FLUZONE® |
Connaught |
Influenza Virus Vaccine Trivalent Types A and B Whole Virion and Subvirion |
Active Immunizing Agent |
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Description: Fluzone is a trivalent, inactivated influenza vaccine prepared
from virus grown in allantoic fluids of chick embryos. The viruses are inactivated with
formaldehyde and purified in a linear sucrose density gradient solution using a continuous
flow centrifuge. The virus is either further purified (whole virion) or chemically
disrupted and then further purified (subvirion). Thimerosal 0.01% is added as a
preservative. |
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Indications And Clinical Uses: The National Advisory Committee on Immunization
recommends: |
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People at High Risk: Vaccination of people at high risk is the single most
important measure for reducing the impact of influenza. Priority should be given to ensure
annual vaccination of people in the following groups: |
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Adults and children with chronic cardiac or pulmonary disorders (including
bronchopulmonary dysplasia, cystic fibrosis, and asthma) severe enough to require regular
medical follow-up or hospital care: Chronic cardiac and pulmonary disorders are by far
the most important risk factors for influenza-related death. |
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People of any age who are residents of nursing homes and other chronic care
facilities: Such residents generally have one or more of the medical conditions
outlined in the first group. In addition, their institutional environment may promote
spread of the disease. Recent studies have shown that the use of vaccine in this setting
will decrease occurrence of illness and has an even greater impact in reducing the rates
of hospitalization, pneumonia and death. |
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Geriatrics: The risk of severe illness and death related to influenza is
moderately increased in healthy people in this age group but is not nearly as great as in
people with chronic underlying disease. |
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Adults and children with chronic conditions such as diabetes and other metabolic
diseases, cancer, immunodeficiency, immunosuppression, renal disease, anemia and
hemoglobinopathy: The degree of risk associated with chronic renal and metabolic
diseases in children in uncertain but this uncertainly should not preclude consideration
of vaccination. |
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Children and adolescents (age 6 months to 18 years) with conditions
treated for long periods with acetylsalicylic acid: This therapy might increase the
risk of Reye's syndrome after influenza. |
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People capable of transmitting influenza to those at high risk: People who are
potentially capable of transmitting influenza to those at high risk should receive annual
vaccination. |
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Health care and other personnel who have extensive contact with people in the high
risk groups previously described: The potential for infecting people at high risk
outlined above, particularly those in institutions, may be reduced through vaccination
programs for health care personnel. |
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Household contacts (including children) of people at high risk who either cannot be
vaccinated or may respond inadequately to vaccination: Because low antibody responses
to influenza vaccine may occur in some people at high risk (e.g., the elderly, people with
immunodeficiency), annual vaccination of their household contacts may reduce the risk of
influenza exposure. |
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Other People: People who provide essential community services may be considered
for vaccination to minimize disruption of routine activities in epidemics. The vaccine may
also be administered to those who wish to reduce their chances of acquiring infection. |
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Foreign Travelers: For vaccine eligible persons embarking on foreign travel,
their influenza vaccination history and the seasonal occurrence of influenza at their
destination should be reviewed. If no vaccine was received during the previous fall,
vaccination before travel should be considered. Influenza can occur throughout the year in
the tropics. Persons in the high-risk categories especially should be encouraged to
receive the vaccine. The most current vaccine should be used. High-risk persons given the
previous season's vaccine before travel should be revaccinated in the fall/winter with
current vaccine. |
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Contra-Indications: Influenza virus vaccine is propagated in eggs. Therefore,
this vaccine should not be administered to anyone with a history of hypersensitivity
(allergy) and especially anaphylactic reactions to eggs or egg products. It is also a
contraindication to administer this vaccine to individuals known to be sensitive to
thimerosal. In any case, epinephrine HCl solution (1:1 000) must be immediately
available should an acute anaphylactic reaction occur due to any component of the vaccine. |
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The vaccine should not be used in the presence of acute febrile illnesses or active
infection. |
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Manufacturers' Warnings In Clinical States: If influenza virus vaccine is used
in persons with malignancies receiving immunosuppressive therapy, or those who are
otherwise immunocompromised, the expected immune response may not be obtained. |
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Although influenza vaccination can inhibit the clearance of warfarin and theophylline,
clinical studies have consistently failed to show any adverse effects attributable to
these drugs in people receiving influenza vaccine. |
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Influenza virus is remarkably capricious in that significant antigenic changes may
occur from time to time. It is known definitely that influenza virus vaccine, as now
constituted, is not effective against all possible strains of influenza virus. Protection
is afforded most people only against those strains of virus from which the vaccine is
prepared or against closely related strains. |
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As with any vaccine, vaccination with influenza virus vaccine may not result in
sero-conversion in all individuals given the vaccine. |
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Precautions: The possibility of allergic reactions in individuals sensitive to
the components of the product should be borne in mind. Epinephrine HCl solution
(1:1 000) should be readily available for use in case an anaphylactic or acute
hypersensitivity reaction occurs. |
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During the course of any febrile illness or other active infection, use of influenza
virus vaccine should be delayed. |
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Prior to an injection of any vaccine, all known precautions should be taken to prevent
side reactions. This includes a review of the patient's history with respect to possible
sensitivity to the vaccine or similar vaccine. |
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A separate sterile syringe and needle should be used for each patient to prevent
transmission of hepatitis B virus or other infectious agents from one person to another.
Do not recap needles. |
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Children: The use of influenza vaccine in infants less than 6 months of
age is not recommended. |
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Pregnancy: NACI recommends that pregnant women in high-risk groups for
influenza complications should be vaccinated. |
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Simultaneous Administration of Other Vaccines: Pneumococcal vaccine and
influenza vaccine can be given at the same time at different sites without an increase in
side effects, but it should be emphasized that, whereas influenza vaccine is given
annually, pneumococcal vaccine should be given only once to adults. Detailed immunization
records should be provided to each patient to help ensure that additional doses of
pneumococcal vaccine are not given. Children at high risk may receive influenza vaccine at
the same time as routine pediatric vaccines but at separate sites with separate syringes. |
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Adverse Reactions: Because influenza vaccine contains only noninfectious
viruses, it cannot cause influenza. Respiratory disease after vaccination represents
coincidental illness unrelated to influenza vaccination. The most frequent side effect of
vaccination is soreness at the vaccination site that lasts for up to 2 days; this is
reported by fewer than one-third of vaccinees. In addition, 2 types of systemic
reactions have occurred: 1. Fever, malaise, myalgia, and other systemic symptoms occur
infrequently and most often affect persons who have had no exposure to the influenza virus
antigens in the vaccine (e.g., young children). These reactions begin 6 to
12 hours after vaccination and can persist for 1 to 2 days. |
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2. Immediate - presumably allergic - reactions (such as hives, angioedema, allergic
asthma, or systemic anaphylaxis), occur rarely after influenza vaccination. These
reactions probably result from hypersensitivity to some vaccine component - the majority
are most likely related to residual egg protein. Although current influenza vaccines
contain only a small quantity of egg protein, this protein may induce immediate
hypersensitivity reactions among persons with severe egg allergy. Individuals with
anaphylactic hypersensitivity to eggs should not be given influenza vaccine. Such persons
include those who, on eating eggs, develop swelling of the lips or tongue or experience
acute respiratory distress or collapse. |
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Prophylactic acetaminophen may decrease the frequency of some side effects in adults. |
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Children: In children aged 2 to 12 years fever and local reactions
are no more frequent after administration of split-virus vaccine than after placebo
injections. In those less than 24 months of age fever occurs more often but is seldom
severe. |
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Unlike the 1976-77 swine influenza vaccine, subsequent vaccines prepared from
other virus strains have not been associated clearly with an increased frequency of
Guillain-Barré syndrome (GBS). However, it is difficult to make a precise estimate of
risk for a rare condition such as GBS. In 1990-91 in the United States, although
there was no overall increase in frequency of GBS among vaccine recipients, there may have
been a small increase in GBS cases in vaccinated persons 18 to 64 years of age,
but not in those aged ³65 years. In contrast to the swine influenza vaccine, the
epidemiologic features of the possible association of the 1990-91 vaccine with GBS
were not as convincing. Even if GBS were a true side effect, the very low estimated risk
for GBS is less than that of severe influenza that could be prevented by vaccine.
Influenza vaccine is not known to predispose to Reye's syndrome. |
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Other neurologic illnesses, including facial paralysis, encephalitis, encephalopathy,
demyelinating disease and labyrinthitis following influenza vaccination have been
reported. Relationship to vaccine other than temporal has not been established. |
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Fatalities from a variety of other causes have been reported in the high-risk
population following influenza vaccination without the establishment of a definite causal
relationship. |
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Health care providers should report any occurrences temporally related to the
administration of the product in accordance with local requirements and to the Medical
Director, Connaught Laboratories Limited, 1755 Steeles Avenue West, Willowdale,
Ontario, Canada, M2R 3T4. |
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Dosage And Administration: See Table I. |
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Do not inject i.v. Injections of influenza virus vaccine are recommended to be given
i.m., preferably in the deltoid muscle or anterolateral thigh. Other routes of
administration of inactivated influenza vaccine should be avoided because of unpredictable
results. Before injection, the skin over the site to be injected should be cleansed with a
suitable germicide. After insertion of the needle, aspirate to insure the needle has not
entered a blood vessel. The product may contain a precipitate which settles on standing,
therefore the vial should be shaken vigorously before withdrawing each dose. Shake the
prefilled syringe well before administering dose. |
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Whole virion vaccine: Not recommended for children under 12 years of age.
Adults and children 13 years of age and older: one 0.5 mL injection. |
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Subvirion vaccine: May be used for all age groups. It is not recommended for
infants under 6 months of age. |
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Split-virus vaccines, produced by chemically disrupting the influenza virus, are
generally associated with somewhat fewer side effects in children and young adults than
are whole-virus vaccines; consequently, only split-virus vaccines are recommended for
persons less than 13 years of age. |
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Availability And Storage: Vials of 5 mL. Prefilled syringes of
0.5 mL. Store between 2 and 8°C. Potency is destroyed by freezing; do not use
influenza vaccine that has been frozen. |
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Reviewed Reviewed 1996 |