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

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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)

Tilgjengelig fra:

A-S Medication Solutions

Administreringsrute:

INTRAMUSCULAR

Indikasjoner:

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

Produkt oppsummering:

Product: 50090-1693 NDC: 50090-1693-0 5 mL in a VIAL, MULTI-DOSE / 1 in a PACKAGE

Autorisasjon status:

Biologic Licensing Application

Preparatomtale

IPOL- POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED), POLIOVIRUS
TYPE 2
ANTIGEN (FORMALDEHYDE INACTIVATED), AND POLIOVIRUS TYPE 3 ANTIGEN
(FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION
A-S MEDICATION SOLUTIONS
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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 vaccine concentrates
diluted w