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FLUZONE Quadrivalent

Sanofi Pasteur Product Monograph 450/477 - FLUZONE Quadrivalent Page 1 of 35 PRODUCT MONOGRAPH FLUZONE Quadrivalent Influenza Virus Vaccine Quadrivalent Types A and B (Split Virion) Suspension for Injection Active Immunizing Agent for the Prevention of Influenza ATC Code: J07B B Manufactured by: Sanofi Pasteur Limited Toronto, Ontario, Canada Fabricated by: Sanofi Pasteur Inc. Swiftwater, PA 18370 USA Control #: 238593 Date of Approval: April 29, 2020 Sanofi Pasteur Product Monograph 450/477 - FLUZONE Quadrivalent Page 2 of 35 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION .. 4 SUMMARY PRODUCT INFORMATION .. 4 DESCRIPTION .. 4 INDICATIONS AND CLINICAL USE .. 4 CONTRAINDICATIONS .. 5 WARNINGS AND PRECAUTIONS .. 5 General .. 5 Hematologic .. 6 Immune .. 6 Neurologic .. 6 Special Populations .. 7 ADVERSE REACTIONS .. 7 Adverse Drug Reaction Overview.

age, 190 adults ≥18 years of age, and 225 adults ≥65 years of age). (6) (7) (8) For children requiring a second dose as per the U.S. ACIP guidelines, the doses were administered approximately 4 weeks apart. The most common injection-site reaction in children and adults occurring after vaccine administration was pain.

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