ZOSTAVAX- zoster vaccine live injection, powder, lyophilized, for suspension STERILE DILUENT- sterile water injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN (UNII: GPV39ZGD8C) (VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN - UNII:GPV39ZGD8C)

Available from:

Merck Sharp & Dohme LLC

INN (International Name):

VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN

Composition:

VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN 19400 [PFU] in 0.65 mL

Administration route:

SUBCUTANEOUS

Therapeutic indications:

ZOSTAVAX® is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older. Limitations of Use of ZOSTAVAX: - ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia (PHN). - ZOSTAVAX is not indicated for prevention of primary varicella infection (Chickenpox). Do not administer ZOSTAVAX to individuals with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin or any other component of the vaccine. Neomycin allergy manifested as contact dermatitis is not a contraindication to receiving this vaccine. {1} Do not administer ZOSTAVAX to individuals who are immunodeficient or immunosuppressed due to disease or therapy, as serious or fatal disseminated vaccine strain varicella-zoster virus disease may occur. Causes of immunodeficiency or immunosuppression may include, but are not limited to, primary or acquired immunodeficiency states, AIDS or other clinical manifestations of infection with human immunodeficiency

Product summary:

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). Storage 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 an average temperature between -58°F and +5°F (-50°C and -15°C) is acceptable for storing ZOSTAVAX. Routine defrost cycling of a frost-free freezer is acceptable. 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 information regarding the product or questions regarding storage conditions, call 1-800-MERCK-90. Before reconstitution, protect from light. DO NOT FREEZE RECONSTITUTED VACCINE.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

ZOSTAVAX- ZOSTER VACCINE LIVE INJECTION, POWDER, LYOPHILIZED, FOR
SUSPENSION
STERILE DILUENT- STERILE WATER INJECTION
MERCK SHARP & DOHME LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOSTAVAX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOSTAVAX.
ZOSTAVAX® (ZOSTER VACCINE LIVE)
SUSPENSION FOR SUBCUTANEOUS INJECTION
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
ZOSTAVAX is a live attenuated virus vaccine indicated for prevention
of herpes zoster (shingles) in
individuals 50 years of age and older. (1)
Limitations of Use of ZOSTAVAX:
ZOSTAVAX is not indicated for the treatment of zoster or postherpetic
neuralgia (PHN) (1)
ZOSTAVAX is not indicated for prevention of primary varicella
infection (Chickenpox) (1)
DOSAGE AND ADMINISTRATION
Single 0.65 mL subcutaneous injection (2.1)
DOSAGE FORMS AND STRENGTHS
Single dose vials with not less than 19,400 plaque-forming units [PFU]
per 0.65 mL dose when
reconstituted to a suspension. (2.1, 3, 16)
CONTRAINDICATIONS
History of anaphylactic/anaphylactoid reaction to gelatin, neomycin,
or any other component of the
vaccine. (4.1)
Immunosuppression or Immunodeficiency. (4.2)
Pregnancy. (4.3, 8.1)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions including anaphylaxis have occurred with
ZOSTAVAX (5.1)
Transmission of vaccine virus may occur between vaccinees and
susceptible contacts (5.2)
Deferral should be considered in acute illness (for example, in the
presence of fever) or in patients with
active untreated tuberculosis (5.3)
Avoid pregnancy for 3 months following vaccination with ZOSTAVAX (8.1)
ADVERSE REACTIONS
The most frequent adverse reactions, reported in ≥1% of subjects
vaccinated with ZOSTAVAX, were
headache and injection-site reactions. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MERCK SHARP & DOHME
CORP., A
SUBSIDIARY OF MERCK & CO., INC., AT 1-877-888-4231 OR VAERS AT
1-800-822-7967 OR
WWW.VAERS.HHS.GOV.
DRUG INTERACTIONS
In a randomized clinical study, a reduc