VARIVAX- varicella virus vaccine live injection, powder, lyophilized, for suspension

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Merck Sharp & Dohme LLC

INN (International Name):

VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN

구성:

VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN 1350 [PFU] in 0.5 mL

관리 경로:

SUBCUTANEOUS

치료 징후:

VARIVAX is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age and older. Do not administer VARIVAX to individuals with a history of anaphylactic or severe allergic reaction to any component of the vaccine (including neomycin and gelatin) or to a previous dose of a varicella-containing vaccine. Do not administer VARIVAX to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy. Disseminated varicella disease and extensive vaccine-associated rash have been reported in individuals who are immunosuppressed or immunodeficient who were inadvertently vaccinated with a varicella-containing vaccine. Do not administer VARIVAX to individuals with an active febrile illness with fever >101.3°F (>38.5°C). Do not administer VARIVAX to individuals with active, untreated tuberculosis (TB). Do not administer VARIVAX to individuals who are pregnant or planning on becoming pregnant in the next 3 months. Wild-type varicella is known to cau

제품 요약:

VARIVAX is supplied as follows: (1) a box of 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4827-00 (2) a box of 10 prefilled syringes of sterile diluent, NDC 0006-4175-88 (package B) OR a box of 10 vials of sterile diluent, NDC 0006-4309-00 (package B) Storage Vaccine Vial During shipment, maintain the vaccine at a temperature between –58°F and +5°F (–50°C and –15°C). Use of dry ice may subject VARIVAX to temperatures colder than –58°F (–50°C). Before reconstitution, store the lyophilized vaccine in a freezer at a temperature between –58°F and +5°F (–50°C and –15°C). Any freezer (e.g. , chest, frost-free) that reliably maintains an average temperature between –58°F and +5°F (–50°C and –15°C) and has a separate sealed freezer door is acceptable for storing VARIVAX. Routine defrost cycling of a frost-free freezer is acceptable. VARIVAX may be stored at refrigerator temperature (36°F to 46°F, 2°C to 8°C) for up to 72 continuous hours prior to reconstitution. Vaccine stored at 2°C to 8°C which is not used within 72 hours of removal from +5°F (–15°C) storage should be discarded. Before reconstitution, protect from light. Sterile Diluent The sterile diluent should be stored at room temperature (68°F to 77°F, 20°C to 25°C), or in the refrigerator. DISCARD IF RECONSTITUTED VACCINE IS NOT USED WITHIN 30 MINUTES. For information regarding the product or questions regarding storage conditions, call 1-800-9-VARIVAX (1-800-982-7482).

승인 상태:

Biologic Licensing Application

제품 특성 요약

VARIVAX- VARICELLA VIRUS VACCINE LIVE INJECTION, POWDER, LYOPHILIZED,
FOR
SUSPENSION
MERCK SHARP & DOHME LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VARIVAX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VARIVAX.
VARIVAX®
VARICELLA VIRUS VACCINE LIVE
SUSPENSION FOR INTRAMUSCULAR OR SUBCUTANEOUS INJECTION
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Dosage and Administration
Dose and Schedule (2.1)
02/2023
Reconstitution Instructions (2.2)
08/2023
Administration (2.3)
02/2023
INDICATIONS AND USAGE
VARIVAX is a vaccine indicated for active immunization for the
prevention of varicella in individuals 12
months of age and older. (1)
DOSAGE AND ADMINISTRATION
For intramuscular or subcutaneous injection only. (2.1, 2.3)
A single dose is approximately 0.5 mL.
_Children (12 months to 12 years of age)_
The first dose is administered at 12 to 15 months of age. (2.1)
The second dose is administered at 4 to 6 years of age. (2.1)
There should be a minimum interval of 3 months between doses. (2.1)
_Adolescents (≥13 years of age) and Adults_
Two doses are administered at a minimum interval of 4 weeks. (2.1)
DOSAGE FORMS AND STRENGTHS
Suspension for injection (approximately 0.5 mL dose) supplied as a
lyophilized vaccine to be reconstituted
using the accompanying sterile diluent. (2.2, 3, 16)
CONTRAINDICATIONS
History of severe allergic reaction to any component of the vaccine
(including neomycin and gelatin) or
to a previous dose of varicella vaccine. (4.1)
Immunosuppression. (4.2)
Moderate or severe febrile illness. (4.3)
Active untreated tuberculosis. (4.4)
Pregnancy. (4.5, 8.1, 17)
WARNINGS AND PRECAUTIONS
Evaluate individuals for immune competence prior to administration of
VARIVAX if there is a family
history of congenital or hereditary immunodeficiency. (5.1)
Avoid close contact with high-risk individuals susceptible to
varicella because of possible transmission of
varicella vaccine virus. (5.3)
Immune Globulins (IG) and other bl