For 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
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
A reinforcing injection of 0.5 ml. intramuscularly should be
administered between four and six years of age (i.e. at the time of
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
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
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
WITHDRAWING THE VACCINE FROM A RUBBER-STOPPERED VIAL
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 glass
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
Gene Vac-B™ (Recombinant Hepatitis - B Vaccine,
I.P.) is a non infectious recombinant DNA Hepatitis B
Vaccine. It contains purified surface antigen of the virus
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 and formulated as a
suspension of the antigen adsorbed on aluminium hydroxide
and thiomersal is added as preservative. The vaccine does
not contain any material of human or animal origin.
Each ml contains :
|20 mcg of purified
Hepatitis B surface antigen
|Adsorbed on Aluminium
Produced in Hansenula Polymorpha (yeast)
||1 Paediatric dose -
||1 Adult dose - 1 ml
Gene Vac-B™ is indicated for active immunisation against
Hepatitis-B infection in subjects considered at risk of
exposure to HBV-positive material.
Immunisation against hepatitis B is expected in the long
term to reduce not only the incidence of this disease, but
also its chronic complications such as chronic active
hepatitis B and hepatitis B associated cirrhosis and primary
In areas of low prevalence of hepatitis B, immunisation with
Gene Vac-B™ is recommended for neonates/infants and
adolescents as well as for subjects who are, or will be, at
increased risk of infection such as.
- Health Care
- Patients receiving
frequent blood products.
- Personnel and
residents of institution.
- Persons at
increased risk due to their sexual behaviour.
- Illicit users of
addictive injectable drugs.
- Travellers to
areas with a high endemicity of HBV.
- Infants born of
mothers who are HBV carries.
originating from areas with a high endemicity of HBV.
- Others: Police
personnel, fire brigade personnel, armed forces
personnel and anybody who through their work or personal
lifestyle may be exposed to HBV.
- Household contacts
of any of the above groups and of patients with acute or
chronic HBV infection.
In areas of intermediate or high prevalence
of hepatitis B, with most of the population at risk of
acquiring the disease, immunisation should be offered to all
neonates and young children. Immunisation should also be
considered for adolescents and young adults.
The vaccine can be safely and effectively given
simultaneously but at different injection site with DTP, DT,
TT, BCG, Polio vaccine (OPV and IPV) and yellow fever
Gene Vac-B™ should not be
administered to subjects with known hypersensitivity to
any component of the vaccine, or to subjects having
shown signs of hypersensitivity after previous Hepatitis
B Vaccine administration.
PRECAUTIONS AND WARNINGS
Because of the period of latency of hepatitis-B
infection it is possible for unrecognised infection to
be present at the time of immunisation. The vaccine may
not prevent hepatitis B infection in such cases.
The vaccine will not prevent infection caused by other
agents such as hepatitis A, hepatitis C and hepatitis E
and other pathogens known to infect the liver.
The immune response to Hepatitis B vaccines is related
to age. In general, people over 40 years of age respond
In haemodiaysis patients and persons with an impaired
immune system, adequate anti-HBs antibody titres may not
be obtained after the primary immunisation course and
such patients may therefore require administration of
additional doses of vaccine (see Dosage recommendation
for Immunocompromised persons)
As with all injectable vaccines, appropriate medication
(eg adrenaline) should always be readily available for
treatment in case of rare anaphylactic reactions
following the administration of the vaccine.
Gene Vac-B™ should not be administered in the gluteal
muscle or intradermally since this may result in a lower
Gene Vac-B™ may be used to complete a primary
immunisation course started either with plasma-derived
or with other genetically-engineered hepatitis B
vaccines, or as a booster dose in subjects who have
previously received a primary immunisation course with
plasma-derived or with other genetically-engineered
hepatitis B vaccines.
The undersirable events are temporally related to
the administration of Hepatitis B Vaccine. They are
usually mild and confined to the first few days of the
vaccination. The most common reactions are mild
soreness, erythema, induration, fatigue, fever, malaise,
Less common systemic reactions include nausea, vomiting,
diarrhoea, abdominal pain, abnormal liverfunction tests,
arthralgia, mystalgia, rash, pruritus, urticaria, liver
DOSAGE AND ADMINISTRATION
Paediatric dose vaccines 10 mcg dose (in 0.5 ml
suspension) is recommended for neonates, infants and
children upto 10 years of age.
Adult dose vaccine 20 mcg dose (1.0 ml suspension) is
recommended for adults and children above 10 years of
Primary Immunisation A series of three intramuscular
injections is required to achieve optimal protection.
Two primary immunisation schedules can be recommended:
A rapid schedule, with immunisation at 0,1 and 2
months, will confer protection more quickly and is
expected to provide better patient compliance.
Schedules which have more time between the second
and third doses. such as immunisation at 0,1 and 6
months, may take longer to confer protection, but
will produce higher anti-HBs antibody titres.
The immunisation schedule may be adapted to meet local
The following timing of injections gives general
||at elected date
||4 to 10 weeks after the 1st dose
||1 to 5 months after the 2nd dose
It would seem advisable to recommend a booster dose when the
anti-HBs antibody titre falls below 10 IU/L, particularly
for all people at risk.
- After the 0, 1, 2 month primary
immunisation schedule a booster dose is recommended 12
months after the first dose. The next booster may be
required after 8 years.
- After the 0, 1, 6 month primary
immunisation schedule a booster dose may be required
after 5 years after the primary course.
SPECIAL DOSAGE RECOMMENDATIONSDOSAGE
RECOMMENDATION FOR NEONATES BORN OF MOTHERS WHO ARE HBV
The 0, 1, 2 month immunisation schedule is recommended,
and should start at birth. Concommitant administration of
Hepatitis B immunoglobulin not necessary, but when Hepatitis
B immunoglobulin is given simultaneously with Gene Vac-B™ a
separate injection site must be chosen.
DOSAGE RECOMMENDATION FOR KNOWN OR PRESUMED EXPOSURE OF HBV
In circumstances where exposure to HBV has recently occurred
(eg needlesstick with contaminated needle) the first dose of
Gene Vac-B™ can be administered simultaneously with
Hepatitis B immunoglobulin which however must be given at a
separate injection site. The rapid immunisation schedule
should be advised.
DOSAGE RECOMMENDATION FOR IMMUNOCOMPROMISED PERSONS.
The primary immunisation schedule for chronic haemodialysis
patients or persons who have an impaired immune system is
four doses of 40 mcg at 0, 1, 2 and 6 months from the date
of first dose. The immunisation schedule should be adapted
in order to ensure that the anti-HBs antibody titre remains
above the accepted protective level of 10 IU/L
METHOD OF ADMINISTRATION
Gene Vac-B™ should be injected intramusculary in the
deltoid region in adults and children or in the
anterolateral thigh in neonates, infants and young children.
The vaccine may be administered subcutaneously in patients
with thrombocytopenia or bleeding disorders. The vaccine
should be well shaken before use. Only sterile needle and
syringes should be used for each injection.
Gene Vac-B™ should be stored between 2° and 8°C. Not to be
frozen. Discard if vaccine has been frozen.
||Single dose (Paediatric) vial
||10 doses (Paediatric) vial
||Single dose (Adult) vial
||10 doses (Adult) vial