Adacel® Suspension for Injection

Երկիր: Սինգապուր

Լեզու: անգլերեն

Աղբյուրը: HSA (Health Sciences Authority)

Ակտիվ բաղադրիչ:

(Acellular Pertussis) Filamentous Haemagglutinin Adsorbed (FHA); (Acellular Pertussis) Fimbriae Type 2 and 3 Adsorbed (FIM); (Acellular Pertussis) Pertactin Adsorbed (PRN); (Acelullar Pertussis) Pertussis Toxoid Adsorbed (PT); Diphtheria Toxoid Adsorbed; Tetanus Toxoid Adsorbed

Հասանելի է:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC կոդը:

J07AJ52

Դոզան:

5 micrograms

Դեղագործական ձեւ:

INJECTION, SUSPENSION

Կազմը:

(Acellular Pertussis) Filamentous Haemagglutinin Adsorbed (FHA) 5 micrograms; (Acellular Pertussis) Fimbriae Type 2 and 3 Adsorbed (FIM) 5 micrograms; (Acellular Pertussis) Pertactin Adsorbed (PRN) 3 micrograms; (Acelullar Pertussis) Pertussis Toxoid Adsorbed (PT) 2.5 micrograms; Diphtheria Toxoid Adsorbed 2 Lf; Tetanus Toxoid Adsorbed 5 Lf

Կառավարման երթուղին:

INTRAMUSCULAR

Ռեկվիզորի տեսակը:

Prescription Only

Պատրաստված է:

Sanofi Pasteur Ltd.

Լիազորման կարգավիճակը:

ACTIVE

Հաստատման ամսաթիվը:

2012-09-20

Տեղեկատվական թերթիկ

Singapore proposed PI-Sept 2012 

1 

ADACEL
®

TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS
VACCINE ADSORBED 
Intramuscular injection 
Suspension for injection 

DESCRIPTION 

ADACEL
®
, [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed], is a 
sterile,  uniform,  cloudy,  white  suspension  of  tetanus  and  diphtheria  toxoids  adsorbed  separately  on 
aluminum phosphate, combined with acellular pertussis vaccine and suspended in water for injection. The 
acellular pertussis vaccine is composed of 5 purified pertussis
antigens (PT, FHA, PRN and FIM). 

INDICATIONS AND CLINICAL USE 
ADACEL
®
  is  indicated  for  active  booster  immunization  for  the  prevention  of  tetanus,  diphtheria  and 
pertussis (whooping cough) as a single dose in persons aged 4
to 64 years. 
In  accordance  with local  recommendations,  ADACEL
®
  may  be  considered  as an  alternative  for the  fifth 
dose  of  tetanus,  diphtheria  and  acellular  pertussis  vaccine  (DTaP),  concomitantly  administered  with 
Inactivated  Poliomyelitis  Vaccine  (IPV)  at  separate  sites  to  complete  the  vaccination  series  for  this  age, 
when indicated. 
Persons  who  have  had  tetanus,  diphtheria  or  pertussis  should  still  be  immunized  since  these  clinical 
infections do not always confer immunity. Human Immunodeficiency Virus (HIV)-infected persons, both 
asymptomatic and symptomatic, should be immunized against tetanus, diphtheria and pertussis according 
to standard schedules. 
ADACEL
®
 is not to be used for the treatment of disease caused by _B. pertussis, C. diphtheriae _or _C. tetani _
infections. 
GERIATRICS 
Clinical data are not available for use of the
product�

Ապրանքի հատկությունները

SG/ADA/0923/EUSmPC
ADACEL
®
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis
Vaccine Adsorbed
Intramuscular injection
Suspension for injection
DESCRIPTION
ADACEL
®
, [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis
Vaccine
Adsorbed], is a sterile, uniform, cloudy, white suspension of tetanus
and diphtheria toxoids
adsorbed separately on aluminum phosphate, combined with acellular
pertussis vaccine and
suspended in water for injection. The acellular pertussis vaccine is
composed of 5 purified
pertussis antigens (PT, FHA, PRN and FIM).
INDICATIONS AND CLINICAL USE
ADACEL
®
is indicated for active booster immunization for the prevention of
tetanus, diphtheria
and pertussis (whooping cough) in persons 4 years of age and older.
ADACEL
®
may be considered as an alternative for the fifth dose of tetanus,
diphtheria and
acellular
pertussis
vaccine
(DTaP)
in
children
4
through
6
years
of
age,
concomitantly
administered with Inactivated Poliomyelitis Vaccine (IPV) at separate
sites to complete the
vaccination series for this age, when indicated.
Persons who have had tetanus, diphtheria or pertussis should still be
immunized since these
clinical infections do not always confer immunity. Human
Immunodeficiency Virus (HIV)-
infected persons, both asymptomatic and symptomatic, should be
immunized against tetanus,
diphtheria and pertussis according to standard schedules.
ADACEL
®
is not to be used for the treatment of disease caused by Bordetella
pertussis,
Corynebacterium diphtheriae or Clostridium tetani infections.
Pediatrics
ADACEL
®
is not indicated for immunization of children below the age of 4
years.
Tetanus Prophylaxis in Wound Management
The need for active immunization with a tetanus toxoid-containing
preparation such as Td
Adsorbed vaccine or ADACEL
®
, with or without passive immunization with Tetanus Immune
Globulin, depends on both the condition of the wound and the
patient’s vaccination history. (See
DOSAGE AND ADMINISTRATION.)
SG/ADA/0923/EUSmPC
CONTRAINDICATIONS
Hype