Infanrix-penta

Country: New Zealand

Bahasa: Inggeris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Diphtheria toxoid, adsorbed 30 [iU]; Hepatitis B surface antigen, recombinant 10ug; Pertactin 8ug; Pertussis filamentous haemagglutinin 25ug; Pertussis toxoid, adsorbed 25ug; Polio virus type 1 40 DAgU (/dose); Polio virus type 2 8 DAgU (/dose); Polio virus type 3 32 DAgU (/dose); Tetanus toxoid, adsorbed 40 [iU]

Boleh didapati daripada:

GlaxoSmithKline NZ Limited

INN (Nama Antarabangsa):

Diphtheria toxoid, adsorbed 30 IU

Dos:

0.5 mL

Borang farmaseutikal:

Suspension for injection

Komposisi:

Active: Diphtheria toxoid, adsorbed 30 [iU] Hepatitis B surface antigen, recombinant 10ug Pertactin 8ug Pertussis filamentous haemagglutinin 25ug Pertussis toxoid, adsorbed 25ug Polio virus type 1 40 DAgU (/dose) Polio virus type 2 8 DAgU (/dose) Polio virus type 3 32 DAgU (/dose) Tetanus toxoid, adsorbed 40 [iU] Excipient: Aluminium hydroxide Aluminium phosphate Formaldehyde Glycine Medium 199 Monobasic potassium phosphate Neomycin sulfate Polymyxin B sulfate Polysorbate 20 Potassium chloride Sodium chloride Sodium phosphate (32P) Water for injection

Unit dalam pakej:

Syringe, glass, single dose, 0.5 mL

Kelas:

Prescription

Jenis preskripsi:

Prescription

Dikeluarkan oleh:

GSK Vaccines GmbH

Tanda-tanda terapeutik:

INFANRIX®-penta is indicated for immunisation against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis in infants from the age of 6 weeks and may also be given to infants who received a first dose of hepatitis B vaccine at birth.

Ringkasan produk:

Package - Contents - Shelf Life: Syringe, glass, single dose - 0.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, glass, 10 x 0.5ml doses - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, single dose, - 0.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Tarikh kebenaran:

1999-08-24

Ciri produk

 
INFANRIX
®
-_PENTA_ DATASHEET 

NAME OF THE MEDICINE 

INFANRIX
®
-_PENTA_ 
Combined diphtheria, tetanus, acellular pertussis, hepatitis B and
inactivated polio vaccine. 

QUALITATIVE AND QUANTITATIVE COMPOSITION 

INFANRIX
®
-_penta_ contains diphtheria toxoid, tetanus toxoid, three purified
pertussis 
antigens 
[pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin
(PRN; 69 
kiloDalton outer membrane protein)
] and the purified major surface antigen (HBsAg) of the 
hepatitis B virus (HBV), adsorbed on aluminium salts. It also contains
three types of 
inactivated polio viruses (type 1: Mahoney strain; type 2: MEF-1
strain; type 3: Saukett 
strain). 

The tetanus and diphtheria toxoids are obtained by formaldehyde
treatment of purified 
_Corynebacterium diphtheriae_
 and_ Clostridium tetani_ toxins. The acellular pertussis
vaccine 
components are obtained by extraction and purification from phase
I _Bordetella pertussis _
cultures, followed by irreversible detoxification of the pertussis
toxin by glutaraldehyde and 
formaldehyde treatment, and formaldehyde treatment of FHA and PRN. The
diphtheria 
toxoid, tetanus toxoid and acellular pertussis components are adsorbed
onto aluminium 
salts. The DTPa-HBV-IPV components are formulated in saline and
contain 2-
phenoxyethanol. 

The surface antigen of the HBV is produced by culture
of genetically-engineered yeast 
cells  _(Saccharomyces cerevisiae) _which carry the gene coding for
the major surface 
antigen of the HBV.  This HBsAg expressed in yeast cells is purified
by several physico-
chemical steps.  The HBsAg assembles spontaneously, in the absence of
chemical 
treatment, into spherical particles of 20 nm in average diameter
containing non-
glycosylated HBsAg polypeptide and a lipid matrix consisting mainly of
phospholipids.  
Extensive tests have demonstrated that these particles display the
characteristic 
properties of the natural HBsAg. 

The three polioviruses are cultivated on�