ADACEL POLIO

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ (FHA); FIMBRAE TUPES 2 + 3 (FIM); INACTIVATED POLIO VIRUS (IPV) TYPE 1; INACTIVATED POLIO VIRUS (IPV) TYPE 2; INACTIVATED POLIO VIRUS (IPV) TYPE 3; PERTACTIN (PRN); PERTUSSIS TOXOID VACCINE; TETANUS TOXOID

זמין מ:

SANOFI ISRAEL LTD

קוד ATC:

J07CA02

טופס פרצבטיות:

SUSPENSION FOR INJECTION

הרכב:

FIMBRAE TUPES 2 + 3 (FIM) 5 MCG/DOSE; PERTUSSIS TOXOID VACCINE 2.5 MCG/DOSE; FILAMENTOUS HAEMAGGLUTININ (FHA) 5 MCG/DOSE; PERTACTIN (PRN) 3 MCG/DOSE; DIPHTHERIA TOXOID 2 LF / 1 DOSES; TETANUS TOXOID 5 LF / 1 DOSES; INACTIVATED POLIO VIRUS (IPV) TYPE 1 40 DU/DOSE; INACTIVATED POLIO VIRUS (IPV) TYPE 2 8 DU/DOSE; INACTIVATED POLIO VIRUS (IPV) TYPE 3 32 DU/DOSE

מסלול נתינה (של תרופות):

I.M

סוג מרשם:

Required

תוצרת:

SANOFI PASTEUR, FRANCE

קבוצה תרפויטית:

DIPHTHERIA-PERTUSSIS-POLIOMYELITIS-TETANUS

איזור תרפויטי:

DIPHTHERIA-PERTUSSIS-POLIOMYELITIS-TETANUS

סממני תרפויטית:

Active immunization against diphtheria, tetanus, pertussis and poliomyelitis in subjects aged 4 years and over as a booster following primary immunisation.Adacel polio is not indicated for primary immunisation. Adacel polio is not indicated for treating diseases caused by B.pertussis, C.Diphtheriae or C.tetani or by poliomyelitis infections

תאריך אישור:

2015-01-31

עלון מידע

אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה
_____ ךיראת
27.03.2014
__________________
______תילגנאב רישכת םש
ADACEL POLIO
_______םושיר רפסמ
142603193800
_____________ מ"עב לקידמ י'צידמ___םושירה לעב םש
םיטרפ
לע
םי/יונישה
םי/שקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
SPECIAL WARNING
AND PRECAUTIONS
FOR USE
קט תפסות
טס
Syncope (fainting) has been reported
following vaccination with
ADACEL
®
-POLIO.
Procedures shouls be in place to prevent
falling injury and manage syncopal reactions
POST MARKET
ADVERSE DRUG
REACTIONS
קט תפסות
טס
_GASTROINTESTINAL DISORDERS_:
Abdominal pain
ובש ,ןולעה
םינמוסמ
םייונישה
םישקובמה
בוהצב
רבעוה
ראודב
ינורטקלא
.......ךיראתב
27.03.2014
...........

מאפייני מוצר

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
4.1
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.
4.1
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
RECOMMENDED DOSE
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
Immuniz