FLUBLOK- influenza vaccine injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN (UNII: 1SE9Z7D2QR) (INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN - UNII:1SE9Z7D2QR), INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN (UNII: D2053D6YQU) (INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN - UNII:D2053D6YQU), INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN (UNII: POQ8DQO9S3) (INFLUENZA B

Available from:

Protein Sciences Corporation

Administration route:

INTRAMUSCULAR

Therapeutic indications:

Flublok is a vaccine indicated for active immunization against disease caused by influenza virus subtypes A and type B contained in the vaccine. Flublok is approved for use in persons 18 years of age and older. In persons 18 through 49 years of age, this indication is based on a controlled clinical study demonstrating a decrease in influenza disease after vaccination with Flublok. In persons 50 years of age and older, this indication is based on the immune response elicited by Flublok; data demonstrating a decrease in influenza disease in persons 50 years and older after vaccination with Flublok are not available. (see Clinical Studies [ 14] ) Flublok is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine (see Description [11] and Postmarketing Experience [6.2] ). Reproduction studies have been performed in rats at a dose approximately 300 times the human dose (on a mg/kg basis) and have revealed no evidence of impaired fertility or harm t

Product summary:

Flublok is supplied as a single-dose, 0.5 mL vial in a 10 vial carton: Presentation                     Carton NDC Number           Components and NDC Number                                    Single-Dose Vial 42874-015-10 Ten 0.5 mL single-dose vials [NDC 42874-015-01]

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

FLUBLOK- INFLUENZA VACCINE INJECTION, SOLUTION
PROTEIN SCIENCES CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUBLOK SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR FLUBLOK.
FLUBLOK (INFLUENZA VACCINE)
STERILE SOLUTION FOR INTRAMUSCULAR INJECTION
2015-2016 FORMULA
INITIAL U.S. APPROVAL: 2013
RECENT MAJOR CHANGES
Indications and Usage (1) 10/2014
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
A sterile solution for injection supplied in 0.5mL single dose vials.
(3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PROTEIN SCIENCES
CORPORATION AT 1-888-855-7871 OR
VAERS AT 1-800-822-7967 OR WWW.VAERS.HHS.GOV.
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2015
®
Flublok is a vaccine indicated for active immunization against disease
caused by influenza virus subtypes A and type B
contained in the vaccine. Flublok is approved for use in persons 18
years of age and older. (1)
In persons 18 through 49 years of age, this indication is based on a
controlled clinical study demonstrating a decrease
in influenza disease after vaccination with Flublok. In persons 50
years of age and older, this indication is based on the
immune response elicited by Flublok; data demonstrating a decrease in
influenza disease in persons 50 years and
older after vaccination with Flublok are not available. (14)
FOR INTRAMUSCULAR (IM) INJECTION ONLY (0.5 ML). (2)
Severe allergic reaction (e.g., anaphylaxis) to any component of the
vaccine. (4, 6.2, 11)
Appropriate medical treatment and supervision must be available to
manage possible anaphylactic reactions following
administration of Flublok. (5.1)
If Guillain-Barré syndrome has occurred within 6 weeks of receipt of
a prior influenza vaccine, the decision to give
Flublok should be based on careful consideration of potential benefits
and risks.