INFANRIX

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ (FHA); PERTACTIN; PERTUSSIS TOXOID (PT); TETANUS TOXOID

可用日期:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC代码:

J07CA

药物剂型:

SUSPENSION FOR INJECTION

组成:

DIPHTHERIA TOXOID NLT 30 IU; TETANUS TOXOID NLT 40 IU; PERTACTIN 8 MCG / 0.5 ML; FILAMENTOUS HAEMAGGLUTININ (FHA) 25 MCG / 0.5 ML; PERTUSSIS TOXOID (PT) 25 MCG / 0.5 ML

给药途径:

I.M

处方类型:

Required

厂商:

GLAXO SMITH KLINE BIOLOGICALS S.A

治疗组:

BACTERIAL AND VIRAL VACCINES, COMBINED

疗效迹象:

Infanrix is indicated as a booster dose for children 15 months to 7 years of age who have previously been immunised with three or four doses of either DTPa vaccine or diphtheria, tetanus and whole-cell pertussis (DTPw) vaccine. Active primary immunisation against diphteria, tetanus and pertussis from the age 2 months onward.

授权日期:

2012-01-31

资料单张

העדוה
העדוה
לע
לע
הרמחה
הרמחה
עדימ (
עדימ (
ןולעב )תוחיטב
ןולעב )תוחיטב
אפורל
אפורל
ךיראת :
27.11.2012
םש
רישכת
תילגנאב :
INFANRIX
רפסמ
םושיר :
104-10-28630
םש
לעב
םושירה
GLAXOSMITHKLINE (ISRAEL) LTD :
םיטרפ
לע
םי/יונישה
םי/שקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
WARNINGS AND
PRECAUTIONS
The potential risk of apnoea and the need for
respiratory monitoring for 48-72h 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
Respiratory, thoracic and mediastinal
disorders:
Apnoea _[see section “Warnings and _
_Precautions” for apnoea in very premature _
_infants (≤ 28 weeks of gestation)_

产品特点

250
250
_The format of this leaflet was determined by the Ministry of Health
and its content _
_was checked and approved in April 2013_
INFANRIX
™
Diphtheria - Tetanus - acellular Pertussis Vaccine (DTPa)
SCOPE
TRADE NAME
Infanrix™
FORMULATION AND STRENGTH
Suspension for injection.
Infanrix contains diphtheria toxoid, tetanus toxoid and three purified
pertussis
antigens
[pertussis
toxoid
(PT),
filamentous
haemagglutinin
(FHA)
and
69
kiloDalton outer membrane protein (pertactin)] adsorbed onto aluminium
salts.
The diphtheria and tetanus toxins obtained from cultures of _
Corynebacterium _
_diphtheriae_ and _ Clostridium tetani_ are detoxified and purified.
The acellular
pertussis vaccine components (PT, FHA and pertactin) are prepared by
growing
phase I _ Bordetella pertussis_ from which the PT and FHA and
pertactin are
extracted, purified, and treated with formaldehyde; PT is irreversibly
detoxified.
The diphtheria toxoid, tetanus toxoid and acellular pertussis vaccine
components
are adsorbed on aluminium salts. The final vaccine is formulated in
saline.
Infanrix meets the World Health Organisation requirements for
manufacture of
biological substances and for diphtheria and tetanus vaccines. No
substances of
human origin are used in its manufacture.
A 0.5 ml dose of the vaccine contains not less than 30 International
Units (IU) of
diphtheria toxoid, 40 IU of tetanus toxoid, 25 mcg of PT, 25 mcg of
FHA and 8
mcg of pertactin.
EXCIPIENTS
Aluminium hydroxide, sodium chloride, water for injections.
RESIDUES
Formaldehyde
Polysorbate 80
CLINICAL INFORMATION
INDICATIONS
Infanrix
is indicated for active primary immunisation against diphtheria,
tetanus
and pertussis from the age of 2 months onwards.
Infanrix
is indicated as a booster dose for children 15 months to 7 years of
age
who have previously been immunised with three or four doses of either
DTPa
vaccine or diphtheria, tetanus and whole-cell pertussis (DTPw)
vaccine.
DOSAGE AND ADMINISTRATION
POSOLOGY
The recommended dose (0.5 ml) of the vaccine must be administ