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Afluria (Influenza Virus Vaccine) - Warnings and Precautions

 
 



WARNINGS AND PRECAUTIONS

Fever and Febrile Seizures

Administration of CSL's 2010 Southern Hemisphere influenza vaccine has been associated with increased postmarketing reports of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years.

Guillain-Barrę Syndrome (GBS)

If GBS has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA should be based on careful consideration of the potential benefits and risks.

Altered Immunocompetence

If AFLURIA is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.

Preventing and Managing Allergic Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

Limitations of Vaccine Effectiveness

Vaccination with AFLURIA may not protect all individuals.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with AFLURIA. It is also not known whether AFLURIA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AFLURIA should be given to a pregnant woman only if clearly needed.

Nursing Mothers

AFLURIA has not been evaluated in nursing mothers. It is not known whether AFLURIA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AFLURIA is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of AFLURIA in children below 6 months of age have not been established. The safety and immunogenicity of AFLURIA was evaluated in 298 children between the ages of 6 months and 9 years (Study 4). In this study the incidence of fever in children 6 months to < 3 years of age following the first and second doses of AFLURIA was 23%. Among children 3 years to < 9 years of age the incidence was 16% following the first dose and 8% following the second dose. Administration of CSL's 2010 Southern Hemisphere influenza vaccine has been associated with increased postmarketing reports of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years (see Adverse Reactions [6.2] and Warnings and Precautions [5.1] ).

Geriatric Use

In four clinical studies, 343 subjects ages 65 years and older received AFLURIA. Hemagglutination-inhibiting antibody responses in geriatric subjects were lower after administration of AFLURIA in comparison to younger adult subjects (see Clinical Studies [14] ). Adverse event rates were generally similar in frequency to those reported in subjects ages 18 to less than 65 years, although some differences were observed (see Adverse Reactions [6.2]).

Page last updated: 2010-08-05

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