INFANRIX HIB INJECTION

Country: Սինգապուր

language: անգլերեն

source: HSA (Health Sciences Authority)

active_ingredient:

DIPHTHERIA TOXOID (D)

MAH:

GLAXOSMITHKLINE PTE LTD

ATC_code:

J07CA

dosage:

min 30IU/0.5ml

pharmaceutical_form:

INJECTION

administration_route:

INTRAMUSCULAR

prescription_type:

Prescription Only

manufactured_by:

GLAXOSMITHKLINE BIOLOGICALS SA

authorization_date:

1999-06-25

PIL

1 
Proposed Package Insert (IDS version 4)  

INFANRIX
TM
-HIB  

1.NAME OF THE MEDICINAL PRODUCT 
_INFANRIX_
_TM_
_-HIB _
Diphtheria, tetanus, acellular pertussis and adsorbed
conjugated _Haemophilus influenzae_ 
type b vaccine. 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
_INFANRIX_
_TM_
_-HIB_ contains diphtheria toxoid, tetanus toxoid and
three purified pertussis 
antigens [pertussis toxoid (PT), filamentous haemagglutinin (FHA)
and pertactin (69 
kiloDalton outer membrane protein)] adsorbed
onto aluminium salts. It also contains purified 
polyribosyl-ribitol-phosphate capsular polysaccharide (PRP) of Hib,
covalently bound to 
tetanus toxoid. 
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 irreversibly
detoxified.   
The diphtheria toxoid, tetanus toxoid and acellular pertussis
vaccine components are 
adsorbed on aluminium salts. The final vaccine is formulated in
saline. 
The Hib polysaccharide is prepared from Hib, strain 20,752
and coupled to tetanus toxoid.  
After purification the conjugate is lyophilised in the presence
of lactose as stabiliser. 
_INFANRIX_
_TM_
_-HIB_ meets the World Health Organisation requirements for
manufacture of 
biological substances, of Hib conjugate vaccines and of diphtheria,
tetanus, pertussis and 
combined vaccines. 
An 0.5 ml dose of the vaccine contains not less than 30
International Units (IU) of diphtheria 
toxoid, not less than 40 IU of adsorbed
tetanus toxoid, 25 mcg of PT, 25 mcg of FHA, 8 mcg 
of pertactin and 10mcg of purified capsular polysaccharide of
Hib covalently bound to 
approximately 30 mcg tetanus toxoid. 

3. PHARMACEUTICAL FORM 
Powder and suspensi