INFANRIX HEXA VACCINE

Country: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ; HEPATITIS B SURFACE ANTIGEN (PURIFIED); HIB PURIFIED CAPSULAR POLYSACCHARIDE BOUND TO TETANUS TOXOID; PERTACTIN (69 kDa OMP); PERTUSSIS TOXOID; POLIOVIRUS TYPE 1 (INACTIVATED); POLIOVIRUS TYPE 2 (INACTIVATED); POLIOVIRUS TYPE 3 (INACTIVATED)

Fáanlegur frá:

GLAXOSMITHKLINE PTE LTD

ATC númer:

J07CA09

Skammtar:

min 30 iu/0.5 ml

Lyfjaform:

INJECTION

Samsetning:

DIPHTHERIA TOXOID min 30 iu/0.5 ml; FILAMENTOUS HAEMAGGLUTININ 25 mcg/0.5 ml; HEPATITIS B SURFACE ANTIGEN (PURIFIED) 10 mcg/0.5 ml; HIB PURIFIED CAPSULAR POLYSACCHARIDE BOUND TO TETANUS TOXOID 10 mcg/0.5 ml; PERTACTIN (69 kDa OMP) 8 mcg/0.5 ml; PERTUSSIS TOXOID 25 mcg/0.5 ml; POLIOVIRUS TYPE 1 (INACTIVATED) 40 du/0.5 ml; POLIOVIRUS TYPE 2 (INACTIVATED) 8 du/0.5 ml; POLIOVIRUS TYPE 3 (INACTIVATED) 32 du/0.5 ml

Stjórnsýsluleið:

INTRAMUSCULAR

Gerð lyfseðils:

Prescription Only

Framleitt af:

GLAXOSMITHKLINE BIOLOGICALS SA

Leyfisstaða:

ACTIVE

Leyfisdagur:

2003-05-07

Upplýsingar fylgiseðill

_GLAXOSMITHKLINE _
_Infanrix hexa_™  
1
INFANRIX HEXA™ 
COMBINED DIPHTHERIA-TETANUS-ACELLULAR PERTUSSIS, HEPATITIS B,
ENHANCED 
INACTIVATED POLIO VACCINE 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)   
Tetanus toxoid
1

not less than 40 International units (IU) 
_Bordetella pertussis_ antigens 
Pertussis toxoid
1

 25 micrograms 
Filamentous Haemagglutinin
1

 25 micrograms 
Pertactin
1
8 micrograms
Hepatitis B surface antigen
2,3
10 micrograms
Poliovirus (inactivated) 
type 1 (Mahoney strain)
4

40 D-antigen unit 
type 2 (MEF-1 strain)
4

8 D-antigen unit 
type 3 (Saukett strain)
4

32 D-antigen unit 
_Haemophilus influenzae_ type b polysaccharide 
10 micrograms 
(polyribosylribitol phosphate)
3

conjugated to tetanus toxoid as carrier protein 
20 - 40 micrograms 
1
adsorbed on aluminium hydroxide, hydrated (Al(OH)
3
) 
0.5 milligrams Al
3+

2
produced in yeast cells (_Saccharomyces cerevisiae_) by recombinant
DNA technology 
3
adsorbed on aluminium phosphate (AlPO
4
) 
0.32 milligrams Al
3+

4
propagated in VERO cells 
The DTPa-HBV-IPV component is presented as a turbid white suspension.
Upon 
storage, a white deposit and clear supernatant can be observed.   
The Hib component is presented as a white powder. 
For excipients, see _List of Excipients_. 
PHARMACEUTICAL FORM 
Powder and suspension for suspension for injection. 
CLINICAL PARTICULARS 

_GLAXOSMITHKLINE _
_ _
_Infanrix hexa_™  

2
INDICATIONS

_Infanrix hexa_
_TM_
 is indicated for primary and booster vaccination of infants
against 
diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis
and _Haemophilus influenzae_ 
type b.  
DOSAGE AND ADMINISTRATION

POSOLOGY 

 
PRIMARY VACCINATION 
The primary vaccination schedule consists of three doses of 0.5 ml.
 There should be 
an interval of at least 1 month

Vara einkenni

_ _
1
INFANRIX HEXA
DIPHTHERIA (D), TETANUS (T), PERTUSSIS (ACELLULAR, COMPONENT) (PA),
HEPATITIS B (RDNA) (HBV), POLIOMYELITIS (INACTIVATED) (IPV) AND
_HAEMOPHILUS INFLUENZAE_ TYPE B VACCINE (ADSORBED)
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)
Tetanus toxoid
1
not less than 40 International Units (IU)
_Bordetella pertussis_ antigens
Pertussis toxoid (PT)
1
25 micrograms
Filamentous Haemagglutinin (FHA)
1
25 micrograms
Pertactin (PRN)
1
8 micrograms
Hepatitis B surface antigen (HBs)
2,3
10 micrograms
Poliovirus (inactivated) (IPV)
type 1 (Mahoney strain)
4
40 D-antigen unit
type 2 (MEF-1 strain)
4
8 D-antigen unit
type 3 (Saukett strain)
4
32 D-antigen unit
_Haemophilus influenzae_ type b polysaccharide
10 micrograms
(polyribosylribitol phosphate, PRP)
3
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
produced in yeast cells (_Saccharomyces cerevisiae_) by recombinant
DNA technology
3
adsorbed on aluminium phosphate (AlPO
4
)
0.32 milligrams Al
3+
4
propagated in VERO cells
The DTPa-HBV-IPV component is presented as a turbid white suspension.
Upon
storage, a white deposit and clear supernatant can be observed. This
is a normal
observation.
The Hib component is presented as a white powder.
For excipients, see _List of Excipients_.
CLINICAL INFORMATION
INDICATIONS
Infanrix hexa is indicated for primary and booster vaccination of
infants and toddlers
from the age of 6 weeks against diphtheria, tetanus, pertussis,
hepatitis B,
poliomyelitis and _Haemophilus influenzae_ type b.
The use of Infanrix hexa should be in accordance with official
recommendations.
_ _
2
DOSAGE AND ADMINISTRATION
POSOLOGY
The primary vaccination schedule consists of three doses (of 0.5 mL)
which should be
administered according to official recommendations (see
_Pharmacodynamics _fo