Fluogen (Influenza Virus Vaccine, Trivalent, Types A and B) is a sterile product for intramuscular injection composed of the antigens of the strains of influenza virus recommended for vaccine use during the 2000-2001 season by the US Public Health Service It is formulated to contain no less than 45 micrograms of hemagglutinin antigen (HA) content per 0.5 mL dose in the recommended ratio of 15µg of HA of the A influenza virus component representative of A/New Caledonia/20/99 (H1N1), 15 µg of HA of the A influenza virus component representative of A/Panama/2007/99 (A/Moscow/10/99-like) (H3N2), and 15 µg of HA of the B influenza virus component representative of B/Yamanashi/166/98 (B/Beijing/184/93-like).

Influenza virus is propagated in embryonated chicken eggs using an inoculum containing approximately 1 mg/mL streptomycin sulfate. The allantoic fluids containing the virus are harvested, clarified by filtration, and concentrated and refined by ultracentrifugation and zonal centrifugation. Polysorbate 80, USP, is added to the refined concentrate, which is subsequently extracted with ethyl ether to disrupt the virus and allow removal of a high proportion of pyrogenic substances. The extracted concentrate is inactivated with formaldehyde. The vaccine is diluted to its final volume with phosphate-buffered-saline solution. Thimerosal (mercury derivative) 0.01% is added as a preservative. Streptomycin sulfate is undetectable (less than the limit of detection of the assay) in the final product.

Treatment of the influenza virus with ethyl ether results in disruption or "splitting" of the virus. The active immunizing antigens, hemagglutinin and neuraminidase, are retained while a high proportion of egg protein and pyrogenic substances are removed. The resultant split-virus vaccine has been shown to be less reactogenic than whole-virus vaccines in younger age groups.

The inoculation of antigen prepared from inactivated influenza virus stimulates the production of specific antibodies. Protection is afforded only against those strains of virus from which the vaccine is prepared or closely related strains.

The effectiveness of influenza vaccine in preventing or attenuating illness varies, depending primarily on the age and immunocompetence of the vaccine recipient and the degree of similarity between the virus strains included in the vaccine and those that circulate during the influenza season. When a good match exists between vaccine and circulating viruses, influenza vaccine has been shown to prevent illness in approximately 70%-90% of healthy persons ages less than 65 years. Under these circumstances, studies also have indicated that the effectiveness of influenza vaccine in preventing hospitalization for pneumonia and influenza among elderly persons living in settings other than nursing homes or similar chronic-care facilities ranges from 30%-70%. Among elderly persons residing in nursing homes, influenza vaccine is most effective in preventing severe illness, secondary complications, and death. Studies in this population have indicated that the vaccine can be 50%-60% effective in preventing hospitalization and pneumonia and 80% effective in preventing death, even though efficacy in preventing influenza illness may often be in the range of 30%-40% among the frail elderly. Achieving a high rate of vaccination among nursing home residents can reduce the spread of infection in a facility, thus preventing disease through herd immunity. Vaccination of health care workers in nursing homes has also been demonstrated to reduce the impact of influenza among residents.

Based on the most recent epidemiological and laboratory data, the US Public Health Service anticipates that the strains prevalent in 2000-2001 will be closely related to A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (A/Moscow/10/99-like) (H3N2), and B/Yamanashi/166/98 (B/Beijing/184/93-like). Therefore, these strains will be included in the influenza virus vaccine for use during the 2000-2001 season.

Fluogen is indicated for the production of immunity to influenza virus containing antigens related to those in the vaccine.

Influenza vaccine is strongly recommended for any person 6 months of age or older who, because of age or underlying medical condition, is at increased risk for complications of influenza. Health-care workers and others (including household members) in close contact with persons in high-risk groups should also be vaccinated. In addition, influenza vaccine may be administered to any person aged >/= 6 months who wishes to reduce the chance of becoming infected with influenza. Guidelines for the use of vaccine among certain patient populations follow. 1


To maximize protection of high-risk persons, they and their close contacts should be targeted for organized vaccination programs.

Groups at increased risk for influenza-related complications:

  1. Persons 50 years of age or older.
  2. Residents of nursing homes and other chronic-care facilities that house persons of any age who have chronic medical conditions.
  3. Adults and pediatric patients with chronic disorders of the pulmonary or cardiovascular systems, including asthma.
  4. Adults and pediatric patients 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).
  5. Pediatric patients and young adults (6 months to 18 years of age) who are receiving long-term aspirin therapy and, therefore, may be at risk for developing Reye syndrome after influenza.

Groups that can transmit influenza to persons at high risk:

Persons who are clinically or subclinically infected and who care for or live with members of high-risk groups can transmit influenza virus to them. Some persons at high risk (eg, the elderly, transplant recipients, and persons with acquired immunodeficiency syndrome [AIDS]) can have a low antibody response to influenza vaccine. Efforts to protect these members of high-risk groups against influenza might be improved by reducing the likelihood of influenza exposure from their caregivers.

Therefore, the following groups should be vaccinated:

  1. Physicians, nurses, and other personnel in both hospital and outpatient-care settings.
  2. Employees of nursing homes and chronic-care facilities who have contact with patients or residents.
  3. Employees of assisted living and other residences for persons in high-risk groups.
  4. Providers of home care to persons at high risk (eg, visiting nurses, volunteer workers).
  5. Household-members (including the pediatric population 6 months of age or older) of persons in high-risk groups.


General population:   Physicians should administer influenza vaccine to any person greater than or equal to age 6 months who wishes to reduce the likelihood of becoming ill with influenza. Persons who provide essential community services should be considered for vaccination to minimize disruption of essential activities during influenza outbreaks. Students or other persons in institutional settings, such as those who reside in dormitories, should be encouraged to receive vaccine to minimize the disruption of routine activities during epidemics.

Pregnant women:   Influenza-associated excess mortality among pregnant women has not been documented except during the pandemics of 1918-19 and 1957-58. However, because death-certificate data often do not indicate whether a woman was pregnant at the time of death, studies conducted during interpandemic periods may underestimate the impact of influenza in this population. Case reports and limited studies suggest that pregnancy may 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 recent study of the impact of influenza during 17 interpandemic influenza seasons documented that the relative risk of 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 compared with rates among women who were 1-6 months postpartum. Women in their third trimester of pregnancy were hospitalized at a rate comparable to that of nonpregnant women who have high-risk medical conditions for whom influenza vaccine was traditionally recommended. Physicians generally avoid prescribing unnecessary drugs and biologics for pregnant women especially in the first trimester; however, there are no data specifically to contraindicate vaccination with the available killed virus vaccine in pregnant women who have underlying high-risk conditions. (See also PRECAUTIONS .)

Persons infected with human immunodeficiency virus (HIV):   Limited information exists regarding the frequency and severity of influenza illness or the benefits of influenza vaccination among persons with human immunodeficiency virus (HIV) infection. However, a recent retrospective study of young and middle-aged women enrolled in Tennessee's Medicaid program 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 be prolonged and the risk for complications from influenza increased for some HIV-infected persons.

Influenza vaccine has produced 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. However, in patients who have advanced HIV disease and low CD4 + T-lymphocyte cell counts, influenza vaccine might not induce protective antibody titers; a second dose of vaccine does not improve the immune response in these persons. Because influenza can result in serious illness and complications and because influenza vaccination can result in the production of protective antibody titers vaccination will benefit many HIV-infected patients, including HIV-infected pregnant women.

Foreign travelers:   The risk for exposure to influenza during foreign travel varies, depending on season and destination. In the tropics, influenza can occur throughout the year; in the Southern Hemisphere, most activity occurs from April through September. Because of the short incubation period for influenza, exposure to the virus during travel can result in clinical illness that begins while travelling, an inconvenience or potential danger, especially for persons at increased risk for complications. Persons preparing to travel to the tropics at any time of year, travel with large organized tourist groups at any time of year, or to travel to the Southern Hemisphere from April through September should review their influenza vaccination histories. If they were not vaccinated the previous fall/winter, they should consider influenza vaccination before travel. Persons in the high-risk categories should be especially encouraged to receive the most current vaccine. Persons at high risk who received the previous season' vaccine before travel should be revaccinated in the fall/winter with the current vaccine.


Beginning each September, when vaccine for the upcoming influenza season becomes available, persons at high risk who are seen by health-care providers for routine care or as a result of hospitalization should be offered influenza vaccine. Opportunities to vaccinate persons at high risk for complications of influenza should not be missed.

The optimal time for organized vaccination campaigns for persons in high-risk groups is usually the period from the beginning of October through mid-November. In the United States, influenza activity generally peaks between late December and early March. High levels of influenza activity infrequently occur in the contiguous 48 states before December. Although vaccine generally becomes available in August or September, in some years, vaccine for the upcoming influenza season might not be available in some locations until later in the fall. To minimize the possibility that large organized vaccination campaigns will need to be canceled because vaccine is unavailable, persons planning large organized vaccination campaigns may consider scheduling these events after mid-October because the availability of vaccine in any location cannot be assured consistently in the early fall. Administering vaccine too far in advance of the influenza season should be avoided in facilities such as nursing homes because antibody levels might begin to decline within a few months of vaccination. Vaccination programs can be undertaken as soon as current vaccine is available if regional influenza activity is expected to begin earlier than December.

Pediatric patients under 9 years of age who have not been vaccinated previously should receive two doses of vaccine at least one month apart to maximize the likelihood of a satisfactory antibody response to all three vaccine antigens. The second dose should be administered before December, if possible. Vaccine should be offered to both the pediatric and adult populations up to and even after influenza virus activity is documented in a community.

The degree of protection afforded by immunization with any vaccine may not be sufficient to prevent the disease if the exposure to the influenza virus strains is overwhelming or if the virus strains are not closely related antigenically to those used in the production of vaccine.



In persons suspected of having an allergic condition, immunization procedures should be preceded by testing and/or desensitization procedures conducted under the supervision of a physician. A positive skin reaction contraindicates immunization with the vaccine. See PRECAUTIONS .

Immunization should be deferred in the presence of any acute respiratory disease or other active infection.


Persons being given immunosuppressive therapy or other immunosuppressed individuals may experience a lower than expected antigenic response.

The packaging of this product contains natural rubber latex which may cause allergic reactions.



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.

Although current influenza vaccines contain only a minute quantity of egg protein, they do, on rare occasions, provoke anaphylactic hypersensitivity reactions. Epinephrine 1 mg/mL (1:1000) should be available and ready for immediate use should such reactions occur.

Because of the possibility of a febrile reaction following immunization with influenza virus vaccine, the wisdom of attempting to immunize patients with a history of febrile convulsion should be given careful consideration. Persons with acute febrile illnesses usually should not be vaccinated until their temporary symptoms have abated.

Proper precautions should be taken for persons with known sensitivity to latex, which is present in packaging components of this product.

Drug Interactions

Although influenza vaccination can inhibit the clearance of warfarin and theophylline, studies have failed to show any adverse clinical effects attributable to these drugs in patients receiving influenza vaccine.

Concomitant influenza vaccination and immunosuppressive therapy (eg, corticosteroids, chemotherapy) may be associated with impaired immune response to the vaccine.


Pregnancy Category C:

Animal reproduction studies have not been conducted with influenza vaccine. It is also not known whether influenza vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza vaccine should be given to a pregnant woman only if clearly needed. (See also .)

Nursing Mothers

Influenza vaccine does not affect the safety of breastfeeding for mothers or infants. Breastfeeding does not adversely affect immune response and is not a contraindication for vaccination.

Pediatric Use

The safety and effectiveness of Fluogen in infants below the age of 6 months have not been established.


Side effects of influenza vaccine administration are generally inconsequential in adults and occur at low frequency. The most frequent side effect of vaccination is soreness at the vaccination site that lasts for up to two days. Severe reactions are uncommon in adults, and truly disabling effects appear to be exceedingly rare.

The following types of systemic reactions to influenza vaccine have occurred:

Fever, malaise, myalgia, and other systemic symptoms of toxicity occurring 6 to 12 hours after vaccination and persisting one or two days. These responses to influenza vaccine are usually attributed to characteristics of the influenza virus antigens (even though the virus is inactivated) and represent the bulk of the side effects of influenza vaccination. Such effects occur most frequently in persons who have had no exposure to the influenza virus antigen in the vaccine (eg, young children).

Immediate, presumably allergic, responses, such as hives, angioedema, allergic asthma, and systemic anaphylaxis, are expressions of hypersensitivity. These reactions occur rarely after influenza vaccination. They probably derive from exquisite sensitivity to some vaccine component, most likely to residual egg protein.

Neurologic disorders, including such central nervous system conditions as encephalopathy, have a temporal association with influenza vaccination.

Rare occurrences of optic neuritis and vasiculitis following administration of influenza vaccine have been recently reported in the literature.

The 1976 swine influenza vaccine was associated with an increased frequency of Guillain-Barré syndrome(GBS). Among persons who received the swine influenza vaccine in 1976, the rate of GBS that exceeded the background rate was slightly less than 10 cases per million persons vaccinated. Evidence for a casual relationship of GBS with subsequent vaccines prepared from other virus strains is less clear. Obtaining strong epidemiologic evidence for a possible small increase in risk is difficult for a rare condition such as GBS, which has an annual incidence of only 10-20 cases per million adults, and stretches the limits of epidemiologic investigation. More definitive data probably will require the use of other methodologies such as laboratory studies of the pathophysiology of 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 following vaccination, representing an excess of slightly more than one additional case of GBS per million persons vaccinated; the combined number of GBS cases peaked 2 weeks after vaccination. Thus, investigations to date suggest no large 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 quite small--slightly more than one additional case per million persons vaccinated. Cases of GBS following influenza infection have been reported, but no epidemiologic studies have documented such an association. Good evidence exists that several infectious illnesses, most notably Campylobacter jejuni as well as upper respiratory tract infections in general, are associated with GBS.

Even if GBS were a true side effect of vaccination in the years after 1976, the estimated risk for GBS of slightly more than one additional case per million persons vaccinated is substantially less than the risk for severe influenza, which could be prevented by vaccination in all age groups, especially persons aged >65 years and those who have medical indications for influenza vaccination. During different epidemics occurring from 1972 through 1981, estimated rates of influenza-associated hospitalization have ranged from approximately 200 to 300 hospitalizations per million population for previously healthy persons aged 5-44 years and from 2,000 to > 10,000 hospitalizations per million population for persons aged >65 years. During epidemics from 1972-1973 through 1994-1995, estimated rates of influenza-associated death have ranged from approximately 300 to > 1,500 per million persons aged >65 years, who account for more than 90% of all influenza-associated deaths. 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. However, no evidence indicates that the case-fatality ratio for GBS differs among vaccinated persons and those not vaccinated.

The incidence of GBS in the general population is very 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 coincidentally 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. Whether influenza vaccination specifically might increase the risk for recurrence of GBS is not known. Therefore, it would seem prudent to avoid influenza vaccination of persons who are not at high risk for severe influenza complications and who are known to have developed GBS within 6 weeks of a previous influenza vaccination. However, many experts believe that for most persons who have a history of GBS and who are at high risk for severe complications from influenza, the established benefits of influenza vaccination justify yearly vaccination.


Although the current influenza vaccine can contain one or more of the antigens administered in previous years, annual vaccination with the current vaccine is necessary because immunity declines in the year following vaccination. Because the 2000-2001 vaccine differs from the 1999-2000 vaccine, supplies of 1999-2000 vaccine should not be administered to provide protection for the 2000-2001 influenza season. 1

Two doses administered at least one month apart may be required for satisfactory antibody responses among pediatric patients under 9 years of age who are receiving influenza vaccine for the first time. (See timing for vaccination under .) To minimize febrile reactions, only subvirion or purified-surface-antigen preparations should be used for pediatric patients 6 months to 12 years of age. 1 Studies of vaccines similar to those being used currently have indicated little or no improvement in antibody response when a second dose is administered to adults during the same season. 1

The intramuscular route is recommended for influenza vaccine. Adults and older children should be vaccinated in the deltoid muscle. Infants and young children should be vaccinated in the anterolateral aspect of the thigh. 1 Do Not Inject Intravenously.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and containers permit.

The dosage may be administered by the intramuscular route as follows:

  1. Persons 9 years and older, a single injection of 0.5 mL.
  2. Persons 3 years through 8 years, one or two injections of 0.5 mL. *  
  3. Persons 6 months through 35 months, one or two injections of 0.25 mL. *   **

* Two doses administered at least one month apart are recommended for children under 9 years of age who are receiving influenza virus vaccine for the first time.
** Note: based on limited data. Because the likelihood of febrile convulsions is greater in this age group, special care should be taken in weighing risks and benefits.


NDC 64029-2000-2--5 mL multiple-dose vials.

NDC 64029-2000-1--0.5 mL disposable syringes. Supplied in packages of 10.

Storage--Store at temperature between 2° and 8°C (36° and 46°).

Freezing destroys potency.

Shake before use.


  1. Centers for Disease Control. and Prevention. Recommendations of the Public Health Service Advisory Committee on Immunization Practices--Prevention and Control of Influenza. MMWR , Vol. 49, No. RR-3(April 14, 2000).
  2. Centers for Disease Control. Recommendation of the Public Health Service Immunization Practices Advisory Committee--Influenza Vaccines, 1983-1984. MMWR , Vol. 32, No. 26 (July 8, 1983).

IMPORTANT INFORMATION for Group Immunization Programs

If any portion of this product is to be used in an immunization program sponsored by any organization WHERE A TRADITIONAL PHYSICIAN/PATIENT RELATIONSHIP DOES NOT EXIST, each recipient (or legal guardian) should be made aware of the benefits and risks, including a possible risk of a form of paralysis sometimes known as Guillain-Barré syndrome. These are summarized in the current labeling, and informed consent should be obtained from the recipient (or legal guardian) before immunization.

PLEASE CONTACT YOUR LOCAL MONARCH REPRESENTATIVE for copies of the following group immunization forms:

  1. Group immunization acknowledgment form
  2. Group immunization patient informed consent form (sample)
  3. Posters announcing the group immunization program

Rx only

Manufactured by: Parkdale Pharmaceuticals, Inc.

Rochester, MI 48307

Rev. 5/00