Influenza Virus Vaccine should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection unless, in the judgment of the physician, the potential benefits clearly outweigh the risk of administration.

Patients with impaired immune responsiveness, whether due to the use of immunosuppressive therapy (including irradiation, corticosteroids, anti metabolites, alkylating agents, and cytotoxic agents), a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have a reduced antibody response in active immunization procedures.

As with any vaccine, immunization with Influenza Virus Vaccine may not result in seroconversion of all individuals given the vaccine.

Special care should be taken to prevent injection into a blood vessel.

General

1.  PRIOR TO ADMINISTRATION OF ANY DOSE OF INFLUENZA VIRUS VACCINE, THE PARENT, GUARDIAN, OR ADULT PATIENT SHOULD BE ASKED ABOUT THE RECENT HEALTH STATUS, MEDICAL AND IMMUNIZATION HISTORY OF THE PATIENT TO BE IMMUNIZED IN ORDER TO DETERMINE THE EXISTENCE OF ANY CONTRAINDICATION TO IMMUNIZATION WITH INFLUENZA VIRUS VACCINE (see CONTRAINDICATIONS, WARNINGS).
2.  BEFORE ADMINISTRATION OF ANY BIOLOGICAL, THE PHYSICIAN SHOULD TAKE ALL PRECAUTIONS KNOWN FOR PREVENTION OF ALLERGIC OR ANY OTHER SIDE REACTIONS. This should include: a review of the patient's history regarding possible sensitivity, the ready availability of epinephrine 1:1000 and other appropriate agents used for control of immediate allergic reactions, and a knowledge of the recent literature pertaining to use of the biological concerned, including the nature of side effects and adverse reactions that may follow its use.
3.  A separate sterile syringe and needle or a sterile disposable unit must be used for each individual patient to prevent transmission of infectious agents from one person to another.

Use in pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Influenza Virus Vaccine (FLUVIRIN®). It is also not known whether Influenza Virus Vaccine (FLUVIRIN®) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza Virus Vaccine (FLUVIRIN®) should be given to a pregnant woman only if clearly needed. See IMMUNIZATION OF OTHER GROUPS, Pregnant Women.

The clinical judgment of the attending physician should prevail at all times in determining whether to administer Influenza Virus Vaccine to a pregnant woman.

Pediatric use

The safety and immunogenicity of FLUVIRIN® have been established in the age group 4 years to 16 years.The use of FLUVIRIN® in these age groups is supported by evidence from adequate and well-controlled studies of FLUVIRIN® in adults that demonstrate the immunogenicity of FLUVIRIN®.

The safety and immunogenicity of FLUVIRIN® have not been established in children < 4 years of age. See CLINICAL PHARMACOLOGY section for additional information.

Geriatric use

Of the total number of subjects in clinical studies of FLUVIRIN® (n = 632), 37% were 65 and over, while 2.4%were 75 and over. No overall differences in safety or immunogenicity were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. See CLINICAL PHARMACOLOGY section for additional information.

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