Use in the prevention of influenza

Vaccine; Vaccine, Inactivated (Viral)

Most adults have antibody protection within 2 weeks of vaccination (CDC/ACIP)

Severe allergic reaction (eg, anaphylaxis) to a previous influenza vaccination or to any component of the formulation.

1. Information related to use in the first trimester is relatively limited
2. The risk for severe illness and complications from influenza infection is increased during pregnancy, particularly during the second and third trimesters(CDC/ACIP)

1. Not known if inactivated influenza vaccine (IIV) is present in breast milk.
2. Anti-influenza IgA antibodies can be detected in breast milk following maternal vaccination with the trivalent IIV vaccine.

>10%:
Gastrointestinal: Anorexia(infants, children,and adolescents:9-32%; adults and older adults:4-8%), diarrhea(4-13%), nausea(?12%), vomiting(infants, children,and adolescents:?15%;adults and older adults:?3%)
Local: Erythema at injection site(1-37%), induration at injection site(?17%), pain at injection site(17-67%), swelling at injection site(?25%), tenderness at injection site (21-69%)
Nervous system: Drowsiness(infants and children:8-38%), fatigue(?22%), headache(1-27%), irritability(infants and children:2-54%), malaise(?38%), uncontrolled crying(infants and children:33-41%)
Neuromuscular & skeletal: Arthralgia(4-15%), myalgia(8-40%)
Respiratory: Cough(infants, children, and adolescents:1-15%), rhinorrhea(infants and children:1-11%), wheezing
Miscellaneous: Fever(infants, children, and adolescents:1-16%; adults and older adults:?4%)
1% to 10%:
Dermatologic: Skin rash
Gastrointestinal: Change in appetite
Local: Bruising at injection site
Nervous system: Chills, shivering
Respiratory: Flu-like symptoms, nasal congestion, nasopharyngitis, oropharyngeal pain

Adults ?64 years of age: IM or via PharmaJet Stratis Needle-Free Injection System: 0.5 mL per dose as a single dose (1 dose per season).
Adults >64 years of age: IM: 0.5 mL per dose as a single dose (1 dose per season).

Children?9 years and Adolescents: single dose per season
Infants ?6 months and Children <9 years: depend on vaccination history
(1) One dose: If received ?2 doses of trivalent or quadrivalent influenza vaccine prior to July 1 preceding the current flu season start. The 2 doses need not have been received during the same season or consecutive seasons.
(2) Two doses(separated by ?4 weeks)if:It is the patient's first season of vaccination./received ?1 dose of trivalent or quadrivalent influenza vaccine prior to July 1 preceding the current flu season start./If vaccination history cannot be determined.

No dosage adjustments provided in the manufacturer's labeling

No dosage adjustments provided in the manufacturer's labeling

Refrigerate between 2 and 8 degrees C