BOOSTRIX

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ (FHA); PERTACTIN (PRN OR 69 KDA OMP); PERTUSSIS TOXOID (PT); TETANUS TOXOID

Verfügbar ab:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC-Code:

J07AM51

Darreichungsform:

SUSPENSION FOR INJECTION

Zusammensetzung:

DIPHTHERIA TOXOID NLT 2 IU / 0.5 ML; TETANUS TOXOID NLT 20 IU / 0.5 ML; FILAMENTOUS HAEMAGGLUTININ (FHA) 8 MCG / 0.5 ML; PERTUSSIS TOXOID (PT) 8 MCG / 0.5 ML; PERTACTIN (PRN OR 69 KDA OMP) 2.5 MCG / 0.5 ML

Verabreichungsweg:

I.M

Verschreibungstyp:

Required

Hergestellt von:

GLAXO SMITH KLINE BIOLOGICALS S.A

Therapiegruppe:

TETANUS TOXOID, COMBINATIONS WITH DIPHTHERIA TOXOID

Therapiebereich:

TETANUS TOXOID, COMBINATIONS WITH DIPHTHERIA TOXOID

Anwendungsgebiete:

For Booster vaccination against diphtheria, tetanus and pertussis of individuals from the age of four years onwards.The administration of Boostrix should be based on official recommendations

Berechtigungsdatum:

2020-12-31

Gebrauchsinformation

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician’s prescription
only
Boostrix
Suspension for injection
Each dose (0.5 ml) contains:
diphtheria toxoid – NLT 2 IU
tetanus toxoid – NLT 20 IU
pertussis toxoid (PT) – 8 mcg
filamentous hemagglutinin (FHA) – 8 mcg
pertactin (PRN, or 69kDa OMP) – 2.5 mcg
For the list of the inactive and allergenic ingredients in the
medicine, see
section 2 – "Important information about some of the ingredients in
the
medicine" and section 6 – "Additional information".
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions, refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if it seems to you that their medical condition is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Booster vaccination against diphtheria, tetanus and pertussis of
individuals
from the age of four years onwards.
The administration should be based on official recommendations.
Therapeutic group: bacterial vaccines, pertussis vaccines.
How does the vaccine work?
The vaccine works by causing the body to produce its own protection
(antibodies) against these diseases (diphtheria, tetanus, and
pertussis).
None of the ingredients of this vaccine can cause these diseases.
2. BEFORE USING THE MEDICINE
Do not use Boostrix if:
• you or your child have previously had any allergic reaction to
Boostrix or to
any of the additional ingredients contained in this vaccine (listed in
section
6), or to formaldehyde. Signs of an allergic reaction may include
itchy skin
rash, shortness of breath, and swelling of the face or tongue.
• you or your child have previously had an allergic reaction to any
vaccine
against diphtheria, tetanus or pertussis diseases.
• you or your child experienced problems of the nervous system
(encephalopathy) within

Fachinformation

Page 1 of 14
BOOSTRIX
1.
NAME OF THE MEDICINAL PRODUCT
Boostrix suspension for injection
Diphtheria, tetanus and pertussis (acellular, component) vaccine
(adsorbed, reduced antigen(s)
content)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) contains:
Diphtheria toxoid
1
not less than 2 International Units (IU) (2.5 Lf)
Tetanus toxoid
1
not less than 20 International Units (IU) (5 Lf)
_Bordetella pertussis_
antigens
Pertussis toxoid
1
8 micrograms
Filamentous Haemagglutinin
1
8 micrograms
Pertactin
1
2.5 micrograms
1
adsorbed on aluminium hydroxide, hydrated (Al(OH)
3
)
0.3 milligrams Al
3+
and aluminium phosphate (AlPO
4
)
0.2 milligrams Al
3+
The vaccine may contain traces of formaldehyde which is used during
the manufacturing process
(see section 4.3).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Boostrix is a turbid white suspension.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Boostrix is indicated for booster vaccination against diphtheria,
tetanus and pertussis of
individuals from the age of four years onwards (see section 4.2).
The administration of Boostrix should be based on official
recommendations.
4.2
Posology and method of administration
Posology
Page 2 of 14
A single 0.5 ml dose of the vaccine is recommended.
Boostrix may be administered from the age of four years onwards.
The use of Boostrix may be considered during the third trimester of
pregnancy. For the use of the
vaccine before the third trimester of pregnancy, see section 4.6.
Boostrix should be administered in accordance with official
recommendations and/or local
practice regarding the use of vaccines with reduced content of
diphtheria, tetanus and pertussis
antigens.
Boostrix may be administered to adolescents and adults with unknown
vaccination status or
incomplete vaccination against diphtheria, tetanus and pertussis as
part of an immunisation series
against diphtheria, tetanus and pertussis. Based on data in adults,
two additional doses of a
diphtheria and tetanus c