TdaPBooster, suspension for injection in pre-filled syringe.Diphtheria, tetanus and pertussis (acellular component) vaccine (adsorbed, reduced antigen content)

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Diphtheria toxoid, purified; Tetanus toxoid, purified; Pertussis toxoid, purified

থেকে পাওয়া:

AJ Vaccines A/S

এটিসি কোড:

J07AJ; J07AJ52

INN (আন্তর্জাতিক নাম):

Diphtheria toxoid, purified; Tetanus toxoid, purified; Pertussis toxoid, purified

ডোজ:

< 2 international unit(s)

ফার্মাসিউটিকাল ফর্ম:

Suspension for injection in pre-filled syringe

প্রেসক্রিপশন টাইপ:

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

থেরাপিউটিক এলাকা:

Pertussis vaccines; pertussis, purified antigen, combinations with toxoids

অনুমোদন অবস্থা:

Not marketed

অনুমোদন তারিখ:

2013-07-04

তথ্য লিফলেট

2
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 OR YOUR CHILD ARE
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.
-
If you 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 TdaPBooster is and what it is used for
2.
What you need to know before you or your child are vaccinated with
TdaPBooster
3.
How you or your child 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 (4 years or older),
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD ARE VACCINATED WITH
TDAPBOOSTER
YOU OR YOUR CHILD SHOULD NOT BE VACCINATED WITH TDAPBOOSTER
-
if you are allergic to the active substances or any of the other
ingredients of this medicine (listed
in section 6) or to formaldehyde that may be present in very small
amount.
-
if you are suffering from progressive neurological diseases.
-
if you are ill with high fever, vaccination should be postponed.
-
if you have experienced problems of the nervous system
(encephalopathy) within 7 days after
previous vaccination with a vaccine against pertussis (whooping cough)
disease.
WARNINGS AND PRECAUTIONS
The docto

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
22 February 2021
CRN009ZF6
Page 1 of 7
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).
One 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 (Al(OH)
3
) corresponding to 0.5 mg aluminium (Al
3+
)
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.
Personswith unknown status of
vaccinationorincompleteprimaryvaccination canbe vaccinated. However, a