Triaxis, suspension for injection in a pre-filled syringeDiphtheria, Tetanus, Pertussis (acellular component) Vaccine (adsorbed, reduced antigen(s) content)

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diphtheria toxoid; Tetanus toxoid; Pertussis toxoid; Filamentous haemagglutinin; Pertactin (prn); Fimbriae types 2 and 3

Available from:

Sanofi Pasteur

ATC code:

J07AJ; J07AJ52

INN (International Name):

Diphtheria toxoid; Tetanus toxoid; Pertussis toxoid; Filamentous haemagglutinin; Pertactin (prn); Fimbriae types 2 and 3

Dosage:

0 international unit(s)

Pharmaceutical form:

Suspension for injection in pre-filled syringe

Prescription type:

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

Therapeutic area:

Pertussis vaccines; pertussis, purified antigen, combinations with toxoids

Authorization status:

Not marketed

Authorization date:

2016-06-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIAXIS
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Diphtheria, Tetanus, Pertussis (acellular, component) 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 TRIAXIS is and what it is used for
2.
What you need to know before TRIAXIS is given to you or your child
3.
How and when TRIAXIS is given
4.
Possible side effects
5.
How to store TRIAXIS
6.
Contents of the pack and other information
1
WHAT TRIAXIS IS AND WHAT IT IS USED FOR
TRIAXIS (Tdap) 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
that cause the targeted diseases.
This vaccine is used to boost protection against diphtheria, tetanus
and pertussis (whooping cough) in
children from the age of 4 years, adolescents and adults, following a
complete primary course of
vaccination.
Use of TRIAXIS 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
TRIAXIS will only prevent these diseases if they are caused by the
bacteria targeted by the vaccine. You or
your child could still get similar diseases if they are caused by
other bacteria or viruses.
TRIAXIS does not contain any live bacteria or viruses and it cannot
cause any of the infectious diseases
against which it protects.
Remember that no vaccine can provide complete, lifelong protection i

Summary of Product characteristics

Health Products Regulatory Authority
29 May 2023
CRN00DCX7
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Triaxis, suspension for injection in a pre-filled syringeDiphtheria,
Tetanus, Pertussis (acellular component) Vaccine (adsorbed,
reduced antigen(s) content)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 mL) contains:
Diphtheria Toxoid Not less than 2 IU* (2 Lf)
Tetanus Toxoid Not less than 20 IU* (5 Lf)
Pertussis Antigens
Pertussis Toxoid 2.5 micrograms
Filamentous Haemagglutinin 5 micrograms
Pertactin 3 micrograms
Fimbriae Types 2 and 3 5 micrograms
Adsorbed on aluminium phosphate 1.5 mg (0.33 mg Al
3+
)
* As lower confidence limit (p = 0.95) of activity measured according
to the assay described in the European Pharmacopoeia.
This vaccine may contain traces of formaldehyde and glutaraldehyde
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 PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
Triaxis appears as a cloudy white suspension
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TRIAXIS (Tdap) is indicated for:
Active immunization against tetanus, diphtheria and pertussis in
persons from 4 years of age as a booster following primary
immunization.
Passive protection against pertussis in early infancy following
maternal immunization during pregnancy (see sections 4.2, 4.6,
and 5.1).
TRIAXIS should be used in accordance with official recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
A single injection of one (0.5 mL) dose is recommended in all
indicated age groups.
In adolescents and adults with an unknown or incomplete diphtheria or
tetanus vaccination status against diphtheria or
tetanus, one dose of TRIAXIS can be administered as part of a
vaccination series to protect against pertussis and in most cases
also against tetanus and diphtheria. One additional dose of a
diphtheria- and tetanus- (dT) containing vaccine can be
administered one month later f