boostrix polio

Ülke: Singapur

Dil: İngilizce

Kaynak: HSA (Health Sciences Authority)

Aktif bileşen:

Diphtheria toxoid

Mevcut itibaren:

GLAXOSMITHKLINE PTE LTD

ATC kodu:

J07CA02

Doz:

2.5 Lf/0.5 ml

Farmasötik formu:

INJECTION, SUSPENSION

Uygulama yolu:

INTRAMUSCULAR

Reçete türü:

Prescription Only

Tarafından üretildi:

GlaxoSmithKline Biologicals s.a.

Yetkilendirme tarihi:

2006-02-14

Bilgilendirme broşürü

three purified pertussis antigens [pertussis toxoid (PT), filamentous
hemagglutinin (FHA) and pertactin (PRN/69 kiloDalton outer membrane
protein)] adsorbed onto aluminium salts. It 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 of pertussis toxin, and formaldehyde treatment of FHA and
PRN.
The diphtheria toxoid, tetanus toxoid and acellular pertussis
components
are adsorbed onto aluminium salts.
The three polioviruses are cultivated on a continuous VERO cell line,
purified
and inactivated with formaldehyde.
BOOSTRIX
™
 POLIO meets the World Health Organisation requirements for
the manufacture of biological substances, of diphtheria, tetanus,
pertussis
combined vaccines, and of inactivated poliomyelitis vaccines.
A 0.5 ml dose of vaccine contains not less than 2 IU (2.5 Lf) of
adsorbed
diphtheria toxoid, not less than 20 IU (5 Lf) of adsorbed tetanus
toxoid, 8
μg of PT, 8 μ of FHA, 2.5 μg of pertactin, 40 D antigen units of
type 1
(Mahoney), 8 D antigen units of type 2 (MEF-1) and 32 D antigen units
of
type 3 (Saukett) of the polio virus.
3. PHARMACEUTICAL FORM
Suspension for injection.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
A single 0.5 ml dose of the vaccine is recommended.
BOOSTRIX
™
 POLIO may be administered from the age of four years onwards.