IMOVAX POLIO INJECTION

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Ingredientes activos:

Inactivated Poliomyelitis Virus Type 1 (Mahoney); Inactivated Poliomyelitis Virus Type 2 (MEF-1); Inactivated Poliomyelitis Virus Type 3 (Saukett)

Disponible desde:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Código ATC:

J07BF03

Dosis:

8 D.U.

formulario farmacéutico:

INJECTION

Composición:

Inactivated Poliomyelitis Virus Type 1 (Mahoney) 40 D.U./0.5 mL; Inactivated Poliomyelitis Virus Type 2 (MEF-1) 8 D.U./0.5 mL; Inactivated Poliomyelitis Virus Type 3 (Saukett) 32 D.U./0.5 mL

Vía de administración:

SUBCUTANEOUS, INTRAMUSCULAR

tipo de receta:

Prescription Only

Fabricado por:

SANOFI PASTEUR

Estado de Autorización:

ACTIVE

Fecha de autorización:

1999-01-06

Información para el usuario

IMOVAX POLIO 
POLIOMYELITIS VACCINE (INACTIVATED)  
SUSPENSION FOR INJECTION IN A PREFILLED SYRINGE 

READ THIS ENTIRE LEAFLET CAREFULLY BEFORE GETTING VACCINATED. 
Keep this leaflet until you have completed
the entire  vaccination  regimen. You might  need to 
read it again. 
Follow the advice of your doctor or nurse carefully. If you need more information
or advice, ask 
your doctor or nurse. 
Make sure to complete the entire vaccination regimen. If you do
not,  you may not be completely 
protected. 
The vaccine has been prescribed for you. Do not pass it on to
others. 

THE ACTIVE SUBSTANCES ARE: 

 One dose (0.5 ml) contains 

Poliovirus
#
 type 1, Mahoney strain (inactivated) . . . . . . . . . . . . .
. .40 DU*†

Poliovirus
#
 type 2, MEF-1 strain (inactivated) . . . . . . . . . . . . . .
. . . . . 8 DU*†

Poliovirus
#
 type 3, Saukett strain (inactivated) . . . . . . . . . . .
 32 DU*†

This vaccine is in compliance with
European  Pharmacopoeia requirements and WHO 
recommendations. 

#

cultured on VERO cells 
* 
DU: D-antigen Unit 
† or the equivalent antigenic quantity,
determined by suitable immunochemical method. 

THE OTHER INGREDIENTS ARE:  2-phenoxyethanol,
ethanol, formaldehyde, medium 199 Hanks 
(containing in particular amino acids, mineral salts,
vitamins, glucose, polysorbate 80 and water 
for injections), hydrochloric acid
or sodium hydroxide for pH adjustment. 

PRODUCT OWNER: 

SANOFI PASTEUR SA - 2, avenue Pont Pasteur - 69007 LYON 

1. WHAT IMOVAX POLIO IS AND WHAT IT IS USED FOR 

IMOVAX POLIO is presented  in the form of a  suspension
for injection (0.5 ml) in a prefilled 
syringe with an attached needle or with two separate
needles – box of 1 or 20.  

This vaccine is indicated for the prevention
of poliomyelitis in infants, children a

Ficha técnica

SG/IMO/0423/SPC0722
_ _
_1_
_ _
NAME OF THE MEDICINAL PRODUCT
IMOVAX POLIO, SUSPENSION FOR INJECTION IN PREFILLED SYRINGE
POLIOMYELITIS VACCINE (INACTIVATED)
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 mL) contains:
Poliomyelitis virus (inactivated)
Type 1 (Mahoney
strain)#..............................................................................................................40
DU*
+
Type 2 (MEF-1 strain)#
....................................................................................................................8
DU*
+
Type 3 (Saukett strain)#
................................................................................................................32
DU*
+
This vaccine complies with European Pharmacopoeia requirements and WHO
recommendations.
# produced on VERO cells
* DU: D-antigen unit
+
or equivalent antigenic quantity determined by a suitable
immunochemical method.
IMOVAX
POLIO
may contain traces of neomycin, streptomycin
and
polymyxin B (see section
Contraindications).
Excipients with known effect:
Phenylalanine………………………………………………………………………………….12.5
micrograms
Ethanol………………………………………………………………………………………………2
milligrams
(See section Special warnings and precautions for use).
For the full list of excipients, see section List of excipients.
PHARMACEUTICAL FORM
Suspension for injection in prefilled syringe.
IMOVAX POLIO is a clear and colourless suspension.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
This vaccine is indicated for the prevention of poliomyelitis in
infants, children and adults, for primary
and booster vaccination.
IMOVAX POLIO must be used according to effective official
recommendations.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
•
From the age of 2 months, 3 successive doses of 0.5 mL of IMOVAX POLIO
should be
administered at intervals of one or two months, followed by a first
booster 12 months after the last
dose.
•
_For subsequ