Adacel Suspension for Injection in pre-filled syringe

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

TETANUS TOXOID, DIPHTHERIA TOXOID, PERTUSSIS TOXOID, FILAMENTOUS HAEMAGGLUTININ, FHA, PERTACTIN, FIMBRIAE TYPES, AND, ALUMINIUM PHOSPHATE

Tillgänglig från:

Sanofi Pasteur 14 Espace Henry Vallée , 69007 Lyon, France

ATC-kod:

J07AJ52

INN (International namn):

ALUMINIUM PHOSPHATE 1.5 mg TETANUS TOXOID 20 IU DIPHTHERIA TOXOID 2 IU PERTUSSIS TOXOID 2.5 µg FILAMENTOUS HAEMAGGLUTININ (FHA) 5 µg PERTACTIN 3 µg FIMBRIAE TYPES 2 AND 3 5 µg

Läkemedelsform:

SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Sammansättning:

ALUMINIUM PHOSPHATE 1.5 mg TETANUS TOXOID 20 IU DIPHTHERIA TOXOID 2 IU PERTUSSIS TOXOID 2.5 µg FILAMENTOUS HAEMAGGLUTININ (FHA) 5 µg PERTACTIN 3 µg FIMBRIAE TYPES 2 AND 3 5 µg

Receptbelagda typ:

POM

Terapiområde:

VACCINES

Bemyndigande status:

Authorised

Tillstånd datum:

2016-08-26

Bipacksedel

PAGE 1 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
ADACEL
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 ADACEL is and what it is used for
2.
What you need to know before ADACEL is given to you or your child
3.
How and when ADACEL is given
4.
Possible side effects
5.
How to store ADACEL
6.
Contents of the pack and other information
1
WHAT ADACEL IS AND WHAT IT IS USED FOR
ADACEL (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 ADACEL 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
ADACEL 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.
ADACEL 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

Produktens egenskaper

PAGE 1 OF 15
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ADACEL,
suspension for injection in pre-filled syringe.
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 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.
ADACEL appears as a cloudy white suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADACEL (Tdap) is indicated for:
Active immunization against tetanus, diphtheria and pertussis in
persons from 4 years of age as a
booster following primary immunization.
PAGE 2 OF 15
Passive protection against pertussis in early infancy following
maternal immunization during
pregnancy (see sections 4.2, 4.6, and 5.1).
ADACEL 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 ADACEL 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 followed by a
3rd dose of a diphtheria or dT contai