Preparation for Administration1
Shake the syringe vigorously before administering the vaccine and shake the multidose vial preparation each time before withdrawing a dose of vaccine.
Inspect FLUVIRIN® syringes and multidose vials visually for particulate matter and/or discoloration prior to administration [see DESCRIPTION (11)]. If either of these conditions exists, the vaccine should not be administered.
Between uses, return the multidose vial to the recommended storage conditions between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen.
A separate sterile syringe and needle must be used for each injection to prevent transmission of infectious agents from one person to another. Needles should be disposed of properly and not recapped.
It is recommended that small syringes (0.5 mL or 1 mL) should be used to minimize any product loss.
For intramuscular use only.
Recommended Dose and Schedule
|4 years through 8 years||One or two dosesa, 0.5 mL each||If 2 doses, administer at least 1 month apart|
|9 years and older||One dose, 0.5 mL||-|
a 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines.
"-" indicates information is not applicable
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 ®, 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). Cambridge, MA.