TRIPACEL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

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

Available from:

MEDICI MEDICAL LTD, ISRAEL

ATC code:

J07AJ52

Pharmaceutical form:

SUSPENSION FOR INJECTION

Composition:

PERTUSSIS ACELLULAR 10 MCG / 0.5 ML; FILAMENTOUS HAEMAGGLUTININ (FHA) 5 MCG / 0.5 ML; FIMBRAE TUPES 2 + 3 (FIM) 5 MCG / 0.5 ML; PERTACTIN 3 MCG / 0.5 ML; DIPHTHERIA TOXOID 30 IU / 0.5 ML; TETANUS TOXOID 40 IU / 0.5 ML

Administration route:

I.M

Prescription type:

Required

Manufactured by:

SANOFI PASTEUR LTD, CANADA

Therapeutic group:

PERTUSSIS, PURIFIED ANTIGEN, COMBINATIONS WITH TOXOIDS

Therapeutic area:

PERTUSSIS, PURIFIED ANTIGEN, COMBINATIONS WITH TOXOIDS

Therapeutic indications:

Is indicated for the primary immunization of infants at or above the age of 2 months and as a booster in children up to their 6th birthday against diphtheria, tetanus and pertussis.

Authorization date:

2010-11-30

Patient Information leaflet

העדוה
העדוה
לע
לע
הרמחה
הרמחה
עדימ (
עדימ (
ב
ב
ןולעב )תוחיט
ןולעב )תוחיט
אפורל
אפורל
ךיראת
____
04.11.12
__________________
םש
רישכת
____תילגנאב
TRIPACEL
רפסמ
___םושיר
120
73
30035
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
EFFECTS
BLOOD AND LYMPHATIC DISORDERS
Lymphadenopathy

Summary of Product characteristics

TRIPACEL
®
COMPONENT PERTUSSIS VACCINE COMBINED WITH DIPHTHERIA AND TETANUS
TOXOIDS ADSORBED
PHARMACEUTICAL FORM
Suspension for injection.
TRIPACEL
®
is supplied as a sterile, uniform, cloudy, white to off-white
suspension.
COMPOSITION
1 dose = 0.5 mL.
ACTIVE INGREDIENTS:
Pertussis Toxoid (PT)
10 µg
Filamentous Haemagglutinin (FHA)
5 µg
Fimbrial Agglutinogens 2+3 (FIM)
5 µg
Pertactin (PRN)
3 µg
Diphtheria toxoid
≥
30 IU
(15 Lf)
Tetanus toxoid
≥
40 IU
(5 Lf)
OTHER INGREDIENTS:
Aluminum Phosphate (adjuvant) (aluminum 0.33 mg)
1.5 mg
2-phenoxyethanol
0.6 v/v
water for injection
qs 0.5 mL
_Manufacturing Process Residuals:_
formaldehyde and glutaraldehyde are present in trace amounts.
INDICATIONS
Is indicated for the primary immunization of infants at or above the
age of 2 months and as a booster in children up to their 6th birthday
against
diphtheria, tetanus and pertussis.
Children who have had tetanus or diphtheria should still be immunized
since these clinical infections do not always confer immunity.
Children who have
had natural pertussis should continue to receive pertussis-containing
vaccines.
_Human Immunodeficiency Virus (HIV) Infected Persons _
_ _
HIV-infected persons, both asymptomatic and symptomatic, should be
immunized against diphtheria, pertussis and tetanus according to
standard
schedules.
TRIPACEL
®
is not to be used for the treatment of disease caused by
_Corynebacterium diphtheriae,_
_Clostridium tetani _
or
_Bordetella pertussis_
infections.
PEDIATRICS
TRIPACEL
®
is not indicated for persons less than 2 months of age or persons 7
years of age or older.
GERIATRICS
TRIPACEL
®
is not indicated for use in adult and elderly populations
CONTRAINDICATIONS
_HYPERSENSITIVITY _
Known systemic hypersensitivity reaction or a life threatening
reaction to any component of TRIPACEL
®
after previous administration of the vaccine or
a vaccine containing one or more of the same components are
contraindications to vaccination. Because of uncertainty as to which
component of the
vaccine may be respons