TETATOX
TT VACCINE
TETANUS VACCINE (ADSORBED)
 
COMPOSITION

Human vaccinating dose 0.5 ml contains:
Purified Òåtanus Òîxoid
not less than 40 IU
Àluminium hydroxide (Al+++)
not more than 1.25 mg
Òhiomersal not more than 0.05 mg
Sodium chloride not more than 5.00 mg
Water for injection q. s. 0.5 ml

The vaccine meets the requirement of WHO for TT vaccine (Requirements for Tetanus vaccine (adsorbed);
WHO Technical Report Series ¹ 800, 1990)


ADMINISTRATION

Tetatox is used for specific prophylaxis against tetanus. Immunity appears shortly after the second injection, and lasts for 10 years after each booster immunization. The vaccine is used for:
- Booster active immunization for long term prophylaxis of tetanus;
- Tetanus post-exposure prophylaxis in persons with recent injures that might be contaminated with tetanus spores and who did not receive prior vaccination or whose prior vaccination is incomplete or unknown;
- Neonatal tetanus prophylaxis.

The vaccine should be shaken before use in order to get a homogeneous suspension. It should be injected intramuscularly in the deltoid region. A sterile needle and a sterile syringe should be used for each person.
Tetatox must not be administered I.D. ot I.V.! 

Once opened, multi-dose vials should be kept between +2°C and +8°C. Multi-dose vials of Tetatox from which one or more doses of vaccine have been removed during an immunization session may be used in subsequent immunization sessions for up to a maximum of 4 weeks, provided that all of the following conditions are met (as described in WHO policy statement: The use of opened multi dose vials in subsequent immunization sessions. WHO/V&B/00.09):
  • The expiry date has not passed;
  • The vaccines are stored under appropriate cold chain conditions;
  • The vaccine vial septum has been submerged in water;
  • Aseptic technique has been used to withdraw all doses


IMMUNIZATION SCHEDULE
Single immunization dose: 0.5 ml
The immunization for the prevention of tetanus/including neonatal tetanus/ consists of two primary doses of 0.5 ml given intramuscularly at least four weeks apart followed by the third dose at least 6 months later. To maintain the immunity of women against tetanus through the child-bearing period, a total of five doses are recommended. A fourth dose should be given at least one year after the third dose, and a fifth dose at least one year after the fourth dose.
Tetatox immunization can be administered safely during pregnancy even during the first trimester. In previously non-immunized women, two doses of Tetatox are recommended in pregnancy, at least 4 weeks apart, the second dose should be given at least two weeks before childbirth, in order to prevent maternal and neonatal tetanus.
Tetatox may be given at the same time as BCG, measles, rubella, mumps, polio (OPV and IPV), hepatitis B, Haemophilus influenzae type b, and yellow fever vaccines and vitamin A supplementation.

SIDE EFFECTS
Rare and mild. Some transitional tenderness and redness at the site of the injection and occasional fever may occur, but they disappear in 1-2 days. It is safe to give during pregnancy.

CONTRAINDICATIONS
Strongly expressed reactions to the first immunization with Tetatox.
The lethal risk associated with tetanus in wound post – exposure therapy, rules out the potential contraindications.


IMMUNE DEFICIENCY
Individuals infected with human immunodeficiency virus (HIV), both asymptotic and symptomatic, should be immunized with Tetatox vaccine according to standard schedules.

STORAGE
Tetatox should be protected from light and stored and transported between +2°C and +8°C, in dark.
IT MUST NOT BE FROZEN.

PRESENTATION
The vaccine comes in ampoules 1 dose - 0.5 ml; vials of 10 doses - 5.0 ml and 20 doses - 10.0 ml.

NAME AND ADDRESS OF MANUFACTURER
BB - NCIPD Ltd. BULGARIA
1504 Sofia, 26 Yanko Sakazov Blvd.
Tel.:**359 2 944 69 99 / 243
Fax: **359 2 943 30 75
E-mail: bulbio@bulbio.com

Last Revision: May 2004


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