Regulatory Information
GLAXOSMITHKLINE PTE LTD
GLAXOSMITHKLINE PTE LTD
Therapeutic
Prescription Only
Formulation Information
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
**Dosage and Administration** **Posology** Primary immunisation consists of one dose of vaccine. A second dose of measles-containing vaccine should be administered according to the Singapore’s national immunization program. It is preferable to respect an interval of at least 6 weeks between doses. In no circumstances should this interval be less than 4 weeks. **Method of administration** The vaccine is to be injected subcutaneously (SC) or intramuscularly (IM) in the deltoid region or in the anterolateral area of the thigh. 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-Tetra_ is indicated for active immunisation of subjects from the age of 12 months against measles, mumps, rubella and varicella. (see also _Warnings and Precautions, Pharmacodynamics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The use of _Priorix-Tetra_ should be based on official recommendations.
**Contraindications** _Priorix-Tetra_ is contraindicated in subjects with known 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-Tetra_ is contraindicated in subjects having shown signs of hypersensitivity after previous administration of measles, mumps, rubella and/or varicella vaccines. _Priorix-Tetra_ 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_). _Priorix-Tetra_ is contraindicated in subjects with 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% (see also _Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
J07BD54
measles, combinations with mumps, rubella and varicella, live attenuated
Manufacturer Information
GLAXOSMITHKLINE PTE LTD
GlaxoSmithKline Biologicals s.a.
Aspen Notre Dame de Bondeville - Diluent in syringes
Delpharm Tours - Diluent in Ampoules
Catalent Belgium SA (Diluent in syringes)
Fidia Farmaceutici S.P.A (Diluent in ampoule)
Active Ingredients
Live attenuated measles virus (Schwarz strain)
≥ 10³ CCID50/dose
Live attenuated varicella virus (OKA strain)
≥ 10³·³ PFU/dose
Live attenuated rubella virus (Wistar RA 27/3 strain)
≥ 10³ CCID50/dose
Live attenuated mumps virus (RIT4385 strain)
≥ 10⁴·⁴ CCID50/dose
Documents
Package Inserts
Priorix Tetra PI.pdf
Approved: January 19, 2021