| DIFTEKOK |
| DTP
VACCINE |
| DIPHTHERIA,
TETANUS AND PERTUSSIS VACCINE (ADSORBED) |
| VACCINUM
DIPHTHERIAE, TETANI ET PERTUSSIS ADSORBATUM |
| |
| COMPOSITION |
Human vaccinating dose 0.5 ml contains: |
| Purified
DiphtheriaÒîxoid |
not
less than 30 IU |
| Purified
Òåtanus Òîxoid |
not
less than 40 IU |
| Inactivated
B. pertussis suspension |
not
less than 4 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 DTP vaccine (Requirements
for Diphtheria,Tetanus, Pertussis and combined vaccines; WHO
Technical Report Series No. 800,1990). |
ADMINISTRATION |
DTP
is used for specific prophylaxis of infants, above the age
of six weeks against diphtheria, tetanus and whooping cough.
The vaccine should be shaken before use in order to get a
homogeneous suspension. It should be injected intramuscularly
or deep subcutaneously. The anterolateral aspect of the upper
thigh is the preferred site of injection. An injection into
a child’s buttocks may cause injury to the sciatic nerve and
is not recommended. It must not be injected into the skin
as this may give rise to local reaction.
A sterile needle and a sterile syringe should be used for
each person.
|
| Once
opened, multi-dose vials should be kept between +2°C and +8°C.
Multi-dose vials of DTP 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
|
In
countries where pertussis is of particular danger to young
infants, DTP immunization should be started as soon as possible
with the first dose given as early 6 weeks and two subsequent
injections of 0.5 ml given in an interval not less than 4
weeks.
Reimmunization – not earlier than 12 months after 3-rd injection
with 0.5 ml.
When there are contraindications to pertussis component, DT
vaccine is applied by the immunization schedule of DTP vaccine.
DPT vaccine can be given safely and effectively at the same
time as BCG, Measles and Polio vaccines (OPV and IPV), Hepatitis
B, Hib, Yellow Fever vaccine and vitamin A supplementation.
DTP vaccine can be given safely at the same time as other
EPI vaccine according to national immunization schedules. |
SIDE
EFFECTS |
Mild
local reactions such as pain, tenderness, erythema, induration
are common and may be associated with temperature elevation
(38-39°C). Other reactions that may be observed include chills,
irritability, persistent crying in infants and general malaise.
Most reactions last for 48 hours. In such cases the use of
antipyretics and in the case of local reactions, should be
considered. Adverse reactions due to the pertussis vaccine
are occasional fever of short duration with rare cases of
convulsions. Within 24 hours of vaccination collapse and shock
are rare.
The national childhood encephalopathy study in the United
Kingdom showed a small increased risk of acute encephalopathy
(primarily seizures) following DTP immunization. However subsequent
detailed reviews of all available studies by a number of groups,
including the United States Institute of Medicine, the Advisory
Committee on Immunization Practices, and the pediatric associations
of Australia, Canada, the United Kingdom and the United States,
concluded that the data did not demonstrate a causal relationship
between DPT and chronic nervous system dysfunction in children.
Thus there is no scientific evidence that hypotonic-hyporesponsive
episode and febrile convulsions have any permanent consequences
for the children. |
CONTRAINDICATIONS
|
Strongly
expressed reactions to the first dose with DTP.
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 DTP vaccine according
to standard schedules. |
STORAGE
|
DTP
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! |
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 |