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For the use only of a Registered Medical Practitioner or a Hospital

or a Laboratory
MEASLES VACCINE
(LIVE) I.P. (FreezeDried)
DESCRIPT
ION
Sii Measles Vaccine (Live) I.P. freeze-dried is prepared from the Edmonston strain measles virus
which has been further attenuated by twenty two passages on human diploid cells (HDC) and
is known as the Edmonston-Zagreb strain. The virus in the fnal vaccine is also propagated on
HDC and is from the second cell culture passage from the seed virus. The vaccine is lyophilized
and is provided with diluent. The product has the appearance of a yellowish-white dry cake. The
vaccine meets the requirements of I.P. and WHO when tested by the methods outlined in I.P. and
WHO, TRS 840 (1994).
COMPOSITI
ON
Each dose of 0.5 ml contains not less than 1000 CCID of Measles virus on reconstitution with
the diluent (Sterile 50
Water for Injections I.P.)
provided.
INDICATI
ONS
Sii Measles Vaccine (Live) I.P. is indicated for immunisation of all susceptible children
against measles. It is recommended to be given to children at 9 months of age, or as soon as
thereafter, to protect against measles in early life. Immunisation against measles is particularly
important for institutionalized children and for children who may be malnourished or subject to
chronic diseases such as heart disease, cystic fbrosis, asthma, tuberculosis or other chronic
pulmonary disorders. The vaccine can also be administered to children and adolescents who
have been vaccinated before or have had measles infection earlier. Measles vaccine can be
safely and effectively given simultaneously with DTP, DT, TT, Td, BCG, Polio vaccine (OPV and
IPV), Haemophilus infuenzae type b, Hepatitis B and Yellow fever vaccine and vitamin A
supplementation.
APPLICATION
DOSAGE

AND

The vaccine should be reconstituted only with the entire contents of the diluent supplied
(Sterile water for injections I.P.) using a sterile syringe and needle. With gentle shaking the dried
cake is easily dissolved. After reconstitution the vaccine should be used immediately. A single
dose of 0.5 ml should be administered by deep subcutaneous injection into the anterolateral
aspect of upper thigh in infants and upper arm in older children. If the vaccine is not used
immediately then it should be stored in the dark between +2C and +8C for no longer than 6
hours and should remain in sterile condition. Any opened container remaining at the end of a
session (within six hours of reconstitution) should be discarded. The vaccine vial monitor (see
fgure), for this type of vaccine is attached to the vial cap and should be discarded when the
vaccine is being reconstituted.
The diluent supplied is specially designed for use with the vaccine. Only this diluent must be used
to reconstitute the vaccine. Do not use diluents from other types of vaccine or for Measles
vaccine from other manufacturers. Water for injection must NOT be used for this purpose.
Using an incorrect diluent may result in damage to the vaccine and/or serious reactions to
those receiving the vaccine. Diluent must not be frozen, but should be kept cool.
The diluent and reconstituted vaccine should be inspected visually for any foreign particulate

matter and / or variation of physical aspects prior to administration. In the event of either being
observed, discard the diluents or reconstituted vaccine.
ADVERSE
REACTIONS
The measles vaccine may cause within 24 hours of vaccination mild pain and tenderness at the
injection site. In most cases, they spontaneously resolve within two to three days without further
medical attention. A mild fever can occur in
5-15% of vaccinees 7 to 12 days after vaccination and last for 1-2 days. Rash occurs in
approximately 2% of recipients, usually starting 7-10 days after vaccination and lasting 2
days. The mild side effects occur less frequently after the second dose of a measlescontaining vaccine and tend to occur only in person not protected by the frst dose.
Encephalitis has been reported following measles vaccination at a frequency of approximately
one case per million

doses administered although a causal link is not proven. In susceptible individuals the vaccine
may very rarely cause allergic reactions like urticaria, pruritis and allergic rash within 24 hours of
vaccination.
DRUG
INTERACTIONS
Due to the risk of inactivation, the measles vaccine should not be given within the 6 weeks,
and if it is possible the 3 months, after an injection of immunoglobulins or blood product
containing immunoglobulins (blood, plasma).
For the same reason, immunoglobulins should not be administered within the two weeks after
the vaccination. Tuberculin positive individuals may transitionally become tuberculin negative
after vaccination.
CONTRAINDICATIONS
WARNINGS

AND

There are few contraindications to the administration of measles vaccine. Individuals receiving
corticosteroids, other immuno-suppressive drugs or undergoing radio-therapy may not develop
an optimal immune response. The vaccine should not be given in acute infectious diseases,
leukaemia, severe anaemia and other severe diseases of the blood system, severe impairment of
the renal function, decompensated heart disease, following administration of gammaglobulin or
blood transfusions.
Persons with a history of an anaphylactic reaction to any component of the vaccine should not be
vaccinated. There are extremely rare reports of hypersensitivity reactions with Measles vaccine
in individuals who are allergic to cows milk. Such individuals should not receive the vaccine.
Low-grade fever, mild respiratory infections or diarrhoea, and other minor illness should not be
considered as contraindications. it is particularly important to immunize children with
malnutrition. Since the effect of the live measles vaccine on the fetus is not known, it is also
contraindicated in pregnancy.
IMMUNE
DEFICIENCY
Children with known or suspected HIV infection are at increased risk of severe measles and
should be offered measles vaccine as early as possible. Measles vaccine is contraindicated in
persons who are severely immunocompromised as a result of a congenital immune disorder, HIV
infection, advanced leukaemia or lymphoma, serious malignant disease, or treatment with highdose steroids, alkylating agents or antimetabolites, or in persons who are receiving
immunosuppressive therapeutic radiation.
STORA
GE
IT IS IMPORTANT TO PROTECT BOTH THE LYOPHILIZED AND RECONSTITUTED VACCINE FROM
THE LIGHT. The vaccine should be stored in the dark between +2C and +8C. For long term
storage a temperature of -20C is recommended for the lyophilised vaccine. Protect from light.
The diluent should not be frozen, but should be kept cool.
PRESENTAT
ION
1 dose vial plus diluent
(0.5 ml)
2 dose vial plus diluent
(1 ml)
5 dose vial plus diluent
(2.5 ml)
10 dose vial plus diluent
(5 ml)

THE VACCINE VIAL MONITOR


(Optional)
Inner square lighter than outer circle. If the expiry date has
not been passed, USE the vaccine.
At a later time, inner square still lighter than outer circle. If the expiry date
has not been passed, USE the vaccine.
Discard
point:
Inner square matches colour of
outer circle.

DO NOT use the


vaccine.
Beyond the discard
point:
Inner square darker
outer ring.
DO NOT use the
vaccine.

than

Vaccine Vial Monitors (VVMs) are on the cap of Sii Measles Vaccine (Live) I.P. freeze-dried
supplied through ABC Institute of India Pvt. Ltd. This is a time-temperature sensitive dot that
provides an indication of the cumulative heat to which the vial has been exposed. It warns the
end user when exposure to heat is likely to have degraded the vaccine beyond an acceptable
level.
The interpretation of the VVM is simple. Focus on the central square. Its colour will change
progressively. As long as the colour of this square is lighter than the colour of the ring, then the
vaccine can be used. As soon as the colour of the central square is the same colour as the ring or
of a darker colour than the ring, then the vial should be discarded.
MOST
IMPORTANT
WARNING
1.

Please ensure that the vaccine is administered by subcutaneous route only. In rare cases
anaphylactic shock may occur in susceptible individual and for such emergency please
keep handy 1:1000 adrenaline injection ready to be injected intramuscularly or
subcutaneously. For treatment of severe anaphylaxis the initial dose of adrenaline is 0.10.5 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 paediatric dose should not exceed 0.5mg (0.5ml).
This will help in tackling the anaphylactic shock/reaction effectively

2.

The mainstay in the treatment of severe anaphylaxis is the prompt use of adrenaline,
which can be lifesaving. It should be used at the frst suspicion of anaphylaxis. As with the
use of all vaccines the vaccinees should remain under observation for not less than 30
minutes for possibility of occurrence of rapid allergic reactions. Hydrocortisone and
antihistaminics should also be available in addition to supportive measures such as oxygen
inhalation.

FREEZE-DRIED
PREPARATIONS
Instructions for use
1)

Draw the diluents from the ampoule into a syringe, pierce the bung of the vial with the
needle and gently inject the diluent into the vial.
2) Detach the syringe, leaving the needle in vial bung. After 15 seconds
remove the needle
3) Rotate the vial gently between your palms till the material dissolves. Avoid shaking the
vial as this would cause frothing.
4) Withdraw the reconstituted solution into the syringe, now ready
for administration
Manufacture
d by:
Protection
onwards

from

birth

Bacillus
Calmette-Guerin
Vaccine I.P.
(FreezeDried)
DESCRIPT
ION
Bacillus Calmette-Guerin Vaccine I.P. is a live freeze-dried vaccine derived from attenuated strain
of mycobacterium bovis. (Bacillus Calmette-Guerin) used for the prevention of tuberculosis. It
contains Sodium Glutamate as stabilizer. The vaccine meets the requirements of W.H.O. and I.P.
when tested by the methods outlined in W.H.O., TRS. 979 (2013) and I.P.

COMPOSITI
ON
Each 1 ml contains
between :
2 x 10 6 and 8 x 10 6 Colony Forming
Units (C.F.U.) Diluent :Sodium Chloride
Injection I.P.
Dose : 0.05 ml for children under one
month of age.
0.1 ml for children over one month of age
and adults. by intradermal injection
RECONSTITU
TION
BCG vaccine 10/20 dose vial should be reconstituted by adding the entire contents of Sodium
Chloride Injection I.P. supplied. Carefully invert the vial a few times to resuspend freeze dried
BCG. Gently swirl the vial of resuspended vaccine before drawing up each subsequent dose.
The resulting suspension should be homogenous, slightly opaque and colourless. Reconstitute
only with diluent provided by manufacturer. Using an incorrect diluent may result in damage to
the vaccine and/or serious reactions to those receiving the vaccine. Use immediately after
reconstitution. If the vaccine is not used immediately then it should be stored in the dark
between 2 and 8C for no longer than 6 hours (1 immunisation session).
Any opened vial remaining at the end of a vaccination session (within six hours of reconstitution)
must be discarded. The vaccine vial monitor for this type of vaccine is attached to the vial cap
and should be discarded when the vaccine is being reconstituted.
The diluent and reconstituted vaccine should be inspected visually for any foreign particulate
matter and/or variation of physical aspects prior to administration. In the event of either being
observed, discard the diluent or reconstituted vaccine.
DOSAGE
ADMINISTRATION

AND

This vaccine is intended to be injected strictly via the


intradermal route.
Universal Immunization Programme (UIP) of Government of India recommends 0.05 ml for
children under one month of age and 0.1 ml for children over one month of age and adults of
reconstituted vaccine given intradermally. The vaccine should be preferably given with a
tuberculin syringe or 25G/26G sterile needle and syringe.
Skin testing with tuberculin is not generally carried out before giving BCG, but when performed,
those who are found to be positive reactors need not be immunized.
INTRADERMAL
TECHNIQUE

INJECTION

The skin is stretched between thumb and forefnger and sterile needle (25 G or 26 G) inserted
bevel upwards for about 2 mm into superficial layers of the dermis (almost parallel with the
surface). Raised blanched bleb showing tips of hair follicles is a sign of correct injection 7 mm
bleb = 0.1 ml injection. The site of injection is at insertion of the deltoid muscle into the
humerus. Sites higher on the arm are likely to lead to keloid formation.
INDICATIONS AND IMMUNIZATION
SCHEDULE
BCG vaccine should be given routinely to all infants at risk of early exposure to tuberculosis. In
India the national policy is to administer BCG very early in infancy at birth. BCG administered
early in life provides high level of protection particularly against severe forms of childhood

tuberculosis and tubercular meningitis. In countries with low prevalance of tuberculosis, BCG
vaccination should be restricted to high risk groups such as hospital personnel and tuberculin
negative contacts of known cases of tuberculosis. The vaccine can be given simultaneously with
DTP, DT, TT, Measles, Polio and Hepatitis B, Haemophilus infuenzae type b, yellow fever
vaccines and vitamin A supplementation, but at a separate site.
CONTRAINDICATIONS
PRECAUTIONS

AND

BCG vaccine is contraindicated in hypogamma-globulinemia, congenital immunodefciency,


sarcoidosis, leukaemia, generalised malignancy, HIV infections or any other disorder in which
natural immune response is alterted, as also those on immunosuppressive therapy,
corticosteroids, radiotherapy. In chronic eczema or other dermatological disease, the vaccine can
be given in a healthy area of the skin. Keloid and lupoid reactions may also occur at the site of
injection and such children should not be revaccinated.
INFORMATION
OF
TUBERCULOSIS DRUGS

ANTI

The Minimum Inhibitory Concentration (MIC) towards the Mycobacterium bovis BCG Moscow
strain 361 I is indicated in below mentioned table.
Drug

Minimum Inhibitory Concentration (MIC)

Isoniazid

0.5 g/ml

Streptomycin

1.0 g/ml

Rifampicin

1.0 g/ml

Ethambutol

5.0 g/ml

In case of systemic or persistent local infection with BCG vaccine occurs, expert advice should be
taken for the necessary treatment. BCG Moscow strain 361 I is resistant to pyrazineamide.
SPECIAL CASE OF CHILDREN
SEROPOSITIVE MOTHERS.

BORN

TO

HIV

The obligatory passage of maternal antibodies of the lgG type through the placenta makes it
impossible to interpret the serology of the child until the age of about 9-10 months (persistence
of the maternal antibodies has been detected up to
14
months).
It is therefore necessary to wait until the child has been found to be seronegative, as determined
by immuno-transfer (Western Blot) with the support, if necessary, of techniques for detecting the
viral genome, before confrming that the child is not infected.
If the child is infected, BCG vaccine is contraindicated irrespective of the childs condition,
given the potential risk of development of BCG-itis in the vaccinated child. The advice of a
specialized medical team is required.
DRUG INTERACTIONS AND OTHER
INTERACTIONS
The BCG vaccine may be routinely given to any child exposed early to the risk of contact with
the disease (tuberculosis). In order to avoid possible interactions between several medicinal
products, any other ongoing treatment should be systematically reported to your doctor.
There is no indication to vaccinate women during
pregnancy. Breast feeding can continue despite
vaccination with BCG vaccine.
As a general rule, during pregnancy and breast feeding, it is always recommended to ask your
doctor's advice before using a medicinal product.
SIDE
EFFECTS
A local reaction is normal. Following BCG vaccination, 2 to 3 weeks later a papule develops at the
site of vaccination and increases slowly in size to a diameter of 4-8 mm in 5 weeks. It then
subsides or breaks into a shallow ulcer covered with a crust. Healing occurs spontaneously in 6-

12 weeks leaving a permanent, tiny round scar 2-10 mm in diameter. In rare cases an abscess
may appear at the point of injection, or satellite adenitis, leading in exceptional cases to
suppuration.
Exceptional cases of lupus vulgaris at the injection site have been reported. Inadvertent
subcutaneous injection produces abscess formation and may lead to ugly scars. A risk of
generalised reaction to BCG exists in immunodepressed individuals vaccinated with BCG or living
in contact with a vaccinated individual.

STORA
GE
BCG vaccine should be stored in dark between 2 and 8C. Protect from light. The diluent
should not be frozen, but should be kept cool.
SHELF
LIFE
24 months from the date of last satisfactory potency test if stored in a dark place at
recommmended temperature
PRESENTAT
ION
10/20 doses vial plus diluent
(1 ml).
10 x 10/20 doses vial plus
diluent (1 ml).
50 x 10/20 doses vial plus
diluent (1 ml).
Vaccine Vial Monitors (VVMs) are on the cap of Bacillus Calmette-Guerin Vaccine I.P. supplied
through ABC Institute of India Pvt. Ltd. This is a time-temperature sensitive dot that provides an
indication of the cumulative heat to which the vial has been exposed. It warns the end user
when exposure to heat is likely to have degraded the vaccine beyond an acceptable level.
The interpretation of the VVM is simple. Focus on the central square. Its colour will change
progressively. As long as the colour of this square is lighter than the colour of the ring, then the
vaccine can be used. As soon as the colour of the central square is the same colour as the ring or
of a darker colour than the ring, then the vial should be discarded.
LYOPHILISED PREPARATIONS
Instructions for use
A) Breaking of ampoules only possible in the axis and over the cut.
1. Hold the bottom part of the ampoule with coloured dot facing front side.
2. Grip the bulb between the thumb and the bent index finger of the right hand.
3. The thumb should cover the dot.
4. Apply force to the top part with the right thumb while resisting with left index fnger
and snap the ampoule
away from you. The force applied should be constant and should not be
disproportionate to cause breakage.
(B) Reconstitution of Lyophilised Vials
1.

Draw the diluents from the ampoule into a syringe, pierce the bung of the vial with the
needle and gently inject the diluents into the vial.
2. Detach the syringe, leaving the needle in vial bung. After 15 seconds remove the needle.
3. Rotate the vial gently between your palms till the material dissolves. Avoid shaking the
vial as this would cause frothing.
4. Withdraw the reconstituted solution into the syringe, now ready for administration.
Diphtheria,
Tetanus,
Pertussis
(Whole
Haemophilus Type b Conjugate Vaccine
(Adsorbed)
I.P.

Cell),

Hepatitis

(rDNA)

and

DESCRIPTI
ON
Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus Type b
Conjugate Vaccine (Adsorbed) I.P. supplied by ABC Institute of India Pvt. Ltd., in a single dose or
a multi-dose vial is a homogeneous liquid containing purified diphtheria and tetanus toxoids,
inactivated whooping cough (pertussis) organisms, highly purified, non- infectious particles
of Hepatitis B surface antigen (HBsAg) and Hib component as a bacterial subunit vaccine
containing highly purified, non-infectious Haemophilus infuenzae type b (Hib) capsular
polysaccharide chemically conjugated to a protein (Tetanus Toxoid). 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 using recombinant DNA
procedures is purified through several chemical steps. Thiomersal is added as preservative. The
Hib polysaccharide is prepared from capsular polysaccharide of H. infuenzae type b strain and
after activation is coupled to Tetanus Toxoid. The vaccine meets the requirements of I.P. and
WHO when tested by the methods outlined in I.P. and WHO, TRS 978 (2013), 980 (2014) and
897
(2000).
Each dose of 0.5 ml
contains
Diphtheria Toxoid 25 Lf (
30 IU) Tetanus Toxoid
2.5 Lf ( 40 IU)
B. pertussis (whole cell) 16 OU
( 4 IU) HBsAg (rDNA) 10 mcg
Purified
capsular
Hib
Polysaccharide (PRP)
conjugated to Tetanus Toxoid (carrier
protein) 10 mcg Adsorbed on Aluminium
Phosphate, Al+++ 1.25 mg Preservative:
Thiomersal 0.005 %
Dose : 0.5 ml by intramuscular
injection.
Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus Type b
Conjugate Vaccine (Adsorbed) I.P. 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. Hib vaccine does not protect against disease due to other types of H.infuenzae nor
against meningitis caused by other organisms.
INDICATI
ONS
Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus Type b
Conjugate Vaccine (Adsorbed) I.P. is indicated for the active immunization of infants, at or above
the age of 6 weeks against Diphtheria, tetanus, whooping cough, Hepatitis B and Haemophilus
infuenzae type b infections. In young children the EPI recommends as many antigens as possible
to be administered at a single visit.
Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus Type b
Conjugate Vaccine (Adsorbed) I.P. should NOT be used for the birth dose.
The combined vaccine can be given safely and effectively at the same time as BCG, MMR,
Measles and Polio vaccines
(OPV and IPV), Yellow fever vaccines and Vitamin A
supplementation.
DOSAGE
ADMINISTRATION

AND

For active immunization of infants and preschool children, it is recommended that three
intramuscular injections of 0.5 ml be administered with an interval of four weeks between doses
starting at six weeks of age. In countries where perinatal transmission of Hepatitis B virus is
common, the frst dose of Hepatitis B vaccine should be given as soon as possible after birth. In
this case, the combination vaccine can be used to complete the primary series from 6 weeks of
age.
Dose
1st dose
2nd dose

Age at immunization
6 weeks
10 weeks

3rd dose

14 weeks

Source: WHO / IAP recommended immunization schedule. A booster dose of DTP and Hib should
be given at the age of
15-18
months.
A reinforcing injection of DTP should be administered at 5 years of age (i.e. at the time of
school entry). IAP (Indian Academy of Pediatrics) recommends that wherever combination
vaccines are available they can be substituted for monovalent formulations in the national
immunisation schedule wherever indicated.
ADMINISTRAT
ION

The liquid vaccine vial should be shaken before use to homogenize the suspension. The vaccine
should be injected intramuscularly. Do not inject subcutaneously or intravenously. The
anterolateral aspect of the upper thigh is the preferred site of injection, or into the deltoid
muscles of older children. 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
reactions. One pediatric dose is 0.5 ml. A sterile syringe and sterile needle must be used for the
injection. Another injection if co-administered with Diphtheria, Tetanus, Pertussis (Whole Cell),
Hepatitis B (rDNA) and Haemophilus Type b Conjugate Vaccine (Adsorbed) I.P. should be given
at a different site. Only sterile needles and syringes should be used for each injection. Once
opened, multi-dose vials should be kept between +2C and +8C. Multi-dose vials of Diphtheria,
Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus Type b Conjugate
Vaccine (Adsorbed) I.P. 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 28 days, provided that all of the following conditions are met (as described in the WHO
policy statement: Handling of multi dose vaccine vials after opening, WHO/IVB/14.07):
The vaccine is currently prequalifed by WHO;
The vaccine is approved for use for up to 28 days after opening the vial, as determined by
WHO;
The expiry date of the vaccine has not passed;
The vaccine vial has been, and will continue to be, stored at WHO - or
manufacturer recommended temperatures; furthermore, the vaccine vial monitor, if one
is attached, is visible on the vaccine label and is not past its discard point, and the vaccine
has not been damaged by freezing.
The vaccine should be visually inspected for any foreign particulate matter and /or variation of
physical aspect prior to administration. In event of either being observed discard the vaccine.
Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus Type b
Conjugate Vaccine (Adsorbed) I.P. should not be mixed with any other vaccine before injection.
CONTRAINDICAT
IONS
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 is not a contraindication for further use.
WARNIN
GS
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 Diphtheria, Tetanus, Pertussis (Whole
Cell), Hepatitis B (rDNA) and Haemophilus Type b Conjugate Vaccine (Adsorbed) I.P., the
decision to give subsequent doses of vaccine containing the pertussis component should be
carefully considered.
Temperature 40.5C (105F) or more within 48 hours of a dose unexplained by another cause.
Collapse or shock-like state (hypotonic-hypo responsive 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. There may be circumstances, such as a high incidence
of pertussis, when the potential benefts outweigh possible risks, particularly since these events
are not associated with permanent sequelae.
Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus Type b

Conjugate Vaccine (Adsorbed) I.P. should not be given to children with any coagulation
disorder, including thrombocytopenia that would contraindicate intramuscular injection
unless the potential beneft clearly outweighs the risk of administration. Infants and children with
a history of convulsions in frst-degree family members (i.e. siblings and parents) when
administered DTP containing vaccine have an increased risk for neurologic events and
permanent neurologic damage when compared with infants without such history.

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 vaccination. The administration of Diphtheria,
Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus Type b Conjugate Vaccine
(Adsorbed) I.P. to children with proven or suspected underlying neurologic disorders that are not
actively evolving must be decided on an individual basis.
PRECAUTI
ONS
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 children may not respond.
Prior to administration of Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and
Haemophilus Type b Conjugate Vaccine (Adsorbed) I.P., health care personnel should inform the
guardian of the child the benefits and risks of immunization, and also inquire about the recent
health status of the child 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 administration of any DTP
containing vaccine 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.
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 (0.1-0.5 ml of
1:1000 injection) given s/c or i/m. Single dose should not exceed 1 mg (1 ml). For infants and
children the recommended dose of adrenaline is 0.01 mg/kg (0.01 ml/kg of 1:1000 injection).
Single pediatric dose should not exceed 0.5 mg (0.5 ml). 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 vaccinee should remain under observation for not less than 30
minutes for possibility of occurrence of immediate or early allergic reactions. Hydrocortisone
and antihistaminics should also be available in addition to supportive measures such as oxygen
inhalation.
DRUG
INTERACTIONS
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 intra-articular, bursal, or
tendon injections with corticosteroids should not be immunosuppressive.
ADVERSE
REACTIONS
Adverse reactions associated with the use of this vaccine include local tenderness, redness,
swelling, fever, loss of appetite, refusal of feeds, vomiting, diarrhoea, irritability, persistent
crying, hindrance of limb movement 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 type and rate of severe adverse reactions do not differ significantly from the DTP, HepB and
Hib vaccine reactions described separately.
For DTP, mild local or systemic reactions are common. Some temporary swelling, tenderness and
redness at the site of injection together with fever occur in a large proportion of cases.
Occasionally severe reactions of high fever, irritability and screaming develop within 24 hours of

administration. Hypotonic-hyporesponsive episodes have been reported. Febrile convulsions have


been reported at a rate of one per 12500 doses administered.
Administration of paracetamol at the time and 4-8 hours after immunization decreases the
subsequent incidence of febrile reactions. 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 paediatric associations of Australia, Canada, the United Kingdom
and the United States,

concluded that the data did not demonstrate a causal relationship between DTP and chronic
nervous system dysfunction in children. Thus there is no scientifc evidence that these reactions
have any permanent consequences for the children.
Hepatitis B vaccine is very well tolerated. In placebo-controlled studies, with the exception of
local pain, reported events such as myalgia and transient fever have not been more frequent
than in the placebo group. Reports of severe anaphylactic reactions are very rare. Available data
do not indicate a causal association between hepatitis B vaccine and Guillain Barr syndrome, or
demyelinating disorders including multiple sclerosis, nor is there any epidemiological data to
support a causal association between hepatitis B vaccination and chronic fatigue syndrome,
arthritis, autoimmune disorders, asthma, sudden infant death syndrome, or diabetes.
Hib vaccine is very well tolerated. Localized reactions may occur within 24 hours of vaccination,
when recipients may experience pain and tenderness at the injection site. These reactions are
generally mild and transient. In mostcases, they spontaneously resolve within two to three days
and further medical attention is not required. Mild systemic reactions, including fever, rarely
occur following administration of Hib vaccines. More serious reactions are very rare; a causal
relationship between more serious reactions and the vaccine has not been established.
IMMUNE
DEFICIENCY
Individuals infected with the human immuno-defciency virus (HIV), both asymptomatic and
symptomatic, should be immunized with combined vaccine according to standard schedules.
STORA
GE
The vaccine should be stored at a temperature between +2C and +8C
(35.6 to 46.4F). NOT TO BE FROZEN. Product which has been exposed
to freezing should not be used. SHELF LIFE
Do not exceed the expiry date stated on the
external packaging.
PRESENTAT
ION
0.5 ml -1 dose
vial
1 ml - 2 doses
vial
2.5 ml 5 doses
vial
5 ml 10 doses
vial
Vaccine Vial Monitors (VVMs) are on the cap (2 ml vial) / part of the label of Diphtheria, Tetanus,
Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus Type b Conjugate Vaccine
(Adsorbed) I.P. supplied through ABC Institute of India Pvt. Ltd. This is a time-temperature
sensitive dot that provides an indication of the cumulative heat to which the vial has been
exposed. It warns the end user when exposure to heat is likely to have degraded the vaccine
beyond an acceptable level.
The interpretation of the VVM is simple. Focus on the central square. Its colour will change
progressively. As long as the colour of this square is lighter than the colour of the ring, then the
vaccine can be used. As soon as the colour of the central square is the same colour as the ring or
of a darker colour than the ring, then the vial should be discarded.
TETANUS VACCINE (ADSORBED) I.P.

For Active Immunization against Tetanus


DESCRIPTION:
Sii Tetanus Vaccine (Adsorbed) I.P. as supplied by ABC Institute of India Pvt. Ltd. is a sterile,
whitish turbid, uniform suspension of tetanus toxoid adsorbed on aluminium phosphate and
suspended in isotonic sodium chloride solution.
Each dose of 0.5 ml contains
Tetanus Toxoid 5 Lf ( 40 IU )

Adsorbed on Aluminium Phosphate, AI++


+ 1.25 mg
Preservative:
0.005%
Thiomersal.
This vaccine fulfils the I.P. requirements for Tetanus
Vaccine (Adsorbed)
INDICATIO
NS:
As Tetanus can occur in cases of even minor injuries it is advisable to actively
immunize every person in general. With this aim in view, it is desirable:
1. To actively immunize all children from the age of 6 weeks onwards.
2. To protect infants against the risks of tetanus neonatorum by immunizing pregnant
mothers.
3. To actively immunize civil population particularly those who are exposed to
occupational risks such as road workers, athletes agricultural workers, industrial workers
etc.
4. To actively immunize civil and defense personnel, home guards and police personnel.
DOSAG
E:
The full basic course of immunization against tetanus toxoid consists of three primary doses of
0.5 ml at least four weeks apart, followed by booster doses at 18 months, 5 years, 10 years and
16 years and then every 10 years.
PROTECTION
OF
AGAINST TETANUS

THE

NEWBORN

For prevention of neonatal tetanus, tetanus toxoid is recommended for immunization of


women of childbearing age, and especially pregnant women. Tetanus toxoid may be safely
administered during pregnancy and should be given to the mother at frst contact or as early as
possible in pregnancy.
Pregnancy : After completing the full basic course of 7 doses, there is no need for additional
doses during pregnancy at least for the next 10 years; thereafter a single booster would be
suffcient to extend immunity for another 10 years. For pregnant woman who have not had
previous immunisation, at least 2 doses of TT at 4 weeks interval, second dose at least 2 weeks
before delivery should be given during pregnancy so that protective antibody would be
transferred to the infant in order to prevent neonatal tetanus.
VACCINATION OF INJURED
PERSONS
For those subjects who have proof of either completing their course of primary immunizations
containing tetanus toxoid or receiving a booster shot within the previous 5 years no addtional
dose of tetanus toxoid is recommended.
If more than 5 years have elapsed and infection with tetanus because of injury or other cause is
suspected, 0.5 ml of the adsorbed tetanus toxoid should be given immediately. Where the
immunization history is inadequate 1500 IU tetanus antiserum and 0.5 ml Tetanus toxoid should
be injected, with separate syringes, to different body sites. (If available, 250 units of tetanus
immune globulin (human origin) can be substituted for the tetanus antiserum). A second 0.5 ml
dose of toxoid is recommended after 2 weeks and a third dose after a further 1 month. (A note of
caution : if Tetanus antiserum from heterologous origin is used in prophylaxis, the patient should
be tested for sensitivity to horse serum protein prior to its administration. It is desirable to have
1 ml of Epinephrine Hydrochloride solution (1:1000) immediately available and the normal
precautions followed when injecting antitoxins).
ADMINISTRAT

ION:
The vaccine should be administered by deep intramuscular injection. Tetanus toxoid should be
injected intramuscularly into the deltoid muscle in women and older children. If there are
indications for the use of tetanus toxoid in younger children the preferred site for intramuscular
injection is the anterolateral aspect of the upper thigh since it provides the largest muscular
area. 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.
Once opened, multi-dose vials should be kept between +2 C and +8 C. Multi-dose vials of
Tetanus vaccin 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 28 days, provided that all of the following conditions are met (as described in the W.H.O.
policy statement: Handling of multi dose vaccine vials after opening, W.H.O./IVB/14.07):

The vaccine is currently prequalifed by W.H.O.;


The vaccine is approved for use for up to 28 days after opening the vial, as determined by
W.H.O.;
The expiry date of the vaccine has not passed;
The vaccine vial has been, and will continue to be, stored at W.H.O.- or
manufacturer recommended temperatures; furthermore, the vaccine vial monitor, if one is
attached, is visible on the vaccine label and is not past its discard point, and the vaccine
has not been damaged by freezing.
The vaccine should be visually inspected for any foreign particulate matter and /or variation of
physical aspect prior to administration. In event of either being observed discard the vaccine.
ADVERSE
REACTIONS:
Mild local reactions consisting of pain, erythema, tenderness and induration at the injection site
are common and may be associated with systemic reactions including mild to moderate transient
fever and irritability.
Persistent nodules at the site of injection have occured following the use of an adsorbed vaccine,
but this complication is unusual.
CONTRAINDICAT
IONS:
Sii Tetanus Vaccine (Adsorbed) I.P. should not be administered to infants or children with high
fever or other evidence of acute illness.
The specific contraindications adopted by individual national health authorities should refect 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
WARNING:

AND

Individuals receiving corticosteroids or other immunosuppressive drugs may not develop an


optimum immunologic response. The possibility of allergic reactions in individuals sensitive to the
component of the product shoud be borne in mind. A separate sterile syringe should be used for
each individual patient to prevent the transmission of hepatitis or other infectious agents.
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. To open the ampoule snap off the top of the ampoule by pressing the narrow part of
the neck away from you with easy even pressure.
WITHDRAWING THE VACCINE FROM A RUBBERSTOPPERED 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.
STORA
GE:

Sii Tetanus Vaccine (Adsorbed) I.P. should be stored between +2C and +8C (35 and 46F).
NOT TO BE FROZEN. Product which has been exposed to freezing should not be used.
PRESENTAT
ION:
Sii Tetanus Vaccine (Adsorbed) I.P. is supplied, ready to use, in rubber-stoppered multi-dose
vials, and in single-dose glass ampoules in the following packings:
0.5 ml x
ampoules

10

5 ml 10 doses x 10
vials
5 ml 10 doses x 50
vials
Vaccine Vial Monitors (VVMs) are part of the label on Sii Tetanus Vaccine (Adsorbed) I.P. supplied
through ABC Institute of India Pvt. Ltd. The colour dot which appears on the label of the vial is a
VVM. This is a time-temperature sensitive dot that provides an indication of the cumulative heat
to which the vial has been exposed. It warns the end user when exposure to heat is likely to have
degraded the vaccine beyond an acceptable level.
The interpretation of the VVM is simple. Focus on the central square. Its colour will change
progressively. As long as the colour of this square is lighter than the colour of the ring, then the
vaccine can be used. As soon as the colour of the central square is the same colour as the ring or
of a darker colour than the ring, then the vial should be discarded.