INFANRIX HEXA VACCINE

国: マレーシア

言語: 英語

ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有効成分:

Diphtheria Toxoid; Tetanus Toxoid; PERTUSSIS TOXOID (PT); HAEMOPHILUS INFLUENZA TYPE B CONJUGATE TO; PERTACTIN (69 KDA OUTER MEMBRANE PROTEIN-69K); INACTIVATED POLIO VIRUS TYPE 3; INACTIVATED POLIO VIRUS TYPE 2; INACTIVATED POLIO VIRUS TYPE 1; FILAMENTOUS HAEMAGGLUTININ (FHA); R-DNA HEPATITIS B ANTIGEN

から入手可能:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN（国際名）:

Diphtheria Toxoid; Tetanus Toxoid; PERTUSSIS TOXOID (PT); HAEMOPHILUS INFLUENZA TYPE B CONJUGATE TO; PERTACTIN (69 KDA OUTER MEMBRANE PROTEIN-69K); INACTIVATED POLIO VIRUS TYPE 3; INACTIVATED POLIO VIRUS TYPE 2; INACTIVATED POLIO VIRUS TYPE 1; FILAMENTOUS HAEMAGGLUTININ (FHA); R-DNA HEPATITIS B ANTIGEN

パッケージ内のユニット:

3ml1Units mL; 0.5ml1Units mL

製:

GLAXOSMITHKLINE BIOLOGICALS S.A

情報リーフレット

Not Applicable

製品の特徴

CONFIDENTIAL
1
[GSK logo]
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.
PHARMACEUTICAL FORM
Powder and suspension for suspension for injection.
CLINICAL INFORMATION
Indications
Infanrix hexa is indicated for primary immunisation against
diphtheria, tetanus, pertussis,
hepatitis B, poliomyelitis and Haemophilus influenzae type B in
infants from the age of 6
weeks and may be given to infants who received a first dose of
Hepatitis vaccine at birth.
CONFIDENTIAL
2
Dosage and Administration
Posology
The primary vaccination schedule consists of two or three doses (of
0.5 ml) which should
be a