ProQuad Refrigerator Stable Formulation

Basic Information

Product Name

Dosage Form

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Regulatory Information

Approval Number

SIN13563P

Approval Date

October 23, 2008

Forensic Classification

Prescription Only

Drug Type

Therapeutic

Route of Administration

SUBCUTANEOUS

Record Created

August 10, 2023

Last Updated

May 30, 2025

ATC Business ID

XJ07BD54

Active Ingredients

Varicella Virus

Strength: 3.99 log PFU/ dose

Rubella Virus

Strength: 3.00 log TCID 50/ dose

Mumps Virus

Strength: 4.30 log TCID 50/ dose

Measles virus

Strength: 3.00 log TCID 50/ dose

Detailed Information

Contraindications

**V. CONTRAINDICATIONS** History of hypersensitivity to any component of the vaccine, including gelatin. History of anaphylactoid reaction to neomycin. Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system. Immunosuppressive therapy (including high-dose corticosteroids); however, ProQuad is not contraindicated for use in individuals who are receiving topical corticosteroids or low-dose corticosteroids, as are commonly used for asthma prophylaxis or in patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease. Vaccination with a live attenuated vaccine, such as varicella, can result in a more extensive vaccine-associated rash or disseminated disease in individuals on immunosuppressant doses of corticosteroids. Individuals who are on immunosuppressant drugs are more susceptible to infections than healthy individuals. Primary and acquired immunodeficiency states, including immunosuppression in association with AIDS or other clinical manifestations of infection with human immunodeficiency viruses; cellular immune deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states. Measles inclusion body encephalitis, pneumonitis, and death as a direct consequence of disseminated measles vaccine virus infection have been reported in severely immunocompromised individuals inadvertently vaccinated with measles-containing vaccine. Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated. Active untreated tuberculosis. Any active febrile illness with fever >38.5°C (>101.3°F); however, low-grade fever itself is not a contraindication to vaccination. Pregnancy; the possible effects of the vaccine on fetal development are unknown at this time. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for 3 months following vaccination. (See **PREGNANCY** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.)

Indication Information