Measles, Mumps & Rubella Vaccine SII

Measles, Mumps & Rubella Vaccine SII

vaccine, mmr

Manufacturer:

Serum Institute of India

Distributor:

Masu
Full Prescribing Info
Contents
Measles virus ≥ 1,000 CCID50, mumps virus ≥ 5,000 CCID50, rubella virus ≥ 1,000 CCID50 (live, attenuated).
Description
The vaccine is prepared from the live, attenuated strains of Edmonston-Zagreb measles virus, Leningrad-Zagreb (L-Z) mumps virus and Wistar RA 27/3 rubella virus. The measles and rubella viruses are propagated on human diploid cells (HDC) and the mumps virus is grown on chick fibrolasts from SPF eggs (Specific pathogen free eggs). The vaccine is lyophilized and is provided with diluent. The product has the appearance of 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 measles virus, 5000 CCID50 of mumps virus and 1000 CCID50 of Rubella virus. In addition, the freeze-dried vaccine when stored at 37°C for 7 days shows no loss in potency (less than 1.0 log10 loss in virus titres).
Indications/Uses
For active immunization against measles, mumps and rubella in children from 12 months to 10 years 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.
There are reports that children above 6 years, adolescents and adult may show higher incidence of reactions like parotitis. These age groups should be vaccinated after considering the benefits and potential risk.
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, Yellow fever vaccine and vitamin A supplementation.
Dosage/Direction for Use
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 toddlers and the 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 diluent supplied is specifically 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 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.
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.
Contraindications
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. 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.
Immune Deficiency: 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 leukemia 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.
Use in Pregnancy: MMR vaccine should not be administered during pregnancy 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 receive rubella-containing vaccine in early pregnancy.
Warnings
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 subcutaenously. For treatment of severe anaphylaxis the initial dose of adrenaline is 0.1-0.5 mg (0.1-0.5 ml of 1:1000 injection) given s/c or i/m. Single dose should not exceed 1 mg (1 ml). For infants and children the recommended dose of adrenaline is 0.01 mg/kg (0.01 ml/kg of 1:1000 injection). Single paediatric dose should not exceed 0.5 mg (0.5 ml). 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 vaccine should remain under observation for not less than 30 minutes for possibility of occurrence of rapid allergic reactions. Hydrocortisone and antihistamines should also be available in addition to supportive measures such as oxygen inhalation.
Use In Pregnancy & Lactation
MMR vaccine should not be administered during pregnancy 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 receive rubella-containing vaccine in early pregnancy.
Adverse Reactions
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, the spontaneously resolve within two to three days without further medical attention. A mild fever can occur in 5-15% of vaccines 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 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 30000 doses administered. Anaphylactic reactions are also rare. In susceptible individuals the vaccine may 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.
Drug Interactions
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.
Storage
IT IS IMPORTANT TO PROTECT BOTH THE LYOPHILIZED AND RECONSTITUTED VACCINE FROM THE LIGHT. 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: 30 months from the date of last satisfactory potency test, if stored in a dark place at a temperature between 2-8°C.
ATC Classification
J07BD52 - measles, combinations with mumps and rubella, live attenuated ; Belongs to the class of morbilli viral vaccines.
Presentation/Packing
Inj (vial) 0.5 ml (1 dose) + diluent.
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