INFANRIX VACCINE

Country: Սինգապուր

language: անգլերեն

source: HSA (Health Sciences Authority)

active_ingredient:

DIPHTHERIA TOXOID

MAH:

GLAXOSMITHKLINE PTE LTD

ATC_code:

J07AJ51

dosage:

30 iu/0.5 ml

pharmaceutical_form:

INJECTION

administration_route:

INTRAMUSCULAR

prescription_type:

Prescription Only

manufactured_by:

GLAXOSMITHKLINE BIOLOGICALS SA

authorization_date:

1996-05-07

PIL

1 

INFANRIX
TM

DIPHTHERIA (D), TETANUS (T), PERTUSSIS (ACELLULAR, COMPONENT) (PA)
VACCINE 

QUALITATIVE AND QUANTITATIVE COMPOSITION

_INFANRIX_
_TM_
 contains diphtheria toxoid, tetanus toxoid and three purified
pertussis antigens 
[pertussis toxoid (PT), filamentous haemagglutinin (FHA) and 69
kiloDalton outer membrane 
protein (pertactin)] adsorbed onto aluminium salts. 
The diphtheria and tetanus toxins obtained from cultures
of _Corynebacterium diphtheriae_ and 
_Clostridium tetani_ are detoxified and purified. The acellular
pertussis vaccine components 
(PT, FHA and pertactin) are prepared by growing phase I _Bordetella
pertussis_ from which the 
PT and FHA and pertactin are extracted, purified and treated with
formaldehyde; PT is 
irreversibly detoxified. 
The diphtheria toxoid, tetanus toxoid and acellular pertussis vaccine
components are adsorbed 
on aluminium salts. The final vaccine is formulated in saline. 
_INFANRIX_
_TM_
 meets the World Health Organisation requirements for manufacture of
biological 
substances and for diphtheria and tetanus vaccines.
No substances of human origin are used in 
its manufacture. 
A 0.5 ml dose of the vaccine contains not less than 30 International
Units (IU) of diphtheria 
toxoid, 40 IU of tetanus toxoid, 25 mcg of PT, 25 mcg of FHA and
8 mcg of pertactin. 
PHARMACEUTICAL FORM

Suspension for injection. 
CLINICAL PARTICULARS

INDICATIONS

_INFANRIX_
_TM_
 is indicated for active primary immunisation against diphtheria,
tetanus and 
pertussis from the age of 2 months onwards. 
_INFANRIX_
_TM_
 is indicated as a booster dose for children who have previously
been immunised 
with three or four doses of either DTPa vaccine or diphtheria,
tetanus and whole-cell pertussis 
(DTPw) vaccine. 

DOSAGE AND ADMINISTRATION

POSOLOGY 
The recommended dose (0.5 ml) of the vaccine must be administered. 
As vaccination schemes vary from country to country, the schedule
for each country may be