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)
देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
उत्पाद विशेषताएं
(SPC)
12-05-2018
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
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)
थमां उपलब्ध:
Seqirus Inc.
INN (इंटरनेशनल नाम):
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 ANTIGEN HEMAGGLUTININ ANTIGEN - UNII:WLSRJ8JC6S)
रचना:
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
प्राधिकरण का दर्जा:
Biologic Licensing Application
उत्पाद विशेषताएं
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
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