TETAVAX, suspension for injection in multidose presentation, adsorbed tetanus vaccine

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

TETANUS TOXOID

Saadav alates:

Sanofi Pasteur 14 Espace Henry Vallée , 69007 Lyon, France

ATC kood:

J07AM01

INN (Rahvusvaheline Nimetus):

TETANUS TOXOID 40 IU

Ravimvorm:

SUSPENSION FOR INJECTION

Koostis:

TETANUS TOXOID 40 IU

Retsepti tüüp:

POM

Terapeutiline ala:

VACCINES

Volitamisolek:

Withdrawn

Loa andmise kuupäev:

2007-01-31

Infovoldik

5. ¿ CÓMO CONSERVAR TETAVAX ?
Consérvese a una temperatura de entre + 2ºC y + 8ºC (en la
nevera). No congelar.
No deje este medicamento al alcance o a la vista de los niños.
No lo utilice después de la fecha de vencimiento que figura en la
etiqueta y la caja.
Última fecha de aprobación de este prospecto: 06/2002
TAKE SPECIAL PRECAUTIONS WITH TETAVAX:
Inform your doctor:
– if you are suffering from a febrile illness, an acute infection,
or a progressive stage of a
chronic disease (it is preferable to postpone the vaccination),
– if you are suffering from immunodepression or following an
immunosuppressive treat-
ment,
– if you are allergic to or if you have already experienced an
abnormal reaction following a
previous administration of vaccine, or
– if you have received a diphtheria or tetanus vaccine in the last
5 years.
PREGNANCY:
If necessary, this vaccine may be administered during pregnancy.
Ask your doctor or your pharmacist for advice before taking any
medicinal product.
LACTATION:
Ask your doctor or your pharmacist for advice before taking any
medicinal product.
LIST OF EXCIPIENTS WITH A KNOWN EFFECT:
Thiomersal, potassium.
USE OF OTHER MEDICINAL PRODUCTS:
Inform your doctor or your pharmacist if you are taking or
have recently taken any other
medicinal product, even in the case of non-prescription medicinal
products.
3. HOW TO USE TETAVAX?
POSOLOGY:
Post-exposure prevention of tetanus
It is advisable to adhere to the recommended schedule summarised
below:
TYPE OF
PATIENT NOT IMMUNIZED 
PATIENT COMPLETELY
WOUND
OR PARTIALLY IMMUNUZED
IMMUNIZED
TIME SINCE LAST BOOSTER DOSE
5 TO 10 YEARS
>10 YEARS
Clean - 
Begin or complete immunization:
No immunization    Tetanus toxoid:
minor
1 dose of tetanus toxoid
1 dose
Clean -
In one arm:
In one arm:
major or
Human tetanus immune globulin,
Human tetanus
tetanus 
250 I.U.* 
immune globulin,
prone
250 I.U.*
In the other arm:
Tetanus toxoid
In the other arm:
Tetanus toxoid**: 1 dose
1 dose
Tetanus toxoid:
1 dose*
Tetanus
In one a

Toote omadused

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TETAVAX, suspension for injection in multidose presentation, adsorbed
tetanus vaccine.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tetanus toxoid
........................................................................................................
≥
40 I.U.
for one dose of 0.5 ml
3.
PHARMACEUTICAL FORM
Suspension for injection in multidose presentation.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Tetanus prevention and, in particular:
-
post-exposure 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-immunized 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).
Page 2 of 5
The post–tetanus exposure prophylaxis recommendations are summarized
below:
TYPE OF
WOUND
PATIENT NOT
IMMUNIZED OR
PARTIALLY
IMMUNIZED
PATIENT COMPLETELY IMMUNIZED
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-PRONE
In one arm:
Human tetanus
immunoglobulin,
250 I.U.*
In one arm:
Human tetanus
immunoglobulin,
250 I.U.*
In other arm:
Tetanus toxoid**: 1 dose
of 0.5 ml
Tetanus toxoid:
1 dose of 0.5 ml
In other arm:
Tetanus toxoid**: 1 dose
of 0.5 ml
TETANUS-PRONE
DELAYED OR
INCOMPLETE
DEBRIDEMENT
In one arm