DESCRIPTION
Rubella Vaccine, Live, Attenuated (Freeze-Dried) is prepared
using Wistar RA 27/3 strain Rubella vaccine virus. This vaccine virus is
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 WHO when tested by the methods
outlined in 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 live virus particles. Stability
data has shown that the freeze-dried vaccine retains the potency of 1000 CCID50
per dose after 1 week at 37°C.
INDICATIONS
Rubella
vaccine is indicated for : Immunization against Rubella in persons from 12
months of age to puberty.
Immunization of adolescent and adult males may be a useful procedure in
preventing or controlling outbreaks of rubella in circumscribed population
groups.
Immunization of susceptible non pregnant adolescent and adult females of child
bearing age with live attenuated Rubella virus vaccine is indicated if certain
precautions are observed. Vaccinating susceptible postpubertal females confers
individual protection against subsequently acquiring rubella
infection during pregnancy, which in turn prevents infections of foetus and
consequent congenital rubella injury. Women of childbearing age should be
advised not to become pregnant for one month after vaccination.
Postpartum Woman:
It has been found convenient in many instances to vaccinate rubella
susceptible women in the immediate postpartum period.
Revaccination:
Children first vaccinated when younger than 12 months of age should be
revaccinated. Based on available evidence, there is no reason to routinely
revaccinate persons who were vaccinated originally when 12 months of age or
older. However, persons should be revaccinated if there is evidence to suggest
that initial immunization was ineffective.
Rubella 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
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 2º-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 Rubella 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 diluent
or reconstituted vaccine.
ADVERSE
REACTIONS
Reactions are generally mild and transient. Rubella vaccine
may cause mild pain and tenderness at the injection site within 24 hours of
immunization.
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 Rubella 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.
DRUG INTERACTIONS
Due to the risk of inactivation, the rubella
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 AND
WARNINGS
There are few contraindications to the administration of
rubella vaccine. Individuals receiving cortlcosteroids, other
immunosuppressive 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 diseases,
following administration of gammaglobulin or blood transfusions. 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 infection or diarrhoea,
and other minor illness should not be considered as contraindication. It is
particularly important to immunize children with malnutrition. Since the
effect of the live rubella vaccine on the fetus is not known, it is also
contraindicated in pregnancy.
Rubella vaccine should not be administered in pregnant women because of the
theoretical but never demonstrated teratogenic risk. Inadvertent receipt of
Rubella 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 Rubella vaccination. No cases of CRS
have been reported in any pregnant women who inadvertently received
rubella-containing vaccine in early pregnancy.
HIV INFECTION
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.
STORAGE
The vaccine should be stored in the dark at
a temperature between 2-8° 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.
SHELF LIFE
24 months from the date
of last satisfactory potency test, if stored in a dark place at a temperature
between 2-8°C. PRESENTATION
1
Dose vial plus diluent (0.5ml)
1 Dose vial plus diluent (1 ml)
5 Dose
vial plus diluent (2.5 ml)
10 Dose vial plus diluent (5ml)
THE VACCINE VIAL MONITOR (Optional)
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Inner square lighter than outer
circle. If the expiry date has not passed,
USE the vaccine. |
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At a later time, inner square still lighter than
outer circle.
If the expiry date has not passed, USE the vaccine. |
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Discard point:
Inner square matches colour of outer circle.
DO NOT use the vaccine. |
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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 Rubella Vaccine, Live, Attenuated 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.
| 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 pediatric 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 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 oxygen inhalation. |
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