Rubella Vaccine
Live, Attenuated

(Freeze-Dried)

Vaccinum Rubeolae vivum

 


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 2-8C 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)

 

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 outer circle.
If the expiry date has not passed, USE the vaccine.

 

Discard point:
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 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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