Additional Information on the latest new vaccine (posted below)

Influenza A (H1N1) 2009 Monovalent Vaccine (ID Biomedical Corporation of Quebec)

Package Insert:

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Influenza A (H1N1) 2009 Monovalent Vaccine safely and effectively. See full prescribing information for Influenza A (H1N1) 2009 Monovalent Vaccine.
Influenza A (H1N1) 2009 Monovalent Vaccine
Manufactured by ID Biomedical Corporation of Quebec (IDB)
Distributed by GlaxoSmithKline (GSK)
Suspension for Intramuscular Injection
Initial U.S. Approval: 2006
---------------------------RECENT MAJOR CHANGES--------------------
Indications and Usage (1)
11/2009
----------------------------INDICATIONS AND USAGE---------------------
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Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine, indicated for active immunization of adults 18 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus. (1)
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This indication is based on immune response elicited by the seasonal trivalent Influenza Virus Vaccine manufactured by IDB (FLULAVAL). Influenza A (H1N1) 2009 Monovalent Vaccine and FLULAVAL are manufactured by IDB using the same process. There have been no controlled trials demonstrating a decrease in influenza disease after vaccination with FLULAVAL. (14)

-----------------------DOSAGE AND ADMINISTRATION----------------
Based on currently available information, the vaccination regimen is as follows:
Adults 18 years of age and older: A single 0.5-mL intramuscular injection. (2.2)

---------------------DOSAGE FORMS AND STRENGTHS--------------
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Influenza A (H1N1) 2009 Monovalent Vaccine is a suspension for intramuscular injection available in 10-mL multi-dose vials containing 10 doses (each dose is 0.5 mL). (3)
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Thimerosal, a mercury derivative, is added as a preservative. Each 0.5-mL dose contains 25 mcg mercury. (3, 11)

-------------------------------CONTRAINDICATIONS------------------------
Known systemic hypersensitivity reactions to egg proteins, or any other component of Influenza A (H1N1) 2009 Monovalent Vaccine, or life-threatening reaction to previous influenza vaccination. (4.1, 11)

-----------------------WARNINGS AND PRECAUTIONS----------------
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If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give Influenza A (H1N1) 2009 Monovalent Vaccine should be based on careful consideration of the potential benefits and risks. (5.1)
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Immunocompromised persons may have a reduced immune response to Influenza A (H1N1) 2009 Monovalent Vaccine. (5.2)

------------------------------ADVERSE REACTIONS-----------------------
Adverse reactions information is based on studies conducted with seasonal trivalent Influenza Virus Vaccine manufactured by IDB (FLULAVAL).
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Most common (≥10%) local adverse events for FLULAVAL were pain, redness, and/or swelling at the injection site. (6.1)
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Most common (≥10%) systemic adverse events for FLULAVAL were headache, fatigue, myalgia, low grade fever, and malaise. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or VAERS at 1-800-822-7967 and www.vaers.hhs.gov.

-------------------------------DRUG INTERACTIONS------------------------
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Do not mix with any other vaccine in the same syringe or vial. (7.1)
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Immunosuppressive therapies may reduce immune responses to Influenza A (H1N1) 2009 Monovalent Vaccine. (7.2)

-----------------------USE IN SPECIFIC POPULATIONS----------------
Information is based on studies conducted with seasonal trivalent Influenza Virus Vaccine manufactured by IDB (FLULAVAL).
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Safety and effectiveness of Influenza A (H1N1) 2009 Monovalent Vaccine have not been established in pregnant women, nursing mothers, and children. (8.1, 8.3, 8.4)
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Geriatric Use: Antibody responses to FLULAVAL were lower in geriatric subjects than in younger subjects. (8.5)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: November 2009