Varivax
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Uses
VARIVAX® is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age and older.
History
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Other Information
VARIVAX [Varicella Virus Vaccine Live] is a preparation of the Oka/Merck strain of live, attenuated varicella virus. The virus was initially obtained from a child with wild-type 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 for varicella vaccine was performed at Merck Research Laboratories (MRL) in human diploid cell cultures (MRC-5) that were free of adventitious agents. This live, attenuated varicella vaccine is a lyophilized preparation containing sucrose, phosphate, glutamate, and processed gelatin as stabilizers.
VARIVAX, when reconstituted as directed, is a sterile preparation for subcutaneous injection. Each approximately 0.5-mL dose contains a minimum of 1350 plaque-forming units (PFU) of Oka/Merck varicella virus when reconstituted and stored at room temperature for a maximum of 30 minutes. Each 0.5-mL dose also contains approximately 25 mg of sucrose, 12.5 mg hydrolyzed gelatin, 3.2 mg of sodium chloride, 0.5 mg of monosodium L-glutamate, 0.45 mg of sodium phosphate dibasic, 0.08 mg of potassium phosphate monobasic, and 0.08 mg of potassium chloride. The product also contains residual components of MRC-5 cells including DNA and protein and trace quantities of sodium phosphate monobasic, EDTA, neomycin and fetal bovine serum. The product contains no preservative.
Sources
Varivax Manufacturers
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Merck Sharp & Dohme Corp.
![Varivax (Varicella Virus Vaccine Live) Injection, Powder, Lyophilized, For Suspension [Merck Sharp & Dohme Corp.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Varivax | Merck Sharp & Dohme Corp.
Subcutaneous administration only
2.1 Recommended Dose and ScheduleVARIVAX is administered as an approximately 0.5-mL dose by subcutaneous injection into the outer aspect of the upper arm (deltoid region) or the anterolateral thigh.
Do not administer this product intravascularly or intramuscularly.
Children (12 months to 12 years of age)
If a second dose is administered, there should be a minimum interval of 3 months between doses [see Clinical Studies (14.1)].
Adolescents (≥13 years of age) and Adults
Two doses of vaccine, to be administered with a minimum interval of 4 weeks between doses [see Clinical Studies (14.1)].
2.2 Reconstitution InstructionsWhen reconstituting the vaccine, use only the sterile diluent supplied with VARIVAX. The sterile diluent does not contain preservatives or other anti-viral substances which might inactivate the vaccine virus.
Use a sterile syringe free of preservatives, antiseptics, and detergents for each reconstitution and injection of VARIVAX because these substances may inactivate the vaccine virus.
To reconstitute the vaccine, first withdraw the total volume of provided sterile diluent into a syringe. Inject all of the withdrawn diluent 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 subcutaneously. VARIVAX, when reconstituted, is a clear, colorless to pale yellow liquid.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the product if particulates are present or if it appears discolored.
To minimize loss of potency, administer VARIVAX immediately after reconstitution. Discard if reconstituted vaccine is not used within 30 minutes.
Do not freeze reconstituted vaccine.
Do not combine VARIVAX with any other vaccine through reconstitution or mixing.
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