INFANRIX-IPV VACCINE

Country: Սինգապուր

language: անգլերեն

source: HSA (Health Sciences Authority)

active_ingredient:

DIPHTHERIA TOXOID

MAH:

GLAXOSMITHKLINE PTE LTD

ATC_code:

J07CA02

dosage:

min 30 iu/0.5 ml

pharmaceutical_form:

INJECTION

administration_route:

INTRAMUSCULAR

prescription_type:

Prescription Only

manufactured_by:

GLAXOSMITHKLINE BIOLOGICALS SA

authorization_date:

2003-04-25

PIL

_ _

1_ _

INFANRIX
TM
-IPV

COMBINED DIPHTHERIA-TETANUS-ACELLULAR
PERTUSSIS AND INACTIVATED POLIO

QUALITATIVE AND QUANTITATIVE COMPOSITION

_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 poliomyelitis vaccines. 
A 0.5 ml dose of vaccine contains not less than 25 Lf (
 min. 30 IU) of adsorbed diphtheria 
toxoid, not less than 10 Lf (
 min. 40 IU) of adsorbed tetanus toxoid, 25 µg
of PT, 25 µg of 
FHA, 8 µg of pertactin, 40 D antigen units of type 1 (Mahoney),
8 D antigen units of type 2 
(MEF-1) and 32 D antigen units of type 3 (Saukett) of the polio
virus. 

PHARMACEUTICAL FORM

Suspension for injection. 

CLINICAL PARTICULARS

INDICATIONS

_INFANRIX_
_TM_
_-IPV_ is indicated for active immunisation in infants from the
ag