Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: 9JWN7VDQ7N) (INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:U6C4GJ6WZG), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: A5WLI8WK8A) (INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:37H6EG2NAQ), INFLUENZA B VI
Seqirus Pty Ltd
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A ANTIGEN HEMAGGLUTININ ANTIGEN - UNII:U6C4GJ6WZG)
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
INTRAMUSCULAR
AFLURIA® is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. AFLURIA is approved for use in persons 5 years of age and older. AFLURIA is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine (see Description [11]) . Pregnancy Category B: A reproductive and developmental toxicity study has been performed in female rats at a dose approximately 265 times the human dose (on a mg/kg basis) and revealed no evidence of impaired female fertility or harm to the fetus due to AFLURIA. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, AFLURIA should be given to a pregnant woman only if clearly needed. In the reproductive and developmental toxicity study, the effect
Each product presentation includes a package insert and the following components:
Biologic Licensing Application
AFLURIA- INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) AND INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED) INJECTION, SUSPENSION AFLURIA- INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) AND INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED) INJECTION, SUSPENSION SEQIRUS PTY LTD ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AFLURIA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AFLURIA. AFLURIA, INFLUENZA VACCINE SUSPENSION FOR INTRAMUSCULAR INJECTION 2018-2019 SEASON INITIAL U.S. APPROVAL: 2007 INDICATIONS AND USAGE AFLURIA is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. (1) AFLURIA is approved for use in persons 5 years of age and older. (1) DOSAGE AND ADMINISTRATION FOR INTRAMUSCULAR (IM) INJECTION ONLY, BY NEEDLE AND SYRINGE (5 YEARS OF AGE AND OLDER) OR BY PHARMAJET STRATIS NEEDLE-FREE INJECTION SYSTEM (18 THROUGH 64 YEARS OF AGE). A SINGLE DOSE IS 0.5 ML. (2) AG E SC HE DULE * 5 years through 8 years One dose or two doses at least 1 month apart 9 years and older One dose DOSAGE FORMS AND STRENGTHS AFLURIA is a suspension for injection supplied in two presentations: 0.5 mL pre-filled syringe (single dose) (3, 11) 5 mL multi-dose vial (ten 0.5 mL doses) (3, 11) CONTRAINDICATIONS Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine. (4, 11) WARNINGS AND PRECAUTIONS Administration of CSL's 2010 Southern Hemisphere influenza vaccine was associated with increased rates of fever and fe Đọc toàn bộ tài liệu