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Fluvirin

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Fluvirin




Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Guillain-Barré Syndrome

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.

Altered Immunocompetence

If FLUVIRIN® is administered to immunocompromised persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained.

Preventing And Managing Allergic Reactions

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.

Limitations Of Vaccine Effectiveness

Vaccination with FLUVIRIN® may not protect all individuals.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

FLUVIRIN® has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category B

A reproductive and developmental toxicity study has been performed in rabbits at a dose level that was approximately 15 times the human dose based on body weight. The study revealed no evidence of impaired fertility or harm to the fetus due to FLUVIRIN®. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this vaccine should be used during pregnancy only if clearly needed.

In a reproductive and developmental toxicity study, the effect of FLUVIRIN® on embryo-fetal and post-natal development was evaluated in pregnant rabbits. Animals were administered FLUVIRIN® by intramuscular injection twice prior to gestation, during the period of organogenesis (gestation day 7) and later in pregnancy (gestation day 20), 0.5 mL/rabbit/occasion (approximately 15-fold excess relative to the projected human dose on a body weight basis). No adverse effects on mating, female fertility, pregnancy, embryo-fetal development, or post-natal development were observed. There were no vaccine related fetal malformations or other evidence of teratogenicity.

Nursing Mothers

It is not known whether FLUVIRIN® is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLUVIRIN® is administered to a nursing woman.

Pediatric Use

The safety and immunogenicity of FLUVIRIN® have not been established in children under 4 years of age.

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® [see ADVERSE REACTIONS and Clinical Studies].

Geriatric Use

Since 1997, of the total number of geriatric subjects (n = 397) in clinical studies of FLUVIRIN®, 29% were 65 years and over, while 2.1% were 75 years and over.

Antibody responses were lower in the geriatric population than in younger subjects. Adverse events occurred less frequently in geriatric subjects ( ≥ 65 years) than in younger adults. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. [See ADVERSE REACTIONS and Clinical Studies].

Last reviewed on RxList: 5/11/2015
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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Fluvirin - User Reviews

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