INFANRIX IPV+HIB VACCINE

Land: Singapore

Språk: engelska

Källa: HSA (Health Sciences Authority)

Aktiva substanser:

DIPHTHERIA TOXOID (D); FILAMENTOUS HAEMAGGLUTININ (FHA); HIB PURIFIED CAPSULAR POLYSACCHARIDE; PERTACTIN (PRN or 69kDa Outer Membrane Protein); PERTUSSIS TOXOID (PT); POLIO VIRUS TYPE 1 (INACTIVATED); POLIO VIRUS TYPE 2 (INACTIVATED); POLIO VIRUS TYPE 3 (INACTIVATED); TETANUS TOXOID (T)

Tillgänglig från:

GLAXOSMITHKLINE PTE LTD

ATC-kod:

J07CA06

Dos:

min 30IU/0.5ml

Läkemedelsform:

INJECTION

Sammansättning:

DIPHTHERIA TOXOID (D) min 30IU/0.5ml; FILAMENTOUS HAEMAGGLUTININ (FHA) 25mcg/0.5ml; HIB PURIFIED CAPSULAR POLYSACCHARIDE 10 mcg/0.5 ml; PERTACTIN (PRN or 69kDa Outer Membrane Protein) 8mcg/0.5ml; PERTUSSIS TOXOID (PT) 25mcg/0.5ml; POLIO VIRUS TYPE 1 (INACTIVATED) 40DU/0.5ml; POLIO VIRUS TYPE 2 (INACTIVATED) 8DU/0.5ml; POLIO VIRUS TYPE 3 (INACTIVATED) 32DU/0.5ml; TETANUS TOXOID (T) min 40IU/0.5ml

Administreringssätt:

INTRAMUSCULAR

Receptbelagda typ:

Prescription Only

Tillverkad av:

GlaxoSmithKline Biologicals

Bemyndigande status:

ACTIVE

Tillstånd datum:

1999-06-25

Bipacksedel

1 

INFANRIX™-IPV+HIB 
COMBINED DIPHTHERIA-TETANUS-ACELLULAR PERTUSSIS, INACTIVATED
POLIO AND 
_HAEMOPHILUS INFLUENZAE_ TYPE B VACCINE

QUALITATIVE AND QUANTITATIVE COMPOSITION

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 
_Haemophilus influenzae_ type b purified capsular polysaccharide
3

(polyribosylribitol phosphate)

10 micrograms 
conjugated to tetanus toxoid as carrier protein 
approximately 30 micrograms 

1
adsorbed on aluminium hydroxide, hydrated (Al(OH)
3
) 
0.5 milligrams Al
3+ 
2
propagated in VERO cells, purified and inactivated with
formaldehyde 
3
prepared from _Haemophilus influenzae _type b, strain 20,752;
after purification, the conjugate 
is lyophilised in the presence of lactose as stabiliser. 

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, purified and
treated with formaldehyde; 
PT is irreversibly inactivated. 

The DTPa-IPV component of the vaccine is a turbid white suspension.
Upon storage, a white 
deposit and clear supernatant can be observed. 
The Hib component of the vaccine is a white powder. 
PHARMACEUTICAL FORM

Powder and suspension for suspension for injection. 
2 
CLINICAL PARTICULARS

INDICATIONS

_INFANRIX_
_™_
_-IPV+HIB_ is indicated for active immunisation in infants

Produktens egenskaper

1
INFANRIX-IPV+HIB
COMBINED DIPHTHERIA-TETANUS-ACELLULAR PERTUSSIS, INACTIVATED POLIO AND
_HAEMOPHILUS INFLUENZAE_ TYPE B VACCINE
POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 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 (PT)
1
25 micrograms
Filamentous haemagglutinin (FHA)
1
25 micrograms
Pertactin (PRN)
1
8 micrograms
Poliovirus (inactivated) (IPV)
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
_Haemophilus influenzae_ type b purified capsular polysaccharide
3
(polyribosylribitol phosphate) (PRP)
10 micrograms
conjugated to tetanus toxoid as carrier protein
approximately 25 micrograms
1
adsorbed on aluminium hydroxide, hydrated (Al(OH)
3
)
0.5 milligrams Al
3+
2
propagated in VERO cells, purified and inactivated with formaldehyde
3
prepared from _Haemophilus influenzae _type b, strain 20,752; after
purification, the conjugate
is lyophilised in the presence of lactose as stabiliser.
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, purified and
treated with formaldehyde;
PT is irreversibly inactivated.
The Infanrix-IPV component of the vaccine is a turbid white
suspension. Upon storage, a
white deposit and clear supernatant can be observed.
The Hib component of the vaccine is a white powder.
CLINICAL INFORMATION
INDICATIONS
_INFANRIX-IPV+HIB_ is indicated for active immunisation in infants
from the age of 2 months
against diphtheria, tetanus, pertussis, poliomyelitis and _Haemophilus
influenzae_ type b.
_INFANRIX-IPV+HIB_ is also indica