BOOSTRIX VACCINE

Land: Singapore

Språk: engelska

Källa: HSA (Health Sciences Authority)

Aktiva substanser:

DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ; PERTACTIN; PERTUSSIS TOXOID; TETANUS TOXOID

Tillgänglig från:

GLAXOSMITHKLINE PTE LTD

ATC-kod:

J07AJ52

Dos:

2 iu/0.5 ml

Läkemedelsform:

INJECTION

Sammansättning:

DIPHTHERIA TOXOID 2 iu/0.5 ml; FILAMENTOUS HAEMAGGLUTININ 8 mcg/0.5 ml; PERTACTIN 2.5 mcg/0.5 ml; PERTUSSIS TOXOID 8 mcg/0.5 ml; TETANUS TOXOID 20 iu/0.5 ml

Administreringssätt:

INTRAMUSCULAR

Receptbelagda typ:

Prescription Only

Tillverkad av:

GlaxoSmithKline Biologicals

Bemyndigande status:

ACTIVE

Tillstånd datum:

2002-03-09

Bipacksedel

-1- 
Proposed Package Insert 

BOOSTRIX™ 
COMBINED DIPHTHERIA, TETANUS, ACELLULAR PERTUSSIS VACCINE 

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 

1 
adsorbed on aluminium hydroxide (Al(OH)
3
) 0.3 
milligrams 
Al
3+

and aluminium phosphate (AlPO
4
) 0.2 
milligrams 
Al
3+

_BOOSTRIX_
_™_
 is a turbid white suspension. 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_
_™_
 is indicated for booster vaccination
against diphtheria, tetanus and pertussis of 
individuals from the age of four years onwards. 

DOSAGE AND ADMINISTRATION

POSOLOGY 
A single 0.5 ml dose of the vaccine is recommended. 
_BOOSTRIX_
_™_
 can be given in accordance with the
current local medical practices for booster 
vaccination with adult-type combined diphtheria-tetanus vaccine, when a
booster against 
pertussis is desired.  
Repeat vaccination against diphtheria, tetanus and pertussis should
be performed at intervals 
as per official recommendations (generally 10 years). 
_BOOSTRIX_
_™_
 can
be used in the management of tetanus prone injuries in persons who have 
previously received a primary vaccination
series of tetanus toxoid vaccine. Tetanus 
-2- 
immunoglobulin should be administered concomitantly in accordance with official 
recommendations. 

METHOD OF ADMINISTRATION 
_BOOSTRIX_
_™_
 is for deep intramuscular injection, preferably in the deltoid
region (s

Produktens egenskaper

-1-
BOOSTRIX
DIPHTHERIA, TETANUS AND PERTUSSIS (ACELLULAR, COMPONENT) 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
1
adsorbed on aluminium hydroxide, hydrated (Al(OH)
3
)
0.3 milligrams Al
3+
and aluminium phosphate (AlPO
4
)
0.2 milligrams Al
3+
_BOOSTRIX_
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_
is indicated for booster vaccination against diphtheria, tetanus and
pertussis of
individuals from the age of four years onwards (see
_Posology_
).
The use of
_BOOSTRIX_
should be in accordance with official recommendations.
DOSAGE AND ADMINISTRATION
POSOLOGY
A single 0.5 ml dose of the vaccine is recommended.
_BOOSTRIX_
can be given in accordance with the current local medical practices
for booster
vaccination with reduced-content combined diphtheria-tetanus vaccine,
when a booster
against pertussis is desired.
_BOOSTRIX _
can be administered to pregnant women during the second or the third
trimester in
accordance with official recommendations (see
_Pregnancy and Pharmacodynamics_
).
_BOOSTRIX_
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
series against diphtheria, tetanus and pertussis (see
_Pharmacodynamics_
). Based on data in
adults, two additional doses of a diphtheria and tetanus containing
vaccine are recommended
-2-
one and six months after the first dose to maximize the vaccine
response against diphtheria
and tetanus.
Repeat vaccination against diphtheria, tetanus and pertussis should be
performed