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Influenza A H1N1 Monovalent Vaccine

"2009 H1N1 influenza (also called Swine Flu) is caused by a new strain of influenza virus. It has spread to many countries. Like other flu viruses, 2009 H1N1 spreads from person to person through coughing, sneezing, and sometimes through touching "...

Influenza A H1N1 Monovalent Vaccine

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Guillain-Barré Syndrome

Recurrence of Guillain-Barré syndrome (GBS) has been temporally associated with the administration of influenza vaccine. The decision to give Influenza A (H1N1) 2009 Monovalent Vaccine to individuals who have a prior history of Guillain-Barré syndrome should be based on careful consideration of the potential benefits and risks.

Altered Immunocompetence

If Influenza A (H1N1) 2009 Monovalent Vaccine is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.

Preventing and Managing Allergic Reaction

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

Limitations of Vaccine Effectiveness

Vaccination with Influenza A (H1N1) 2009 Monovalent Vaccine may not protect all recipients.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Neither Fluzone vaccine nor Influenza A (H1N1) 2009 Monovalent Vaccine have been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Use In Specific Populations

Sanofi Pasteur's Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza Virus Vaccine (Fluzone vaccine) are manufactured by the same process. Available information for Fluzone vaccine is provided in this section.

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine. It is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this vaccine is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric subjects below the age of 6 months have not been established. The immune response and safety of Fluzone vaccine was evaluated in 31 children between the ages of 6-26 months. [See ADVERSE REACTIONS, Clinical Studies]

Geriatric Use

Immune response to Fluzone vaccine in subjects older than 61 years of age were lower when compared to immune responses in adults 19-59 years of age. [See Clinical Studies]

Last reviewed on RxList: 11/5/2009
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
A A A

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