Zostavax
INDICATIONS
ZOSTAVAX is indicated for prevention of herpes zoster (shingles) in individuals 60 years of age and older.
ZOSTAVAX is not indicated for the treatment of zoster or PHN.
DOSAGE AND ADMINISTRATION
FOR SUBCUTANEOUS ADMINISTRATION.
Do not inject intravascularly.
ZOSTAVAX is administered as a single dose.
Caution: 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.
Reconstitute the vaccine using only the diluent supplied. The supplied diluent is free of preservatives or other antiviral substances which might inactivate the vaccine virus.
Use a separate sterile needle and syringe for reconstituting and administration of ZOSTAVAX to prevent transfer of infectious diseases.
ZOSTAVAX is stored frozen and should be reconstituted immediately upon removal from the freezer. The diluent should be stored separately at room temperature or in the refrigerator.
To reconstitute the vaccine: Withdraw the entire contents of the diluent vial into a syringe. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. ZOSTAVAX when reconstituted is a semi-hazy to translucent, off-white to pale yellow liquid.
Inject all of 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 of reconstituted vaccine subcutaneously; preferably in the upper arm.
THE VACCINE SHOULD BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION, TO MINIMIZE LOSS OF POTENCY.
DISCARD RECONSTITUTED VACCINE IF IT IS NOT USED WITHIN 30 MINUTES.
DO NOT FREEZE reconstituted vaccine.
Needles should be disposed of properly and should not be recapped.
HOW SUPPLIED
No. 4963-00 ZOSTAVAX is supplied as follows: (1) a package of 1 single-dose vial of lyophilized vaccine, NDC 0006-4963-00 (package A); and (2) a separate package of 10 vials of diluent (package B).
No. 4963-41 ZOSTAVAX is supplied as follows: (1) a package of 10 single-dose vials of lyophilized vaccine, NDC 0006-4963-41 (package A); and (2) a separate package of 10 vials of diluent (package B).
Handling and Storage
During shipment, to ensure that there is no loss of potency, the vaccine must be maintained at a temperature of -20°C (-4°F) or colder.
ZOSTAVAX SHOULD BE STORED FROZEN at an average temperature of -15°C (+5°F) or colder until it is reconstituted for injection. Any freezer, including frost-free, that has a separate sealed freezer door and reliably maintains an average temperature of -15°C or colder is acceptable for storing ZOSTAVAX.
For information regarding stability under conditions other than those recommended, call 1-800-MERCK-90.
Before reconstitution, protect from light.
The diluent should be stored separately at room temperature (20 to 25°C, 68 to 77°F), or in the refrigerator (2 to 8°C, 36 to 46°F).
Manuf. and Dist. by:
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
Issued May 2006
Printed in USA
FDA revision date: 05/06
Generic Name: Zoster Vaccine Live
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Zostavax
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