DESCRIPTION
Rubella Vaccine Live,
attenuated (R-VACTM) (Lyophilised)
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 (R-VACTM)
is indicated for :
- Immunization against Rubella in persons
from 12 months of age to puberty
- Vaccination of adolescent and adult males
may be a useful procedure in preventing or controlling outbreaks
of rubella in circumscribed population groups.
- Non pregnant adolescent and adult females
: 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, BCG and Polio vaccine
(OPV and IPV), Hepatitis B and yellow fever vaccine.
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 upper arm.
REACTIONS
Burning and / or stinging of short duration at the injection
site have been reported.Mild local reactions such as induration,
urticaria, rash, malaise, sore throat, fever, headache
dizziness, nausea, vomiting, diarrhoea, regional lymphadenopathy,
polyneuritis and arthralgia and / or arthritis
may occur. Local pain, wheal and flare, induration
and erythema may occur at the site of injection. Reactions
are usually mild and transient, cough and rhinitis have
also been reported. Moderate fever (101-102.9°F)
occurs occasionally and high fever over 103°F occurs
less commonly.
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 tranfusions.
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 to women known to be pregnant. Because a risk to the fetus from administration of these Live virus vaccines cannot be excluded for theoretical reasons. Women should be
counseled to avoid becoming pregnant for 28 days after vaccination with Rubella vaccine
HIV INFECTION
Rubella vaccine (R-VACTM)
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.
DO NOT INJECT INTRAVENOUSLY.
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 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 (Single vial pack)
1 Dose vial plus diluent (Ten vials pack)
5 Dose vial plus diluent
10 Dose vial plus diluent
|
MOST IMPORTANT
WARNING
|
|
Please ensure that the vaccine is administered by subcutaneous
route only. In a rare case anaphylactic shock may occur
in susceptible patient and for such emergency please
keep handy 1:1000 adrenaline injection ready to be injected
intramuscularly. This will help in tackling the anaphylactic
shock/reaction effectively.
|
|
