Diphtheria, Tetanus and Pertussis Vaccine Adsorbed
is prepared by combining purified Diphtheria toxoid, purified Tetanus toxoid and
killed Bordetella pertussis bacilli. The antigens are adsorbed onto aluminium
phosphate as adjuvant. Thiomersal is added as preservative. The vaccine has the
appearance of a greyish - white suspension and does not contain any horse serum
protein. Therefore it does not induce sensitization to sera of equine origin.
The vaccine meets the requirements of WHO, EP and IP when tested by the methods
outlined in WHO, TRS. (1990), 800, EP and IP.
Each single 0.5 ml human dose contains
25Lf ( 30 IU)
Tetanus Toxoid 5Lf
( 40 IU)
16 OU (
Adsorbed on Aluminium Phosphate (AlPO4)
Preservative : 0.01% Thiomersal
For the primary immunization of infants, above the age of six weeks, and of
pre-school children against diphtheria, tetanus and whooping cough. The vaccine
can be safely and effectively given simultaneously with BCG, Measles, Polio vaccines
(IPV and OPV), Hepatitis B and Yellow Fever vaccine, Haemophilus
influenzae-B and Varicella vaccine.
For the purpose of primary immunization it is recommended that
3 doses of 0.5 ml should be inoculated on 3 separate occasions at 4 to 6 week
intervals. The first dose should be given at approximately 6 weeks of age. Reinforcing
injections of 0.5 ml. should be given 12 months after the primary immunization
and also between the ages of 4 to 6 years.
METHOD OF INOCULATION
DTP vaccine should be injected intramuscularly. The anterolateral aspect of
the upper thigh is the preferred site for injection. (an injection into a
buttocks may cause injury to the sciatic nerve and is not recommended). It must
only be injected into the skin as this may give rise to local reaction. Only sterile
needles and syringes should be used for each injection. The vaccine should be
well shaken before use.
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 immunisation session may be used in subsequent immunisation sessions
for upto a maximum of 4 weeks, provided that all of the following conditions are
The expiry date has not passed
are stored under appropriate cold chain conditions
The vaccine vial septum
has not been submerged in water
Aseptic technique has been used to withdraw
Mild, local reactions
such as pain, tenderness, erythema, induration are common and may be associated
with temperature elevation (38-39°C) and an infiltration of 3 to 4 cm in diameter.
Other reactions that may be observed include chills, irritability persistent crying
in infants and general malaise, Most reactions last for 24 to 48 hours: In such
cases the use of antipyretics and in the case of local reaction, cold compresses
should be considered. Occasionally a nodule may develop at the site of injection
but this is without any harmful effects. More serious reactions such as fever
above 40°C excessive screaming, and encephalopathic symptoms (e.g. convulsions)
may also be observed but are extremely rare. By strict observance of the contraindications
listed below the number of such complications will be reduced to a minimum.
ADRENALINE INJECTION (1:1000) MUST
BE IMMEDIATELY AVAILABLE SHOULD AN ACUTE ANAPHYLACTIC REACTION OCCURS DUE TO ANY
COMPONENT OF THE VACCINE. For treatment of severe anaphylaxis
the initial dose of adrenaline is 0.1-0.5 mg (0.1-0.5ml of 1:1000 injection) given
s/c or i/m. Single dose should not exceed 1 mg (1ml). For infants and children
the recommended dose of adrenaline is 0.01mg/kg (0.01ml/kg of 1:1000 injection).
Single pediatric dose should not exceed 0.5mg (0.5ml). The mainstay in the treatment
of severe anaphylaxis is the prompt use of adrenaline, which can be lifesaving.
It should not be used at the first suspicion of anaphylaxis.
As with the use
of all vaccines the vaccines should remain under observation for not less than
30 minutes for the possibility of occurrence of immediate
or early allergic reactions. Efcorlin hydrochloride and antihistaminics should
be available in addition to supportive measures such as oxygen inhalation.
There is an increased incidence of local and systemic reactions to booster doses
of tetanus toxoid when given to previously immunized persons. Special care should
be taken to ensure that the injection does not enter a blood vessel.
EXTREMELY IMPORTANT WHEN THE PARENT, GUARDIAN, OR ADULT PATIENT RETURNS FOR THE
NEXT DOSE IN THE SERIES, THE PARENT, GUARDIAN, OR ADULT PATIENT SHOULD BE QUESTIONED
CONCERNING OCCURRENCE OF ANY SYMPTOMS AND/OR SIGNS OF AN ADVERSE REACTION AFTER
THE PREVIOUS DOSE.
If DTP and TIG or Diphtheria Antitoxin are administered concurrently,
syringes and separate sites should be used.
As with other intramuscular injections,
use with caution in patients on anticoagulant therapy.
therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic
drugs and corticosteroids used in greater than physiologic dose may reduce the
immune response to vaccines.
CONTRAINDICATIONS AND WARNINGS
Not for intradermal use. The administration of pertussis containing vaccine
is contraindicated in children with a personal, or family history in parents or
siblings of idiopathic epilepsy or other familial or hereditary diseases of the
central nervous system. Administration of pertussis vaccine is also contra-indicated
in children with a history of seizures, convulsions, cerebral irritation in the
neonatal period, developmental neurological defect or other disorder of the central
Immunization should be postponed if the infant has an acute
disease. However, low grade fever, mild respiratory infections, malnutrition or
diarrhoea should not be considered as contraindications. Infants who have active
or progressive neurological disease including recent convulsions should not be
given pertussis-containing vaccines. Adsorbed DT vaccine should be given instead.
A second or subsequent dose of DTP vaccine should not be given to a child who
had a severe reaction like persistent screaming, shock, convulsions or encephalopathy
to the previous dose. Adsorbed DT vaccine should be given for the remainder of
DTP vaccine may be used in children
with known or suspected HIV infection. Although the data are limited and further
studies are being encouraged, there is no evidence to date of any increased rate
of adverse reactions using this vaccines in symptomatic or asymptomatic HIV infected
STORAGE OF THE VACCINE
The vaccine should
be stored in a dry, dark place at a temperature between 2-8°C. Transportation
should also be at 2-8°C. DO NOT FREEZE.
24 months from date of manufacture.
1 Dose ampoule of 0.5 ml
10 Dose vial of 5 ml
20 Dose vial of 10 ml