The vaccine is prepared from the live, attenuated strains of
Edmonston-Zagreb measles virus and Wistar RA 27/3 rubella
virus. Both measles and rubella viruses are propagated on
human diploid cells (HDC). 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 U.S.P. and WHO when tested by the methods outlined in U.S.P.
and WHO, TRS 840(1994).
Each single human dose when reconstituted in a volume
of 0.5 ml. contains not less than 1000 CCID50 of measles
virus and 1000 CCID50 of rubella virus.
For active immunization against measles and rubella in
infants, children, adolescents and young adults at risk.
Immunization of susceptible non-pregnant adolescent and adult
females is indicated if certain precautions are observed (see
CONTRAINDICATIONS).The vaccine can be safely and effectively
given simultaneously with DTP, DT, TT, Td, BCG, Polio vaccine
(OPV and IPV), Haemophilus influenzae type b, Hepatitis B,
Yellow fever vaccine and vitamin A supplementation.
APPLICATION AND DOSAGE
The vaccine should be reconstituted only with the entire
diluent supplied (Sterile water for injection) 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
by deep subcutaneous injection into the anterolateral aspect
of upper thigh in toddlers and upper arm in older children. If
the vaccine is not used immediately then it should be stored
in the dark at 2º and 8ºC for no longer than 6 hours.
Any opened container remaining at the end of a session (within
six hours of reconstitution) should be discarded. The
vaccine vial monitor (see figure), if present would have been
removed on reconstitution.
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 MR 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.
CLOSE ATTENTION SHOULD BE PAID TO THE
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 type and rate of severe adverse reactions do not
differ significantly from the measles, mumps and rubella
vaccine reactions described separately.
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 measles-containing vaccine and tend to occur
only in person not protected by the first 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.
The rubella component may commonly result in joint symptoms
manifested as arthralgias (25%) and arthritis (10%) among
adolescent and adult females that usually last from a few days
to 2 weeks. However, such adverse reactions are very rare in
children and in men receiving MR vaccine (0%-3%).
Symptoms typically begin 1-3 weeks after vaccination and last
1 day to 2 weeks. These transient reactions seem to occur in
non-immunes only, for whom the vaccine is important. Low-grade
fever and rash, lymphadenopathy, myalgia and paraesthesiae are
commonly reported. Thrombocytopenia
is rare and has been reported in less than 1 case per 30 000
doses administered. Anaphylactic reactions are also rare. In
susceptible individuals the vaccine may very rarely cause
allergic reactions like urticaria, pruritis and allergic rash
within 24 hours of vaccination.
Clinical experience has exceptionally recorded isolated
reactions involving the CNS. These more serious reactions have
however, not been directly linked to vaccination.
Due to the risk of inactivation, the rubella vaccine should
not be given within 6 weeks, and if it is possible within
3 months, after an injection of immunoglobulins or blood product
containing immunoglobulins (blood plasma).
For the same reason immunoglobulins should not be administered
within two weeks after the vaccination.
Tuberculin positive individuals may transitionally become
tuberculin negative after vaccination.
CONTRAINDICATIONS AND WARNINGS
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 febrile
states, pregnancy, acute infectious diseases, leukaemia,
severe anaemia and other severe diseases of the blood system,
severe impairment of the renal function, decompensated heart
diseases, following administration of gammaglobulin or blood
transfusions or to subjects with potential allergies to
vaccine components. The vaccine may contain traces of
neomycin. Anaphylactic or anaphylactoid reactions to neomycin,
history of anaphylactic or anaphylactoid reactions are
absolute contraindications. 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.
MR vaccine should not be administered in pregnant women
because of the theoretical but never demonstrated teratogenic
risk. Inadvertent receipt of MR vaccine during pregnancy is
not an indication for an abortion. Since MR vaccine is
recommended in adults, if pregnancy is planned, then an
interval of one month should be observed after MR vaccination.
No cases of CRS have been reported in any pregnant women who
inadvertently received rubella-containing vaccine in early
Measles and Rubella vaccine may be used in children with
known or suspected HIV infection. The vaccine is
contraindicated in persons who are severely immunocompromised
as a result of congenital disease, HIV infection, advanced
leukaemia or lymphoma, serious malignant disease, or treatment
with high-dose steroids, alkylating agents or
anti-metabolites, or in persons who are receiving
immunosuppressive therapeutic radiation.
IMPORTANT TO PROTECT BOTH THE LYOPHILIZED AND RECONSTITUTED
VACCINE FROM THE LIGHT. The vaccine should be stored
in the dark at a temperature between 2° and 8°C. For
long term storage a temperature of -20°C is recommended
for the lyophilised vaccine. The diluent should not be frozen, but should
be kept cool.
24 months from the date of last satisfactory potency test,
if stored in a dark place at a temperature between 2°
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 passed,
USE the vaccine.
At a later time, inner square still lighter than
If the expiry date has not passed, USE the vaccine.
Inner square matches colour of outer circle.
DO NOT use the vaccine.
Beyond the discard point:
Inner square darker than outer ring.
DO NOT use the vaccine.
Vaccine Vial Monitors (VVMs) are part
of the label on Measles and Rubella Virus Vaccine Live U.S.P.
supplied through Serum Institute of India 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 indications 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.
|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
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
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 vaccines 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