Dosage and Schedule1
Administer FLUCELVAX® (Influenza Vaccine) as a single 0.5 mL intramuscular injection preferably in the region of the deltoid muscle of the upper arm. Do not inject the vaccine in the gluteal region or areas where there may be a major nerve trunk.1
Shake the syringe vigorously before administering. FLUCELVAX® should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either condition exists, do not administer the vaccine. Do not use the vaccine if the contents have been frozen.1
Attach a sterile needle to the pre-filled syringe and administer intramuscularly.
Important Safety Information
- Do not administer FLUCELVAX® to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.
Warnings & Precautions
- Guillain-Barré Syndrome (GBS): If GBS has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUCELVAX® should be based on careful consideration of the potential benefits and risks.
- Latex: The tip caps of the pre-filled syringes may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.
- Preventing and Managing Allergic Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
- Syncope: Syncope (fainting) can occur in association with administration of injectable vaccines, including Flucelvax. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope by maintaining a supine or Trendelenburg position.
- Altered Immunocompetence: After vaccination with FLUCELVAX®, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response.
- Limitations of Vaccine Effectiveness: Vaccination with FLUCELVAX® may not protect all vaccine recipients against influenza disease.
Most Common Adverse Reactions
- The most common (≥10%) solicited adverse reactions occurring in adults 18-64 years of age within 7 days of vaccination with FLUCELVAX® were pain at the injection site, erythema at the injection site, headache, fatigue, myalgia and malaise. The most common (≥10%) solicited adverse reactions occurring in adults ≥65 years of age within 7 days of vaccination were erythema at the injection site, fatigue, headache and malaise.
- FLUCELVAX® (package insert). Cambridge, MA.