BOOSTRIX POLIO SUSPENSION FOR INJECTION

Maa: Malesia

Kieli: englanti

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

Aktiivinen ainesosa:

Diphtheria Toxoid; Tetanus Toxoid; PERTUSSIS TOXOID (PT); INACTIVATED POLIO VIRUS TYPE 3; INACTIVATED POLIO VIRUS TYPE 2; INACTIVATED POLIO VIRUS TYPE 1; FILAMENTOUS HAEMAGGLUTININ (FHA); PERTACTIN (PRN)

Saatavilla:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Kansainvälinen yleisnimi):

Diphtheria Toxoid; Tetanus Toxoid; PERTUSSIS TOXOID (PT); INACTIVATED POLIO VIRUS TYPE 3; INACTIVATED POLIO VIRUS TYPE 2; INACTIVATED POLIO VIRUS TYPE 1; FILAMENTOUS HAEMAGGLUTININ (FHA); PERTACTIN (PRN)

Kpl paketissa:

0.5ml1Units mL

Valmistaja:

GLAXOSMITHKLINE BIOLOGICALS S.A

Pakkausseloste

Not Applicable

Valmisteyhteenveto

-1-
[GSK logo]
BOOSTRIX POLIO
Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis
(inactivated) vaccine (adsorbed, reduced antigen(s) content)
QUALITATIVE AND QUANTITATIVE COMPOSI TION
1 dose (0.5 ml) contains:
Diphtheria toxoid 1 not less than 2 International Units (IU) (2.5 Lf)
Tetanus toxoid 1 not less than 20 International Units (IU) (5 Lf)
Bordetella pertussis antigens Pertussis toxoid 1 8 micrograms Filamentous Haemagglutinin 1 8 micrograms Pertactin 1 2.5 micrograms
Inactivated poliovirus 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
1adsorbed on aluminium hydroxide, hydrated (Al(OH) 3) 0.3 milligrams Al 3+
and aluminium phosphate (AlPO 4) 0.2 milligrams Al 3+
2propagated in VERO cells
Boostrix Polio is a turbid white suspensi on. Upon storage, a white deposit and clear supernatant can
be observed. This is a normal finding.
PHARMACEUTICAL FORM
Suspension for injection.
CLINICAL PARTICULARS
Indications
Boostrix Polio is indicated for booster vaccination against diphtheria, tetanus, pertussis and
poliomyelitis of individuals from the age of four years onwards.
Boostrix Polio is not intended for primary immunisation.