FLUVIRIN (a/singapore/gp1908/2015 ivr-180 (an a/michigan/45/2015 (h1n1)pdm09-like virus, a/hong kong/4801/2014, nymc x-263b (h3n

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

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04-01-2018

Ingredientes activos:

INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: 3872LLC68G) (INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:3872LLC68G), INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: 3S1ZBQ2B9I) (INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:3S1ZBQ2B9I), INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) ANTIGEN (PROPIOLACTONE

Disponible desde:

Catalent Belgium SA

Vía de administración:

NOT APPLICABLE

Estado de Autorización:

Biologic Licensing Application

Ficha técnica

                                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
----------
FLUVIRIN
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
LICENSED VACCINE BULK INTERMEDIATE
ITE M CODE (SOURCE )
NDC:438 35-0 0 19
ROUTE OF ADMINISTRATION
NOT APPLICABLE
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
INFLUENZA A VIRUS A/VICTO RIA/3 6 1/2 0 11 IVR-16 5 ( H3 N2 ) ANTIGEN
( PRO PIO LACTO NE INACTIVATED) (UNII: 38 72LLC6 8 G) (INFLUENZA A
VIRUS A/VICTORIA/36 1/20 11 IVR-16 5 (H3N2) ANTIGEN (PROPIOLACTONE
INACTIVATED) - UNII:38 72LLC6 8 G)
INFLUENZA A VIRUS
A/VICTORIA/36 1/20 11 IVR-16 5
(H3N2) ANTIGEN (PROPIOLACTONE
INACTIVATED)
15 ug
in 0 .5 mL
INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158 /2 0 0 9 BX-3 9 ANTIGEN
( PRO PIO LACTO NE INACTIVATED) (UNII: 3S1ZBQ2B9 I) (INFLUENZA B VIRUS
B/HUBEI-WUJIAGANG/158 /20 0 9 BX-39 ANTIGEN (PROPIOLACTONE
INACTIVATED) - UNII:3S1ZBQ2B9 I)
INFLUENZA B VIRUS B/HUBEI-
WUJIAGANG/158 /20 0 9 BX-39
ANTIGEN (PROPIOLACTONE
INACTIVATED)
15 ug
in 0 .5 mL
Catalent Belgium SA
INFLUENZA A VIRUS A/CHRISTCHURCH/16 /2 0 10 NIB-7 4 ( H1N1) ANTIGEN
( PRO PIO LACTO NE INACTIVATED) (UNII: H41XP0 E6 G8 ) (INFLUENZA A
VIRUS
A/CHRISTCHURCH/16 /20 10 NIB-74 (H1N1) HEMAGGLUTININ ANTIGEN
(PROPIOLACTONE INACTIVATED) - UNII:W3D48 FDO26 )
INFLUENZA A VIRUS
A/CHRISTCHURCH/16 /20 10 NIB-74
(H1N1) HEMAGGLUTININ ANTIGEN
(PROPIOLACTONE INACTIVATED)
15 ug
in 0 .5 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)
SO DIUM PHO SPHATE, MO NO BASIC, ANHYDRO US (UNII: KH7I0 4HPUU)
TH
                                
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