FLUVIRIN is an inactivated subunit influenza virus vaccine indicated for active immunization of persons aged 4 years and older against influenza disease caused by influenza virus subtypes A and B included in the vaccine.1
|Presentation||Carton NDC Number||Components|
|Pre-filled syringe||70461-120-02||0.5 mL single dose pre-filled syringe, package of 10 syringes per carton (may contain latex) [NDC 70461-120-12]|
|Multi-dose vial||70461-120-10||5.0 mL multi-dose vial, individually packaged in a carton (contains no latex) [NDC 70461-120-11]|
Storage and Handling
- Store FLUVIRIN refrigerated between 2° and 8°C (36° and 46°F).
- Do not freeze. Discard if the vaccine has been frozen.
- Store in the original package to protect from light.
- Do not use after the expiration date.
- Between uses, return the multidose vial to the recommended storage conditions.
Important Safety Information
FLUVIRIN should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (egg or egg products), or to any component of FLUVIRIN, or who has had a life-threatening reaction to previous influenza vaccinations.
If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUVIRIN should be based on careful consideration of the potential benefits and risks.
If FLUVIRIN is administered to immunocompromised persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained. Prior to administration of any dose of FLUVIRIN, the healthcare provider should review the patient’s prior immunization history for possible adverse events, to determine the existence of any contraindication to immunization with FLUVIRIN and to allow an assessment of benefits and risks. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
The tip caps of the FLUVIRIN prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.
Vaccination with FLUVIRIN may not protect all individuals. In clinical trials, the most common adverse events in adults were headache, fatigue, injection site reaction (pain, mass, redness, and induration), and malaise.
- FLUVIRIN (package insert). Holly Springs, NC. Seqirus, Inc: 2016.