Regulatory Information
GLAXOSMITHKLINE PTE LTD
GLAXOSMITHKLINE PTE LTD
Therapeutic
Prescription Only
Formulation Information
INJECTION, POWDER, FOR SOLUTION
**Dosage and Administration** _**Posology**_ A single 0.5 ml dose of the reconstituted vaccine is recommended. As vaccination schemes vary from country to country, the advised schedule for each country must be in accordance with the national recommendations. _**Method of 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 (see “ _Warnings and Precautions_” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The vaccine should be administered subcutaneously in subjects with bleeding disorders (e.g. thrombocytopenia, or any coagulation disorder). For instructions on reconstitution of the medicinal product before administration, see “ _Instructions for Use/Handling_” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
SUBCUTANEOUS, INTRAMUSCULAR
Medical Information
**Indications** **Priorix** is indicated for the active immunisation against measles, mumps and rubella.
**Contraindications** **Priorix** is contraindicated in subjects with known systemic hypersensitivity to neomycin or to any other component of the vaccine (for egg allergy, see “ _Warnings and Precautions_” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). A history of contact dermatitis to neomycin is not a contraindication. **Priorix** is contraindicated in subjects having shown signs of hypersensitivity after previous administration of measles, mumps and/or rubella vaccines. **Priorix** is contraindicated in subjects with severe humoral or cellular (primary or acquired) immunodeficiency e.g. symptomatic HIV infection (see also “ _Warnings and Precautions_” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Priorix** is contraindicated in pregnant women. Pregnancy should be avoided for one month after vaccination (see “ _Pregnancy and Lactation_” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
J07BD52
measles, combinations with mumps and rubella, live attenuated
Manufacturer Information
GLAXOSMITHKLINE PTE LTD
Fidia Farmaceutici S.P.A
GlaxoSmithKline Biologicals - Diluent in ampoules
Delpharm Tours - Diluent in ampoules
Corixa Corporation d/b/a GlaxoSmithKline Vaccines
Aspen Notre Dame De Bondeville - Diluent in syringes
Catalent Belgium SA - Diluent in syringes
Fidia Farmaceutici S.P.A (Diluent in ampoules)
Active Ingredients
MEASLES VIRUS (SCHWARZ STRAIN) (LIVE ATTENUATED)
min 1000 TCID50
MUMPS VIRUS (RIT 4385 STRAIN) (LIVE ATTENUATED)
min 5000 TCID50
Documents
Package Inserts
Priorix Vaccine PI.pdf
Approved: September 12, 2019