ADACEL

Quốc gia: Israel

Ngôn ngữ: Tiếng Anh

Nguồn: Ministry of Health

Thành phần hoạt chất:

DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ (FHA); FIMBRAE TUPES 2 + 3 (FIM); PERTACTIN (PRN); PERTUSSIS TOXOID VACCINE; TETANUS TOXOID

Sẵn có từ:

SANOFI ISRAEL LTD

Mã ATC:

J07CA02

Dạng dược phẩm:

SUSPENSION FOR INJECTION

Thành phần:

TETANUS TOXOID 5 LF / 1 DOSES; PERTUSSIS TOXOID VACCINE 2.5 MCG/DOSE; FILAMENTOUS HAEMAGGLUTININ (FHA) 5 MCG/DOSE; FIMBRAE TUPES 2 + 3 (FIM) 5 MCG/DOSE; PERTACTIN (PRN) 3 MCG/DOSE; DIPHTHERIA TOXOID 2 LF / 1 DOSES

Tuyến hành chính:

I.M

Loại thuốc theo toa:

Required

Sản xuất bởi:

SANOFI PASTEUR LTD, CANADA

Khu trị liệu:

DIPHTHERIA-PERTUSSIS-POLIOMYELITIS-TETANUS

Chỉ dẫn điều trị:

Active booster immunization against diphtheria, tetanus and pertussis in children, adolescents and adults aged 4 to 64 years. Adacel is not indicated for treating diseases caused by B.pertussis, C.diphtheriae or C. tetani infections.

Ngày ủy quyền:

2014-11-30

Đặc tính sản phẩm

1
1
NAME OF THE MEDICINAL PRODUCT
ADACEL®
suspension for injection.
Diphtheria, Tetanus, Pertussis (acellular component) Vaccine
(adsorbed, reduced antigen(s) content)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 mL) contains:
Diphtheria Toxoid
Not less than 2 IU* (2 Lf)
Tetanus Toxoid
Not less than 20 IU* (5 Lf)
Pertussis Antigens
Pertussis Toxoid
2.5 micrograms
Filamentous Haemagglutinin
5 micrograms
Pertactin
3 micrograms
Fimbriae Types 2 and 3
5 micrograms
Adsorbed on aluminium phosphate
1.5 mg (0.33 mg Al
3+
)
* As lower confidence limit (p = 0.95) of activity measured according
to the assay described in the
European Pharmacopoeia.
This vaccine may contain traces of formaldehyde and glutaraldehyde
which are used during the
manufacturing process (see sections 4.3 and 4.4).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Suspension for injection
ADACEL® appears as a cloudy white suspension.
4
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
ADACEL® is indicated for active booster immunization for the
prevention of tetanus, diphtheria and
pertussis in children, adolescents and adults aged 4 to 64 years.
ADACEL® is not to be used for the treatment of disease caused by
_B.ordetella pertussis, C.-_
_orynebacterium diphtheriae _
or
_Clostridium tetani _
infections.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
RECOMMENDED DOSE
2
The immunization schedule with ADACEL® should follow local
recommendations. ADACEL® (0.5mL)
should be administered as a booster dose by the intramuscular route.
Re-dosing with ADACEL® can be used to boost immunity to diphtheria,
tetanus and pertussis at 5 to 10
year intervals.
The preferred site is into the deltoid muscle.
Fractional doses (doses <0.5 mL) should not be given. The effect of
fractional doses on the safety and
efficacy has not been determined.
The use of ADACEL® in management of tetanus-prone wounds should
follow local recommendations.
Canada's National Advisory Committee on Immunization ( NACI ) and US
Advisory Committee on
Immunization