PEDIACEL

Riik: Iisrael

keel: inglise

Allikas: Ministry of Health

Toimeaine:

DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ (FHA); FIMBRAE TUPES 2 + 3 (FIM); PERTACTIN (PRN); PERTUSSIS TOXOID VACCINE; POLIOVIRUS TYPE 1; POLIOVIRUS TYPE 2; POLIOVIRUS TYPE 3; PRP OF HAEMOPHILUS INFL. TYPE B; TETANUS TOXOID

Saadav alates:

MEDICI MEDICAL LTD, ISRAEL

ATC kood:

J07CA

Ravimvorm:

SUSPENSION FOR INJECTION

Koostis:

PERTACTIN (PRN) 3 MCG ML; DIPHTHERIA TOXOID 15 LF ML; TETANUS TOXOID 5 LF ML; PERTUSSIS TOXOID VACCINE 20 MCG ML; FILAMENTOUS HAEMAGGLUTININ (FHA) 20 MCG ML; FIMBRAE TUPES 2 + 3 (FIM) 5 MCG ML; POLIOVIRUS TYPE 1 40 DU ML; POLIOVIRUS TYPE 2 8 DU ML; POLIOVIRUS TYPE 3 32 DU ML; PRP OF HAEMOPHILUS INFL. TYPE B 10 MCG ML

Manustamisviis:

I.M

Retsepti tüüp:

Not required

Valmistatud:

SANOFI PASTEUR LTD, CANADA

Terapeutiline rühm:

BACTERIAL AND VIRAL VACCINES, COMBINED

Näidustused:

Pediacel is indicated for immunization of children at or above the age of 2 months and as a booster in children up to their 7th birthday against diphtheria, tetanus, whooping cough, poliomyelitis and invasive Haemophilus influenzae type b disease. In infants, three infectons are to be given intramuscularly at 2, 4 and 6 months of age followed by a booster at 18 months of age. Children who have had pertusis, tetanus, diphtheria or haemophilus influenzae type b invasive disease should still be immunized since these clinical infections do not always confer immunity. Children who have had natural pertussis can continue to receive pertussis - containing vaccines. Human immunodeficiency virus (HIV) infected persons HIV- infected individuals, both asymptomatic and symptomatic, should be immunized with Pediacel vaccine according to standard schedules.

Loa andmise kuupäev:

2014-06-30

Infovoldik

העדוה
העדוה
לע
לע
הרמחה
הרמחה
עדימ (
עדימ (
ב
ב
ןולעב )תוחיט
ןולעב )תוחיט
אפורל
אפורל
ךיראת
____
01.01.13
__________________
םש
רישכת
____תילגנאב
PEDIACEL
רפסמ
___םושיר
141 -
01
-
31746 -
00
_____________
םש
לעב
מ"עב לקידמ י'צידמ_ __:םושירה
______________________________
םיטרפ
לע
םי/יונישה
םי/שקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
WARNING AND
PRECAUTION
.
_ _
_Pediatric_
The potential risk of apnea and the need for respiratory
monitoring for 48 - 72 hours should be considered when
administering the primary immunization series to very
premature infants (born
≤
28 weeks of gestation) and
particularly for those with a previous history of
respiratory immaturity. As the benefit of vaccination is
high in this group of infants, vaccination should not
be withheld or delayed
.
ADVERSE REACTIONS
_ _
PSYCHIATRIC
DISORDERS
_ _
,
screaming
PSYCHIATRIC DISORDERS
Irritability , screaming
.
ADVERSE REACTIONS
NERVOUS SYSTEM DISORDERS
Somnolence
ADVERSE REACTIONS
הרבעה
לש
טסקטה
VASCULAR DISORDERS
Edematous reactions affecting one or both
lower limbs have occurred following
vaccination with _H. influenza_ type b
containing vaccines. When this reaction
occurs, it does so mainly after primary
injections and is observed within the first few
hours following vaccination. Associated
symptoms may include cyanosis, redness,
transient purpura and severe crying. All
events resolved spontaneously without
sequelae within 24 hours
.
Pallor
ADVERSE REACTIONS
טסקט
שדח
RESPIRATORY, THORACIC AND MEDIASTINAL
DISORDERS
Apnea
ADVERSE REACTIONS
GENERAL DISORDERS AND ADMINISTRATION SITE
CONDITIONS
High fever (>40.5°C), injection site mass,
pallor, somnolence, asthenia, irritability and
listlessness
.
Large injection site reactions (>50 mm)
including
extensive limb swelling which may
extend from the injection site beyond one or
both joints, have been reported in children
fol

Toote omadused

PEDIACEL
®
DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR
PERTUSSIS VACCINE ADSORBED COMBINED WITH
INACTIVATED POLIOMYELITIS VACCINE AND HAEMOPHILUS B
CONJUGATE VACCINE (TETANUS PROTEIN - CONJUGATE)
Intramuscular injection. Suspension for injection.
DESCRIPTION
PEDIACEL
®
[Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine
Adsorbed Combined with Inactivated Poliomyelitis Vaccine and
Haemophilus b
Conjugate Vaccine (Tetanus Protein - Conjugate)] is a sterile,
uniform, cloudy,
white to off-white suspension of diphtheria and tetanus toxoids and
acellular
pertussis vaccine adsorbed separately on aluminum phosphate combined
with
inactivated poliomyelitis vaccine (vero cell origin) types 1, 2 and 3
(IPV), and
_H. influenzae_ type b capsular polysaccharide (polyribosylribitol
phosphate,
PRP) covalently bound to tetanus protein, 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
PEDIACEL
®
is indicated for primary immunization of infants from the
age of 2 months and in children up to 6 years of age (prior to their
7th birthday) against diphtheria, tetanus, pertussis (whooping cough),
poliomyelitis and invasive _H. influenzae_ type b disease. (See DOSAGE
AND
ADMINISTRATION.)
Currently, Haemophilus b conjugate vaccines are not recommended for
infants younger than 2 months of age.
Children who have had pertussis, tetanus, diphtheria or _H.
influenzae_ type b
(Hib) invasive disease 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 diphtheria, tetanus,
pertussis,
poliomyelitis and _H. influenzae_ type b, according to standard
schedules.
PEDIACEL
®
is not to be used for the treatment of diseases caused by
_Corynebacterium diphtheriae_, _Clostridium tetani_, _Bordetella
pertussis_, poliovirus
or _Haemophilus influenzae_ type b infections.
PEDIATRI