Generic name: VARICELLA ZOSTER LIVE(ATTENUATED) ANTIGEN 1350[PFU] in 0.5mL
Dosage form: injection, powder, lyophilized, for suspension
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FOR SUBCUTANEOUS ADMINISTRATION
Do not inject intravascularly
Children 12 months to 12 years of age should receive a 0.5-mL dose administered subcutaneously. If a second 0.5-mL dose is administered, it should be given a minimum of 3 months later.
Adolescents and Adults
Adolescents and adults 13 years of age and older should receive a 0.5-mL dose administered subcutaneously at elected date and a second 0.5-mL dose 4 to 8 weeks later.
VARIVAX is for subcutaneous administration. The outer aspect of the upper arm (deltoid) is the preferred site of injection.
VARIVAX SHOULD BE STORED FROZEN at an average temperature of –15°C (+5°F) or colder until it is reconstituted for injection (see HOW SUPPLIED, Storage). Any freezer (e.g., chest, frost-free) that reliably maintains an average temperature of –15°C and has a separate sealed freezer door is acceptable for storing VARIVAX. The diluent should be stored separately at room temperature or in the refrigerator. To reconstitute the vaccine, first withdraw 0.7 mL of diluent into a syringe. Inject all the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents into a syringe and inject the total volume (about 0.5 mL) of reconstituted vaccine subcutaneously, preferably into the outer aspect of the upper arm (deltoid) 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 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 Merck sterile diluent supplied with VARIVAX, M-M-R II, or the component vaccines of M-M-R II, 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 VARIVAX (see also PRECAUTIONS).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. VARIVAX when reconstituted is a clear, colorless to pale yellow liquid.