VARIVAX (REFRIGERATED) [SIN13090P]

Product Info

VARIVAX (REFRIGERATED)

[SIN13090P]

INDICATIONS AND USAGE
Refrigerator-stable VARIVAX is indicated for vaccination against varicella in individuals 12 months of age and older.

DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR OR SUBCUTANEOUS ADMINISTRATION.
Do not inject intravascularly.

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

Children
Children 12 months to 12 years of age should receive an approximately 0.5 mL dose administered intramuscularly or subcutaneously.
If a second approximately 0.5 mL dose is administered, it should be given a minimum of 3 months later (see CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Adolescents and Adults
Adolescents and adults 13 years of age and older should receive an approximately 0.5 mL dose administered intramuscularly or subcutaneously at elected date and a second approximately 0.5 mL dose 4 to 8 weeks later.

Refrigerator-stable VARIVAX is for intramuscular or subcutaneous administration. The outer aspect of the upper arm (deltoid region) is the preferred site of injection.

Methods of administration

Prefilled syringe of diluent
To reconstitute the vaccine, inject all of the diluent (0.7 mL) in the prefilled syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents into the syringe and inject the total volume (approximately 0.5 mL) of reconstituted vaccine intramuscularly or subcutaneously, preferably into the outer aspect of the upper arm (deltoid region) or the anterolateral thigh. 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.

Do not freeze reconstituted vaccine.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. VARIVAX (Refrigerated) when reconstituted is a clear, colorless to pale yellow liquid.

Vial of diluent
To reconstitute the vaccine, first withdraw 0.7 mL of diluent into a syringe. Inject all of the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents into the syringe and inject the total volume (approximately 0.5 mL) of reconstituted vaccine intramuscularly or subcutaneously, preferably into the outer aspect of the upper arm (deltoid region) or the anterolateral thigh. 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.

CAUTION: A sterile syringe free of preservatives, antiseptics, and detergents should be used for each injection and/or reconstitution of refrigerator-stable VARIVAX because these substances may inactivate the vaccine virus.

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.

To reconstitute the vaccine, use only the diluent supplied with refrigerator-stable VARIVAX, since it is free of preservatives or other anti-viral substances which might inactivate the vaccine virus.

Do not freeze reconstituted vaccine.

Do not give immune globulin, including Varicella Zoster Immune Globulin, concurrently with refrigerator-stable VARIVAX (see also PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Refrigerator-stable VARIVAX when reconstituted is a clear, colorless to pale yellow liquid.

CONTRAINDICATIONS
A history of hypersensitivity to any component of the vaccine, including gelatin.

A history of anaphylactoid reaction to neomycin (each dose of reconstituted vaccine contains trace quantities of neomycin).

Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.

Individuals receiving immunosuppressive therapy. Individuals who are on immunosuppressant drugs are more susceptible to infections than healthy individuals. Vaccination with live attenuated varicella vaccine can result in a more extensive vaccine-associated rash or disseminated disease in individuals on immunosuppressant doses of corticosteroids.

Individuals with primary and acquired immunodeficiency states, including those who are immunosuppressed in association with AIDS or other clinical manifestations of infection with human immunodeficiency virus²³; cellular immune deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states.

A family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated.

Active untreated tuberculosis.

Any febrile respiratory illness or other active febrile infection.

Pregnancy; the possible effects of the vaccine on fetal development are unknown at this time. However, wild-type varicella is known to sometimes cause fetal harm. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for three months following vaccination (see PRECAUTIONS, Pregnancy – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

23 Center for Disease Control: Immunization of Children Infected with Human T-Lymphotropic Virus Type III/Lymphadenopathy — Associated Virus, Ann of Intern Med, 106: 75–78, 1987.