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Zostavax

Zostavax Recall

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Manufacturer Warnings

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Uses

ZOSTAVAX® is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older.

Limitations of Use of ZOSTAVAX:

  • ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia (PHN).
  • ZOSTAVAX is not indicated for prevention of primary varicella infection (Chickenpox).
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History

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Other Information

ZOSTAVAX is a lyophilized preparation of the Oka/Merck strain of live, attenuated varicella-zoster virus (VZV). ZOSTAVAX, when reconstituted as directed, is a sterile suspension for subcutaneous administration. Each 0.65-mL dose contains a minimum of 19,400 PFU (plaque-forming units) of Oka/Merck strain of VZV when reconstituted and stored at room temperature for up to 30 minutes.

Each dose contains 31.16 mg of sucrose, 15.58 mg of hydrolyzed porcine gelatin, 3.99 mg of sodium chloride, 0.62 mg of monosodium L-glutamate, 0.57 mg of sodium phosphate dibasic, 0.10 mg of potassium phosphate monobasic, 0.10 mg of potassium chloride; residual components of MRC-5 cells including DNA and protein; and trace quantities of neomycin and bovine calf serum. The product contains no preservatives.

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Zostavax Manufacturers

  • Merck Sharp & Dohme Corp.
    Zostavax | Merck Sharp & Dohme Corp.
    No Recall

    Zostavax | Merck Sharp & Dohme Corp.

    Zostavax | Merck Sharp & Dohme Corp.

    Subcutaneous administration only. Do not inject intravascularly or intramuscularly.

    2.1 Recommended Dose and Schedule

    Administer ZOSTAVAX as a single 0.65-mL dose subcutaneously in the deltoid region of the upper arm.

    2.2 Preparation for Administration

    Use only sterile syringes free of preservatives, antiseptics, and detergents for each injection and/or reconstitution of ZOSTAVAX. Preservatives, antiseptics and detergents may inactivate the vaccine virus.

    ZOSTAVAX is stored frozen and should be reconstituted immediately upon removal from the freezer.

    When reconstituted, ZOSTAVAX is a semi-hazy to translucent, off-white to pale yellow liquid.

    Reconstitution:

    Use only the diluent supplied. Withdraw the entire contents of the diluent into a syringe. To avoid excessive foaming, slowly inject all of the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents of reconstituted vaccine into a syringe and inject the total volume subcutaneously. ADMINISTER IMMEDIATELY AFTER RECONSTITUTION to minimize loss of potency. Discard reconstituted vaccine if not used within 30 minutes. Do not freeze reconstituted vaccine.
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