Tetravac, suspension for injection in prefilled syringeDiphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine,(adsorbed).

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Purified tetanus toxoid; Purified diphtheria toxoid ph. eur.; Adsorbed purified pertussis toxoid; Adsorbed purified filamentous haemagglutinin; Inactivated Poliomyelitis Virus Ph. Eur; Inactivated type 1 poliovirus; Inactivated type 2 poliovirus; Inactivated type 3 poliovirus

متاح من:

Sanofi Pasteur

ATC رمز:

J07CA; J07CA02

INN (الاسم الدولي):

Purified tetanus toxoid; Purified diphtheria toxoid ph. eur.; Adsorbed purified pertussis toxoid; Adsorbed purified filamentous haemagglutinin; Inactivated Poliomyelitis Virus Ph. Eur; Inactivated type 1 poliovirus; Inactivated type 2 poliovirus; Inactivated type 3 poliovirus

جرعة:

0.5 millilitre(s)

الشكل الصيدلاني:

Suspension for injection in pre-filled syringe

نوع الوصفة الطبية :

Product subject to prescription which may not be renewed (A)

المجال العلاجي:

Bacterial and viral vaccines, combined; diphtheria-pertussis-poliomyelitis-tetanus

الوضع إذن:

Not marketed

تاريخ الترخيص:

2001-03-23

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER
TETRAVAC, SUSPENSION FOR INJECTION IN PREFILLED SYRINGE
DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT) AND
POLIOMYELITIS (INACTIVATED) VACCINE,
ADSORBED.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD IS VACCINATED
BECAUSE IT CONTAINS IMPORTANT
INFORMATION.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, or pharmacist or
nurse.
-
This medicine has been prescribed only for your child. Do not pass it
on to others.
-
If your child gets any side effects, talk to your doctor, or
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tetravac is and what it is used for
2.
What you need to know before Tetravac is given to your child
3.
How to use Tetravac
4.
Possible side effects
5.
How to store Tetravac
6.
Contents of the pack and other information
1.
WHAT TETRAVAC IS AND WHAT IT IS USED FOR
Tetravac is a vaccine (DTaP-IPV vaccine) used to protect against
infectious diseases.
Tetravac helps to protect your child against diphtheria, tetanus,
whooping cough (pertussis) and
poliomyelitis.
It is given as a primary series vaccination in children from 2 months
of age and as a booster
vaccination in children who received this vaccine or a similar vaccine
when they were younger.
When an injection of Tetravac is given, the body’s natural defences
will produce protection against
these different diseases.
•
Diphtheria is an infectious disease that usually first affects the
throat. In the throat, the infection
causes pain and swelling which can lead to suffocation. The bacteria
that cause the disease also
produce a toxin (poison) that can damage the heart, kidneys and
nerves.
•
Tetanus (often called lock jaw) is caused by the tetanus bacteria
entering a deep wound. The
bacteria produce a toxin (poison) that causes spasms of the muscles,
leading to an inability to
breathe and the possibility of suffocation.
•
Pertussis (often called

خصائص المنتج

Health Products Regulatory Authority
06 February 2024
CRN00DLG4
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tetravac, suspension for injection in prefilled syringeDiphtheria,
tetanus, pertussis (acellular, component) and poliomyelitis
(inactivated) vaccine,(adsorbed).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 mL) contains:
Diphtheria Toxoid1 not less than 20 IU 2,3 (30 Lf)
Tetanus Toxoid1 not less than 40 IU 3,4 (10 Lf)
_Bordetella pertussis_ antigens
Pertussis Toxoid 1 25 micrograms
Filamentous Haemagglutinin1 25 micrograms
Poliovirus (Inactivated)
5
Type 1 (Mahoney) 29 D-antigen units
6
Type 2 (MEF-1) 7 D-antigen units
6
Type 3 (Saukett) 26 D-antigen units
6
1 Adsorbed on aluminium hydroxide, hydrated (0.3 mg Al3+)
2 As lower confidence limit (p= 0.95) and not less than 30 IU as mean
value
3 Or equivalent activity determined by immunogenicity evaluation
4 As lower confidence limit (p = 0.95)
5 Cultivated on Vero cells
6 These antigen quantities are strictly the same as those previously
expressed as 40-8-32 D-antigen units, for virus type 1, 2
and 3 respectively, when measured by another suitable immunochemical
method.
The vaccine may contain traces of glutaraldehyde, neomycin,
streptomycin and polymyxin B which are used during the
manufacturing process (see section 4.4).
Excipients with known effect
Phenylalanine……………12.5 micrograms
(See section 4.4)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection in prefilled syringe
Tetravac is a whitish turbid suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tetravac is indicated for primary and booster vaccination of infants
and children from 2 months of age against diphtheria,
tetanus, pertussis and poliomyelitis.
The use of this vaccine should be in accordance with official
recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Tetravac (DTaP-IPV) is a full antigen(s) content formulation.
Posology
_Primary vaccination:_
Health Products Regulatory