TDAPBOOSTER 0.5 Milligram Suspension for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DIPHTHERIA TOXOID, PURIFIED, TETANUS TOXOID, PURIFIED, PERTUSSIS TOXOID, PURIFIED, ALUMINIUM HYDROXIDE, HYDRATE CORR. TO ALUMINIUM

Available from:

Statens Serum Institute

ATC code:

J07AJ52

INN (International Name):

DIPHTHERIA TOXOID, PURIFIED, TETANUS TOXOID, PURIFIED, PERTUSSIS TOXOID, PURIFIED, ALUMINIUM HYDROXIDE, HYDRATE CORR. TO ALUMINI

Dosage:

0.5 Milligram

Pharmaceutical form:

Suspension for Injection

Prescription type:

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

Therapeutic area:

Benzothiazepine derivatives

Authorization status:

Authorised

Authorization date:

2013-07-04

Patient Information leaflet

CONFIDENTIAL 
Page 1 of 6 
 27-Jun-2013 

 Final 

TdaP Vaccine SSI 

1.3.1 PIL Proposed 

PACKAGE LEAFLET: INFORMATION FOR THE USER 
TDAPBOOSTER 
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 
DIPHTHERIA, TETANUS AND PERTUSSIS (ACELLULAR COMPONENT) VACCINE
(ADSORBED, REDUCED 
ANTIGEN CONTENT) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE VACCINATED  
•  Keep this leaflet. You may need to read it again. 
•  If you have any further questions, ask your doctor, pharmacist
or nurse. 
•  If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, 
please tell 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 TdaPBooster is and what it is used for 
2. 
What you need to know before you are vaccinated with TdaPBooster 
3. 
How you are vaccinated with TdaPBooster  
4. 
Possible side effects 
5. 
How to store TdaPBooster 
6. 
Contents of the pack and other information 
1 
WHAT TDAPBOOSTER IS AND WHAT IT IS USED FOR 
•  TdaPBooster is used to vaccinate children, adolescents and
adults. 
•  TdaPBooster is a vaccine that provides protection against
diphtheria, tetanus and whooping 
cough (pertussis). 
•  TdaPBooster stimulates the body to produce antibodies against
diphtheria, tetanus and 
pertussis bacteria. 
You will receive TdaPBooster only if you already have been vaccinated
against diphtheria, tetanus 
and pertussis. 

CONFIDENTIAL 
Page 2 of 6 
 27-Jun-2013 

 Final 

TdaP Vaccine SSI 

1.3.1 PIL Proposed 

2 
WHAT YOU NEED TO KNOW BEFORE YOU ARE VACCINATED WITH 
TDAPBOOSTER 
YOU SHOULD NOT BE VACCINATED WITH TDAPBOOSTER 
•   If you are allergic to the active substance, to any of the
excipients (listed in section 6) or to 
formaldehyde that may be present in very small amount. 
•  If you are suffering from progressive neurological diseases. 

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TdaPBooster suspension for injection in pre-filled syringe.
Diphtheria, tetanus and pertussis (acellular component) vaccine (adsorbed, reduced antigen content).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen content).
1 dose (0.5 mL) contains:
Diphtheria Toxoid, purified
1
Not less than 2 IU
Tetanus Toxoid, purified
1
Not less than 20 IU
Pertussis Toxoid, purified
1
20 micrograms
1
Adsorbed on Aluminium hydroxide, hydrated (0.5 mg Al)
The diphtheria and tetanus toxins are produced from cultures of _Corynebacterium diphtheriae _and _Clostridium tetani_
and subsequently purified and detoxified. The pertussis toxin is produced from cultures of _Bordetella pertussis _and
subsequently purified and detoxified.
TdaPBooster may contain traces of formaldehyde which are used during the manufacturing process (see section 4.3).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
TdaPBooster is a colourless suspension of white or grey particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TdaPBooster is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals from the age of
four years onwards (see section 4.2).
Clinical studies have been performed in children, adolescents and adults, from the age of 4 years up to 55 years of age
(see section 5.1).
TdaPBooster should be used according to official recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
A single injection of one dose (0.5 mL) is recommended in all age groups.
Vaccination with TdaPBooster should be performed in accordance with official recommendations and/or local practice.