FLUBLOK QUADRIVALENT influenza vaccine injection solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INFLUENZA A VIRUS A/MICHIGAN/45/2015 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN (UNII: 69H0YJ871T) (INFLUENZA A VIRUS A/MICHIGAN/45/2015 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN - UNII:69H0YJ871T)

Available from:

Protein Sciences Corporation

INN (International Name):

INFLUENZA A VIRUS A/MICHIGAN/45/2015 RECOMBINANT HEMAGGLUTININ ANTIGEN RECOMBINANT HEMAGGLUTININ ANTIGEN - UNII:69H0YJ871T)

Composition:

INFLUENZA A VIRUS A/MICHIGAN/45/2015 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN 45 ug in 0.5 mL

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

FLUBLOK QUADRIVALENT- 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 QUADRIVALENT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUBLOK
QUADRIVALENT.
FLUBLOK QUADRIVALENT (INFLUENZA VACCINE)
STERILE SOLUTION FOR INTRAMUSCULAR INJECTION
2017-2018 FORMULA
INITIAL U.S. APPROVAL: 2013
INDICATIONS AND USAGE
•
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR (IM) INJECTION ONLY (0.5 ML). (2)
DOSAGE FORMS AND STRENGTHS
A sterile solution for injection supplied in 0.5mL single dose
pre-filled syringes. (3)
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
•
•
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: 7/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
®
Flublok Quadrivalent is a vaccine indicated for active immunization
against disease caused by influenza A subtype
viruses and influenza type B viruses contained in the vaccine. Flublok
Quadrivalent is approved for use in persons 18
years of age and older. (1)
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 Quadrivalent. (5.1)
If Guillain-Barré syndrome has occurred within 6 weeks of receipt of
a prior influenza vaccine, the decision to give
Flublok Quadrivalent should be based on careful consideration of
potential benefits and risks. (5.2)
In adults 18 through 49 years of age, the most common (≥10%)
injection-site reactions were tenderness (48%) and
pain (37%); the most common (≥10%) solicited systemic adverse
reactions were headache (20%), fatigue (17%),
myalgia (13%) and arthralgia (10%). (6.1)
In adults