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)

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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)

Available from:

Catalent Belgium SA

INN (International Name):

INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 ANTIGEN HEMAGGLUTININ ANTIGEN - UNII:WLSRJ8JC6S)

Composition:

INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

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
CATALENT BELGIUM SA
----------
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
PRINCIPAL DISPLAY PANEL - FLUVIRIN INJECTION PREFILLED SYRINGES CARTON
LABEL
SEQIRUS ™
10 x 0.5 mL pre-filled syringes
For four years of age and older
Rx Only
INFLUENZA VIRUS VACCINE
FLUVIRIN
2017 - 2018 FORMULA
®
®
®
®
PRINCIPAL DISPLAY PANEL - FLUVIRIN INJECTION PREFILLED SYRINGES LABEL
0.5 ML
US LICENSE NO. 2055
INFLUENZA VIRUS
VACCINE FLUVIRIN
2017 - 2018 FORMULA
®
FLUVIRIN
a/singapore/gp1908/2015 ivr-180 (an a/michigan/4 5/2015
(h1n1)pdm09-like virus, a/hong kong/4 801/2014 , nymc
x-263b (h3n2) (an a/hong kong/4 801/2014 -like virus), and
b/brisbane/60/2008, wild type (a b/brisbane/60/2008-
like virus) injection, suspension
PRODUCT INFORMATION
PRODUCT T YPE
VACCINE
ITE M CODE (SOURCE )
NDC:438 35-0 0 20
ROUTE OF ADMINISTRATION
INTRAMUSCULAR
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
INFLUENZA A VIRUS A/SINGAPO RE/GP19 0 8 /2 0 15 IVR-18 0 ( H1N1)
ANTIGEN
( PRO PIO LACTO NE INACTIVATED) (UNII: V8 PC20 UBCN) (INFLUENZA A
VIRUS
A/SINGAPORE/GP19 0 8 /20 15 IVR-18 0 (H1N1) HEMAGGLUTININ ANTIGEN
(PROPIOLACTONE INACTIVATED) - UNII:WLSRJ8 JC6 S)
INFLUENZA A VIRUS
A/SINGAPORE/GP19 0 8 /20 15 IVR-
18 0 (H1N1) ANTIGEN
(PROPIOLACTONE
INACTIVATED)
15 ug
in 0 .5 mL
INFLUENZA A VIRUS A/HO NG KO NG/4 8 0 1/2 0 14 X-2 6 3 B ( H3 N2 )
ANTIGEN
( PRO PIO LACTO NE INACTIVATED) (UNII: 3DZY3Q314E) (INFLUENZA A VIRUS
A/HONG KONG/48 0 1/20 14 X-26 3B (H3N2) HEMAGGLUTININ ANTIGEN
(PROPIOLACTONE INACTIVATED) - UNII:C2C4DA