"March 24, 2011 - People age 50 and older can now get Merck's Zostavax shingles vaccine, the FDA today ruled.
The vaccine already was approved for people age 60 and older. The approval is based on a Merck clinical trial that showed the"...
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 frost-free, 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., Whitehouse Station, NJ 08889, USA. Revised: Feb 2014
Last reviewed on RxList: 10/14/2014
This monograph has been modified to include the generic and brand name in many instances.
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