|
DESCRIPTION
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
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).
POTENCY
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.
INDICATIONS
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 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 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
at 2-8°C 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 dilutent supplied is specially designed for use with the
vaccine. Only this dilutent 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
CONTRAINDICATIONS LISTED
The diluent and recontituted 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.
ADVERSE REACTIONS
The type and rate of severe adverse reactions do not differ
significantly from the measles, mumps and rubella vaccine
reactions described seperately.
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 or 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
persons 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 casual link is not proven.
The rubella component may commonly result in joint symptoms
manifested as arthralgis (25%) and arthritis (10%) among adolecent
and adult females that usually last from a few days to 2 weeks.
However such adverse reactions are very rare in children and
men receiving MR vaccine (0%-3%). Symptoms typically begin
1-3 weeks after vaccination and last 1 day to 2 weeks. These
transient reactions 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.
Clinical experience has exceptionally recorded isolated reactions
involving the CNS. These more serious reactions have however,
not been directly linked to vaccination.
DRUG INTERACTIONS
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.
DO NOT ADMINISTER THE VACCINE DURING PREGNANCY, CAUTION VACCINEES
NOT TO CONCEIVE FOR 28 DAYS PERIOD FOLLOWING VACCINATION.
HIV INFECTION
Measles and Rubella virus vaccine live may be used in
children with known or suspected HIV infection. Although the
data are limited and further studies are being encouraged,
there is no evidence to date of any increaed rate of adverse
reactions using this or other measles and rubella vaccines
in symptomatic or asymptomatic HIV-infected children. The
vaccine should be avoided in other cell-mediated immune deficiency
states.
RECOMMENDED STORAGE
IT IS
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 vaccine. 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 a temperature between 2°
and 8°C.
PRESENTATION
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)
|
MOST IMPORTANT
WARNING
|
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 suspicion of anaphylaxis.
As with the use of all vaccines the vaccinees should remain
under observation for not less than 30 minutes for the
possibility of occurrence of
rapid allergic reactions. Efcorlin hydrochloride and antihistaminics
should be available in addtion to supportive measures
such as oxygen inhalation. |
|