BOOSTRIX POLIO SUSPENSION FOR INJECTION

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

Diphtheria toxoid; Filamentous Hemagglutinin (FHA); Inactivated polio virus type 1; Inactivated polio virus type 2; Inactivated polio virus type 3; Pertactin (PRN); Pertussis toxoid (PT); Tetanus toxoid

זמין מ:

GLAXOSMITHKLINE PTE LTD

קוד ATC:

J07CA02

טופס פרצבטיות:

INJECTION, SUSPENSION

הרכב:

Diphtheria toxoid 2.5 Lf/ 0.5 ml - not less than 2 IU; Filamentous Hemagglutinin (FHA) 8 mcg/0.5ml; Inactivated polio virus type 1 40 DU/0.5 ml; Inactivated polio virus type 2 8 DU/0.5 ml; Inactivated polio virus type 3 32 DU/0.5 ml; Pertactin (PRN) 2.5 mcg/0.5 ml; Pertussis toxoid (PT) 8 mcg/0.5 ml; Tetanus toxoid 5.0 Lf/0.5ml - not less than 20 IU

מסלול נתינה (של תרופות):

INTRAMUSCULAR

סוג מרשם:

Prescription Only

תוצרת:

GlaxoSmithKline Biologicals SAS

מצב אישור:

ACTIVE

תאריך אישור:

2020-02-20

מאפייני מוצר

-1-
BOOSTRIX POLIO
DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT) AND
POLIOMYELITIS
(INACTIVATED) VACCINE (ADSORBED, REDUCED ANTIGEN(S) CONTENT)
SUSPENSION FOR INJECTION
QUALITATIVE AND QUANTITATIVE COMPOSITION
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
1
adsorbed on aluminium hydroxide, hydrated (Al(OH)
3
)
0.3 milligrams Al
3+
and aluminium phosphate (AlPO
4
)
0.2 milligrams Al
3+
2
propagated in VERO cells
Boostrix Polio is a turbid white suspension. Upon storage, a white
deposit and clear supernatant
can be observed. This is a normal finding.
CLINICAL INFORMATION
INDICATIONS
Boostrix Polio is indicated for booster vaccination against
diphtheria, tetanus, pertussis and
poliomyelitis of individuals from the age of three years onwards (see
_Posology)_
.
The use of Boostrix Polio should be in accordance with official
recommendations.
DOSAGE AND ADMINISTRATION
POSOLOGY
A single 0.5 ml dose of the vaccine is recommended.
Boostrix Polio may be administered from the age of three years
onwards. Boostrix Polio
should be administered in accordance with official recommendations
and/or local practice
-2-
regarding the use of vaccines with reduced content of
diphtheria toxoid plus tetanus toxoid in
combination with pertussis and poliomyelitis antigens.
Boostrix Polio can be administered to pregnant women during the second
or the third
trimester in accordance with official recommendations (see
_Pregnancy_
and
P
_harmacodynamics_
).
Boostrix Polio may also be administered to adolescents and adults with
unknown vaccination
status or incomplete vaccination against diphtheria, tetanus and
pertussis as part of an
immunisation