"April 23, 2012 -- The shingles vaccine is "generally safe and well tolerated," according to a study of nearly 200,000 patients.
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Details with Side Effects
Limitations of Use of ZOSTAVAX:
DOSAGE AND ADMINISTRATION
Subcutaneous administration only. Do not inject intravascularly or intramuscularly.
Recommended Dose and Schedule
Administer ZOSTAVAX as a single 0.65-mL dose subcutaneously in the deltoid region of the upper arm.
Preparation for Administration
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.
ZOSTAVAX is stored frozen and should be reconstituted immediately upon removal from the freezer.
When reconstituted, ZOSTAVAX is a semi-hazy to translucent, off-white to pale yellow liquid.
- Use only the diluent supplied.
- Withdraw the entire contents of the diluent into a syringe.
- To avoid excessive foaming, slowly inject all of the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly.
- Withdraw the entire contents of reconstituted vaccine into a syringe and inject the total volume subcutaneously.
- ADMINISTER IMMEDIATELY AFTER RECONSTITUTION to minimize loss of potency. Discard reconstituted vaccine if not used within 30 minutes. Do not freeze reconstituted vaccine.
Dosage Forms And Strengths
ZOSTAVAX is a lyophilized preparation of live, attenuated varicella-zoster virus (Oka/Merck) to be reconstituted with sterile diluent to give a single dose suspension with a minimum of 19,400 PFU (plaque forming units) when stored at room temperature for up to 30 minutes.
Storage And Handling
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).
To maintain potency, ZOSTAVAX must be stored frozen between -58°F and +5°F (-50°C and -15°C). Use of dry ice may subject ZOSTAVAX to temperatures colder than -58°F (-50°C).
Before reconstitution, ZOSTAVAX SHOULD BE STORED FROZEN at a temperature between -58°F and +5°F (-50°C and -15°C) until it is reconstituted for injection. Any freezer, including frostfree, that has a separate sealed freezer door and reliably maintains a temperature between -58°F and +5°F (-50°C and -15°C) is acceptable for storing ZOSTAVAX.
ZOSTAVAX may be stored and/or transported at refrigerator temperature between 36°F and 46°F (2°C to 8°C) for up to 72 continuous hours prior to reconstitution. Vaccine stored between 36°F and 46°F (2°C to 8°C) that is not used within 72 hours of removal from +5°F (-15°C) storage should be discarded. ZOSTAVAX should be reconstituted immediately upon removal from the freezer. The diluent should be stored separately at room temperature (68°F to 77°F, 20°C to 25°C), or in the refrigerator (36°F to 46°F, 2°C to 8°C).
For further product information call 1-800-MERCK-90.
Before reconstitution, protect from light.
DO NOT FREEZE RECONSTITUTED VACCINE.
Dist. by : Merck Sharp & Dohme Corp., a Subsidiary of MERCK & CO., INC., White house Station, NJ 08889, USA. Issued June 2011
Last reviewed on RxList: 7/25/2011
This monograph has been modified to include the generic and brand name in many instances.
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