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 BP and W.H.O.
when tested by the methods outlined in BP 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 live virus particles. Stability
data has shown that the 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 child bearing age
should be advised not to become pregnant for 28 days 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 and Polio vaccine (OPV and IPV),
Haemophilis influenza 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 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 with 24 hours of immunization.
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 Rubella 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.
DRUG INTERACTIONS
Due
to the risk of inactivation, the rubella vaccine should not be given within the
6 week, 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 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 corticosteroids, 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.
DO NOT AMINISTER THE VACCINE DURING PREGNANCY, CAUTION VACCINEES NOT TO CONCEIVE
FOR 28 DAYS PERIOD FOLLOWING VACCINATION.
HIV INFECTION
Rubella vaccine 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 increased rate of adverse reactions using this or
other rubella vaccines in symptomatic or asymptomatic HIV - infected children.
Rubella vaccine should be avoided in other cell-mediated immune deficiency states.
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)
| 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 suspicion of anaphylaxis.
As with the use of all vaccines the vaccines 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 addition to supportive measures such as oxygen inhalation. |
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