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Drug Information for Poliovirus Vaccine Inactivated IPOL (Sanofi Pasteur Inc.): DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL - Vial
- PRINCIPAL DISPLAY PANEL - Syringe
- Liens externes liés à Poliovirus Vaccine Inactivated IPOL (Sanofi Pasteur Inc.)
IPOL®, Poliovirus Vaccine Inactivated, produced by Sanofi Pasteur SA, is a sterile suspension of three types of poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). IPOL vaccine is a highly purified, inactivated poliovirus vaccine with enhanced potency. Each of the three strains of poliovirus is individually grown in vero cells, a continuous line of monkey kidney cells cultivated on microcarriers.1,2 The cells are grown in Eagle MEM modified medium, supplemented with newborn calf serum tested for adventitious agents prior to use, originated from countries free of bovine spongiform encephalopathy. For viral growth the culture medium is replaced by M-199, without calf serum. This culture technique and improvements in purification, concentration and standardization of poliovirus antigen produce a more potent and consistent immunogenic vaccine than the inactivated poliovirus vaccine (IPV) available in the US prior to 1988.3,4
After clarification and filtration, viral suspensions are concentrated by ultrafiltration, and purified by three liquid chromatography steps; one column of anion exchanger, one column of gel filtration and again one column of anion exchanger. After re-equilibration of the purified viral suspension, with Medium M-199 and adjustment of the antigen titer, the monovalent viral suspensions are inactivated at +37°C for at least 12 days with 1:4000 formalin.
Each dose (0.5 mL) of trivalent vaccine is formulated to contain 40 D antigen units of Type 1, 8 D antigen units of Type 2, and 32 D antigen units of Type 3 poliovirus. For each lot of IPOL vaccine, D-antigen content is determined in vitro using the D-antigen ELISA assay and immunogenicity is determined by in vivo testing in animals. IPOL vaccine is produced from vaccine concentrates diluted with M-199 medium. Also present are 0.5% of 2-phenoxyethanol and a maximum of 0.02% of formaldehyde per dose as preservatives. Neomycin, streptomycin and polymyxin B are used in vaccine production, and although purification procedures eliminate measurable amounts, less than 5 ng neomycin, 200 ng streptomycin and 25 ng polymyxin B per dose may still be present. The residual calf serum protein is less than 1 ppm in the final vaccine.
The vaccine is clear and colorless and should be administered intramuscularly or subcutaneously.
- Drug Information Provided by National Library of Medicine (NLM).