INFANRIX-IPV VACCINE

Country: Malaysia

Language: English

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

Active ingredient:

Diphtheria Toxoid; Tetanus Toxoid; PERTUSSIS TOXOID (PT); PERTACTIN (69 KDA OUTER MEMBRANE PROTEIN-69K); INACTIVATED POLIO VIRUS TYPE 3; INACTIVATED POLIO VIRUS TYPE 2; INACTIVATED POLIO VIRUS TYPE 1; FILAMENTOUS HAEMAGGLUTININ (FHA)

Available from:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (International Name):

Diphtheria Toxoid; Tetanus Toxoid; PERTUSSIS TOXOID (PT); PERTACTIN (69 KDA OUTER MEMBRANE PROTEIN-69K); INACTIVATED POLIO VIRUS TYPE 3; INACTIVATED POLIO VIRUS TYPE 2; INACTIVATED POLIO VIRUS TYPE 1; FILAMENTOUS HAEMAGGLUTININ (FHA)

Units in package:

1ml1Units mL

Manufactured by:

GlaxoSmithKline Biologicals

Patient Information leaflet

Not Applicable

Summary of Product characteristics

1
Infanrix TM-IPV
Combined diphtheria-tetanus-acellular pertussis and inactivated polio
QUALITATIVE AND QUANTITATIVE COMPOSITION
Suspension for injection.
1 dose (0.5 ml) contains:
Diphtheria toxoid 1 not less than 30 International Units (IU) (25 Lf)
Tetanus toxoid 1 not less than 40 International Units (IU) (10 Lf)
Bordetella pertussis antigens
Pertussis toxoid 1 25 micrograms
Filamentous haemagglutinin 1 25 micrograms
Pertactin 1 8 micrograms
Poliovirus (inactivated)
type 1 (Mahoney strain) 2 40 D-antigen unit
type 2 (MEF-1 strain) 2 8 D-antigen unit
type 3 (Saukett strain) 2 32 D-antigen unit
1adsorbed on aluminium hydroxide, hydrated (Al(OH) 3) 0.5 milligrams Al 3+ 2propagated in VERO cells
Infanrix TM-IPV is a turbid white suspension. Upon storage, a white deposit and clear
supernatant can be observed. This does not constitute a sign of deterioration.
Infanrix TM-IPV contains diphtheria toxoid, tetanus toxoid, three purified pertussis antigens
pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN/69 kiloDalton
outer membrane protein) adsorbed on aluminium salts. It contains three types of inactivated
polio viruses (type 1: Mahoney strain; type 2: MEF-1 strain; type 3: Saukett strain).
The diphtheria and tetanus toxoids obtained from cultures of Corynebacterium diphtheriae
and Clostridium tetani are inactivated and purified. The acellular pertussis vaccine
components (PT, FHA and pertactin) are prepared by growing phase I Bordetella pertussis
from which the PT, FHA and pertactin are extracted and purified. FHA and pertactin are
treated with formaldehyde, PT is treated with glutaraldehyde and formaldehyde, and
irreversibly inactivated.
The three polioviruses are cultivated on a continuous VERO cell line, purified and inactivated
with formaldehyde.
The DTPa-IPV components are formulated in saline.
Infanrix TM-IPV meets the World Health Organisation requirements for the manufacture of
biological substances, of diphtheria, tetanus, pertussis and combined vaccines, and of
inactivated poli