Active Immunization against Diphtheria, Tetanus and Whooping Cough
This vaccine fulfils the I.P. requirements for
Diphtheria Toxoid, Tetanus Toxoid and Pertussis Vaccine.
Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) (Sii Triple
Antigen) as supplied by Serum Institute of India Ltd. is a sterile,
whitish turibid, uniform suspension of diphtheria, tetanus toxoids
and pertussis vaccine adsorbed on aluminium phosphate and suspended
in isotonic sodium chloride solution. Each dose of 0.5 ml contains:
DPT Vaccine (Adsorbed) is indicated for the primary immunization
of infants, at or above the age of 6 weeks, and of children through
six years of age against diphtheria, tetanus and whooping cough.
For the purpose of primary immunization it is recommended that 3
doses each of 0.5 ml should be inoculated on 3 separate occasions
at 4 weeks interval.
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.
Although it is recommended that immunization be started at 6 weeks,
if for any reason it is delayed, the same schedule may be used up
to the sixth birthday.
A reinforcing injection of 0.5 ml. intramuscularly should be administered
between four and six years of age (i.e. at the time of school entry).
This booster dose is not necessary if the fourth primary immunizing
dose has been administered after the fourth birthday.
DPT vaccine should be administered by deep intramuscular injection.
The preferred site for injection is the anterolateral aspect of
the upper thigh.
Only sterile needles and syringes should be used for each injection.
The vaccine should be well shaken before use.
Each injection of the primary immunization series should be made
into a different site with a sterile disposable syringe and needle.
Mild local reactions consisting of erytherna, pain and tenderness,
swelling and induration at the injection site are common, usually
self-limited and subside without treatment. Persistent nodules at
the site of injection have occurred following the use of an adsorbed
vaccine, but this complication is unusual. Abscess at the site of
injection has been reported (6-10 per million doses).
Mild to moderate systemic reactions occur frequently following injections
of this vaccine. These usually consist of one or more of the following
symptoms and signs: temperature elevation 38°C, drowsiness,
fretfulness, anorexia, vomiting, irritability, persistent or unusual
crying. These symptoms are most frequent during the first 24 hours
following vaccine injection and may persist for one to two days.
The following adverse reactions -high fever (40.5°C), collapse,
screaming episodes, convulsions, signs of encephalopathy which can
be serious and, occasionally fatal have been reported following
administration of preparations containing pertussis vaccine. The
incidence of these reactions is unknown, but they seem to be exceedingly
rare, if any of these reactions occur, further immunization against
pertussis is contraindicated. See also Contraindications and Precautions.
Sudden-infant-death-syndrome (SIDS) has been reported following
administration of vaccine containing diphtheria, tetanus toxoids
and pertussis vaccine. The significance of these reports is not
clear. It should be borne in mind that the three primary immunizing
doses of these vaccine are usually administered to infants between
the age of 6 weeks and 6 months and that approximately 85% of SIDS
cases occur in the period from one through six months of age with
the peak incidence at age two to four months.
DPT Vaccine (Adsorbed) should not be administered to infants or
children with high fever, or other evidence of acute illness or
infection. The presence of an evolving or changing neurological
disorder is a contraindication to receipt of this vaccine. While
data to support exclusion of pertussis immunization because of a
family history of convulsive or other neurological disorders are
scarce, a personal or family history of central nervous system disease
or convulsions is considered a contraindication to use of this vaccine.
Occurence of any of the following signs, symptoms or conditions
following administration is a contraindication to further use of
this product and or pertussis vaccine as the single antigen: fever
over 40°C (104°F); convulsion(s) with or without accompanying
fever; alterations of consciousness; focal neurologic signs; screaming
episodes; shock; collapse; thrombocytopenia purpura.
DPT Vaccine (Adsorbed) should not be administered to children over
six years of age or to adults because of the danger of reactions
to diphtheria toxoid or to pertussis vaccine and because pertussis
is less severe in these age groups than in infants and young children.
The specific contraindications adopted by individual national health
authorities should reflect a balance between the risk from the vaccine
and the risk from the disease. Because the risk from the vaccine
remains extremely low in comparison to the risk from the disease
in many developing countries, authorities there may choose to offer
immunization to children who are mildly to moderately ill or malnourished.
PRECAUTIONS AND WARNING
Individuals receiving corticosteroids or other immunosuppressive
drugs may not develop an optimum immunologic response. This product
should be used only for infants and children from 6 weeks through
six years of age. The possibility of allergic reactions in individuals
sensitive to the components of the vaccine should be borne in mind.
Adrenaline injection (1:1000) should be kept ready for immediate
use in case an anaphylactic or acute hypersensitivity reaction occurs.
Frequent booster doses of tetanus toxoid in the presence of adequate
or excessive serum levels of tetanus antitoxin have been associated
with increased incidence and severity of reactions and should be
avoided. If hypersensitivity to the diphtheria component is suspected,
tetanus toxoid should be used for reinforcing doses.
A separate sterile syringe and needle should be used for each individual
patient to prevent the transmission of hepatitis or other infectious
DPT VACCINE (ADSORBED) SHOULD BE USED ONLY FOR INFANTS AND CHILDREN
THROUGH SIX YEARS OF AGE.
WITHDRAWING THE VACCINE FROM A SEALED GLASS AMPOULE
Shake the ampoule to disperse the contents thoroughly immediately
before withdrawing the dose. Tap the ampoule to ensure that the solution
is in the lower portion rather than in the neck of the ampoule Wipe
the neck of the ampoule with a suitable antiseptic using a sterile
piece of cotton break off the top of the ampoule at the constriction
by thumb pressure.
WITHDRAWING THE VACCINE FROM A RUBBER-STOPPERED
DO NOT REMOVE THE RUBBER STOPPER FROM THE VIAL
Shake the vial to disperse the contents thoroughly immediately before
each withdrawal of vaccine. Apply a sterile piece of cotton moistened
with a suitable antiseptic to the surface of the rubber stopper
and allow to dry. Draw into the sterile syringe a volume of air
equal to the amount of vaccine to be withdrawn from the vial. Pierce
the centre of the rubber stopper with the sterile needle of the
syringe. invert the vial, slowly inject into it the air contained
in the syringe, and keeping the point of the needle immersed. withdraw
into the syringe the required amount of vaccine. Then hold the syringe
plunger steady and withdraw the needle from the vial.
Carefully insert the needle intramuscularly at the prepared injection
site. In order to avoid intravenous injection, pull back the plunger
of the syringe to make certain that no blood is withdrawn before
injecting the desired dose.
Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) should be stored
at a temperature between 2°C and 8°C (35° to 46°F).
NOT TO BE FROZEN.
Product which has been exposed to freezing should not be used.
Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) is supplied,
ready for use, in rubber-stoppered multi-dose vials, and in single-dose
i) 0.5 ml X 10 ampoules box
ii) 0.5 ml X 50 ampoules box
iii) 5 ml - 10 dose single vial carton
iv) 5 ml - 10 dose X 50 vials box