| DIFTET |
| DT
VACCINE |
| DIPHTHERIA
AND TETANUS VACCINE (ADSORBED) |
| VACCINUM
DIPHTHERIAE ET TETANI ADSORBATUM |
| |
| COMPOSITION |
Human vaccinating dose 0.5 ml contains: |
| Purified
Diphtheria Òîxoid |
not
less than 30 IU |
| 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 DT vaccine (Requirements
for Diphtheria, Tetanus, Pertussis and combined vaccines; WHO
Technical Report Series No. 800, 1990).
|
|
ADMINISTRATION
|
DT
vaccine is recommended for reimmunization against diphtheria
and tetanus in children below 7 years of age.
DT vaccine is used for primary immunization and reimmunization
against diphtheria and tetanus of children above six weeks,
if there are contraindications for administration of DTP vaccine.
For persons 7 years and older, a special adsorbed vaccine
for adults, Td, is recommended.
The vaccine vial should be shaken before use to homogenize
the suspension. The vaccine should be injected intramuscularly
or deep subcutaneously. A sterile syringe and a sterile needle
should be used for each person.
Do not injected 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 (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 |
DT vaccine is used for reimmunization of children below 7
years of age with single dose 0.5 ml. Vaccine should be injected
intramuscularly.
Primary immunization – when there are contraindications to
pertussis component, DT vaccine is applied by the immunization
schedule of DIFTETKOK (DPT). Three intramuscular injection
of 0.5 ml given in an interval not less than 4 weeks.
DT may be given at the same time as BCG, Measles, Rubella,
Mumps, Polio vaccines (OPV and IPV), Hepatitis B, Hib, Yellow
Fever vaccine 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. |
CONTRAINDICATIONS |
Strongly
expressed reactions to the first dose with DT.
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 DT vaccine according
to standard schedule. |
STORAGE |
DT vaccine should be stored and transported between +2°C and
+8°C, in dark.
IT MUST NOT BE FROZEN.
Freeze vaccine is unfit for application!
Keep out the reach of children.
|
PRESENTATION |
|
The vaccine comes in ampoules 0.5 ml – 1 dose and vials of 5.0
ml – 10 doses and vials of 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 |