| TETADIF |
| Td
Vaccine |
|
TETANUS AND DIPHTHERIA VACCINE (ADSORBED) FOR CHILDREN OVER
7 YEARS OF AGE AND ADULTS |
| |
| COMPOSITION |
Human vaccinating dose 0.5 ml contains: |
| Purified
Òåtanus Òîxoid |
not
less than 40 IU |
| Purified
Diphtheria Òîxoid |
not
less than 2 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 Td vaccine (Requirements
for Diphtheria,Tetanus, Pertussis and combined vaccines; WHO
Technical Report Series No. 800,1990). |
|
ADMINISTRATION
|
Td
vaccine is used for reimmunization against tetanus and diphtheria
of adults and children 7 years of age and older.
Td vaccine may be used as a primary immunization, when it
started at 7 years of age.
The vaccine should be shaken before use in order to get a
homogeneous suspension. It should be injected intramuscularly
in the m. deltoideus. A sterile needle and a sterile syringe
should be used for each person.
Td must not be administered I.D.!
|
| Once
opened, multi-dose vials should be kept between +2°C and +8°C.
Multi-dose vials of DT 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 (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 |
Reimmunization
against tetanus and diphtheria of adults and children 7 years
of age and older with 0.5 ml injected intramuscularly in the
m. deltoideus.
Primary immunization for the prevention of tetanus and diphtheria,
when it started at 7 years of age, consists of two doses of
0.5 ml in an interval at least 4 weeks.
A third dose is recommended at least 6 months after the second
dose.
Reimmunization is performed every 10 years with single dose
0.5 ml. I.M.
Td vaccine may be given at the same time as measles, polio
(OPV and IPV), hepatitis B, Haemophilus influenzae type b,
and yellow fever vaccines and vitamin A supplementation.
|
SIDE
EFFECTS |
Some
transitional tenderness and redness at the site of the injection
and occasional fever, but they disappear in 1 – 2 days.
It can safely replace monovalent tetanus toxoid (TT) vaccine,
including during pregnancy, instead of Td vaccine.
|
CONTRAINDICATIONS
|
Strongly
expressed reactions to the first dose with Td vaccine.
Manifestation of adverse reactions, related with some of constituents
of preparation.
|
IMMUNE DEFICIENCY |
| Individuals
infected with human immunodeficiency virus (HIV), both asymptotic
and symptomatic, should be immunized with Td vaccine according
to standard schedules. |
STORAGE |
Td
vaccine should be protected from light and stored and transported
between +2°C and +8°C, in dark.
IT MUST NOT BE FROZEN.
Freeze vaccine is unfit for application!
|
PRESENTATION |
The vaccine comes in ampoules 0.5 ml – one dose and vials
of 5.0 ml – 10 doses and 10.0 ml - 20 doses. |
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 |