AND HEPATITIS B VACCINE ADSORBED
Diphtheria, Tetanus, Pertussis and Hepatitis B Vaccine
Adsorbed as supplied by Serum Institute of India Ltd., is sterile,
opaque, uniform suspension of diphtheria toxoid, tetanus toxoid,
killed Bordetella pertussis bacilli and Hepatitis B surface antigen
adsorbed on aluminum gel and suspended in isotonic sodium chloride
solution. Surface antigen of the Hepatitis B virus (HBV) is obtained
by culturing genetically engineered Hansenula polymorpha yeast
cells having the surface antigen gene of the Hepatitis B virus.
The Hepatitis-B surface antigen (HBsAg) expressed in the cells
of Hansenula polymorpha is purified through several chemical steps
using recombinant DNA procedures. Thiomersal is added as preservative.
Each dose of 0.5 ml contains :
> 20 Lf to < 30 Lf
> 5 Lf to < 25 Lf
B. pertussis (whole cell)
> 4 IU
> 10 mcg
Preservative: Thiomersal <
DTP-HB vaccine does not prevent Hepatitis caused by other agents
different from HBV (as virus A, C and E) but it is considered
effective in preventing Hepatitis caused by the delta agent.
DTP-HB Vaccine Adsorbed is indicated for the active immunization
of infants, at or above the age of 6 weeks of birth and of children
through 6 years of age against Diphtheria, tetanus, whooping cough
and Hepatitis B. In young children the EPI recommends as many
antigens as possible to be administered at a single visit. The
combined vaccine can be given safely and effectively at the same
time as BCG, Measles and Polio vaccines (OPV and IPV), Hib, Yellow
Fever vaccines and Vitamin A supplementation.
For active immunization of infants and preschool children, it
is recommended that three intramuscular injection of 0.5 ml be
administered with an interval of four weeks between doses.
Although the customary age for first dose of primary
immunization is two months but is now recommended to be given
at 6 weeks of age. If for any reason it is delayed the same schedule
may be used upto the sixth birth day.
Specifically, IAP recommends DTP to be given at 6, 10
and 14 weeks. A booster of DTP can be given at the age of 1 ½
years a reinforcing injection of the 0.5 ml intramuscularly of
the combination should be administered at 5 years of age (i.e.
at the time of school entry).
SHAKE WELL BEFORE USE.
Do not inject subcutaneously or intravenously.
The vaccine vial should be well shaken to get an opaque
suspension. The vaccine should be administered
by intramuscular injection. The anterolateral aspect
of the thigh is the preferred injection site for infants and deltoid
for children. Another injection if coadministered with DTP-HB
vaccine should be made at a different site. Only sterile needles
and syringes should be used for each injection.
Hypersensitivity to any component of the vaccine. It is a contraindication
to use this or any other related vaccine after an immediate anaphylactic
reaction associated with a previous dose.
It is a contraindication to administer the vaccine in
the presence of any evolving neurological condition. Encephalopathy
after a previous dose is a contraindication to further use. Immunization
should be deferred during the cause of an acute illness. Vaccination
of infants and children with severe, febrile illness should generally
be deferred until recovery. However, the presence of minor illnesses
such as mild upper respiratory infections with or without low-grade
fever are not contraindications to further use. Elective immunization
procedures should be deferred during an outbreak of poliomyelitis.
Due to the long incubation period of Hepatitis B (upto 6 months
or more), cases where prior exposure to Hepatitis B virus has
taken place, vaccination may not be effective.
If any of the following events occur in temporal relation
to receipt of DTP, the decision to give subsequent doses of vaccine
containing the pertussis component should be carefully considered.
There may be circumstances, such as a high incidence of pertussis,
when the potential benefits outweigh possible risks, particularly
since these events are not associated with permanent sequelae.
Temperature 40.5°C (105°F)
or more within 48 hours of a dose unexplained by another cause.
Collapse or shock-like state (hypotonic-hyporesponsive
episode) within 48 hours.
Persistent, inconsolable crying
lasting 3 hours or more occurring within 48 hours.
Convulsions with or without fever
occurring within three days.
Persons who experience Arthus-type
hypersensitivity reactions or a temperature of 39.4°C ( >
103° F) following a prior dose of tetanus toxoid usually have
high serum tetanus antitoxin levels and should not be given even
emergency doses of Td more frequently than every 10 years even if
they have a wound that is neither clean not minor.
DTP should not be given to children with any coagulation
disorder, including thrombocytopenia that would contraindicate intramuscular
injection unless the potential benefit clearly outweighs the risk
Recent studies suggest that infants and children with a
history of convulsions in first-degree family members (i.e. siblings
and parents) have a 3:2 fold increased risk for neurologic events
compared DTP vaccine and permanent neurologic damage. Infants and
children with recognized possible or potential underlying neurologic
conditions seem to be at enhanced risk for the appearance of manifestation
of the underlying neurologic disorder within two or three days following
The administration of DTP to children with proven or suspected underlying
neurologic disorders that are not actively evolving must be decided
on an individual basis.
Prior to an injection of any vaccine, all known precautions
should be taken to prevent adverse reactions. This includes a review
of the parent's history with respect to possible sensitivity and
any previous adverse reactions to the vaccine or similar vaccines.
Previous immunization history, current health status and a current
knowledge of the literature concerning the use of the vaccine under
consideration. Immunosuppressed patients may not respond.
Prior to administration of DTP, health care personnel should
inform the patient or guardian of the patient the benefits and risks
of immunization, and also inquire about the recent health status
of the patient to be injected. Parents of a child with a
family history of seizures should be informed that their child has
an increased risk of seizures following DTP administration and should
be instructed regarding appropriate medical care in the unlikely
event of a seizure. Special care should be taken to ensure that the
injection does not enter a blood vessel. WHO does not recommend
mixing different vaccines in one syringe before injection.
ADRENALINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE
SHOULD AN ACUTE ANAPHYLACTIC REACTION OCCUR 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.
As with the use of all vaccines the vaccine should remain
under observation for not less than 30 minutes for possibility of
occurrence of immediate or early allergic reactions. Efcorlin hydrochloride
and antihistaminics should also be available in addition to supportive
measures such as oxygen inhalation.
As with other intramuscular injections, use with caution in patients
on anticoagulant therapy. Immunosuppressive therapies, including
irradiation, antimetabolites, alkylating agents, cytotoxic drugs,
and corticosteroids (used in greater than physiologic doses) may
reduce the immune response to vaccines. Short-term (< 2 weeks)
corticosteroid therapy or intraarticular, bursal, or tendon injections
with corticosteroids should not be immunosuppressive.
Adverse reactions associated with the use of this vaccine
include local redness, warmth, edema, and induration with or without
tenderness, as well as urticaria and rash. Systemic reactions such
as fever, headache, nausea and weakness may appear in a few subjects.
Some data suggests that febrile reactions are more likely to occur
in those who have experienced such responses after prior doses.
The frequency of local reactions and fever following DTP vaccination
is significantly higher with increasing number of doses of DTP,
while other mild to moderate systemic reactions. (e.g. fretfulness,
vomiting) are significantly less frequent. If local redness 2.5
cm occurs the likelihood of recurrence after another DTP dose increases
significantly. Evidence does not indicate a causal reaction between
DTP vaccine and SIDS. Studies showing a temporal relation between
these events are consistent with the expected occurrence of SIDS
over the age range in which DTP immunization typically occurs. Deaths
due to causes other than SIDS including deaths due to serious injections
have occurred in infants following the administration of DTP. No
association has been shown for hospitalizations due to infectious
diseases and receipt of DTP.
Mild systemic reactions such as fever, drowsiness, fretfulness and
anorexia occur quite frequently. Rarely, an anaphylactic reaction
(i.e. hives, swelling of the mouth, difficulty in breathing, hypertension
or shock and death) have been reported after receiving preparations
containing diphtheria, tetanus and / or pertussis antigens.
Arthus-type hypersensitivity reactions characterized by severe local
reactions (generally starting 2 to 8 hours after an injection),
may follow receipt of tetanus toxoid.
Moderate to severe systemic events, including high fever (i.e. temperature
of 40.5°C (105°F) and persistent, inconsolable crying lasting
3 hours or more. These events occur infrequently and appear to be
Occasionally, a nodule may be palpable at the injection site of
adsorbed products for several weeks. Sterile abscesses at the site
of injection have been reported (6 to 10 per million doses).
The following neurologic illnesses have been reported as temporally
associated with vaccine containing tetanus toxoid; neurological
complications including cochlear lesion, brachial plexus neuropathies,
paralysis of the radial nerve, paralysis of the recurrent nerve,
accommodation paresis, and EEG disturbances with encephalopathy.
It has been suggested that there is a causal relation between Guillain-Barre
syndrome (GBS) and vaccines containing tetanus toxoid. In the differential
diagnosis of polyradiculoneuropathies following administration of
a vaccine containing tetanus toxoid should be considered as a possible
etiology. Short-lived convulsions (usually febrile), or collapse
(hypotonic hyporesponsive episode) occur infrequently and appear
to be without sequelae.
More severe neurologic events, such as a prolonged convulsion,
or encephalopathy, although rare, have been reported in temporal
association with DTP administration. An analysis of these data failed
to show any cause and effect association.
An infant who developed myocarditis several hours after immunization
has been reported.
Respiratory difficulties including apnea have been observed.
Rash and allergic reactions have been observed.
Diphtheria, Tetanus, Pertussis and Hepatitis B Vaccine Adsorbed
should be stored at a temperature between 2°C and 8°C (35°
NOT TO BE FROZEN
Product, which has been exposed to freezing, should not be used.
0.5 ml - 1 dose ampoule carton
5 ml-10 doses vial carton.