IMOVAX POLIO VACCINE

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

INACTIVATED POLIOMYELITIS VIRUS,TYPE 3; INACTIVATED POLIOMYELITIS VIRUS,TYPE 2; INACTIVATED POLIOMYELITIS VIRUS,TYPE 1

Available from:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Name):

INACTIVATED POLIOMYELITIS VIRUS,TYPE 3; INACTIVATED POLIOMYELITIS VIRUS,TYPE 2; INACTIVATED POLIOMYELITIS VIRUS,TYPE 1

Units in package:

0.5ml mL; 0.5 ml mL

Manufactured by:

SANOFI PASTEUR

Patient Information leaflet

NONE

Summary of Product characteristics

MY/IMO/0223/SPC0722
1
N
AME OF THE MEDICINAL PRODUCT
IMOVAX POLIO, SUSPENSION FOR INJECTION IN PREFILLED SYRINGE
POLIOMYELITIS VACCINE (INACTIVATED)
2
Q
UALITATIVE 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
polymycin B (see section
4.3).
Excipients with known effect:
Phenylalanine…………………………………………………………………….12.5
micrograms
Ethanol……………………………………………………….………………………2
milligrams
For the full list of excipients, see section 6.1
3
P
HARMACEUTICAL FORM
Suspension for injection in prefilled syringe.
IMOVAX POLIO is a clear and colourless suspension.
MY/IMO/0223/SPC0722
4
C
LINICAL PARTICULARS
4.1
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_PEDIATRIC POPULATION _
_Primary vaccination _
One dose at the age of 2 and 4 months.
_Booster _
One dose at the age of 11 months.
From 6 weeks of age, IMOVAX POLIO may be administered following the
6-, 10-, 14-week
schedule, as per the recommendations of the Expanded Programme on
Immunization of the World
Health Organisation.
_ADULT POPULATION _
_Primary vaccination _
2 doses of 0.5 ml at an interval of two months.
_Booster: _
First booster: 8 to 12 months after