TETAVAX, suspension for injection in prefilled syringe, adsorbed tetanus vaccine.

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

TETANUS TOXOID

Tilgængelig fra:

Sanofi Pasteur 14 Espace Henry Vallée , 69007 Lyon, France

ATC-kode:

J07AM01

INN (International Name):

TETANUS TOXOID

Lægemiddelform:

SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Sammensætning:

TETANUS TOXOID

Recept type:

POM

Terapeutisk område:

VACCINES

Autorisation status:

Authorised

Autorisation dato:

2007-01-31

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
NAME OF THE MEDICINAL PRODUCT
TETAVAX, SUSPENSION FOR INJECTION IN PREFILLED SYRINGE
ADSORBED TETANUS VACCINE
BOXED TEXT
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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 you pharmacist if you need more information or advice.
•
If you or your child 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 TETAVAX, suspension for injection in prefilled syringe is and
what it is used for
2.
What you need to know before you use TETAVAX, suspension for injection
in prefilled syringe
3.
How to use TETAVAX, suspension for injection in prefilled syringe
4.
Possible side effects
5.
How to store TETAVAX, suspension for injection in prefilled syringe
6.
Contents of the pack and other information.
1.
WHAT TETAVAX, SUSPENSION FOR INJECTION IN PREFILLED SYRINGE IS AND
WHAT IT IS
USED FOR
Pharmacotherapeutic group: vaccine against tetanus - ATC code: J07AM01
This vaccine is an anti-infectious medicinal product indicated in the
prevention of tetanus.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TETAVAX, SUSPENSION FOR INJECTION
IN PREFILLED SYRINGE
DO NOT USE TETAVAX
(TT)
, SUSPENSION FOR INJECTION IN PREFILLED SYRINGE
•
if you are allergic to any of the vaccine components or any of the
other ingredients of this medicine (listed in
section 6).
•
if you experienced allergic reactions or neurological disorder after a
previous vaccine injection.
•
if you have fever or an acute disease or chronic progressive illness,
vaccination should be postponed.
If you have doubts, it is important that you ask your doctor or
pharmacist for advice.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using TETAVAX.
Inform

Produktets egenskaber

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TETAVAX, suspension for injection in prefilled syringe
Adsorbed tetanus vaccine.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 ml) contains:
Tetanus toxoid.
………..................................................................................................
≥ 40 I.U.
Adsorbed on hydrated aluminium hydroxide
...........................................................0.6 mg Al
3+
Excipient(s) with known effect:
Sodium……………………..less than 23 mg
Potassium…………….…….less than 39 mg
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
Tetanus prevention and, in particular:
-
Post-exposure tetanus prophylaxis for recent wounds that may have been
contaminated
with tetanus spores in subjects who have not had any primary
vaccination or for whom
primary vaccination is incomplete or uncertain,
-
Neonatal tetanus prophylaxis in non-immunised women either of
childbearing age or
pregnant in countries where neonatal tetanus is frequent,
-
Primary vaccination,
-
Booster injections.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Post-tetanus exposure prophylactic vaccination_
:
-
When dealing with minor wounds, the doctor must evaluate the risks of
_Clostridium tetani _
_ _
infection at the injured
site.
-
Disinfecting, debriding the wound and administering the vaccine
excepted, the subject
must, in some cases, be passively immunized with a human tetanus
immunoglobulin
injected at a different site (See table hereafter).
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Post–tetanus exposure prophylaxis recommendations are summarized
below:
TYPE
OF
WOUND
PATIENT
NOT
IMMUNISED
OR
PARTIALLY
IMMUNISED
PATIENT
COMPLETELY
IMMUNISED
TIME SINCE LAST BOOSTER DOSE
5 TO 10 YEARS
> 10 YEARS
MINOR - CLEAN
Begin
or
complete
vaccination:
Tetanus
toxoid, 1 dose of 0.5 ml
None
Tetanus
toxoid:
1
dose of 0.5 ml
MAJOR - CLEAN OR
TETANUS-PR