Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN (UNII: GPV39ZGD8C) (VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN - UNII:GPV39ZGD8C)
Merck Sharp & Dohme LLC
VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN
VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN 1350 [PFU] in 0.5 mL
SUBCUTANEOUS
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
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).
Biologic Licensing Application
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 Baca dokumen lengkap