TRIAXIS Unknown Suspension for Injection

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

TETANUS TOXOID, DIPHTHERIA TOXOID, PERTUSSIS TOXOID, FILAMENTOUS HAEMAGGLUTININ, PERTACTIN, FIMBRIAE TYPES 2 AND 3, ADSORBED ALUMINIUM PHOSPHATE

Beszerezhető a:

Sanofi Pasteur

ATC-kód:

J07AJ52

INN (nemzetközi neve):

TETANUS TOXOID, DIPHTHERIA TOXOID, PERTUSSIS TOXOID, FILAMENTOUS HAEMAGGLUTININ, PERTACTIN, FIMBRIAE TYPES 2 AND 3, ADSORBED ALU

Adagolás:

Unknown

Gyógyszerészeti forma:

Suspension for Injection

Recept típusa:

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

Terápiás terület:

Pertussis, Purified Antigen, Combinations with Toxoids

Engedélyezési státusz:

Authorised

Betegtájékoztató

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 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.
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, life long protection in
all people who are vaccinated.
WHAT YOU NEED TO KNOW BEFORE TRIAXIS IS GIVEN TO YOU OR YOUR CHILD
To make sure that TRIAXIS is suitable for you or your child, it is
importa

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TRIAXIS, suspension for injection.
Diphtheria, 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 aluminium)
* 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
Triaxis appears as a cloudy white suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TRIAXIS is indicated for active immunization against tetanus,
diphtheria and pertussis in persons from 4 years of age
as a booster following primary immunization.
The use of TRIAXIS should be determined on the basis of 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.
TRIAXIS is a vaccine containing low-dose diphtheria-, tetanus- and
pertussis-antigens indicated for booster
vaccinations. When administering the vaccine, indications and dosing
intervals according to the official
recommendations should be considered for all antigens contained in the
vaccine.
Individuals with an incomplete, or no history of a primary series of
diphtheria and tetanus toxoids should not be
vaccinated with TRIAXIS.
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