Prescribing Information for ZOSTAVAX

Description: ZOSTAVAX is a lyophilized preparation of the Oka/Merck strain of live, attenuated varicella-zoster virus (VZV). | ZOSTAVAX5 Zoster Vaccine Live Oka Merck ZOSTAVAX Zoster Vaccine Live Oka Merck DESCRIPTION ZOSTAVAX is a lyophilized preparation of the Oka Merck strain of live attenuated varicella-zoster virus VZV . The virus was initially obtained from a child with naturally-occurring varicella then introduced into human embryonic lung cell cultures adapted to and propagated in embryonic guinea pig cell cultures and finally propagated in human diploid cell cultures WI-38 . Further passage of the virus was performed at Merck Research Laboratories MRL in human diploid cell cultures MRC-5 .The cells virus seeds virus bulks and bovine serum used in the manufacturing are all tested to provide assurance that the final product is free of adventitious agents. ZOSTAVAX when reconstituted as directed is a sterile preparation for subcutaneous administration. Each 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 also contains mg of sucrose mg of hydrolyzed porcine gelatin mg of sodium chloride mg of monosodium L-glutamate mg of sodium phosphate dibasic mg of potassium phosphate monobasic 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. CLINICAL PHARMACOLOGY Background Herpes zoster HZ commonly known as shingles or zoster is a manifestation of the reactivation of varicella zoster virus VZV which as a primary infection produces chickenpox varicella . Following initial infection the virus remains latent in the dorsal root or cranial sensory ganglia until it reactivates producing zoster. Zoster is characterized by a unilateral painful vesicular cutaneous eruption with a dermatomal distribution. Although the rash is the most distinctive feature of zoster the most frequently debilitating symptom is pain. .

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