FLUVIRIN influenza virus a/christchurch/16/2010 nib-74 (h1n1) hemagglutinin antigen (propiolactone inactivated) a/switzerland/97

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: H41XP0E6G8) (INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:W3D48FDO26)

Available from:

Novartis Vaccines and Diagnostics Limited

INN (International Name):

INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 ANTIGEN HEMAGGLUTININ ANTIGEN - UNII:W3D48FDO26)

Composition:

INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

FLUVIRIN- INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1)
HEMAGGLUTININ ANTIGEN
(PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS
A/SWITZERLAND/9715293/2013, NIB-88 (H3N2)
HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS
B/PHUKET/3073/2013 - WILD
TYPE HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) INJECTION,
SUSPENSION
NOVARTIS VACCINES AND DIAGNOSTICS LIMITED
----------
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
2015-2016 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 sy