MEASLES, MUMPS, AND RUBELLA (MMR)

Each single human dose when reconstituted in a volume of 0.5 ml contains :

Active Ingredients:

Measles virus not less than 1000 CCID₅₀

Mumps virus not less than 5000 CCID₅₀

Rubella virus not less than 1000 CCID₅₀

In addition, the freeze-dried vaccine when stored at 37ºC for 7 days shows no loss in potency (less than 1.0 log₁₀ loss in virus titres).

Each dose also contains: Partially Hydrolyzed Gelatin 2.5%, Sorbitol 5%, L-Histidine 0.21%, L-Alanine 0.10%, Tricine 0.30%, L-Arginine Hydrochloride 1.60%, Lactalbumin Hydrolysate 0.35% and Minimum Essential Medium (MEM).

Freeze-Dried.

For active immunization against measles, mumps and rubella in children from 12 months to 10 years of age. Second dose of MMR is usually advocated any time before the age of 6 years (elementary school entry  4-6 years).In children above 10 years, adolescents and adults, Measles and Rubella (MR) vaccine is recommended.  Revaccination may seroconvert primary failures or boost antibody titres of previously vaccinated individuals whose titers  have declined. The Advisory Committee on Immunization Practices (ACIP) recommends administration of the first dose of  MMR at 12-15 months of age and administration of the second dose of MMR at 4-6 years of age. 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, or Yellow fever vaccine or vitamin A supplementation.

The vaccine should be reconstituted only with the entire diluent supplied (Sterile water for injections) 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 toddlers and upper arm in older children. If the vaccine is not used immediately then it should be stored in the dark at 2-8ºC 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), for this type of vaccine is attached to the vial cap and should be discarded when the  vaccine is being reconstituted.

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 MMR vaccine from other manufacturers. Water for injections  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 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.

The type and rate of severe adverse reactions do not differ significantly from the measles, mumps and rubella vaccine reactions described separately.

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 to 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 person 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 causal link is not  proven.

The mumps component may result in parotitis and low grade fever. Febrile seizures and orchitis may also occur. However,  moderate fever occurs rarely and aseptic meningitis has been reported very rarely. Vaccine associated meningitis resolves spontaneously in less than 1 week without any sequelae. The onset of aseptic meningitis is  delayed, which may limit the ability to detect these cases by passive surveillance. Vaccine associated aseptic meningitis is  observed between 15-35 days post 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 MMR 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. Clinical experience has exceptionally recorded isolated reactions involving the CNS. These more serious  reactions have however, not been directly linked to vaccination.

Due to the risk of inactivation, the MMR 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.

Due to the risk of inactivation, the MMR 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.

Individuals receiving corticosteroids, other immuno-suppressive drugs or undergoing radiotherapy 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 gamma-globulin 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 to eggs (Hypersensitivity to eggs), are absolute contraindications. There are extremely rare reports of hypersensitivity reactions with MMR vaccine in individuals who are allergic to cow’s milk. Such individuals should not receive the vaccine. 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.

Measles, Mumps and 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.

MMR vaccine should not be administered in pregnant women because of the theoretical but never demonstrated teratogenic risk. Inadvertent receipt of MMR 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 MR vaccination. No cases of CRS have been reported in any pregnant women who inadvertently received rubella-containing vaccine in early pregnancy

No evidence on the effects on the ability to drive and use of machines have been reported.

No case of overdose has been reported. Do not use vaccine overdose. If getting overdose, follow the patient to have the appropriate treatment.

ATC Code J07BD52

• MMR vaccine stimulates active immunity to measles, mumps and rubella by inducing production of measles-specific, mumps-specific and rubella-specific IgG antibodies.

MMR vaccine is a mixture of live attenuated measles, mumps and rubella viruses to provide active immunization against these diseases.

Clinical studies have shown that the MMR vaccine is highly immunogenic and generally well tolerated

NotApplicable

IT IS IMPORTANT TO PROTECT BOTH THE FREEZE-DRIED AND RECONSTITUTED VACCINE FROM THE LIGHT.

The vaccine should be stored in the dark at a temperature between 2-8ºC. For long term storage a temperature of -20ºC is recommended for the freeze-dried vaccine. The diluent should not be frozen, but should be kept cool.

30 months from the date of last satisfactory potency test, if stored in a dark place at a temperature between 2-8ºC.

1 Dose vial plus diluent (0.5 ml)