Tetanol Pure ®
Preservative-free tetanus toxoid vaccine-Adsorbat
LEAFLET
-- Please read this leaflet carefully before you proceed with this vaccine vaccinated.
-- Keep this leaflet. You might want to read this again.
-- If you have any questions, please contact your doctor or pharmacist
-- This vaccine has been for you personally and should not be passed on to other people
will.
This leaflet:
1st What is Tetanol ® Pure and what the vaccine is applied
2nd Evidence of the use of pure Tetanol ®
3rd How to apply pure Tetanol ®
4th Possible side effects
5th Notes on the preservation of pure Tetanol ®
A dose (0.5 ml suspension) contains at least 40 IU Adsorbat tetanus vaccine (adsorbed on
1.5 mg aluminium hydroxide as adjuvant).
Excipients:
Salts, formaldehyde <0001 mg and water for injections.
The vaccine contains no preservatives.
Z.Nr.: 2-00079
Manufacturers and authorisation holder:
Chiron Behring GmbH & Co, 35006 Marburg, Germany
Sales in Austria:
Novartis Pharma GmbH, A-1235 Vienna
1st What is Tetanol ® pure and what is this vaccine?
Tetanol ® pure serves the active immunization (vaccination) against tetanus (Wundstarrkrampf)
in
Infants from the beginning of the 3rd Lebensmonates, children, adolescents and adults and will
also to prevent tetanus in infringement case.
Properties and mode of action:
Tetanol ® is a pure white, cloudy suspension and contains purified as tetanus toxoid
substance and alumina to reinforce the immunizing effect.
Tetanol pure injection is a suspension in a pre-filled syringe or ampoule. It may in packs
with 1 or 10 are offered, but not necessarily all on the market.
After complete primary vaccination with Tetanol ® Pure (3 vaccination) is a protective
Antibody levels against tetanus in nearly all patients.
The protective effect occurs about 14 days after the 2nd Vaccination and stops at almost all
patients
about 1 year. After the 3rd Vaccination, the current protection for the infringement case up to 5
years
. In the case of a breach more than 5 years after the 3rd After a vaccination or booster vaccination
has therefore a precautionary tetanus vaccine (tetanus prophylaxis). The antibody levels in
Blood against tetanus fall gradually.
The individual antibody levels against tetanus toxin may be subject to specific tests to be
determined.
To sufficient antibody levels - the protection threshold is 0.1 IU / ml - maintain
should at least every 10 years a routine booster vaccination.
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2nd Evidence of the use of pure Tetanol ®:
Please tell your doctor if you or your child has allergies or if you or
Your child health problems after a previous vaccination occurred.
Contraindications - In these cases, pure ® Tetanol not be used:
Behandlungsbedürftigen people with acute illnesses should be earlier than 2 weeks after
Convalescence be vaccinated (except in case of injury).
Vaccination with tetanus vaccine Adsorbat should in principle be omitted if, after an
previous tetanus vaccination temporary thrombocytopenia (temporary decrease
Blood platelets) or neurological (nervous system concerned) complications occurred
One with complications verlaufene vaccination is to clarify the cause of a contraindication
against a further vaccination with the same vaccine.
In case of injury, there are few absolute contraindications (known, severe allergic
Reactions to the vaccine components, in particular adverse reactions, which is not based on the
Impfstelle limit).
In these cases, tetanus immunoglobulin alone apply, and 2 x 250 IU at a distance of
4 weeks.
Special precautions in the use of pure Tetanol ®:
The vaccine should not be used in a blood vessel (intravasal) administration.
The vaccine should not be mixed with Tetanusimmunglobulin.
The if necessary concomitant administration of tetanus immunoglobulin should kontralateral
(into a
opposite the body) are being administered.
The basic immunization for vollendetem 2nd Month of life, the combination of vaccination
against
Diphtheria, pertussis and tetanus (DPT vaccine) preferred, except for existing
Contra-indications.
Especially in infant and young child, the age-tetanus vaccination with combination vaccines
preferred.
HIV-infected can be vaccinated against tetanus.
Congenital or acquired immunodeficiencies: congenital or acquired immune deficiency can
Impferfolg the restricted or open to question. A review will serological
recommended.
Preterm: premature babies should be independent of their birth weight in accordance with the
Impfalter recommended vaccinated.
Pregnancy and breast-feeding period:
Please inform your doctor if you are pregnant.
During pregnancy and lactation can be vaccinated.
Tetanus prophylaxis in pregnancy: In areas with incidence of neonatal tetanus
(Tetanusneonatorum) are the basic and refresher vaccinations in time so that when
The highest birth titer antibodies in the blood of pregnant women is available.
Simultaneous administration of other vaccines:
Intervals to other vaccinations are not required.
Interactions with other medicines:
Please tell your doctor if you or your child currently with other medicines treated
, to exclude possible interaction.
If the vaccination during treatment with medicines, dampen the immune system
or if an acquired immune deficiency exists, the vaccine reduced.
3rd As