Prioix – GSK
Indication and Usage –
- Priorix is indicated for the active immunisation against measles, mumps and rubella.
- A single 0.5 ml dose of the reconstituted vaccine is recommended.
Dosage and Administration –
- Priorix is for subcutaneous injection, although it can also be given by intramuscular injection, in the deltoid region or in the anterolateral area of the thigh.
- The vaccine should be administered subcutaneously in subjects with bleeding disorders.
- The first dose is administered at 12 to 15 months of age. A second dose is administered at 4 to 6 years of age.
- The second dose may be administered prior to 4 years of age, provided that there is a minimum interval of one month between the doses of measles, mumps and rubella virus vaccine.
- Children who received an initial dose of measles, mumps and rubella vaccine prior to their first birthday should receive additional doses of vaccine at 12-15 months of age and at 4-6 years of age to complete the vaccination series.
Contraindications –
- Hypersensitivity to the active substances or to any of the excipients or neomycin. A history of contact dermatitis to neomycin is not a contraindication. For hypersensitivity reactions to egg proteins.
- Pregnancy should be avoided for 1 month following vaccination.
- As with other vaccines, the administration of PRIORIX should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
- Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+ <25%; children between 12-35 months: CD4+ < 20%; children between 36-59 months: CD4+ < 15%.
Adverse reactions –
- In the comparative studies, a statistically significant lower incidence of local pain, redness and swelling was reported with Priorix compared with the comparator.
- Adverse reactions which might occur following the use of a combined mumps, measles and rubella vaccine correspond to those observed after administration of the monovalent vaccines alone or in combination.
- In controlled clinical studies, signs and symptoms were actively monitored during a 42-day follow-up period. The vaccinees were also requested to report any clinical events during the study period.
- The most common adverse reactions following PRIORIX administration were injection site redness and fever ≥38°C (rectal) or ≥37.5°C (axillary/oral).
Drug interactions and other interactions –
- Due to an increased risk of fever, tenderness at the injection site, change in eating habits and irritability when Bexsero was co-administered with a combined measles-mumps-rubella-varicella (MMR-V) vaccine, separate vaccination with PRIORIX can be considered when possible.
- If PRIORIX is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.
- If not given at the same time, an interval of at least one month is recommended between administration of PRIORIX and other live attenuated vaccines.
