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FLUZONE HD INJ PFS 10X.5ML - 60 ug/.5mL, 60 ug/.5mL, 60 ug/.5mL INJECTION, SUSPENSION
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FLUZONE HD INJ PFS 10X.5ML

Generic: INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136/RV/2023 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)

FLUZONE HD INJ PFS 10X.5ML

NDC:49281-0125-65
Manufacturer:Sanofi Pasteur Inc.
Strength:60 ug/.5mL, 60 ug/.5mL, 60 ug/.5mL
Dosage Form:INJECTION, SUSPENSION
Route:INTRAMUSCULAR

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Drug Information

Identification

Generic Name

INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136/RV/2023 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)

Brand Name

FLUZONE HIGH DOSE NORTHERN HEMISPHERE

Labeler / Distributor

Sanofi Pasteur Inc.

Product Type

VACCINE

Administration

Dosage Form

INJECTION, SUSPENSION

Route of Administration

INTRAMUSCULAR

FDA Application Number

BLA103914

Active Ingredients

IngredientStrength
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)60 ug/.5mL
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)60 ug/.5mL
INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)60 ug/.5mL

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Clinical Drug Information

Indications & Usage

Use for relief of occasional sleeplessness caused by stress and repetitive thoughts

Warnings

Warnings When using this product keep away from eyes Stop use and ask a doctor if sleeplessness persists for more than two weeks: insomnia can be a symptom of serious underlying medical illness If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions adults: apply 2 sprays onto the tongue. Additional sprays may be taken during the night as needed. children under 12: ask a doctor

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.