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Afluria®

AFLURIA is an inactivated influenza virus vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. AFLURIA is approved for use in persons 5 years of age and older.

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AFLURIA is contraindicated in individuals with known severe allergic reactions (eg, anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine.

Administration of CSL's 2010 Southern Hemisphere influenza vaccine was associated with postmarketing reports of increased rates of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years; these increased rates were confirmed by postmarketing studies. Febrile events were also observed in children 5 to less than 9 years of age.

Guillain-Barré Syndrome (GBS) has occurred following vaccination with AFLURIA. 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.

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

AFLURIA should be given to a pregnant woman only if clearly needed.

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.

Antibody responses in persons 65 years of age and older were lower after administration of AFLURIA as compared to younger adult subjects.

In children 5 through 17 years of age, the most common injection-site reactions observed in clinical studies with AFLURIA were pain, redness, and swelling. The most common systemic adverse events were headache, myalgia, malaise, and fever.

In adults 18 through 64 years of age, the most common injection-site adverse reactions observed in clinical studies with AFLURIA were tenderness and pain. The most common systemic adverse reactions observed were headache, malaise, and muscle aches.

In adults 65 years of age and older, the most common injection-site adverse reactions observed in clinical studies with AFLURIA were tenderness and pain.

Vaccination with AFLURIA may not protect all individuals.

Afluria Products

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Pneumovax® 23

PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).

PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged >2 years who are at increased risk for pneumococcal disease.

PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

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Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any component of the vaccine.

The most common adverse reactions, reported in >10% of subjects vaccinated with PNEUMOVAX 23 in clinical trials, were: injection-site pain/soreness/tenderness, injection-site swelling/induration, headache, injection-site erythema, asthenia and fatigue, and myalgia.

PNEUMOVAX 23 is not approved for use in children younger than 2 years of age because children in this age group do not develop an effective immune response to capsular types contained in the polysaccharide vaccine.

Since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out.

Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23.

Use caution and appropriate care in administering

PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.

Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness.

For subjects aged 65 years or older in a clinical study, systemic adverse reactions which were determined by the investigator to be vaccine-related were higher following revaccination than following initial vaccination.

Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.

Pneumovax 23 Products

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Fluvirin®

Influenza Virus Vaccine, Fluvirin vaccine, Types A and B (Surface Antigen) is a sterile parenteral for intramuscular use only. It is a purified sub-unit vaccine. Fluvirin vaccine is prepared from the extraembryonic fluid of embryonated chicken eggs inoculated with a specific type of influenza virus suspension containing neomycin and polymyxin.

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Serious allergic reactions, including anaphylactic shock, have been observed in people receiving FLUVIRIN Influenza Virus Vaccine. FLUVIRIN vaccine should not be administered to individuals with a history of systemic hypersensitivity reaction to eggs or egg proteins or other components of FLUVIRIN vaccine, including thimerosal, or to anyone who has had a life-threatening reaction to previous influenza vaccination.

Pre-filled syringes of 2010/2011 FLUVIRIN influenza vaccine are tipped with caps which may contain natural rubber latex in trace amounts. Do not administer pre-filled syringe doses of FLUVIRIN vaccine to any patients with a demonstrated history of hypersensitivity to latex. Multi-dose vial presentations of FLUVIRIN are latex-free.

In clinical trials, the most common adverse events in adults were headache, fatigue, injection site reactions (pain, mass, redness, and induration), and malaise. These adverse events were generally mild/moderate and transient. Vaccination with FLUVIRIN vaccine may not protect all individuals who are susceptible to influenza.

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a reduced immune response to FLUVIRIN vaccine. If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to use FLUVIRIN vaccine should be based on careful consideration of the potential benefits and risks. All people, including those who are pregnant, nursing, and/or taking other medications, should consult their healthcare providers before receiving FLUVIRIN vaccine.

Fluvirin Products

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Fluzone®

Fluzone Intradermal vaccine is an inactivated influenza virus vaccine given to people 18 through 64 years of age for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

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Redness, firmness, swelling, and itching at the injection site occur more frequently with Fluzone Intradermal vaccine than with Fluzone vaccine. Other common side effects to Fluzone Intradermal vaccine include pain, headache, fatigue, and muscle aches. Side effects other than those listed above may occur. Fluzone Intradermal vaccine should not be administered to anyone with a severe allergic reaction to any vaccine component, including eggs, egg products, or to a previous dose of any influenza vaccine. Tell the doctor if you have ever experienced Guillain-Barré syndrome (severe muscle weakness) after a previous dose of influenza vaccine. If you notice any other problems or symptoms following vaccination, please contact your health care professional immediately. Vaccination with Fluzone Intradermal vaccine may not protect all individuals.

Fluzone Products

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Flulaval®

FLULAVAL is a vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLULAVAL is approved for use in persons 18 years of age and older.

This indication is based on immune response elicited by FLULAVAL, and there have been no controlled trials adequately demonstrating a decrease in influenza disease after vaccination with FLULAVAL.

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Do not administer FLULAVAL to anyone with known severe allergic reactions (eg, anaphylaxis) to any component of the vaccine including egg protein or to a previous dose of any influenza vaccination.

If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLULAVAL should be based on careful consideration of the potential benefits and risks.

If FLULAVAL is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons.

Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

In clinical trials with FLULAVAL, the most common adverse reactions included injection site pain, redness, and/or swelling, fatigue, headache, and myalgia/arthralgia. (See Adverse Reactions section of the Prescribing Information for FLULAVAL for other potential adverse reactions and events).

Vaccination with FLULAVAL may not result in protection in all vaccine recipients.

Flulaval Products

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