IMOVAX POLIO

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

POLIOVIRUS TYPE 1 INACTIVATED; POLIOVIRUS TYPE 2 INACTIVATED; POLIOVIRUS TYPE 3 INACTIVATED

Commercializzato da:

SANOFI ISRAEL LTD

Codice ATC:

J07BF

Forma farmaceutica:

SUSPENSION FOR INJECTION

Composizione:

POLIOVIRUS TYPE 1 INACTIVATED 40 U/VIAL; POLIOVIRUS TYPE 2 INACTIVATED 8 U/VIAL; POLIOVIRUS TYPE 3 INACTIVATED 32 U/VIAL

Via di somministrazione:

S.C, I.M

Tipo di ricetta:

Required

Prodotto da:

SANOFI PASTEUR, FRANCE

Gruppo terapeutico:

POLIOMYELITIS VACCINES

Indicazioni terapeutiche:

Prophylaxis of poliomyelitis.

Data dell'autorizzazione:

2021-07-31

Scheda tecnica

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IMOVAX POLIO, SUSPENSION FOR INJECTION IN A PREFILLED SYRINGE
OR MULTIDOSE POLIOMYELITIS VACCINE (INACTIVATED)
THERAPEUTIC INDICATIONS
Prophylaxis of poliomyelitis.
DESCRIPTION
IMOVAX POLIO, Poliovirus Vaccine Inactivated, produced by Sanofi
Pasteur, is a sterile
suspension of three types of poliovirus: Type 1 (Mahoney), Type 2
(MEF-1), and Type 3 (Saukett).
IMOVAX POLIO 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. 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.
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 IMOVAX
POLIO vaccine, D-antigen content is determined
_in vitro _
using the D-antigen ELISA assay.
IMOVAX POLIO vaccine is produced from vaccine concentrates diluted
with M-199 medium.
Also present are 0.5% of 2- phenoxyethanol and a maximum o