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Live, attenuated Measles virus (Edmonston - Zagreb Strain)
propagated on Human Diploid Cells (HDC).
COMPOSITION
M-VAC (Measles Vaccine
(Live) I.P.) freeze-dried contains live attenuated measles virus
(Edmonston Zagreb Strain) propagated on Human Diploid Cells
(HDC). Each dose of 0.5 ml contains not less than 1000 CCID50 of Measles virus
on reconstitution with the diluent (Sterile Water for
Injections) provided.
INDICATION
M-VAC 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 fibrosis, asthma,
tuberculosis or other chronic pulmonary disorders.
DIRECTIONS FOR USE
Reconstitute the freeze dried vaccine by adding the entire
contents of the diluent (Sterile Water for Injections) supplied
to the single-dose vial by using sterile disposable 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 upper arm.
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.
The reconstituted vaccine must be used
immediately otherwise it should be discarded.
REACTIONS
Some
mild reactions may occur such as marginal temperature rise
in 5% to 6% of the vaccinated children, mild rash in 1%
to 2% children, occasionally mild rash and slight gastric
disorders or short-lived rhinopharyngitis. Fever or rash,
or both, generally appear between the 5th and the 12th day
after vaccination and last for one to two days.
CONTRAINDICATIONS
It is particularly
important to immunize children suffering from malnutrition.
Low-grade fever, mild respiratory infections or diarrhoea,
and other minor illness should not be considered as contraindications
to immunisation.
Only the following should be regarded as contraindications
:
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Febrile state,
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Acute infectious diseases,
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Severe diseases of
the hematopoietic system,
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Severe impairment
of the renal function,
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Decompensated heart
diseases,
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States of reduced
immunity, either congenital or therapeutically acquired
through irradiation and use of corticosteroid
or cytostatic drugs,
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States of reduced
immunity, following the transplantation of an organ,
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Diseases and disorders
of the central nervous system,
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Within three months
following the administration of gammaglobulin or blood-transfusion,
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Within six months
following exchange transfusion,
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Pregnancy.
ADVANTAGES
M-VAC can also be given to the
patients who are allergic to egg protein or neomycin because
it is prepared on Human Diploid Cells and does not contain
neomycin.
STORAGE
M-VAC should be stored between +2°C and +8°C. Protect
from light. Diluent should not be frozen and should
be stored in a clean place away from heat and sunlight.
PRESENTATION
Sii Measles Vaccine (M-VAC™) is presented as
freeze-dried vaccine
1 Dose x 10 vials plus diluent (0.5ml Sterile Water for Injections
I.P.) and sterile disposable
syringe and needle supplied separately.
M-VAC
fulfils the relevant requirements of W.H.O.
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MOST IMPORTANT
WARNING
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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 0.1-0.5 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 paediatric dose should not
exceed 0.5mg (0.5ml). This will help in tackling the
anaphylactic shock/reaction effectively.
The mainstay in the treatment of severe anaphylaxis is the
prompt use of adrenaline, which can be lifesaving. It
should be used at the first 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.
Efcorlin hydrochloride and antihistaminics should also be
available in addition to supportive measures such as
oxygen inhalation. |
FREEZE-DRIED PREPARATIONS
Instructions for use
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1) Draw the diluent from the ampoule in to a
syringe, pierce the bung of the vial with the needle and
gently inject the diluent into the vial. |
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2) Detach the syringe,
leaving the needle in vial bung. After 15 seconds remove the
needle. |
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3) Rotate the vial gently between your palms
till the material dissolves.
Avoid shaking the vial as this would cause frothing. |
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4) Withdraw the re-constituted solution
into the syringe, now ready for administration. |
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