TdaP-Booster

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Diphtheria toxoid, adsorbed 2 [iU] (NLT); Pertussis toxoid, adsorbed 20ug; Tetanus toxoid, adsorbed 20 [iU] (NLT)

Dostupné s:

Seqirus (NZ) Ltd

INN (Mezinárodní Name):

Diphtheria toxoid, adsorbed 2 IU (NLT)

Léková forma:

Suspension for injection

Složení:

Active: Diphtheria toxoid, adsorbed 2 [iU] (NLT) Pertussis toxoid, adsorbed 20ug Tetanus toxoid, adsorbed 20 [iU] (NLT) Excipient: Aluminium as aluminium hydroxide Sodium chloride Sodium hydroxide Water for injection

Druh předpisu:

Prescription

Výrobce:

Statens Serum Institut

Terapeutické indikace:

For booster vaccination against tetanus, diphtheria and pertussis of individuals from the age of 4 years and onwards.

Přehled produktů:

Package - Contents - Shelf Life: Syringe, glass, 1 x 0.5mL - 0.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 5 x 0.5mL - 2.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 10 x 0.5mL - 5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 20 x 0.5mL - 10 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Datum autorizace:

2013-07-17

Informace pro uživatele

New Zealand Consumer Medicine Information
TDAP-BOOSTER™
(
_tee-dee-ay-pee boo-ster_
)
TETANUS, DIPHTHERIA AND PERTUSSIS (ACELLULAR MONO-COMPONENT) VACCINE
(ADSORBED, REDUCED ANTIGEN CONTENT)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about TDAP-BOOSTER
™
.
It does not contain all the available information.
It does not take the place of talking to your doctor, nurse or
pharmacist.
All medicines, including vaccines, have risks and benefits
.
Your doctor has weighed the risks
of you or your child (of four years or older) having TDAP-BOOSTER
™
against the benefits they
expect it will have.
IF YOU HAVE ANY CONCERNS ABOUT THIS VACCINE, TALK TO YOUR DOCTOR,
NURSE OR PHARMACIST.
KEEP THIS LEAFLET.
You might need to read it again.
WHAT TDAP-BOOSTER
™ IS USED FOR
TDAP-BOOSTER
™
is a “combination” vaccine. It helps prevent THREE diseases, each
caused by
a different infection. The diseases are
•
diphtheria _ _
•
tetanus _and _
•
pertussis (whooping cough).
These infections are serious and can be life-threatening.
TDAP-BOOSTER
™
is used to revaccinate children (≥ 4 years of age), adolescents and
adults
who have previously received at least three doses of a vaccine for
primary immunisation
against diphtheria, tetanus and whooping cough. TDAP-BOOSTER
™ is not intended for primary
immunisation against diphtheria, tetanus and whooping cough.
TDAP-BOOSTER
™
_ _is given as one ADDITIONAL dose (BOOSTER dose) with intervals
according to
national recommendations.
_HOW TDAP-BOOSTER_
_™_
_ WORKS _
TDAP-BOOSTER
™
works by getting your body to produce its own protection against the
three
types of bacteria (germs). The germs are those that cause three
different and serious
infections
•
diphtheria_ _
•
tetanus _and _
•
pertussis (whooping cough)._ _
_ _
The vaccine does not contain live germs and cannot give you these
illnesses.
After you have TDAP-BOOSTER
™
, your body makes substances called antibodies. These
antibodies fight the diphtheria, the

Charakteristika produktu

NEW ZEALAND DATA SHEET
1. PRODUCT NAME
TdaP-Booster
™
. Diphtheria, tetanus and pertussis (acellular mono-component) vaccine
(adsorbed, reduced antigen content).
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
TdaP-Booster
™
is a suspension for injection in pre-filled syringe.
1 dose (0.5 mL) contains:
Diphtheria Toxoid, purified ≥ 2 IU
Tetanus Toxoid, purified ≥ 20 IU
Pertussis Toxoid, purified 20 µg
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.
3. PHARMACEUTICAL FORM
TdaP-Booster vaccine is a sterile suspension of white or grey
particles in colourless liquid supplied in
a single-dose single-dose pre-filled syringe.
4. CLINICAL PARTICULARS
The clinical studies have been performed in children, adolescents and
adults, from 4 years up to
55 years of age.
In clinical studies antibodies were measured one month after
vaccination with TdaP-Booster
™
:
STUDY POPULATION
AGE
CHILDREN
5-6 YEARS
CHILDREN 10 YEARS
ADOLESCENTS
14-15 YEARS
ADULTS
18-55
YEARS
VACCINATION
HISTORY
3 x DTaP
(1) first
year of
life
3 x DT first year of
life, aP/wP
vaccination/disease
3 x DTaP(5)
first year of
life:
1 x TdaP(5)
4-6 years
3-4 x D,
T and wP
first
year of
life
ANTIGEN
IMMUNE RESPONSE
TETANUS
≥ 0.1 IU/ML
99.3 %
100 %
100 %
100 %
DIPHTHERIA
≥ 0.1 IU/ML
99.3%
100 %
100 %
98.5 %
PERTUSSIS
ANTI-PT
BOOSTER
RESPONSE
97.4 %*)
N.A. **)
95.6 %***)
92.0 %
****)
ANTI-PT
ANTIBODY
(GMC)
223
IU/mL
N.A. **)
74.2 IU/mL
122
IU/mL
(1) Mono-component pertussis vaccine
(5) Five-component pertussis vaccine
*) ≥ 4-fold increase
**) Median anti-PT antibody concentration 16.5 to >400 IU/mL
***) ≥ 2-fold increase and ≥ 4 IU/mL
****) ≥ 4-fold increase, if <20 IU/mL before vaccination; ≥ 2-fold
increase, if ≥ 20 IU/mL before
vaccination
Serological correlates of