AHFS Category 80:12

http://www.vaccineshoppe.com/US_PDF/Fluzone_P-free_2002.2003_4675.4681.pdf

propagated in chicken embryos. The virus-containing fluids are harvested and inactivated with formaldehyde. Influenza virus is

concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically

"split-antigen." The split-antigen is then further purified by chemical means and suspended in sodium phosphate-buffered isotonic sodium

chloride solution. Fluzone has been standardized according to USPHS requirements for the 2002-2003 influenza season and is formulated

to contain 45 micrograms (µg) hemagglutinin (HA) per 0.5 mL dose, in the recommended ratio of 15 µg HA each, representative of the

following three prototype strains: A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2) (an A/Moscow/10/99-like strain) and B/Hong

preservative-free presentations distinguished by a pink syringe plunger rod: a 0.25 mL prefilled syringe (for pediatric use) and a 0.5 mL

prefilled syringe and 5 mL vial of vaccine, of which both contain the preservative thimerosal [(mercury containing compound), 25 µg

mercury/0.5 mL dose]. Fluzone, after shaking syringe/vial well, is essentially clear and slightly opalescent in color.

ANTIBIOTICS ARE NOT USED IN THE MANUFACTURE OF FLUZONE.

Epidemics of influenza typically occur during the winter months and are responsible for an average of approximately 20,000 deaths per

year in the United States (US). Influenza viruses also can cause pandemics during which rates of illness and death from influenzarelated

complications can increase dramatically worldwide. Influenza viruses cause disease among all age groups. Rates of infection

Influenza vaccination is the primary method for preventing influenza and its severe complications. The primary target groups recommended

persons of any age with certain chronic medical conditions); b) persons aged 50–64 years, because this group has an elevated prevalence

of certain chronic medical conditions; and c) persons who live with or care for persons at high risk (eg, health-care workers and household

members who have frequent contact with persons at high risk and can transmit influenza to persons at high risk). Vaccination is associated

with reductions in influenza-related respiratory illness and physician visits among all age groups, hospitalization and death among persons

People 2000 goal of 60%. Although 1999 influenza vaccination coverage reached the highest levels recorded among black, Hispanic,

Increasing vaccination coverage among persons who have high-risk conditions and are aged <65 years, including children at high risk,

Vaccination of health-care workers has been associated with reduced work absenteeism and fewer deaths among nursing home

patients. Efforts should be made to educate health-care workers regarding the benefits of vaccination and the potential health

Influenza A viruses are further categorized into subtypes based on two surface antigens: hemagglutinin (H) and neuraminidase (N). Influenza B

viruses are not categorized into subtypes. Both influenza A and B viruses are further separated into groups based on antigenic characteristics.

New influenza virus variants result from frequent antigenic change (i.e., antigenic drift), resulting from point mutations that occur during viral

replication. Influenza B viruses undergo antigenic drift less rapidly than influenza A viruses. Since 1977, influenza A (H1N1) viruses, influenza A

(H3N2) viruses, and influenza B viruses have been in global circulation. A person’s immunity to the surface antigens, especially hemagglutinin,

reduces the likelihood of infection and the severity of disease if infection occurs. However, antibody against one influenza virus type or subtype

confers little or no protection against another virus type or subtype. Furthermore, antibody to one antigenic variant of influenza virus might not

protect against a new antigenic variant of the same type or subtype. The frequent development of antigenic variants through antigenic drift is

Page 1 of 8

Formal subclassification utilizing neuraminidase antigens has not been done for influenza B viruses.

The incubation period for influenza is 1–4 days with an average of 2 days. Adults and children typically are infectious from the day

before symptoms begin until approximately 5 days after illness onset. Children can be infectious for a longer period, and very young

Uncomplicated influenza illness is characterized by the abrupt onset of constitutional and respiratory signs and symptoms (eg, fever,

myalgia, headache, severe malaise, nonproductive cough, sore throat, and rhinitis). Influenza illness typically resolves after a limited

number of days for a majority of persons, although cough and malaise can persist for >2 weeks. Among certain persons, influenza can

exacerbate underlying medical conditions (eg, pulmonary or cardiac disease), or lead to secondary bacterial pneumonia or primary

influenza viral pneumonia, or occur as part of a coinfection with other viral or bacterial pathogens. Influenza infection has also been

Among children aged 0–4 years, hospitalization rates have ranged from approximately 500/100,000 population for those with high-risk

conditions to 100/100,000 population for those without high-risk conditions. Within the 0–4 age group, hospitalization rates are highest

During influenza epidemics from 1969-1970 through 1993-1994, the estimated overall number of influenza-associated hospitalizations

in the US has ranged from approximately 16,000 to 220,000/epidemic. An average of approximately 114,000 influenza-related excess

hospitalizations per year, with 57% of all hospitalizations occurring among persons aged <65 years. Since the 1968 influenza A (H3N2)

virus pandemic, the greatest numbers of influenza-associated hospitalizations have occurred during epidemics caused by type A (H3N2)

Influenza-related deaths can result from pneumonia as well as from exacerbations of cardiopulmonary conditions and other chronic

diseases. In studies of influenza epidemics occurring from 1972–1973 through 1994–1995, excess deaths (ie, the number of influenzarelated

deaths above a projected baseline of expected deaths) occurred during 19 of 23 influenza epidemics. During those 19 influenza

Older adults account for >90% of deaths attributed to pneumonia and influenza. From 1972–1973 through 1994–1995, >20,000

influenza-associated deaths were estimated to occur during each 11 different US epidemics, and >40,000 influenza-associated deaths

were estimated for each of 6 of these 11 epidemics. In the US, pneumonia and influenza deaths might be increasing in part because the

Vaccinating persons at high risk for complications each year before seasonal increases in influenza virus circulation is the most

effective means of reducing the impact of influenza. Vaccination coverage can be increased by administering vaccine to persons during

hospitalizations or routine health-care visits before the influenza season, rendering special visits to physicians’ offices or clinics

unnecessary. When vaccine and epidemic strains are well matched, achieving increased vaccination rates among persons living in

closed settings (eg, nursing homes and other chronic-care facilities) and among the staff can reduce the risk for outbreaks by inducing

herd immunity. Vaccination of health-care workers and other persons in close contact with persons in groups at high risk can also

Influenza vaccine contains three virus strains (two type A and one type B), representing the influenza viruses likely to circulate in the US

The majority of vaccinated children and young adults develop high postvaccination hemagglutination-inhibition antibody titers. These

antibody titers are protective against illness caused by strains similar to those in the vaccine. The effectiveness of influenza vaccine

depends primarily on the age and immunocompetence of the vaccine recipient and the degree of similarity between the viruses in the

vaccine and those in circulation. When the antigenic match between vaccine and circulating viruses is close, influenza vaccine prevents

illness in approximately 70% to 90% of healthy persons younger than 65 years of age. Vaccination of healthy adults also has resulted in

decreased work absenteeism and decreased use of health-care resources, including the use of antibiotics, when the vaccine and

circulating viruses are well matched. Other studies suggest that the use of trivalent inactivated influenza vaccine decreases the

Older persons and persons with certain chronic diseases might develop lower postvaccination antibody titers than healthy young adults

and thus can remain susceptible to influenza-related upper respiratory tract infection. However, among such persons, the vaccine can

be effective in preventing secondary complications and reducing the risk for influenza-related hospitalization and death. Among elderly

persons living outside of nursing homes or similar chronic-care facilities, influenza vaccine is 30%–70% effective in preventing

hospitalization for pneumonia and influenza. Among elderly persons residing in nursing homes, influenza vaccine is most effective in

preventing severe illness, secondary complications, and deaths. In this population, the vaccine can be 50%–60% effective in preventing

hospitalization or pneumonia and 80% effective in preventing death, even though the effectiveness in preventing influenza illness often

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The optimal time to vaccinate is usually during October through November, because influenza activity in the US generally begins to

increase as early as November or December, but has not reached peak levels in the majority of recent seasons until late December.

Although vaccine generally becomes available in August or September, in some years, vaccine for the upcoming influenza season might

not be available until later in the fall. Administering vaccine before October should generally be avoided in facilities such as nursing

homes, because antibody levels can begin to decline within a few months after vaccination. In addition, health-care providers should

also continue to offer vaccine to unvaccinated persons after November and throughout the influenza season even after influenza activity

has been documented in the community. In the US, seasonal influenza activity can begin to increase as early as November or December

but has not reached peak levels in the majority of recent seasons until late December through early March. Therefore, although the

condition – is at increased risk for complications of influenza. In addition, health-care workers and other individuals (including

household members) in close contact with persons in high-risk groups should be vaccinated to decrease the risk of transmitting

Dosage recommendations for the 2002-2003 season are given in Table 1. Guidelines for the use of vaccine among certain patient

Beginning each September, influenza vaccine should be offered, if available, to persons at high risk when they are seen by health-care

who are hospitalized at any time during September – March should be offered and strongly encouraged to receive influenza vaccine

before they are discharged.

Persons planning substantial organized vaccination campaigns might consider scheduling these events after mid-October. Although

influenza vaccine generally becomes available by September, the availability of vaccine in any location cannot be ensured consistently

will ensure that priority is given to high-risk persons. If regional influenza activity is expected to begin earlier than December,

vaccination programs also can be undertaken as early as September. Health-care providers should offer vaccine to unvaccinated

persons even after influenza virus activity is documented in a community and should continue to offer vaccine throughout the influenza

Dosage recommendations vary according to age group (Table 1). Among previously unvaccinated children aged <9 years, who are

responses. If possible, the second dose should be administered before December. Among adults, studies have indicated limited or no

improvement in antibody response when a second dose is administered during the same season. Even when the current influenza

immunity declines during the year after vaccination. Vaccine prepared for a previous influenza season should not be administered to

The intramuscular route is recommended for influenza vaccine. Adults and older children should be vaccinated in the deltoid muscle; a

muscle tissue in certain adults and older children. Infants and young children should be vaccinated in the anterolateral aspect of the

• residents of nursing homes and other chronic-care facilities that house persons of any age who have chronic medical conditions;

• adults and children who have chronic disorders of the pulmonary or cardiovascular systems, including asthma;

• adults and children who have required regular medical follow-up or hospitalization during the preceding year because of chronic

metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, or immunosuppression (including

immunosuppression caused by medications or by human immunodeficiency virus [HIV]);

• children and adolescents (6 months–18 years) who are receiving long-term aspirin therapy and, therefore, might be at risk for

developing Reye syndrome after influenza infection; and

• women who will be in the second or third trimester of pregnancy during the influenza season.

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Vaccination is recommended for persons aged 50–64 years because this group has an increased prevalence of persons with high-risk conditions.

Persons aged 50–64 years without high-risk conditions also receive benefit from vaccination in the form of decreased rates of influenza illness,

decreased work absenteeism, and decreased need for medical visits and medication, including antibiotics. Further, 50 years is an age when other

Also, persons who smoke tobacco products are at increased risk for influenza-related complications and therefore should receive

Persons who are clinically or subclinically infected can transmit influenza virus to persons at high risk for complications from influenza.

Decreasing transmission of influenza from caregivers to persons at high risk might reduce influenza-related deaths among persons at

high risk. Evidence from two studies suggest that vaccination of health-care workers is associated with decreased deaths among

nursing home patients. Vaccination of health-care workers and others in close contact with persons at high risk, including household

• physicians, nurses, and other personnel in both hospital and outpatient-care settings, including emergency response workers (eg,

paramedics and emergency medical technicians);

• employees of nursing homes and chronic-care facilities who have contact with patients or residents;

• employees of assisted living and other residences for persons in groups at high risk;

• persons who provide home care to persons in groups at high risk; and

• household members (including children) of persons in groups at high risk.

In addition, because children aged 0–23 months are at increased risk for influenza-related hospitalization, vaccination is encouraged

for their household contacts and out-of-home caretakers, particularly for contacts of children aged 0–5 months because influenza

Physicians should administer influenza vaccine to any person who wishes to reduce the likelihood of becoming ill with influenza (the

services should be considered for vaccination to minimize disruption of essential activities during influenza outbreaks. Students or other

persons in institutional settings (e.g., those who reside in dormitories) should be encouraged to receive vaccine to minimize the

Studies indicated that rates of hospitalization are higher among young children than older children when influenza viruses are in

circulation. The increased rates of hospitalization are comparable with rates for other groups considered at high risk for influenza-related

complications. However, the interpretation of these findings has been confounded by co-circulation of respiratory syncytial viruses, which

are a cause of serious respiratory viral illness among children and which frequently circulate during the same time as influenza viruses.

Two recent studies have attempted to separate the effects of respiratory syncytial viruses and influenza viruses on rates of hospitalization

among children who do not have high-risk conditions. Both studies reported that otherwise healthy children aged <2 years, and possibly

Because children aged 6–23 months are at substantially increased risk for influenza-related hospitalizations, influenza vaccination of all

children in this age group is encouraged when feasible. However, before a full recommendation to annually vaccinate all children aged

6–23 months can be made, ACIP, the American Academy of Pediatrics, and the American Academy of Family Physicians recognize that

certain key concerns must be addressed. These concerns include increasing efforts to educate parents and providers regarding the

impact of influenza and the potential benefits and risks of vaccination among young children, clarification of practical strategies for

Influenza-associated excess deaths among pregnant women were documented during the pandemics of 1918-1919 and 1957-1958.

Case reports and limited studies also suggest that pregnancy can increase the risk for serious medical complications of influenza as a

result of increases in heart rate, stroke volume, and oxygen consumption; decreases in lung capacity; and changes in immunologic

function. A study of the impact of influenza during 17 interpandemic influenza seasons demonstrated that the relative risk for

hospitalization for selected cardiorespiratory conditions among pregnant women increased from 1.4 during weeks 14–20 of gestation

to 4.7 during weeks 37–42 in comparison with women who were 1–6 months postpartum. Women in their third trimester of pregnancy

were hospitalized at a rate (ie, 250/100,000 pregnant women) comparable with that of nonpregnant women who had high-risk medical

conditions for whom influenza vaccine has traditionally been recommended. It was estimated that immunizing 1,000 women who could

Because of the increased risk for influenza-related complications, women who will be beyond the first trimester of pregnancy (>14 weeks

of gestation) during the influenza season should be vaccinated. Certain providers prefer to administer influenza vaccine during the second

trimester to avoid a coincidental association with spontaneous abortion, which is common in the first trimester, and because exposures to

vaccines traditionally have been avoided during the first trimester. Pregnant women who have medical conditions that increase their risk

for complications from influenza should be vaccinated before the influenza season, regardless of the stage of pregnancy. A study of

influenza vaccination of >2,000 pregnant women demonstrated no adverse fetal effects associated with influenza vaccine. However,

Page 4 of 8

The majority of influenza vaccine distributed in the US contains thimerosal, a mercury-containing compound, as a preservative.

Thimerosal has been used in US vaccines since the 1930s. No data or evidence exists of any harm caused by the level of mercury

exposure that might occur from influenza vaccination. Because pregnant women are at increased risk for influenza-related complications

and because a substantial safety margin has been incorporated into the health guidance values for organic mercury exposure, the benefit

In view of these and other data that suggest that influenza infection may cause increased morbidity in women during the second and

third trimesters of pregnancy, the ACIP recommends that health-care workers who provide care for pregnant women should consider

Influenza vaccine does not affect the safety of mothers who are breast-feeding or their infants. Breastfeeding does not adversely affect

Limited information is available regarding the frequency and severity of influenza illness or the benefits of influenza vaccination among

persons with HIV infection. However, a retrospective study of young and middle-aged women found that the attributable-risk for

cardiopulmonary hospitalizations among women with HIV infection was higher during influenza seasons than in the peri-influenza

periods. The risk of hospitalization for HIV-infected women was higher than the risk for women with other well-recognized high-risk

conditions for influenza complications, including chronic heart and lung diseases. Other reports suggest that influenza symptoms might

Influenza vaccination has been shown to produce substantial antibody titers against influenza in vaccinated HIV-infected persons who have

minimal acquired immunodeficiency syndrome-related symptoms and high CD4+ T-lymphocyte cell counts. A limited, randomized, placebocontrolled

trial determined that influenza vaccine was highly effective in preventing symptomatic, laboratory-confirmed influenza infection

among HIV-infected persons with a mean of 400 CD4+ T-lymphocyte cells/mm3; few persons with CD4+ T-lymphocyte cell counts of less

than 200 were included in this study. In patients who have advanced HIV disease and low CD4+ T-lymphocyte cell counts, influenza vaccine

One study reported that HIV RNA levels increased transiently in one HIV-infected patient after influenza infection. Studies have

demonstrated a transient (ie, 2–4-week) increase in replication of HIV-1 in the plasma or peripheral blood mononuclear cells of HIV-infected

persons after vaccine administration. Other studies using similar laboratory techniques have not documented a substantial increase in

replication of HIV. Deterioration of CD4+ T-lymphocyte cell counts or progression of HIV disease have not been demonstrated among HIVinfected

persons after influenza vaccination compared with unvaccinated persons. The effect of antiretroviral therapy on potential increases

in HIV RNA levels following either natural influenza infection or influenza vaccination is unknown. Because influenza can result in serious

illness and complications and because influenza vaccination can result in the production of protective antibody titers, vaccination will

The risk of exposure to influenza during travel depends on the time of year and destination. In the tropics, influenza can occur

throughout the year. In the temperate regions of the Southern Hemisphere, the majority of influenza activity occurs during

April–September. In temperate climate zones of the Northern and Southern Hemispheres, travelers also can be exposed to influenza

during the summer, especially when traveling as part of large organized tourist groups that includes persons from areas of the world

where influenza viruses are circulating. Persons at high risk for complications of influenza who were not vaccinated with influenza

• travel to the tropics;

• travel with large organized tourist groups at any time of year; or

• travel to the Southern Hemisphere during April–September.

No information is available regarding the benefits of revaccinating persons before summer travel who were already vaccinated in the

preceding fall. Persons at high risk who received the previous season’s vaccine before travel should be revaccinated with the current

embarking on travel during the summer to discuss the symptoms and risks of influenza and the advisability for carrying antiviral

use with pneumococcal vaccine using separate syringes at different sites. Although Influenza Virus Vaccine is recommended for annual

regarding their vaccination history. No studies regarding the simultaneous administration of inactivated influenza vaccine and other

childhood vaccines have been conducted. Children at high risk for influenza-related complications, including those aged 6–23 months,

Page 5 of 8

Fluzone should not be administered to patients with acute respiratory or other active infections or illnesses.

Immunization should be delayed in a patient with an active neurologic disorder, but should be considered when the disease process has

been stabilized.

Fluzone should not be administered to individuals who have a prior history of Guillain-Barré syndrome (GBS).

If Fluzone is administered to immunosuppressed persons, the expected antibody response may not be obtained.

As with any vaccine, vaccination with Fluzone may not protect 100% of susceptible individuals.

GENERAL

Care is to be taken by the health-care provider for the safe and effective use of this vaccine.

During the course of any febrile respiratory illness or other active infection, use of Influenza Virus Vaccine should be delayed.

Since the likelihood of febrile convulsions is greater in children 6 months through 35 months of age, special care should be taken in

weighing relative risks and benefits of vaccination.

Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the

patient’s history with respect to possible sensitivity to the vaccine or similar vaccine, to possible sensitivity to dry natural latex rubber,

current literature concerning the use of the vaccine under consideration.

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

A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to prevent transmission of hepatitis or other

infectious agents from person to person. Needles should not be recapped and should be disposed of according to biohazard waste guidelines.

Caution: The stopper to the vial and the syringe needle cover contain dry natural latex rubber, that may cause allergic reactions.

INFORMATION FOR PATIENT

Patients, parents or guardians should be fully informed by their health-care provider of the benefits and risks of immunization with

Influenza Virus Vaccine.

Patients, parents or guardians should be instructed to report any serious adverse reactions to their health-care provider.

Although influenza vaccination can inhibit the clearance of warfarin, theophylline, phenytoin, and aminopyrine therapy, studies have

If Fluzone is administered to immunosuppressed persons or persons receiving immunosuppressive therapy, the expected antibody response

may not be obtained. This includes patients with asymptomatic HIV infection, AIDS or AIDS-Related Complex, severe combined

immunodeficiency, hypogammaglobulinemia, or aggammaglobulinemia; altered immune states due to diseases such as leukemia, lymphoma, or

Animal reproduction studies have not been conducted with Influenza Virus Vaccine. It is not known whether Influenza Virus Vaccine can

cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza Virus Vaccine should be given

When educating patients about potential side effects, clinicians should emphasize that a) inactivated influenza vaccine contains noninfectious

In placebo-controlled studies among adults, the most frequent side effect of vaccination is soreness at the vaccination site (affecting

Page 6 of 8

Fever, malaise, myalgia, and other systemic symptoms can occur following vaccination and most often affect persons who have had no exposure

1–2 days. Recent placebo-controlled trials demonstrate that among older persons and healthy young adults, administration of split-virus vaccine

Immediate – presumably allergic – reactions (e.g., hives, angioedema, allergic asthma, and systemic anaphylaxis) rarely occur after

influenza vaccination. These reactions probably result from hypersensitivity to certain vaccine components; the majority of reactions

likely are caused by residual egg protein. Although current influenza vaccines contain only a limited quantity of egg protein, this protein

can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Persons who have experienced hives,

have had swelling of the lips or tongue, or have experienced acute respiratory distress or collapse after eating eggs should consult a

physician for appropriate evaluation to help determine if vaccine should be administered. Persons who have documented

immunoglobulin E (IgE)––mediated hypersensitivity to eggs––including those who have had occupational asthma or other allergic

responses to egg protein––also might be at increased risk for allergic reactions to influenza vaccine, and consultation with a physician

who received the swine influenza vaccine in 1976, the rate of GBS that exceeded the background rate was <10 cases/1,000,000

persons vaccinated. Evidence for a causal relationship of GBS with subsequent vaccines prepared from other influenza viruses is

unclear. Obtaining strong epidemiologic evidence for such a possible limited increase in risk is difficult for such a rare condition as GBS,

During three of four influenza seasons studied from 1977–1991, the overall relative risk estimates for GBS after influenza vaccination

were slightly elevated but were not statistically significant in any of these studies. However, in a study of the 1992–1993 and

1993–1994 seasons, the overall relative risk for GBS was 1.7 (95% confidence interval = 1.0-2.8; p = 0.04) during the 6 weeks after

vaccination, representing approximately 1 additional case of GBS/1,000,000 persons vaccinated. The combined number of GBS cases

peaked two weeks after vaccination. Thus, investigations to date indicate that there is no substantial increase in GBS associated with

influenza vaccines (other than the swine influenza vaccine in 1976) and that, if influenza vaccine does pose a risk, it is probably slightly

Even if GBS were a true side effect of vaccination in the years after 1976, the estimated risk for GBS of approximately 1 additional

case/1,000,000 persons vaccinated is substantially less than the risk for severe influenza, which could be prevented by vaccination in

The potential benefits of influenza vaccination in preventing serious illness, hospitalization, and death greatly outweigh the possible

risks for developing vaccine-associated GBS. The average case-fatality ratio for GBS is 6% and increases with age. No evidence

The incidence of GBS among the general population is low, but persons with a history of GBS have a substantially greater likelihood of

subsequently developing GBS than persons without such a history. Thus, the likelihood of coincidently developing GBS after influenza

vaccination is expected to be greater among persons with a history of GBS than among persons with no history of this syndrome.

persons affected were adults, and the described clinical reactions began as soon as a few hours and as late as 2 weeks after

Microscopic polyangitis (vasculitis) has been reported temporally associated with influenza vaccination. However, no cause and effect

Reporting by patients, parents, or guardians of all adverse events after vaccine administration should be encouraged. Adverse events

following immunization with vaccine should be reported by health-care providers to the US Department of Health and Human Services

(DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion

Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration whenever

solution and container permit. If either of these conditions exist, the vaccine should not be administered.

Page 7 of 8

Injections of Influenza Virus Vaccine should be administered intramuscularly, preferably in the region of the deltoid muscle, in adults and

penetrate muscle tissue in certain adults and older children. The preferred site for infants and young children is the anterolateral aspect

of the thigh.1 Before injection, the skin over the site to be injected should be cleansed with a suitable germicide. After insertion of the

needle, aspirate to assure that the needle has not entered a blood vessel.

Fluzone (Subvirion) is to be used for persons 6 months of age and older. Fluzone (Subvirion) is NOT approved for infants under 6 months

of age. The dosage is as follows:

6 – 35 months 0.25 mL 1 or 2* Intramuscular

3 – 8 years 0.50 mL 1 or 2* Intramuscular

† Because of decreased potential for causing febrile reactions, only split-virus (subvirion) vaccines should be used for children <13

years. Immunogenicity and side effects of split- and whole-virus vaccines are similar among adults when vaccines are administered

at the recommended dosage. Whole virus vaccine is not available in the US.

§ For adults and older children, the recommended site of vaccination is the deltoid muscle. The preferred site for infants and young

children is the anterolateral aspect of the thigh.

the first time.

Syringe with 1" needle, 0.25 mL (10 per package) (contains NO preservative) Shake syringe well before administering. – Product No.

49281-369-25

Syringe with 1" needle, 0.5 mL (10 per package) (contains NO preservative) Shake syringe well before administering. – Product No.

49281-369-50

Syringe with 1" needle, 0.5 mL (10 per package) (contains preservative) Shake syringe well before administering. – Product No. 49281-370-11

Vial, 5 mL, for administration with needle and syringe (contains preservative) Shake vial well before withdrawing each dose. – Product

No. 49281-370-15

Product information

Manufactured by: as of July 2002

Swiftwater PA 18370 USA Printed in USA

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4675/4681