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ZOSTAVAX VACCINE (SHINGLES) EA

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ZOSTAVAX VACCINE (SHINGLES) EA

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ZOSTAVAX VACCINE (SHINGLES) EA

ZOSTAVAX® is a vaccine used to help prevent shingles (zoster). It can be given to adults 50 years of age and older.

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). During initial passage of the virus, tissue culture materials sourced from human embryonic stem cells may have been used in the research undertaken in the development of the vaccine. Further passage of the virus was performed at Merck Research Laboratories (MRL) in human diploid cell cultures (MRC-5) that were free of adventitious agents. This live, attenuated zoster vaccine is a lyophilized preparation containing sucrose, phosphate, glutamate, and processed gelatin as stabilizers.

ZOSTAVAX, when reconstituted as directed, is a sterile preparation 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 also contains 41.05 mg of sucrose, 20.53 mg of hydrolyzed porcine gelatin, 8.55 mg of urea, 5.25 mg of sodium chloride, 0.82 mg of monosodium L-glutamate, 0.75 mg of sodium phosphate dibasic, 0.13 mg of
potassium phosphate monobasic, 0.13 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.

The manufacture of this product includes exposure to bovine derived material. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.


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SKU CSL80760101