IMOVAX d.T. adult, suspension for injection in prefilled syringe. Adsorbed diphtheria and tetanus vaccine.

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DIPHTHERIA TOXOID, TETANUS TOXOID

Available from:

Sanofi Pasteur 14 Espace Henry Vallée , 69007 Lyon, France

ATC code:

J07AM51

INN (International Name):

DIPHTHERIA TOXOID TETANUS TOXOID

Pharmaceutical form:

SUSPENSION FOR INJECTION

Composition:

DIPHTHERIA TOXOID TETANUS TOXOID

Prescription type:

POM

Therapeutic area:

VACCINES

Authorization status:

Authorised

Authorization date:

2007-02-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
NAME OF THE MEDICINAL PRODUCT
IMOVAX DT ADULT, SUSPENSION FOR INJECTION IN PREFILLED
SYRINGE ADSORBED DIPHTHERIA AND TETANUS VACCINE
BOXED TEXT
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE VACCINATED BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse have told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
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 IMOVAX DT Adult, suspension for injection in prefilled syringe is
and what it is used for
2.
What you need to know before you use IMOVAX DT Adult, suspension for
injection in prefilled syringe
3.
How to use IMOVAX DT Adult, suspension for injection in prefilled
syringe
4.
Possible side effects
5.
How to store IMOVAX DT Adult, suspension for injection in prefilled
syringe
6.
Contents of the pack and other information
1.
WHAT IMOVAX DT ADULT, SUSPENSION FOR INJECTION IN PREFILLED SYRINGE IS
AND WHAT IT
IS USED FOR
PHARMACOTHERAPEUTIC GROUP: BACTERIAL VACCINES - ATC CODE: J07AM51.
IMOVAX DT Adult is a vaccine. Vaccines are used to protect against
infectious diseases.
This vaccine helps protect against diphtheria and tetanus in adults
from 18 years.
It acts by helping your body produce its own defence (antibodies)
against these diseases.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IMOVAX DT ADULT, SUSPENSION FOR
INJECTION IN PREFILLED SYRINGE
DO NOT USE IMOVAX DT ADULT, SUSPENSION FOR INJECTION IN PREFILLED
SYRINGE
•
If you are allergic (hypersensitive) to the active substance, to any
of the other components of IMOVAX DT
Adult (listed in section 6).
•
If you experienced allergic reactions or neurological disorders after
a previous vaccine injection.
•
If you have fever or an acute disease or a chronic progr

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
IMOVAX DT
IMOVAX DT ADULT, SUSPENSION FOR INJECTION IN PREFILLED SYRINGE
ADSORBED DIPHTHERIA AND TETANUS VACCINE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Diphtheria toxoid
..........................................................................................................................≥
2 I.U
Tetanus toxoid
.............................................................................................................................
≥ 20 I.U
Adsorbed on hydrated aluminium
hydroxide...............................................................................0.6
mg Al
3+
For one 0.5 ml dose
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection in prefilled syringe.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This vaccine is indicated in adults over 18 years of age in the
following cases:
•
Routine booster vaccinations against diphtheria and tetanus. The
diphtheria toxoid content is reduced to one
tenth of the normal dose to minimise the risks of a severe
hypersensitivity reaction,
•
Primary vaccination,
•
Post-exposure prophylaxis following a tetanus-prone wound, if a
booster diphtheria injection is required.
According to the vaccination schedule for subjects under 18 years of
age, the injection of a booster dose of
inactivated diphtheria-tetanus-poliomyelitis vaccine is recommended at
6 years, 11 years and between 16 and 18
years.
However, this adsorbed diphtheria and tetanus vaccine (IMOVAX DT
ADULT) may be administered as a
booster vaccination in children over 10 years of age in whom
poliomyelitis is prevented by administering an oral
attenuated poliomyelitis vaccine.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
•
For routine booster injections, a single dose of 0.5 ml should be
administered every 10 years.
•
For primary vaccination, 3 successive 0.5 ml doses should be
administered at monthly intervals.
•
The post–tetanus exposure prophylaxis recommendations are