AFLURIA®, Influenza Virus Vaccine for intramuscular injection, is a sterile, clear, colorless to slightly opalescent suspension with some sediment that resuspends upon shaking to form a homogeneous suspension. AFLURIA® is prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs. Following harvest, the virus is purified in a sucrose density gradient using a continuous flow zonal centrifuge. The purified virus is inactivated with beta-propiolactone, and the virus particles are disrupted using sodium taurodeoxycholate to produce a “split virion”. The disrupted virus is further purified and suspended in a phosphate buffered isotonic solution.

AFLURIA® is standardized according to USPHS requirements for the 2007-2008 influenza season and is formulated to contain 45 mcg HA per 0.5 mL dose in the recommended ratio of 15 mcg HA for each of the three influenza strains recommended for the 2007-2008 Northern Hemisphere influenza season: A/H1N1 (A/Solomon Islands/3/2006), A/H3N2 (A/Wisconsin/67/2005), and influenza B (B/Malaysia/2506/2004).

The single-dose formulation is preservative-free; thimerosal, a mercury derivative, is not used in the manufacturing process for this formulation. The multi-dose formulation contains thimerosal, added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.

A single 0.5 mL dose of AFLURIA® contains sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (1.5 mcg). From the manufacturing process, each dose may also contain residual amounts of sodium taurodeoxycholate ( ≤ 10 ppm), ovalbumin ( ≤ 0.10 mcg), neomycin sulfate ( ≤ 0.2 picograms [pg]), polymyxin B ( ≤ 0.03 pg), and beta-propiolactone ( < 25 nanograms).

The rubber tip cap and plunger used for the preservative-free, single-dose syringes and the rubber stoppers used for the multi-dose vial contain no latex.

Last updated on RxList: 11/26/2007

AFLURIA® is an inactivated influenza virus vaccine indicated for active immunization of persons ages 18 years and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

This indication is based on the immune response elicited by AFLURIA®; there have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with AFLURIA® (see Clinical Studies).

Prior to Administration

AFLURIA® should be inspected visually for particulate matter and discoloration prior to administration (see DESCRIPTION), whenever suspension and container permit. If either of these conditions exists, the vaccine should not be administered. Any vaccine that has been frozen or is suspected of being frozen must not be used.

Administration

When using the preservative-free, single-dose syringe, shake the syringe thoroughly and administer the dose immediately.

When using the multi-dose vial, shake the vial thoroughly before withdrawing each dose, and administer the dose immediately. Between uses, store the vial at 2-8°C (36-46°F) (see How Supplied/Storage and Handling). Once the stopper has been pierced, the vial must be discarded within 28 days.

AFLURIA® should be administered as a single 0.5 mL intramuscular injection, preferably in the deltoid muscle of the upper arm.

Dosage Forms And Strengths

AFLURIA® is a sterile suspension for intramuscular injection. Each 0.5 mL dose contains 15 micrograms (mcg) of influenza virus hemagglutinin (HA) from each of the three influenza virus strains included in the vaccine (see DESCRIPTION).

AFLURIA® is supplied in two presentations:

• 0.5 mL preservative-free, single-dose, pre-filled syringe.
• 5 mL multi-dose vial containing ten doses. Thimerosal, a mercury derivative, is added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.

Storage And Handling

AFLURIA® is supplied as a 0.5 mL preservative-free, single-dose pre-filled syringe (packaged without needles) and as a 5 mL multi-dose vial containing ten 0.5 mL doses, with thimerosal, a mercury derivative, added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.

Product Description	NDC Number
Package of ten 0.5 mL preservative-free, prefilled syringes	33332-007-01
5 mL multi-dose vial	33332-107-10

Store refrigerated at 2-8°C (36-46°F). Do not freeze. Protect from light. Do not use AFLURIA® beyond the expiration date printed on the label.

CSL Limited Parkville, Victoria, 3052, Australia. US License No. 1764. Distributed by: CSL Biotherapies Inc. King of Prussia, PA 19406 USA. FDA Rev date: 9/28/2007

Last updated on RxList: 11/26/2007

Overall Adverse Reactions

Serious allergic reactions, including anaphylactic shock, have been observed during postmarketing surveillance in individuals receiving AFLURIA®.

The most common local (injection-site) adverse reactions observed in clinical studies with AFLURIA® were tenderness, pain, redness, and swelling. The most common systemic adverse reactions observed were headache, malaise, and muscle aches.

Safety Experience from Clinical Studies

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a vaccine cannot be directly compared to rates in the clinical studies of another vaccine and may not reflect the rates observed in clinical practice.

Clinical safety data for AFLURIA® have been obtained in two clinical studies (see randomized to receive AFLURIA® (1,089 subjects) or placebo (268 subjects) (see Clinical Studies for study demographics). There were no deaths or serious adverse events reported in this study.

A UK study (Study 2) included 275 subjects, ages 65 years and older, randomized to receive preservative-free AFLURIA® (206 subjects) or a European-licensed trivalent inactivated influenza vaccine as an active control (69 subjects) (see Clinical Studies). There were no deaths or serious adverse events reported in this study.

The safety assessment was identical for the two studies. Local (injection-site) and systemic adverse events were solicited by completion of a symptom diary card for 5 days post-vaccination (Table 1). Unsolicited local and systemic adverse events were collected for 21 days post-vaccination (Table 2). These unsolicited adverse events were reported either spontaneously or when subjects were questioned about any changes in their health post-vaccination. All adverse events are presented regardless of any treatment causality assigned by study investigators.

Table 1: Proportion of Subjects With Solicited Local or Systemic Adverse Events* Within 5 days After Administration of AFLURIA® or Placebo, Irrespective of Causality^†

	Study 1 Subjects ≥ 18 to < 65 Years		Study 2 Subjects ≥ 65 Years
Solicited dverse event	AFLURIA®‡ n=1089	Placebo§ n=268	AFLURIA® n=206
Local
Tenderness||	60%	18%	34%
Pain¶	40%	9%	9%
Redness	16%	8%	23%
Swelling	9%	1%	11%
Bruising	5%	1%	4%
Systemic
Headache	26%	26%	15%
Malaise	20%	19%	10%
Muscle aches	13%	9%	14%
Nausea	6%	9%	3%
Chills/ Shivering	3%	2%	7%
Fever ≥ 37.7°C (99.86°F)	1%	1%	1%
Vomiting	1%	1%	0%
* In Study 1, 87% of solicited local and systemic adverse events were mild, 12% were moderate, and 1% were severe. In Study 2, 76.5% were mild, 20.5% were moderate, and 3% were severe. In both studies, most solicited local and systemic adverse events lasted no longer than 2 days. † Values rounded to the nearest whole percent. ‡ Includes subjects who received either the single-dose (preservative-free) or multi-dose formulation of AFLURIA®. § Thimerosal-containing placebo. || Tenderness defined as pain on touching. ¶ Pain defined as spontaneously painful without touch.

Table 2: Adverse Events* Reported Spontaneously by ≥ 1% of Subjects Within 21 Days After Administration of AFLURIA® or Placebo, Irrespective of Causality^†

	Study 1 Subjects ≥ 18 to < 65 years		Study 2 Subjects ≥ 65 years
Adverse Event	AFLURIA®‡ n=1089	Placebo§ n=268	AFLURIA® n=206
Headache	8%	6%	8%
Nasal Congestion	1%	1%	7%
Cough	1%	0.4%	5%
Rhinorrhea	1%	1%	5%
Pharyngolaryngeal Pain	3%	1%	5%
Reactogenicity Event	3%	3%	0%
Diarrhea	2%	3%	1%
Back Pain	2%	0.4%	2%
Upper Respiratory Tract Infection	2%	1%	0.5%
Viral Infection	0.4%	1%	0%
Lower Respiratory Tract Infection	0%	0%	1%
Myalgia	1%	1%	1%
Muscle Spasms	0.4%	1%	0%
* In Study 1, 63% of unsolicited adverse events were mild, 35% were moderate, and 2% were severe. In Study 2, 47% weremild, 51% were moderate, and 3% were severe. In both studies, most unsolicited adverse events lasted no longer than 5 days. † Values greater than 0.5% rounded to the nearest whole percent. ‡Includes subjects who received either the single-dose (preservative-free) or multi-dose formulation of AFLURIA®. § Thimerosal-containing placebo.

Postmarketing Experience

Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. The adverse reactions described have been included in this section because they: 1) represent reactions that are known to occur following immunizations generally or influenza immunizations specifically; 2) are potentially serious; or 3) have been reported frequently. The following adverse reactions also include those identified during postapproval use of AFLURIA® outside the US since 1985.

Blood and lymphatic system disorders

Transient thrombocytopenia

Immune system disorders

Allergic reactions including anaphylactic shock and serum sickness

Nervous system disorders

Neuralgia, paresthesia, and convulsions; encephalopathy, neuritis or neuropathy, transverse myelitis, and GBS

Vascular disorders

Vasculitis with transient renal involvement

Skin and subcutaneous tissue disorders

Pruritus, urticaria, and rash

General disorders and administration site conditions

Influenza-like illness (e.g., pyrexia, chills, headache, malaise, myalgia), injection-site inflammation (e.g., pain, erythema, swelling, warmth), and induration

Other Adverse Reactions Associated With Influenza Vaccination

Anaphylaxis has been reported after administration of AFLURIA®. Although AFLURIA® contains only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis (see CONTRAINDICATIONS).

The 1976 swine influenza vaccine was associated with an increased frequency of GBS. Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than one additional case per 1 million persons vaccinated.

Neurological disorders temporally associated with influenza vaccination, such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy, have been reported.

Microscopic polyangiitis (vasculitis) has been reported temporally associated with influenza vaccination.

Concurrent Use With Other Vaccines

There are no data to assess the concomitant administration of AFLURIA® with other vaccines. If AFLURIA® is to be given at the same time as another injectable vaccine(s), the vaccine(s) should be administered at different injection sites.

AFLURIA® should not be mixed with any other vaccine in the same syringe or vial.

Concurrent Use With Immunosuppressive Therapies

The immunological response to AFLURIA® may be diminished in individuals receiving corticosteroid or immunosuppressive therapies.

Last updated on RxList: 11/26/2007

Included as part of the PRECAUTIONS section.

Guillain-Barre Syndrome (GBS)

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.

Altered Immunocompetence

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

Preventing and Managing Allergic Reactions

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

Limitations of Vaccine Effectiveness

Vaccination with AFLURIA® may not protect all individuals.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

AFLURIA® has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with AFLURIA®. It is also not known whether AFLURIA® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AFLURIA® should be given to a pregnant woman only if clearly needed.

Nursing Mothers

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.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

Geriatric Use

In four clinical studies, 343 subjects ages 65 years and older received AFLURIA®. Hemagglutination-inhibiting (HI) antibody responses in geriatric subjects were lower after administration of AFLURIA® in comparison to younger adult subjects (see Clinical Studies). Adverse event rates were generally similar in frequency to those reported in subjects ages 18 to less than 65 years, although some differences were observed (see ADVERSE REACTIONS).

Last updated on RxList: 11/26/2007

No information provided.

AFLURIA® is contraindicated in individuals with known hypersensitivity to eggs or chicken protein, neomycin, or polymyxin, or in anyone who has had a life-threatening reaction to previous influenza vaccination.

Last updated on RxList: 11/26/2007

Mechanism of Action

Influenza illness and its complications follow infection with influenza viruses. Global surveillance of influenza identifies yearly antigenic variants. For example, since 1977 antigenic variants of influenza A (H1N1 and H3N2) and influenza B viruses have been in global circulation. Specific levels of HI antibody titers post-vaccination with inactivated influenza virus vaccine have not been correlated with protection from influenza virus. In some human studies, antibody titers of 1:40 or greater have been associated with protection from influenza illness in up to 50% of subjects.^1,2

Antibody against one influenza virus type or subtype confers limited or no protection against another. Furthermore, antibody to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype. Frequent development of antigenic variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for the usual change to one or more new strains in each year's influenza vaccine. Therefore, inactivated influenza vaccines are standardized to contain the HA of three strains (i.e., typically two type A and one type B) representing the influenza viruses likely to be circulating in the US during the upcoming winter.

Annual revaccination with the current vaccine is recommended because immunity declines during the year after vaccination and circulating strains of influenza virus change from year to year.³

Clinical Studies

Three randomized, controlled clinical studies of AFLURIA® have evaluated the immune responses (specifically, HI antibody titers) to each virus strain in the vaccine. In these studies, post-vaccination immunogenicity was evaluated on sera obtained 21 days after administration of AFLURIA®. No controlled clinical studies demonstrating a decrease in influenza disease after vaccination with AFLURIA® have been performed.

The US study (Study 1) was a randomized, double-blinded, placebo-controlled, multicenter study in healthy subjects ages 18 to less than 65 years. A total of 1,357 subjects were vaccinated (1,089 subjects with AFLURIA® and 268 with a thimerosal-containing placebo). Subjects receiving AFLURIA® were vaccinated using either a single-dose (preservative-free) or multi-dose (one of three lots) formulation. The evaluable efficacy population consisted of 1,341 subjects (1,077 in the AFLURIA® group and 264 in the placebo group) with complete serological data who had not received any contraindicated medications before the post-vaccination immunogenicity assessment. Among the evaluable efficacy population receiving AFLURIA®, 37.5% were men and 62.5% were women. The mean age of the entire evaluable population receiving AFLURIA® was 38 years; 73% were ages 18 to less than 50 years and 27% were ages 50 to less than 65 years. Additionally, 81% of AFLURIA® recipients were White, 12% Black, and 6% Asian.

In Study 1, the following co-primary immunogenicity endpoints were assessed: 1) the lower bounds of the 2-sided 95% confidence intervals (CI) for the proportion of subjects with HI antibody titers of 1:40 or greater after vaccination, which should exceed 70% for each vaccine antigen strain; and 2) the lower bounds of the 2-sided 95% CI for rates of seroconversion (defined as a 4-fold increase in post-vaccination HI antibody titers from pre-vaccination titers of 1:10 or greater, or an increase in titers from less than 1:10 to 1:40 or greater), which should exceed 40% for each vaccine antigen strain.

In subjects ages 18 to less than 65 years, serum HI antibody responses to AFLURIA® met the pre-specified co-primary endpoint criteria for all three virus strains (Table 3). Clinical lotto-lot consistency was demonstrated for the single-dose (preservative-free) and multi-dose formulations of AFLURIA®, showing that these formulations elicited similar immune responses.

Table 3: Study 1 - Serum HI Antibody Responses in Subjects ≥ 18 to < 65 Years Receiving AFLURIA®

Treatment Arm	Number Enrolled/ Evaluable	Vaccine Strain	Seroconversion Rate* (95% CI)	HI Titer ≥ 1:40† (95% CI)
All active AFLURIA® influenza vaccine formulations †	1089/1077	H1N1	48.7% (45.6, 51.7)	97.8% (96.7, 98.6)
		H3N2	71.5% (68.7, 74.2)	99.9% (99.5, 100.0)
		B	69.7% (66.9, 72.5)	94.2% (92.7, 95.6)
Placebo		H1N1	2.3% (0.8, 4.9)	74.6% (68.9, 79.8)
	270/264	H3N2	0.0% (N/A)	72.0% (66.1, 77.3)
		B	0.4% ( < 0.1, 2.1)	47.0% (40.8, 53.2)
* Seroconversion rate is defined as a 4-fold increase in post-vaccination HI antibody titer from pre-vaccination titer ≥ 1:10, or anincrease in titer from < 1:10 to ≥ 1:40. Lower bound of 95% CI for seroconversion should be > 40% for the study population. † HI titer ≥ 1:40 is defined as the proportion of subjects with a minimum post-vaccination HI antibody titer of 1:40. Lowerbound of 95% CI for HI antibody titer ≥ 1:40 should be > 70% for the study population. ‡ Active formulations include aggregated results for the single-dose (preservative-free) and multi-dose formulations ofAFLURIA®.

The UK study (Study 2) was a randomized, controlled study that enrolled 275 healthy subjects ages 65 years and older. This study compared AFLURIA® with a European-licensed trivalent inactivated influenza vaccine as an active control. The evaluable efficacy population consisted of 274 subjects (206 in the AFLURIA® group and 68 in the control group). Among these subjects, 50% were men and 50% were women, with a mean age of 72 years (range: 65 to 93 years).

The co-primary immunogenicity endpoints for the seroconversion rate and the proportion of subjects with a minimum post-vaccination HI antibody titer of 1:40 are presented in Table 4.

Table 4: Study 2 - Serum HI Antibody Responses in Subjects ≥ 65 Years Receiving AFLURIA®

Number of Subjects	Vaccine Strain	Seroconversion Rate* (95% CI)	HI Titer ≥ 1:40† (95% CI)
206	H1N1	34.0% (27.5, 40.9)	85.0% (79.3, 89.5)
	H3N2	44.2% (37.3, 51.2)	99.5% (97.3, 100.0)
	B	45.6% (38.7, 52.7)	77.7% (71.4, 83.2)
* Seroconversion rate is defined as a 4-fold increase in post-vaccination HI antibody titer from pre-vaccination titer ≥ 1:10, or an increase in titer from < 1:10 to ≥ 1:40. Lower bound of 95% CI for seroconversion should be > 30% for the study population. † HI titer ≥ 1:40 is defined as the proportion of subjects with a minimum post-vaccination HI antibody titer of 1:40. Lower bound of 95% CI for HI antibody titer ≥ 1:40 should be > 60% for the study population.

A second UK study (Study 3) was a randomized, controlled study that enrolled 406 healthy subjects ages 18 years and older (stratified by age from 18 to less than 60 years and 60 years and older). This study compared AFLURIA® with a European-licensed trivalent inactivated influenza vaccine as an active control. In a post-hoc analysis of different age ranges, among subjects ages 18 to less than 65 years receiving AFLURIA® (146 subjects), 47% were men and 53% were women, with a mean age of 48 years for all subjects. Among subjects ages 65 years and older receiving AFLURIA® (60 subjects), 53% were men and 47% were women, with a mean age of 71 years.

The post-hoc analysis of serum HI antibody responses showed that the lower bound of the 95% CI for subjects with HI antibody titers of 1:40 or greater after vaccination exceeded 70% for each strain. HI antibody responses were lower in subjects ages 65 years and older after administration of AFLURIA®. Serum HI antibody responses to the active control were similar to those for AFLURIA® in both age groups.

REFERENCES

1. Hannoun C, Megas F, Piercy J. Immunogenicity and protective efficacy of influenza vaccination. Virus Res 2004;103:133-138.

2. Hobson D, Curry RL, Beare AS, et al. The role of serum hemagglutination-inhibiting antibody in protection against challenge infection with influenza A2 and B viruses. J Hyg Camb 1972;70:767-777.

3. Centers for Disease Control and Prevention. Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2007;56 (RR-6):1-53.

Last updated on RxList: 11/26/2007

• Inform the patient that AFLURIA® is an inactivated vaccine that cannot cause influenza but stimulates the immune system to produce antibodies that protect against influenza. The full effect of the vaccine is generally achieved approximately 3 weeks after vaccination. Annual revaccination is recommended.
• Instruct the patient to report any severe or unusual adverse reactions to their healthcare provider.

Last updated on RxList: 11/26/2007

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

INFLUENZA VIRUS VACCINE - SYRINGE INTRAMUSCULAR

(IN-floo-EN-za)

COMMON BRAND NAME(S): Flushield, Fluvirin, Fluzone

USES: This medication is used to prevent infection by the influenza ("flu") virus. Influenza can cause serious illness (rarely death), especially in people at high risk from the infection (e.g., young children, the elderly, and people with chronic health problems). Vaccines work by causing the body to produce its own protection (antibodies) against the virus.

Vaccination is the best method for preventing infection and decreasing the seriousness of illness if you become infected. The brand and dose of vaccine you receive depends on your age. Check with your healthcare provider to see which age group may be vaccinated with this product. Influenza vaccination is not recommended in infants less than 6 months old.

HOW TO USE: Read the Vaccine Information Statement available from your healthcare provider before being given the vaccination. If you have any questions about the information, ask your doctor or pharmacist.

The syringe should be shaken well before using. This medication is given by injection into a muscle by a health care professional. Adults usually receive the injection in the upper arm, and children receive it in the upper thigh.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

The vaccination is usually given in the time from September to November when the number of cases of influenza virus begins to increase (the start of "flu season"). Only one dose is required for people aged 9 years and older. Children under 9 years of age may receive a second dose depending on when the first dose was given. Discuss the dose schedule with your doctor.

SIDE EFFECTS: Soreness/redness/swelling/bruising at the injection site may occur and may last for up to 1-2 days. Fever, muscle aches, headache or weakness may also occur. If any of these effects continue beyond 2 days or become bothersome, inform your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: mental/mood changes, seizures.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it, to eggs or egg products, to chicken products, to any other vaccines, or to latex; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: any fever, uncontrolled seizures or other nervous system disorder (e.g., encephalopathy).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (e.g., hemophilia, thrombocytopenia), history of Guillain-Barre syndrome, immune system disorders (e.g., autoimmune disorders, radiation treatment), seizures (e.g., epilepsy controlled by medication, febrile seizures) or history of other nervous system disorders, vaccination history including previous reactions to any vaccines.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before receiving this vaccine, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin, heparin), corticosteroids (e.g., hydrocortisone, prednisone), cancer chemotherapy, immunosuppressants (e.g., cyclosporine, efalizumab, tacrolimus).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Vaccination may be given to anyone wishing to reduce the chance of getting influenza. For the best protection, the vaccine must be repeated each year since it may contain different kinds of influenza virus than previous years.

MISSED DOSE: Not applicable.

STORAGE: Refrigerate between 36-46 degrees F (2-8 degrees C). Do not freeze. Protect from light. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.