| DESCRIPTION
TUBERVAC (Bacillus Calmette-Guerin Vaccine I.P.) is a live
freeze-dried vaccine derived from attenuated strain of mycobacterium
bovis. TUBERVAC used for the prevention of tuberculosis. The vaccine
meets the requirements of W.H.O. and I.P. when tested by the methods
outlined in W.H.O., TRS. 745 (1987), 771 (1988) and I.P.
COMPOSITION
Each 1ml contains between :
1 x106 and 33 x 106 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.
RECONSTTUTION
TUBERVAC 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 8°C for no longer than 6 hours.
Any opened vial remaining at the end of a vaccination session
(within six hours of reconstitution) must be discarded.
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 AND ADMINISTRATION
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 INJECTION TECHNIQUE
The skin is stretched between thumb and forefinger and sterile
needle (25 G or 26 G) inserted bevel upwards for about 2mm 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. 7mm bleb = 0.1ml 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
TUBERVAC 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 vaccines, but at a separate site.
CONTRAINDICATIONS AND PRECAUTIONS
TUBERVAC is contraindicated in hypogamma-globulinemia, congenital
immunodeficiency, 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.
SPECIAL CASE OF CHILDREN BORN TO HIV SEROPOSITIVE MOTHERS.
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 confirming that the child is not infected.
If the child is infected, BCG vaccine is contraindicated
irrespective of the child’s 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
TUBERVAC 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.
STORAGE
TUBERVAC should be stored in dark between 2º and 8ºC. 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 recommended temperature.
PRESENTATION
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).
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