MedPath
HSA Product

Priorix-Tetra

Product approved by Health Sciences Authority (SG)

Basic Information

Priorix-Tetra

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Regulatory Information

SIN13627P

April 3, 2009

Prescription Only

Therapeutic

SUBCUTANEOUS, INTRAMUSCULAR

August 10, 2023

June 3, 2025

XJ07BD54

Company Information

Active Ingredients

Live attenuated varicella virus (OKA strain)

Strength: ≥ 10³·³ PFU/dose

Live attenuated mumps virus (RIT4385 strain)

Strength: ≥ 10⁴·⁴ CCID50/dose

Detailed Information

Contraindications

**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_).

Indication 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.

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