diTeBooster, suspension for injection in pre-filled single-dose syringes.Diphtheria and tetanus vaccine (adsorbed, reduced antigen content).

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Diphtheria toxoid; Tetanus toxoid

Tilgængelig fra:

AJ Vaccines A/S

ATC-kode:

J07AM; J07AM51

INN (International Name):

Diphtheria toxoid; Tetanus toxoid

Dosering:

.

Lægemiddelform:

Suspension for injection in pre-filled syringe

Recept type:

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

Terapeutisk område:

Tetanus vaccines; tetanus toxoid, combinations with diphtheria toxoid

Autorisation status:

Marketed

Autorisation dato:

2007-02-02

Indlægsseddel

_Version 4.2, 04/2021_
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
DITEBOOSTER SUSPENSION FOR INJECTION, PRE-FILLED SYRINGE.
Diphtheria and tetanus vaccine (adsorbed, reduced antigen content).
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 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 diTeBooster is and what it is used for
2.
What you need to know before you are vaccinated with diTeBooster
3.
How you are vaccinated with diTeBooster
4.
Possible side effects
5.
How to store diTeBooster
6.
Contents of the pack and other information
1.
WHAT DITEBOOSTER IS AND WHAT IT IS USED FOR
diTeBooster is a vaccine that provides protection against diphtheria
and tetanus.
diTeBooster stimulates the body to produce antibodies against
diphtheria and tetanus.
This vaccine can be used to re-vaccinate children (5 years or older)
and adults who have already
received primary vaccination against diphtheria and tetanus.
The vaccine is also used to vaccinate children (5 years or older) and
adults who have missing,
incomplete or unknown primary vaccination against diphtheria and
tetanus.
In case of deep and potentially contaminated wounds, the vaccine can
also be used as prevention
against tetanus and revaccination against diphtheria.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE VACCINATED WITH DITEBOOSTER
YOU SHOULD NOT BE VACCINATED WITH DITEBOOSTER
•
if you are allergic to the active substances or any of the other
ingredients in the vaccine (listed in
section 6).
•
if you have experienced serious side effects following previous
vaccinations.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before you or your child are
vaccinated with diTeBooster
•
if you are suffering from

Produktets egenskaber

Health Products Regulatory Authority
17 January 2024
CRN00DQNP
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
diTeBooster, suspension for injection in pre-filled single-dose
syringes.Diphtheria and tetanus vaccine (adsorbed, reduced
antigen content).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 ml) contains:
Diphtheria Toxoid, purified
1
6.25 Lf / ≥2 IU
Tetanus Toxoid, purified
1
6.25 Lf / ≥20 IU
1
adsorbed on aluminium hydroxide, hydrated (Al(OH)3) corresponding to
0.5 mg aluminium (Al
3+
).
The diphtheria and tetanus toxins, obtained from cultures of
_Corynebacterium diphtheriae_ and _Clostridium tetani_, are purified
and detoxified.
No substances of human origin are used during the vaccine manufacture.
The vaccine may contain traces of formaldehyde which is used during
the manufacturing process (see section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringes. (Injection).
Colourless or light yellow suspension of white/grey particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Active immunisation against tetanus and diphtheria in individuals from
5 years of age.
Re-vaccination against diphtheria and tetanus, and primary
immunisation in individuals with missing, incomplete or unknown
primary immunisation.
Tetanus prophylaxis in individuals from 5 years of age with tetanus
prone injuries with simultaneous immunisation against
diphtheria.
The use of diTeBooster should be in accordance with official national
recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
diTeBooster should be administered intramuscularly as a single dose of
0.5 ml for all ages.
_Revaccination_
diTeBooster can be used for revaccination of individuals who are
previously primary vaccinated against diphtheria and tetanus
in accordance with national recommendations.
A booster response can only be expected in individuals who have been
primary vaccinated.
Repeat vaccination against diphtheria and tetanus sh