REPEVAX, suspension for injection, in pre-filled syringe Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content)

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Tetanus toxoid; Diphtheria toxoid; Pertussis toxoid; Filamentous haemagglutinin (fha); Pertactin; Polio virus type 1 inactivated; Polio virus type 2 inactivated; Polio virus type 3 inactivated; Adsorbed aluminium phosphate; Adsorbed fimbriae types 2 + 3

Fáanlegur frá:

Sanofi Pasteur

ATC númer:

J07CA; J07CA02

INN (Alþjóðlegt nafn):

Tetanus toxoid; Diphtheria toxoid; Pertussis toxoid; Filamentous haemagglutinin (fha); Pertactin; Polio virus type 1 inactivated; Polio virus type 2 inactivated; Polio virus type 3 inactivated; Adsorbed aluminium phosphate; Adsorbed fimbriae types 2 + 3

Skammtar:

0.5 millilitre(s)

Lyfjaform:

Suspension for injection in pre-filled syringe

Gerð lyfseðils:

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

Lækningarsvæði:

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

Leyfisstaða:

Not marketed

Leyfisdagur:

2003-07-25

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
REPEVAX
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Diphtheria, Tetanus, Pertussis (acellular, component) and
Poliomyelitis (inactivated) Vaccine
(adsorbed, reduced antigen(s) content)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD IS
VACCINATED BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This vaccine has been prescribed for you or for your child only. Do
not pass it on to others.
-
If you or your child get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What REPEVAX is and what it is used for
2.
What you need to know before REPEVAX is given to you or your child
3.
How and when REPEVAX is given
4.
Possible side effects
5.
How to store REPEVAX
6.
Contents of the pack and other information
1.
WHAT REPEVAX IS AND WHAT IT IS USED FOR
REPEVAX (Tdap-IPV) is a vaccine. Vaccines are used to protect against
infectious diseases. They work
by causing the body to produce its own protection against the bacteria
and viruses that cause the targeted
diseases.
This vaccine is used to boost protection against diphtheria, tetanus,
pertussis (whooping cough) and
poliomyelitis (polio) in children from the age of three years,
adolescents and adults following a complete
primary course of vaccination.
Use of REPEVAX during pregnancy allows protection to be passed on to
the child in the womb to protect
her/him from whooping cough during the first few months of life.
LIMITATIONS IN THE PROTECTION PROVIDED
REPEVAX will only prevent these diseases if they are caused by the
bacteria or viruses targeted by the
vaccine. You or your child could still get similar diseases if they
are caused by other bacteria or viruses.
REPEVAX does not contain any live bacteria or viruses and it cannot
cause any of the infectious diseases
against w

Vara einkenni

Health Products Regulatory Authority
13 April 2023
CRN00D626
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
REPEVAX, suspension for injection, in pre-filled syringe Diphtheria,
Tetanus, Pertussis (acellular, component) and Poliomyelitis
(inactivated) Vaccine (adsorbed, reduced antigen(s) content)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 mL) contains:
Diphtheria Toxoid
................................................................. Not
less than 2 IU
1
(2 Lf)
Tetanus Toxoid
......................................................................
Not less than 20 IU
1
(5 Lf)
Pertussis Antigens
Pertussis Toxoid
............................................................... 2.5
micrograms
Filamentous Haemagglutinin
............................................. 5 micrograms
Pertactin
...........................................................................
3 micrograms
Fimbriae Types 2 and 3
..................................................... 5 micrograms
Poliovirus (Inactivated)
2
Type 1 (Mahoney)
............................................................ 29 D
antigen units
3
Type 2
(MEF1)..................................................................
7 D antigen units
3
Type 3
(Saukett)................................................................
26 D antigen units
3
Adsorbed on aluminium phosphate
......................................... 1.5 mg (0.33 mg Al
3+
)
1
As lower confidence limit (p = 0.95) of activity measured according to
the assay described in the European Pharmacopoeia.
2
Cultivated on Vero cells.
3
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.
REPEVAX may contain traces of formaldehyde, glutaraldehyde,
streptomycin, neomycin, polymyxin B and bovine serum
albumin, which are used during the manufacturing process (see sections
4.3 and 4.4).
For the full list of excipients, see section 6.1.
3