País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 0LVY784C09) (POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:0LVY784C09), POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 23JE9KDF4R) (POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:23JE9KDF4R), POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 459ROM8M9M) (POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:459ROM8M9M)
Sanofi Pasteur Inc.
POLIOVIRUS TYPE 1 ANTIGEN - UNII:0LVY784C09)
POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) 40 [D'ag'U] in 0.5 mL
INTRAMUSCULAR
IPOL vaccine is indicated for active immunization of infants (as young as 6 weeks of age), children, and adults for the prevention of poliomyelitis caused by poliovirus Types 1, 2, and 3. (28) It is recommended that all infants (as young as 6 weeks of age), unimmunized children, and adolescents not previously immunized be vaccinated routinely against paralytic poliomyelitis. (29) Following the eradication of poliomyelitis caused by wild poliovirus from the Western Hemisphere (including North and South America) (30), an IPV-only schedule was recommended to eliminate VAPP. (7) All children should receive four doses of IPV at ages 2, 4, 6 to 18 months, and 4 to 6 years. OPV is no longer available in the US and is not recommended for routine immunization. (7) Previous clinical poliomyelitis (usually due to only a single poliovirus type) or incomplete immunization with OPV are not contraindications to completing the primary series of immunization with IPOL vaccine. Children of all ages should have their immuni
Multi-dose vial , 5mL: NDC 49281-860-78. Supplied as package: NDC 49281-860-10. The vaccine is stable if stored in the refrigerator at 2°C to 8°C (35°F to 46°F). The vaccine must not be frozen. Protect from light.
Biologic Licensing Application
IPOL- POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED), POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED), AND POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION SANOFI PASTEUR INC. ---------- POLIOVIRUS VACCINE INACTIVATED IPOL AHFS Category: 80:12 IPV Rx only DESCRIPTION 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 bovine 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 bovine 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. IPOL vaccine is produced from vacc Leer el documento completo