PROQUAD REFRIGERATOR STABLE FORMULATION [SIN13563P]

Product Info

PROQUAD REFRIGERATOR STABLE FORMULATION

[SIN13563P]

III. INDICATIONS

ProQuad is indicated for vaccination against measles, mumps, rubella, and varicella in individuals 12 months through 12 years of age.

IV. DOSAGE AND ADMINISTRATION

Dosage
Individuals 12 months through 12 years of age should receive a single dose of ProQuad administered intramuscularly or subcutaneously.

A second dose of measles-containing vaccine should be administered according to the Singapore's national immunization program.

At least 1 month should elapse between a dose of M-M-R II and a dose of ProQuad. If a second dose of varicella-containing vaccine is administered, there should be a minimum interval of 3 months between doses.

Do not give immune globulin (IG) or Varicella-Zoster Immune Globulin (VZIG) concomitantly with ProQuad (see DRUG INTERACTIONS) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Method of Administration
FOR INTRAMUSCULAR OR SUBCUTANEOUS ADMINISTRATION. DO NOT INJECT INTRAVASCULARLY.

The vaccine is to be injected in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.

The vaccine should be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder.

CAUTION: A sterile syringe free of preservatives, antiseptics, detergents, and other antiviral substances must be used for each injection and/or reconstitution of ProQuad because these substances may inactivate the vaccine viruses.

To reconstitute the vaccine, use only the diluent supplied because it is free of preservatives or other antiviral substances, which might inactivate the vaccine viruses.

It is important to use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one individual to another.

Withdraw the entire volume of solvent into a syringe (if a prefilled syringe is available, this step is not necessary). Inject the entire content of the syringe into the vial containing the powder. Gently agitate to dissolve completely. Withdraw the entire content of the reconstituted vaccine from the vial into the same syringe and inject the entire volume.

IT IS RECOMMENDED THAT THE VACCINE BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION, TO MINIMIZE LOSS OF POTENCY. DISCARD IF RECONSTITUTED VACCINE IS NOT USED WITHIN 30 MINUTES.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Before reconstitution, the lyophilized vaccine is a white to pale yellow compact crystalline plug. ProQuad, when reconstituted, is a clear pale yellow to light pink liquid.

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.

Do not give ProQuad to pregnant females. 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.)