FLUZONE
-
influenza a virus a/california/7/2009 x-179a (h1n1) antigen (formaldehyde inactivated),
influenza a virus a/victoria/210/2009 x-187 (h3n2) antigen (formaldehyde inactivated) and
influenza b virus b/brisbane/60/2008 antigen (formaldehyde inactivated) injection, suspension
FLUZONE HIGH-DOSE
-
influenza a virus a/california/7/2009 x-179a (h1n1) antigen (formaldehyde inactivated),
influenza a virus a/victoria/210/2009 x-187 (h3n2) antigen (formaldehyde inactivated) and
influenza b virus b/brisbane/60/2008 antigen (formaldehyde inactivated) injection, suspension
Sanofi Pasteur Inc.
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FULL PRESCRIBING INFORMATION
1. INDICATIONS AND USAGE
Fluzone® is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. [See Dosage Forms and Strengths (3).]
Fluzone High-Dose is an inactivated influenza virus vaccine indicated for active immunization of persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. [See Dosage Forms and Strengths (3).]
This indication is based on the immune response elicited by Fluzone High-Dose; there have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with Fluzone High-Dose.
2. DOSAGE AND ADMINISTRATION
2.1. Dosage and Schedule
Basic dosing information for Fluzone and Fluzone High-Dose, and their respective age indications, are presented in Table 1 and Table 2.
| Vaccination Status and Age | Dose/Route | Schedule |
|---|---|---|
| Previously unvaccinated or incompletely vaccinated with an influenza vaccine (ie, no previous dose or vaccinated for the first time in the last influenza season and received only 1 dose) | ||
| 6 through 35 months | 0.25 mL/Intramuscular | 2 doses at least 1 month apart |
| 36 months through 8 years | 0.5 mL/Intramuscular | 2 doses at least 1 month apart |
| Previously vaccinated with an influenza vaccine (ie, received two doses last influenza season or one or more doses at any time before last season) | ||
| 6 through 35 months | 0.25 mL/Intramuscular | 1 dose |
| 36 months through 8 years | 0.5 mL/Intramuscular | 1 dose |
| Any vaccination status | ||
| 9 years and older | 0.5 mL/Intramuscular | 1 dose |
| Any vaccination status | Dose/Route | Schedule |
|---|---|---|
| 65 years and older | 0.5 mL/Intramuscular | 1 dose |
2.2. Administration
Inspect Fluzone and Fluzone High-Dose syringes and vials visually for particulate matter and/or discoloration prior to administration. If either of these conditions exist, the vaccine should not be administered.
Shake the syringe or single-dose vial before administering the vaccine and shake the multi-dose vial each time before withdrawing a dose of vaccine.
The vaccine should not be injected into the gluteal region or into areas where there may be a major nerve trunk. For needle length, refer to the Advisory Committee on Immunization Practices (ACIP) recommendations. (1)
If Fluzone or Fluzone High-Dose are to be given at the same time as another injectable vaccine(s), the vaccine(s) should always be administered at separate injection sites.
Pediatrics
The preferred sites for intramuscular injections are the anterolateral aspect of the thigh in infants (6-12 months of age) or the deltoid muscle of the upper arm in children (12 months through 17 years of age).
Adults 18 years of age and older
Fluzone should be administered as a single intramuscular dose preferably in the deltoid muscle.
Adults 65 years of age and older
Fluzone High-Dose should be administered as a single intramuscular dose preferably in the deltoid muscle.
3. DOSAGE FORMS AND STRENGTHS
Sterile suspension for intramuscular injection is supplied in 5 presentations: 4 presentations of Fluzone (including 2 dosage strengths in pre-filled syringes) and 1 presentation of Fluzone High-Dose in a pre-filled syringe. Dosage strengths of the 3 different pre-filled syringes are distinguished by different colored plungers.
Fluzone
Sterile suspension for intramuscular injection supplied in 4 presentations:
1) Prefilled syringe, 0.25 mL, pediatric dose, for 6 through 35 months of age, distinguished by a pink syringe plunger rod.
2) Prefilled syringe, 0.5 mL, for 36 months of age and older, distinguished by a clear syringe plunger rod.
3) Single-dose vial, 0.5 mL, for 36 months of age and older.
4) Multi-dose vial, 5 mL, for 6 months of age and older, contains thimerosal as a preservative. [See Description (11).]
Each 0.25 mL dose of Fluzone contains influenza split virus antigens that are formulated to contain a total of 22.5 mcg of influenza virus hemagglutinin, 7.5 mcg each from the 3 influenza virus strains in the vaccine. Each 0.5 mL dose of Fluzone contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine. [See Description (11).]
Fluzone High-Dose
Sterile suspension for intramuscular injection supplied in prefilled syringes, 0.5 mL, for adults 65 years of age and older, distinguished by a gray syringe plunger rod.
Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. [See Description (11).]
4. CONTRAINDICATIONS
Do not administer Fluzone or Fluzone High-Dose to anyone with a known hypersensitivity to egg proteins or any component of the vaccine listed in Table 5 or life-threatening reactions after previous administration of any influenza vaccine. [See Warnings and Precautions (5) and Description (11)].
5. WARNINGS AND PRECAUTIONS
5.1. Guillain-Barré Syndrome
If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give Fluzone or Fluzone High-Dose should be based on careful consideration of the potential benefits and risks.
5.2. Altered Immunocompetence
If either Fluzone or Fluzone High-Dose are administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.
5.3. Preventing and Managing Allergic Reactions
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine. The tip caps of the Fluzone and Fluzone High-Dose prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.
5.4. Limitations of Vaccine Effectiveness
Vaccination with either Fluzone or Fluzone High-Dose may not protect all recipients.
6. ADVERSE REACTIONS
Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trial of another vaccine, and may not reflect the rates observed in practice.
6.1. Clinical Trial Experience
Fluzone – Pediatric Studies
The 2003-2004 formulation of Fluzone was studied in 19 children 6 to 23 months of age and in 12 children 24 to 36 months of age, given in 2 doses one month apart. Local reactions and systemic events were solicited for 3 days after each dose. Most local and systemic reactions were mild. The proportions of local and systemic reactions in children were similar to the proportions in adults.
Fluzone - Adults
In two observational studies, 120 adults 18-60 years of age received a single dose of either the Year 1999-2000 or the Year 2000-2001 formulations of Fluzone. Solicited injection site and systemic reactogenicity data were collected for three days following vaccination. The most common (occurring in >10% of the study participants in either of the two studies) solicited events were injection site pain, tenderness, swelling, arm stiffness, headache, and myalgia. Most of the solicited injection site and systemic adverse events were reported as mild and resolved within 3 days.
Fluzone High-Dose
A total of 3,876 individuals 65 years of age and older were randomized to receive either Fluzone High-Dose or Fluzone in a phase 3, multi-center, active-controlled, double-blind trial conducted in the US. The safety analysis set included 2,573 Fluzone High-Dose recipients and 1,260 Fluzone recipients.
Table 3 summarizes solicited injection site reactions and systemic adverse events collected within 7 days post vaccination via diary cards. Onset was usually within the first 3 days after vaccination and majority of the reactions resolved within 3 days.
| Fluzone High-Dose (N*= 2573) Percent | Fluzone (N*= 1260) Percent |
|
|---|---|---|
|
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| Injection site reactions | ||
| Pain | 35.6 | 24.3 |
| Erythema | 14.9 | 10.8 |
| Swelling | 8.9 | 5.8 |
| Systemic adverse events | ||
| Myalgia | 21.4 | 18.3 |
| Malaise | 18.0 | 14.0 |
| Headache | 16.8 | 14.4 |
| Fever | 3.6 | 2.3 |
Solicited injection site reactions and systemic adverse events were more frequent after vaccination with Fluzone High-Dose compared to standard Fluzone in adults 65 years of age and older.
Table 4 summarizes the severity of solicited adverse events that occurred during the first week after vaccination (2):
| Fluzone High-Dose (N*= 2573) Percent | Fluzone (N*= 1260) Percent |
|
|---|---|---|
|
||
| Injection Site Pain | ||
| Mild | 31.5 | 22.5 |
| Moderate | 3.7 | 1.7 |
| Severe | 0.3 | 0.2 |
| Injection Site Erythema | ||
| Mild | 11.3 | 9.4 |
| Moderate | 1.9 | 0.8 |
| Severe | 1.8 | 0.6 |
| Injection Site Swelling | ||
| Mild | 5.8 | 3.9 |
| Moderate | 1.6 | 1.3 |
| Severe | 1.5 | 0.6 |
| Myalgia | ||
| Mild | 15.6 | 14.8 |
| Moderate | 4.2 | 3.2 |
| Severe | 1.6 | 0.2 |
| Malaise | ||
| Mild | 11.7 | 9.8 |
| Moderate | 4.7 | 3.7 |
| Severe | 1.6 | 0.6 |
| Headache | ||
| Mild | 12.6 | 11.7 |
| Moderate | 3.1 | 2.5 |
| Severe | 1.1 | 0.3 |
| Fever | ||
| Mild | 2.5 | 2.0 |
| Moderate | 1.1 | 0.2 |
| Severe | 0.0 | 0.1 |
The rates of Serious Adverse Events (SAEs) were comparable between the two groups; 156/2573 (6.1%) of Fluzone High-Dose recipients and 93/1260 (7.4%) of Fluzone recipients experienced SAEs.
No deaths were reported within 28 days post-vaccination. A total of 23 deaths were reported during the follow-up period of the study; 16/2573 (0.6%) among Fluzone High-Dose recipients and 7/1260 (0.6%) among Fluzone recipients. The majority of these participants had a medical history of cardiac, hepatic, neoplastic, renal, and/or respiratory diseases.
6.2. Post-Marketing Experience
The following events have been reported during the post-approval use of Fluzone.
Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
- Blood and Lymphatic System Disorders: Thrombocytopenia, lymphadenopathy
- Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema)
- Nervous System Disorders: Guillain-Barré syndrome (GBS), convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell's palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, paresthesia
- Vascular Disorders: Vasculitis, vasodilatation/flushing
- Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, pharyngitis, rhinitis
- Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome
- General Disorders and Administration Site Conditions: Pruritus, asthenia/fatigue, pain in extremities, chest pain
6.3. Other Adverse Events Associated with Influenza Vaccines
Anaphylaxis has been reported after administration of Fluzone and other influenza vaccines. Although Fluzone and Fluzone High-Dose contain only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have egg allergy. Allergic reactions include anaphylaxis, angioedema, hives, and asthma. [See Contraindications (4).]
The 1976 swine influenza vaccine was associated with an increased frequency of Guillain-Barré syndrome (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 1 additional case/1 million persons vaccinated.
8. USE IN SPECIFIC POPULATIONS
8.1. Pregnancy
Pregnancy Category C: Animal reproduction studies have not been conducted with Fluzone. It is also not known whether Fluzone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Fluzone should be given to a pregnant woman only if clearly needed.
8.3. Nursing Mothers
It is not known whether Fluzone is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fluzone is administered to a nursing woman.
8.4. Pediatric Use
Fluzone
Safety and effectiveness of Fluzone in children below the age of 6 months have not been established. The immune response and safety of Fluzone was evaluated in 31 children between the ages of 6-36 months. [See Clinical Studies (14).]
Fluzone High-Dose
Safety and effectiveness of Fluzone High-Dose in children have not been established.
8.5. Geriatric Use
Fluzone
In two observational studies of Fluzone in 118 adults 18-60 years of age and 123 adults greater than 60 years of age, geometric mean antibody titers post vaccination were lower in the older adults [See Clinical Studies (14).].
Fluzone High-Dose
Fluzone High-Dose is indicated for adults 65 years of age and older. [See Indications and Usage (1) and Clinical Studies (14).]
11. DESCRIPTION
Fluzone (Influenza Virus Vaccine) and Fluzone High-Dose (Influenza Virus Vaccine) are inactivated influenza virus vaccines, for intramuscular use, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is 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 disrupted using a non-ionic surfactant, Octylphenol Ethoxylate (Triton® X-100), producing a "split virus". The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration.
Fluzone and Fluzone High-Dose are clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone or Fluzone High-Dose. The tip caps of the Fluzone and Fluzone High-Dose prefilled syringes may contain natural rubber latex. Vial presentations of Fluzone do not contain latex.
Fluzone and Fluzone High-Dose are standardized according to United States Public Health Service (USPHS) requirements and are formulated to contain the amount of HA per 0.5 mL dose (see Table 5) for each of the three influenza strains recommended for the 2010-2011 Northern Hemisphere influenza season: A/California/07/2009 X-179A (H1N1), A/Victoria/210/2009 X-187 (an A/Perth/16/2009 – like virus) (H3N2), and B/Brisbane/60/2008. (1)
| Quantity (per dose) |
|||
|---|---|---|---|
| Component | Fluzone Pediatric | Fluzone | Fluzone High-Dose |
| (0.25mL Prefilled Syringe) | (0.5 mL Prefilled Syringe) | ||
| Active Substance: Split influenza virus, inactivated strains *: | 22.5 mcg HA total | 45 mcg HA total | 180 mcg HA total |
| A (H1N1) | 7.5 mcg HA | 15 mcg HA | 60 mcg HA |
| A (H3N2) | 7.5 mcg HA | 15 mcg HA | 60 mcg HA |
| B | 7.5 mcg HA | 15 mcg HA | 60 mcg HA |
| Other: | |||
| Sodium phosphate-buffered isotonic sodium chloride solution | QS† to appropriate volume | QS† to appropriate volume | QS† to appropriate volume |
| Formaldehyde | ≤50 mcg | ≤100 mcg | ≤100 mcg |
| Octylphenol Ethoxylate | ≤50 mcg | ≤100 mcg | ≤250 mcg |
| Gelatin | 0.05% | 0.05% | None |
| Preservative | |||
| Single Dose Presentations | None | None | None |
| Multi-Dose Presentation (Thimerosal) | N/A | 25 mcg mercury | N/A |
12. CLINICAL PHARMACOLOGY
12.1. 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) viruses and influenza B viruses have been in global circulation. Specific levels of hemagglutination inhibition (HI) antibody titer post-vaccination with inactivated influenza virus vaccines have not been correlated with protection from influenza virus infection. In some human studies, antibody titers ≥1:40 have been associated with protection from influenza illness in up to 50% of subjects. (3) (4)
Antibodies against one influenza virus type or subtype confer limited or no protection against another. Furthermore, antibodies 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 of one or more new strains in each year's influenza vaccine. Therefore, influenza vaccines are standardized to contain the hemagglutinins of influenza virus strains (ie, typically two type A and one type B), representing the influenza viruses likely to be circulating in the US in the upcoming winter.
Annual vaccination with the current vaccine is recommended because immunity during the year after vaccination declines, and because circulating strains of influenza virus change from year to year. (1)
13. NON-CLINICAL TOXICOLOGY
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Fluzone and Fluzone High-Dose have not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
14. CLINICAL STUDIES
14.1. Immunogenicity of Fluzone in Children
In a study of 2 doses one month apart of Fluzone (2003-2004) in 31 healthy children 6-36 months of age, 77%, 77%, and 48% achieved post vaccination HI titers of 1:40 or greater for the A/H1, A/H3, and B strains, respectively.
14.2. Immunogenicity of Fluzone in Adults
In two observational studies of the immunogenicity of Fluzone, younger adults (median age: 38, range: 19 through 59 years of age) and older adults (median age: 72, range: 61 through 86 years of age) were evaluated. The following results were obtained after vaccination with a single-dose of either the year 1999-2000 (cohort 1999) or 2000-2001 (cohort 2000) formulation of Fluzone. (See Table 6.)
| Antigen | Titer ≥1:40 Percent | 4-Fold Increase Percent |
||
|---|---|---|---|---|
| N = Number of participants | ||||
| A (H3N2) | Cohort 1999 | Younger Adults (N = 60) | 72 | 46 |
| Older Adults (N = 61) | 70 | 42 | ||
| Cohort 2000 | Younger Adults (N = 58) | 79 | 45 | |
| Older Adults (N = 62) | 68 | 44 | ||
| A (H1N1) | Cohort 1999 | Younger Adults (N = 60) | 49 | 34 |
| Older Adults (N = 61) | 38 | 27 | ||
| Cohort 2000 | Younger Adults (N = 58) | 54 | 52 | |
| Older Adults (N = 62) | 23 | 39 | ||
| B | Cohort 1999 | Younger Adults (N = 60) | 38 | 30 |
| Older Adults (N = 61) | 10 | 10 | ||
| Cohort 2000 | Younger Adults (N = 58) | 38 | 29 | |
| Older Adults (N = 62) | 11 | 5 | ||
14.3. Immunogenicity of Fluzone High-Dose in Adults 65 Years of Age and Older
A total of 3,876 individuals 65 years of age and older were randomized to receive either Fluzone High-Dose or Fluzone in a phase 3, multi-center, randomized, active-controlled, double blind trial conducted in the US. Of those, 3,851 (2,576 randomized to Fluzone High-Dose and 1,275 randomized to Fluzone) were included in the immunogenicity analysis according to the vaccine they were randomized to receive. (2)
| Fluzone High-Dose (N=2576) | Fluzone (N=1275) |
|
|---|---|---|
| N = Number of participants in the immunogenicity analysis set | ||
| Gender (Percent) | ||
| Female | 51.3 | 54.7 |
| Male | 48.7 | 45.3 |
| Age (Years) | ||
| Mean (min, max) 75 years and older (%) | 72.9 (65, 97) 35% | 72.9 (65, 94) 36% |
| Race (Percent) | ||
| Asian | 0.3 | 0.5 |
| American Indian or Alaska Native | 0.1 | 0.0 |
| Black | 2.7 | 2.7 |
| Caucasian | 91.7 | 92.9 |
| Hispanic | 4.8 | 3.7 |
| Native Hawaiian or other Pacific Islander | 0.1 | 0.1 |
| Other | 0.3 | 0.2 |
The primary endpoint of the study was HI titer 28 days after vaccination. Pre-specified statistical superiority criteria required that (1) the lower limit (LL) of the 2-sided 95% CI of the GMT ratio [Fluzone High-Dose/Fluzone] be greater than 1.50 for at least two of the strains, and if one strain failed, non-inferiority of that strain must be demonstrated (LL>0.67), and that (2) the lower limit of the 2-sided 95% CI of the seroconversion rate difference [Fluzone High-Dose - Fluzone] be greater than 10% for at least two of the strains, and if one strain failed, non-inferiority of that strain must be demonstrated (LL>-10%). As shown in Table 8, statistically superior HI titers after vaccination with Fluzone High-Dose compared to standard dose Fluzone were demonstrated for two of the three influenza strains. There are no data demonstrating clinically relevant prevention of culture-confirmed influenza or its complications after vaccination with Fluzone High-Dose compared to standard dose Fluzone in individuals 65 years of age and older.
| GMT | GMT Ratio | Seroconversion %* | Difference | Met Both Pre-defined Endpoints?† | |||
|---|---|---|---|---|---|---|---|
| Influenza Strain | Fluzone High-Dose N‡=2576 | Fluzone N‡=1275 | Fluzone High-Dose over Fluzone (95% CI) | Fluzone High-Dose N‡=2576 | Fluzone N‡=1275 | Fluzone High-Dose minus Fluzone (95% CI) | |
| Note: As defined in the study protocol: | |||||||
|
|||||||
| A (H1N1) | 115.8 | 67.3 | 1.7 (1.6; 1.8) | 48.6 | 23.1 | 25.4 (22.4; 28.5) | Yes |
| A (H3N2) | 608.9 | 332.5 | 1.8 (1.7; 2.0) | 69.1 | 50.7 | 18.4 (15.1; 21.7) | Yes |
| B | 69.1 | 52.3 | 1.3 (1.2; 1.4) | 41.8 | 29.9 | 11.8 (8.6; 15.0) | No |
15. REFERENCES
- 1
- Centers for Disease Control and Prevention. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2009;58(RR-8):1-52.
- 2
- NCT00391053: www.clinicaltrials.gov
- 3
- Hannoun C, Megas F, Piercy J. Immunogenicity and protective efficacy of influenza vaccination. Virus Res 2004;103:133-138.
- 4
- Hobson D, Curry RL, Beare AS, Ward-Gardner A. The role of serum haemagglutination-inhibiting antibody in protection against challenge infection with influenza A2 and B viruses. J Hyg Camb 1972;70:767-777.
16. HOW SUPPLIED/STORAGE AND HANDLING
16.1. How Supplied
The tip caps of the Fluzone and Fluzone High-Dose prefilled syringes may contain natural rubber latex. Vial presentations of Fluzone do not contain latex.
Fluzone
Prefilled syringe, without needle, 0.25 mL, package of 10 prefilled syringes per carton (may contain latex) – NDC 49281-010-25.
Prefilled syringe, without needle, 0.5 mL, package of 10 prefilled syringes per carton (may contain latex) – NDC 49281-010-50.
Single-dose vial, 0.5 mL, package of 10 vials per carton (contains no latex) – NDC 49281-010-10.
Multi-dose vial, 5 mL, one vial per carton (contains no latex). The vial contains ten 0.5 mL doses – NDC 49281-386-15.
Fluzone High-Dose
Prefilled syringe, without needle, 0.5 mL, package of 10 prefilled syringes per carton (may contain latex) – NDC 49281-387-65.
16.2. Storage and Handling
Store all Fluzone and Fluzone High-Dose presentations refrigerated at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Discard if vaccine has been frozen.
Between uses, return the multi-dose vial to the recommended storage conditions at 2° to 8°C (35° to 46°F).
Do not use after the expiration date shown on the label.
17. PATIENT COUNSELING INFORMATION
Inform the patient or guardian that Fluzone and Fluzone High-Dose contain killed viruses and cannot cause influenza. Fluzone and Fluzone High-Dose do not prevent other respiratory infections.
- Vaccine recipients and guardians should be instructed to report any severe or unusual adverse reactions to their health care provider and/or to VAERS (see Highlights, Adverse Reactions).
Fluzone is a registered trademark of Sanofi Pasteur Inc.
Product information
as of July 2010.
Manufactured by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA
5959-5961
Patient Information Sheet
Fluzone®/Fluzone® High-Dose
Influenza Virus Vaccine
Please read this information sheet before getting Fluzone® or Fluzone® High-Dose vaccine. This summary is not intended to take the place of talking with your healthcare provider. If you have questions or would like more information, please talk with your healthcare provider.
What are Fluzone and Fluzone High-Dose vaccines?
Fluzone is a vaccine that helps protect against influenza illness (flu).
Fluzone vaccine is for people who are 6 months of age and older.
Fluzone High-Dose vaccine is a higher dose of Fluzone for people 65 years of age and older.
Vaccination with Fluzone or Fluzone High-Dose vaccine may not protect all people who receive the vaccine.
Who should not get Fluzone or Fluzone High-Dose vaccine?
You should not get Fluzone or Fluzone High-Dose vaccine if you:
- are allergic to eggs or egg products.
- ever had a serious (life-threatening) reaction after getting any flu shot.
- are younger than 6 months of age.
Tell your healthcare provider if you or your child have or have had:
- Guillain-Barré syndrome (severe muscle weakness) after getting a flu shot.
- problems with your immune system as the immune response may be diminished.
- an allergy to rubber latex.
How are Fluzone and Fluzone High-Dose vaccines given?
Fluzone or Fluzone High-Dose vaccine is a shot given in the arm.
For infants, Fluzone vaccine is given in the thigh.
What are the possible side effects of Fluzone and Fluzone High-Dose vaccines?
The most common side effects of Fluzone and Fluzone High-Dose vaccines are:
- pain, redness, and swelling where you got the shot
- muscular pain
- tiredness
- headache
- fever
These are not all of the possible side effects of Fluzone or Fluzone High-Dose vaccine. You can ask your healthcare provider for a list of other side effects that is available to healthcare professionals.
Call your healthcare provider for advice about any side effects that concern you. You may report side effects to VAERS at 1-800-822-7967 or http://vaers.hhs.gov.
What are the ingredients in Fluzone and Fluzone High-Dose vaccines?
Both Fluzone and Fluzone High-Dose vaccines contain 3 killed flu virus strains.
Inactive ingredients include formaldehyde, octylphenol ethoxylate, and gelatin.
The preservative thimerosal is in the multidose vial of Fluzone vaccine.
Manufactured by: Sanofi Pasteur Inc.
Swiftwater, PA 18370 USA
PRINCIPAL DISPLAY PANEL - 5 mL Vial Label
Flu
NDC 49281-386-15
Influenza
Virus
Vaccine
Fluzone®
5 mL
Rx only
PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton
NDC 49281-386-15
Influenza
Virus Vaccine
Fluzone®
For 6 months and older
Flu
2010-2011 Formula
5 mL
Latex-free
Rx only
sanofi pasteur
PRINCIPAL DISPLAY PANEL - 0.25 mL Syringe Label
NDC 49281-010-25
0.25 mL Dose
Rx only
Flu
Influenza Virus Vaccine
Fluzone®
IM only
No Preservative: Pediatric Dose
2010-2011 Formula
Mfd by: Sanofi Pasteur Inc.
5882
[L]
[E]
PRINCIPAL DISPLAY PANEL - 0.25 mL Syringe Carton
No Preservative
Pediatric Dose
NDC 49281-010-25
Flu
2010 – 2011 Formula
Influenza
Virus Vaccine
Fluzone®
No Preservative:
PEDIATRIC DOSE
FOR 6 - 35 MONTHS OF AGE
Rx only
10 Prefilled
Syringes
0.25 mL each
sanofi pasteur
PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Label
NDC 49281-387-65
0.5 mL Dose
Rx only
Influenza Virus Vaccine
Fluzone® High-Dose
IM only
2010-2011 Formula
For 65 yrs of age and older
Mfd by: Sanofi Pasteur Inc.
5893
[L]
[E]
PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Carton
NDC 49281-387-65
2010-2011 Formula
No Preservative
10 Prefilled Syringes
0.5 mL each
65+
Influenza Virus Vaccine
Fluzone® High-Dose
For 65 years of age and older
Rx only
sanofi pasteur
| FLUZONE
influenza a virus a/california/7/2009 x-179a (h1n1) antigen (formaldehyde inactivated), influenza a virus a/victoria/210/2009 x-187 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/brisbane/60/2008 antigen (formaldehyde inactivated) injection, suspension |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| BLA | BLA103914 | 07/23/2010 | 06/30/2011 |
| FLUZONE
influenza a virus a/california/7/2009 x-179a (h1n1) antigen (formaldehyde inactivated), influenza a virus a/victoria/210/2009 x-187 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/brisbane/60/2008 antigen (formaldehyde inactivated) injection, suspension |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| BLA | BLA103914 | 07/23/2010 | 06/30/2011 |
| FLUZONE
HIGH-DOSE
influenza a virus a/california/7/2009 x-179a (h1n1) antigen (formaldehyde inactivated), influenza a virus a/victoria/210/2009 x-187 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/brisbane/60/2008 antigen (formaldehyde inactivated) injection, suspension |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| BLA | BLA103914 | 07/23/2010 | 06/30/2011 |
| Labeler - Sanofi Pasteur Inc. (086723285) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Sanofi Pasteur Inc. | 086723285 | MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Sanofi Pasteur Limited | 208206623 | MANUFACTURE | |