune
LLC Package Insert - MedImmune LLC Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Contact (800) 835-4709
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