البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: V8PC20UBCN) (INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:WLSRJ8JC6S)
Seqirus Inc.
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 ANTIGEN HEMAGGLUTININ ANTIGEN - UNII:WLSRJ8JC6S)
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
Biologic Licensing Application
FLUVIRIN- A/SINGAPORE/GP1908/2015 IVR-180 (AN A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE VIRUS, A/HONG KONG/4801/2014, NYMC X-263B (H3N2) (AN A/HONG KONG/4801/2014-LIKE VIRUS), AND B/BRISBANE/60/2008, WILD TYPE (A B/BRISBANE/60/2008-LIKE VIRUS) INJECTION, SUSPENSION SEQIRUS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FLUVIRIN (INFLUENZA VIRUS VACCINE) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUVIRIN . FLUVIRIN (INFLUENZA VIRUS VACCINE) SUSPENSION FOR INTRAMUSCULAR INJECTION 2017-2018 FORMULA INITIAL U.S. APPROVAL: 1988 INDICATIONS AND USAGE FLUVIRIN is an inactivated influenza virus vaccine indicated for active immunization of persons 4 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine (1). FLUVIRIN is not indicated for children less than 4 years of age because there is evidence of diminished immune response in this age group (8.4). DOSAGE AND ADMINISTRATION For intramuscular use only. 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines. (2) “-” indicates information is not applicable (2) AG E DO SE SC HE DULE 4 years through 8 years One or two doses , 0.5 mL each If 2 doses, administer at least 1 month apart 9 years and older One dose, 0.5 mL - DOSAGE FORMS AND STRENGTHS FLUVIRIN , a sterile suspension for intramuscular injection, is supplied in two presentations: 0.5 mL single-dose prefilled syringe (3, 11) 5.0 mL multi-dose vial containing 10 doses (each dose is 0.5 mL) (3,11) CONTRAINDICATIONS History of severe allergic reactions (e.g., anaphylaxis) to egg proteins, or any component of FLUVIRIN , or life- threatening reactions to previous influenza vaccinations. (4.1, 11) WARNINGS AND PRECAUTIONS If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUVIRIN should be اقرأ الوثيقة كاملة