IPOL (poliovirus type 1 antigen (formaldehyde inactivated), poliovirus type 2 antigen (formaldehyde inactivated), and poliovirus

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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)

Available from:

Sanofi Pasteur Inc.

INN (International Name):

POLIOVIRUS TYPE 1 ANTIGEN - UNII:0LVY784C09)

Composition:

POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) 40 [D'ag'U] in 0.5 mL

Administration route:

INTRAMUSCULAR

Therapeutic indications:

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

Product summary:

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.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

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.
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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