AFLURIA ® is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. AFLURIA is approved for use in persons 5 years of age and older.
For intramuscular (IM) injection only, by needle and syringe (5 years of age and older) or by PharmaJet ® Stratis ® Needle-Free Injection System (18 through 64 years of age). A single dose is 0.5 mL. The dose and schedule for AFLURIA are presented in Table 1. Table 1: AFLURIA Schedule Age Schedule 5 years through 8 years One dose or two doses at least 1 month apart 1 or 2 doses depends on vaccination history as pe...
Each product presentation includes a package insert and the following components: Presentation Carton NDC Number Components Pre-Filled Syringe 33332-015-01 Ten 0.5 mL single-dose syringes without needles [NDC 33332-015-02] Multi-Dose Vial 33332-115-10 One 5 mL vial, which contains ten 0.5 mL doses [NDC 33332-115-11] Store refrigerated at 2–8°C (36–46°F). Do not freeze. Discard if product has been frozen. Protect f...
www.vaers.hhs.gov
www.cdc.gov/vaccinesAFLURIA® is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. AFLURIA is approved for use in persons 5 years of age and older.
For intramuscular (IM) injection only, by needle and syringe (5 years of age and older) or by PharmaJet® Stratis® Needle-Free Injection System (18 through 64 years of age). A single dose is 0.5 mL.
The dose and schedule for AFLURIA are presented in Table 1.
| Age | Schedule |
|---|---|
| 5 years through 8 years | One dose or two doses at least 1 month apart * |
| 9 years and older | One dose |
* 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines.
Shake thoroughly and inspect visually before use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever suspension and container permit. If either of these conditions exists, the vaccine should not be administered.
May be administered by needle and syringe (5 years of age and older) or PharmaJet Stratis Needle-Free Injection System (18 through 64 years of age only).
When using the single-dose pre-filled 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.
The preferred site for intramuscular injection is the deltoid muscle of the upper arm.
Between uses, return the multi-dose vial to the recommended storage conditions between 2-8°C (36–46°F). Do not freeze. Discard if the vaccine has been frozen.
AFLURIA is a sterile suspension for intramuscular injection (see Description [11] ).
AFLURIA is supplied in two presentations:
AFLURIA is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine (see Description [11]).
Administration of CSL's 2010 Southern Hemisphere influenza vaccine was associated with postmarketing reports of increased rates of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years; these increased rates were confirmed by postmarketing studies. Febrile events were also observed in children 5 through 8 years of age.
If Guillain-Barré Syndrome (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.
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.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
If AFLURIA is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.
Vaccination with AFLURIA may not protect all individuals.
In children 5 through 17 years of age, the most common injection-site reactions observed in clinical studies with AFLURIA administered by needle and syringe were pain (≥60%), redness (≥20%) and swelling (≥10%). The most common systemic adverse events were headache, myalgia (≥20%), irritability, malaise and fever (≥10%).
In adults 18 through 64 years of age, the most common injection-site adverse reactions observed in clinical studies with AFLURIA administered by needle and syringe were tenderness (≥60%), pain (≥40%), swelling (≥20%), redness and itching (≥10%). The most common systemic adverse events observed were muscle aches (≥30%), headache and malaise (≥20%).
In adults 18 through 64 years of age, using the PharmaJet Stratis Needle-Free Injection System, the most common injection-site adverse reactions observed in a clinical study with AFLURIA up to 7 days post-vaccination were tenderness (≥80%), swelling, pain, redness (≥60%), itching (≥20%) and bruising (≥10%). The most common systemic adverse events within this period were myalgia, malaise (≥30%) and headache (≥20%).
In adults 65 years of age and older, the most common injection-site adverse reactions observed in clinical studies with AFLURIA administered by needle and syringe were tenderness (≥30%) and pain (≥10%). No systemic adverse reactions occurred in ≥10% of subjects in this age group.
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.
Children
In clinical studies, AFLURIA has been administered to, and safety information collected for, 3,009 children ages 6 months through 17 years. Clinical safety data for AFLURIA in children are presented from three clinical studies (Studies 1, 2 and 3). Data from a comparator-controlled trial (Study 1) are presented, followed by pooled data from two open label studies (Studies 2 and 3). Subjects 6 months through 8 years of age received one or two vaccinations, administered by needle and syringe, as determined by previous vaccination history (for further details on clinical study design, dosing and demographics see Clinical Studies [14] ).
Study 1 included 1,468 subjects for safety analysis, ages 6 months through 17 years, randomized to receive AFLURIA (735 subjects) or another U.S.-licensed trivalent inactivated influenza vaccine (manufactured by Sanofi Pasteur, Inc.) (733 subjects).
Study 2 included 1,976 subjects for safety analysis, ages 6 months through 17 years. All subjects received AFLURIA.
Study 3 included 298 subjects for safety analysis, ages 6 months through 8 years. All subjects received AFLURIA.
The safety assessment was similar for the three pediatric studies. Local (injection site) adverse reactions and systemic adverse events were solicited for 7 days post-vaccination (Tables 2 and 3). Unsolicited adverse events were collected for 30 days post-vaccination. All adverse events are presented regardless of any treatment causality assigned by study investigators.
Among the pediatric studies, there were no vaccine-related deaths or vaccine-related serious adverse events reported in children 5 years of age and older.
In this section, safety data from the pediatric studies are limited to children 5 years of age and older. AFLURIA is not approved for use in children less than 5 years of age. See Warnings and Precautions [5.1] and Use in Specific Populations [8.4] for risks of AFLURIA in children less than 5 years of age.
In the comparator-controlled trial (Study 1), the rate of fever after the first dose of AFLURIA in subjects aged 5 through 8 years was 16% as compared to 8% in subjects who received the comparator. The rate of fever in subjects aged 9 through 17 years following a single dose of AFLURIA was 6% as compared to 4% in subjects who received the comparator. In all three pediatric studies, the rates of fever in subjects aged 5 through 8 years who received AFLURIA were lower after dose 2 than dose 1.
Data in Tables 2 and 3 are presented for children 5 years and older.
| Percentage * of Subjects in each Age Group Reporting Event | ||||
|---|---|---|---|---|
| Subjects 5 through 8 years | Subjects 9 through 17 years | |||
| AFLURIA N=161 † | Comparator N=165 † | AFLURIA N=254 † | Comparator N=250 † | |
| After the First Dose | ||||
| Local Adverse Reactions | ||||
| Pain | 63 | 60 | 66 | 60 |
| Redness | 23 | 27 | 17 | 17 |
| Induration | 17 | 17 | 15 | 16 |
| Systemic Adverse Events | ||||
| Myalgia | 34 | 30 | 40 | 37 |
| Malaise | 24 | 13 | 22 | 20 |
| Headache | 21 | 19 | 27 | 26 |
| Any Fever | 16 | 8 | 6 | 4 |
| Fever ≥102.2°F | 5 | 1 | 3 | 1 |
| Nausea/Vomiting | 12 | 8 | 9 | 10 |
| Diarrhea | 7 | 7 | 8 | 10 |
| AFLURIA N=39 † | Comparator N=53 † | |||
| After the Second Dose | ||||
| Local Adverse Reactions | ||||
| Pain | 36 | 38 | - | - |
| Redness | 10 | 19 | - | - |
| Induration | 8 | 17 | - | - |
| Systemic Adverse Events | ||||
| Diarrhea | 13 | 6 | - | - |
| Headache | 13 | 13 | - | - |
| Myalgia | 13 | 17 | - | - |
| Malaise | 5 | 8 | - | - |
| Nausea/Vomiting | 3 | 8 | - | - |
| Any Fever Fever ≥102.2°F | 0 0 | 2 0 | - - | - - |
* Proportion of subjects reporting each solicited local adverse reaction or systemic adverse event by treatment group based on the number of subjects contributing at least one data value for an individual sign/symptom (individual event denominators).
† N = number of subjects in the Safety Population for each treatment group.
| Percentage * of Subjects in each Age Group Reporting Event | |||
|---|---|---|---|
| Studies 2 and 3 Subjects 5 through 8 years | Study 2 Subjects 9 through 17 years | ||
| Dose 1 N=82-595 † | Dose 2 N=82-426 † | Dose 1 N=397 † | |
| Local Adverse Reactions | |||
| Pain | 61 | 56 | 68 |
| Erythema | 24 | 23 | 17 |
| Swelling | 17 | 17 | 13 |
| Systemic Adverse Events | |||
| Irritability ‡ | 18 | 16 | - |
| Headache | 16 | 10 | 27 |
| Malaise or feeling generally unwell § | 16 | 8 | 17 |
| Any Fever | 13 | 6 | 5 |
| Fever ≥ 102.2°F | 3 | 2 | 1 |
| General Muscle Ache (Myalgia) | 12 | 8 | 20 |
| Nausea/Vomiting § | 7 | 3 | 5 |
| Vomiting/Diarrhea ‡ | 5 | 6 | - |
| Loss of appetite ‡ | 5 | 4 | - |
| Diarrhea § | 4 | 2 | 5 |
* Proportion of subjects reporting each solicited local adverse reaction or systemic adverse event by treatment group based on the number of subjects contributing at least one data value for an individual sign/symptom (individual event denominators).
† N = number of subjects in the Safety Population for each treatment group. Denominators for Dose 1 were: N=82 for Vomiting/Diarrhea, Irritability, Loss of appetite, N=513 for Malaise, Diarrhea, Nausea/Vomiting and N=593-595 for all other parameters. Denominators for Dose 2 were: N=82 for Vomiting/Diarrhea, Irritability, Loss of appetite, N=344 for Malaise, Diarrhea and Nausea/Vomiting and N=421-426 for all other parameters.
‡ These preferred terms were used to describe Solicited Adverse Events in Study 3.
§ These preferred terms were used to describe Solicited Adverse Events in Study 2.
In Study 1, unsolicited adverse events that occurred in ≥ 5% of subjects who received AFLURIA in ages 5 years through 8 years following the first or second dose included cough (15%) and pyrexia (9%). Unsolicited adverse events that occurred in ≥ 5% of subjects who received AFLURIA in ages 9 years through 17 years following the first dose included cough (7%), oropharyngeal pain (7%), headache (7%) and nasal congestion (6%).
In Studies 2 and 3, unsolicited adverse events that occurred in ≥ 5% of subjects ages 5 years through 8 years after the first or second dose included the following: upper respiratory tract infection (13%), cough (10%), rhinorrhea (7%), headache (5%), nasopharyngitis (5%) and pyrexia (5%). Unsolicited adverse events that occurred in ≥ 5% of subjects who received AFLURIA in ages 9 years through 17 years following the first dose included upper respiratory tract infection (9%) and headache (8%).
Adults
In clinical studies comparing AFLURIA to placebo or another U.S.-licensed trivalent inactivated influenza vaccine, a single dose of AFLURIA was administered to, and safety information collected for, 11,104 subjects ages 18 through 64 years and 836 subjects ages 65 years and older. Clinical safety data for AFLURIA in adults are presented from three clinical studies (Studies 4 through 6). In these studies, Afluria and comparator vaccine or placebo were administered by needle and syringe.
Study 4 included 1,357 subjects for safety analysis, ages 18 through 64 years, randomized to receive AFLURIA (1,089 subjects) or placebo (268 subjects) (see Clinical Studies [14] ).
Study 5 included 15,020 subjects for safety analysis, ages 18 through 64 years, randomized to receive AFLURIA (10,015 subjects) or placebo (5,005 subjects) (see Clinical Studies [14] ).
Study 6 included 1,266 subjects for safety analysis, ages 65 years and older, randomized to receive AFLURIA (630 subjects) or another U.S.-licensed trivalent inactivated influenza vaccine (manufactured by Sanofi Pasteur Inc.) as an active comparator (636 subjects) (see Clinical Studies [14]).
The safety assessment was identical for the three adult studies. Local (injection-site) adverse reactions and systemic adverse events were solicited for 5 days post-vaccination (Table 4). Unsolicited adverse events were collected for 21 days post-vaccination. All adverse events are presented regardless of any treatment causality assigned by study investigators.
Among adult studies 4 through 6, there were no vaccine-related deaths or vaccine-related serious adverse events reported.
| Percentage * of Subjects in each Age Group Reporting Event | ||||||
|---|---|---|---|---|---|---|
| Study 4 Subjects 18 through 64 years | Study 5 Subjects 18 through 64 years | Study 6 Subjects ≥ 65 years | ||||
| AFLURIA N=1087-1088 † | Placebo N=266 † | AFLURIA N=10,015 † | Placebo N=5005 † | AFLURIA N=630 † | Comparator N=636 † | |
| Local Adverse Reactions | ||||||
| Tenderness (Pain on touching) | 60 | 18 | 69 | 17 | 36 | 31 |
| Pain (without touching) | 40 | 9 | 48 | 11 | 15 | 14 |
| Redness | 16 | 8 | 4 | <1 | 3 | 1 |
| Swelling | 9 | 1 | 4 | <1 | 7 | 8 |
| Bruising | 5 | 1 | 1 | 1 | <1 | 1 |
| Systemic Adverse Events | ||||||
| Headache | 26 | 26 | 25 | 23 | 9 | 11 |
| Malaise | 19 | 19 | 29 | 26 | 7 | 6 |
| Muscle aches | 13 | 9 | 21 | 12 | 9 | 8 |
| Nausea | 6 | 9 | 7 | 6 | 2 | 1 |
| Chills/Shivering | 3 | 2 | 5 | 4 | 2 | 2 |
| Fever | 1 | 1 | 3 | 2 | <1 | 1 |
* Proportion of subjects reporting each solicited local adverse reaction or systemic adverse event by treatment group based on the number of subjects contributing at least one data value for an individual sign/symptom (individual event denominators).
† N = number of subjects in the Safety Population for each treatment group.
In Study 4, headache was the only unsolicited adverse event that occurred in ≥ 5% of subjects who received AFLURIA or placebo (8% versus 6%, respectively).
In Study 5, headache was the only unsolicited adverse event that occurred in ≥ 5% of subjects who received AFLURIA or placebo (12% versus 11%, respectively).
In Study 6, unsolicited adverse events that occurred in ≥ 5% of subjects who received AFLURIA included headache (8%), nasal congestion (7%), cough (5%), rhinorrhea (5%), and pharyngolaryngeal pain (5%).
Studies 1 to 6 were all conducted when AFLURIA was administered by needle and syringe.
Additionally, safety information has been collected in a clinical study of AFLURIA administered using the PharmaJet Stratis Needle-Free Injection System (Study 7). Study 7 included 1,247 subjects for safety analysis, ages 18 through 64 years, randomized to receive AFLURIA by either the PharmaJet Stratis Needle-Free Injection System (624 subjects) or needle and syringe (623 subjects). No deaths or vaccine-related serious adverse events were reported in Study 7. Local (injection-site) adverse reactions and systemic adverse events were solicited for 7 days post-vaccination (Table 5).
| Percentage * of Subjects Reporting Event | ||
|---|---|---|
| Study 7 Subjects 18 through 64 years | ||
| AFLURIA | ||
| PharmaJet Stratis Needle-Free Injection System N=540-616 † | Needle and Syringe N=599-606 † | |
| Local Adverse Reactions | ||
| Tenderness | 89 | 78 |
| Swelling | 65 | 20 |
| Pain | 64 | 49 |
| Redness | 60 | 19 |
| Itching ‡ | 28 | 10 |
| Bruising | 18 | 5 |
| Systemic Adverse Events | ||
| Myalgia | 36 | 36 |
| Malaise | 31 | 28 |
| Headache | 25 | 22 |
| Chills | 7 | 7 |
| Nausea | 7 | 7 |
| Vomiting | 1 | 2 |
| Fever | 0 | 0 |
* Proportion of subjects reporting each local adverse reaction or systemic adverse event by treatment group based on the number of subjects contributing at least one data value for an individual sign/symptom (individual event denominators).
† N = number of subjects in the Safety Population for each treatment group. Denominators for the PharmaJet Stratis Needle-Free Injection System group were: N=540 for itching and N=605-616 for all other parameters. Denominators for the needle and syringe group were: N=527 for itching and N=599-606 for all other parameters.
‡ A total of 155 subjects (approximately randomly distributed between PharmaJet Stratis Needle-Free Injection System and needle and syringe groups) received Diary Cards without itching listed as a solicited symptom.
In Study 7, no unsolicited adverse events occurred in ≥ 5% of subjects who received AFLURIA administered via PharmaJet Stratis Needle-Free Injection System up to 28 days post-vaccination.
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. These adverse reactions reflect experience in both children and adults and include those identified during post-approval 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, convulsions (including febrile seizures), 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
Cellulitis and large injection site swelling
Anaphylaxis has been reported after administration of AFLURIA. Egg protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, asthma, and systemic anaphylaxis (see Contraindications [4] ).
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.
There are no data to assess the concomitant administration of AFLURIA with other vaccines. If AFLURIA is given at the same time as another injectable vaccine(s), the vaccine(s) should be administered in separate syringes and a separate arm should be used.
AFLURIA should not be mixed with any other vaccine in the same syringe or vial.
The immunological response to AFLURIA may be diminished in individuals receiving corticosteroid or immunosuppressive therapies.
Pregnancy Category B: A reproductive and developmental toxicity study has been performed in female rats at a dose approximately 265 times the human dose (on a mg/kg basis) and revealed no evidence of impaired female fertility or harm to the fetus due to AFLURIA. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, AFLURIA should be given to a pregnant woman only if clearly needed.
In the reproductive and developmental toxicity study, the effect of AFLURIA on embryo-fetal and pre-weaning development was evaluated in pregnant rats. Animals were administered AFLURIA by intramuscular injection twice prior to gestation, once during the period of organogenesis (gestation day 6), and once later in pregnancy (gestation day 20), 0.5 mL/rat/occasion (approximately a 265-fold excess relative to the projected human dose on a body weight basis). No adverse effects on mating, female fertility, pregnancy, parturition, lactation parameters, and embryo-fetal or pre-weaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis.
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.
AFLURIA is not approved for use in children less than 5 years of age. In a clinical study in which children received AFLURIA or a US-licensed comparator vaccine (Study 1, see Clinical Trials Experience, [6.1] ), the incidence of fever in children 6 months through 35 months of age following the first and second doses of AFLURIA were 37% and 15%, respectively, as compared to 14% following each dose in the comparator group. Among children 3 years through 4 years of age, the incidence of fever following the first and second doses of AFLURIA were 32% and 14%, respectively, as compared to 11% and 16% in the comparator. In an open-label study (Study 2), fever, irritability, loss of appetite, and vomiting/diarrhea occurred more frequently in children 6 months through 35 months of age as compared to older children. Across three pediatric studies of AFLURIA (Studies 1, 2, and 3), 1.2% of eligible children (n=1,764) were discontinued from the second vaccination because of severe fever (≥ 104°F) within 48 hours of the first vaccination. Across the three pediatric studies, two children, a 7-month old and a 3-year old, experienced vaccine-related febrile seizures (rate of 0.07% across studies), one of which was serious.
Administration of CSL's 2010 Southern Hemisphere influenza vaccine was associated with increased rates of fever and febrile seizures, predominantly in children below the age of 5 years as compared to previous years, in postmarketing reports confirmed by postmarketing studies (see Warnings and Precautions [5.1] ).
The PharmaJet Stratis Needle-Free Injection System is not approved as a method of administering AFLURIA to children and adolescents less than 18 years of age due to lack of adequate data supporting safety and effectiveness in this population.
In clinical studies, AFLURIA has been administered to, and safety information collected for, 836 subjects ages 65 years and older (see Clinical Trials Experience [6.1]). After administration of AFLURIA, hemagglutination-inhibiting antibody responses in persons 65 years of age and older were lower as compared to younger adult subjects (see Clinical Studies [14] ).
The PharmaJet Stratis Needle-Free Injection System is not approved as a method of administering AFLURIA to adults 65 years of age and older due to lack of adequate data supporting safety and effectiveness in this population.
AFLURIA, Influenza 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 continuous flow zonal centrifugation. 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 2015-2016 influenza season and is formulated to contain 45 mcg hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA for each of the three influenza strains recommended for the 2015-2016 Northern Hemisphere influenza season: A/California/7/2009 (H1N1), NYMC X-181, A/South Australia/55/2014 (H3N2), IVR-175, (an A/Switzerland/9715293/2013-like strain) and B/Phuket/3073/2013.
Thimerosal, a mercury derivative, is not used in the manufacturing process for the single dose presentations; therefore these products contain no preservative. The multi-dose presentation 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 0.5 mL dose may also contain residual amounts of sodium taurodeoxycholate (≤ 10 ppm), ovalbumin (< 1 mcg), neomycin sulfate (≤ 3 nanograms [ng]), polymyxin B (≤ 0.5 ng), and beta-propiolactone (≤ 2 ng).
The rubber tip cap and plunger used for the preservative-free, single-dose syringes and the rubber stoppers used for the multi-dose vial were not made with natural rubber latex.
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 hemagglutination inhibition (HI) antibody titers post-vaccination with inactivated influenza 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.2,3
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.1
AFLURIA has not been evaluated for carcinogenic or mutagenic potential, or male infertility in animals. A reproductive study of female rats vaccinated with AFLURIA revealed no impairment of fertility (see Pregnancy, 8.1).
In Study 5, the efficacy of AFLURIA was demonstrated in a randomized, observer-blind, placebo-controlled study conducted in 15,044 subjects. Healthy subjects 18 through 64 years of age were randomized in a 2:1 ratio to receive a single dose of AFLURIA (enrolled subjects: 10,033; evaluable subjects: 9,889) or placebo (enrolled subjects: 5,011; evaluable subjects: 4,960). The mean age of all randomized subjects was 35.5 years. 54.4% were female and 90.2% were White. Laboratory-confirmed influenza was assessed by active and passive surveillance of influenza-like illness (ILI) beginning 2 weeks post-vaccination until the end of the influenza season, approximately 6 months post-vaccination. ILI was defined as at least one respiratory symptom (e.g., cough, sore throat, nasal congestion) and at least one systemic symptom (e.g., oral temperature of 100.0°F or higher, feverishness, chills, body aches). Nasal and throat swabs were collected from subjects who presented with an ILI for laboratory confirmation by viral culture and real-time reverse transcription polymerase chain reaction. Influenza virus strain was further characterized using gene sequencing and pyrosequencing.
Attack rates and vaccine efficacy, defined as the relative reduction in the influenza infection rate for AFLURIA compared to placebo, were calculated using the per protocol population. Vaccine efficacy against laboratory-confirmed influenza infection due to influenza A or B virus strains contained in the vaccine was 60% with a lower limit of the 95% CI of 41% (Table 6).
| Subjects * | Laboratory-Confirmed Influenza Cases | Influenza Infection Rate | Vaccine Efficacy † | ||
|---|---|---|---|---|---|
| N | N | n/N % | % | Lower Limit of the 95% CI | |
| Abbreviations: CI, confidence interval | |||||
| Vaccine-matched Strains | |||||
| AFLURIA | 9889 | 58 | 0.59 | 60 | 41 |
| Placebo | 4960 | 73 | 1.47 | ||
| Any Influenza Virus Strain | |||||
| AFLURIA | 9889 | 222 | 2.24 | 42 | 28 |
| Placebo | 4960 | 192 | 3.87 | ||
Study 1 was a randomized, observer-blind, comparator-controlled study to evaluate the immunological non-inferiority of AFLURIA to a U.S.-licensed trivalent inactivated influenza vaccine (manufactured by Sanofi Pasteur, Inc.) in subjects 6 months through 17 years of age. Study vaccines were administered by needle and syringe. Results are presented for children 5 through 17 years of age (Table 7). A total of 832 subjects (aged 5 through 17 years) were enrolled. Subjects were randomized in a 1:1 ratio to receive AFLURIA (enrolled subjects: 417; evaluable subjects: 383) or the comparator vaccine (enrolled subjects: 415; evaluable subjects: 383).
Children 6 months through 8 years of age with no history of influenza vaccination received 2 doses approximately 28 days apart. Children 6 months through 8 years of age with a history of influenza vaccination and children 9 years of age and older received 1 dose. Children 6 months through 35 months of age received 0.25 mL of AFLURIA or comparator influenza vaccine, and children 3 years of age and older received 0.5 mL of AFLURIA or comparator influenza vaccine. Nearly equal proportions of subjects were male (49.9%) and female (50.1%), and the majority were White (85.0%) or Black (10.3%).
Immunogenicity assessments were performed prior to vaccination and at 21 days after vaccination. The co-primary endpoints were HI Geometric Mean Titer (GMT) ratios (adjusted for baseline HI titers) and the difference in seroconversion rates for each vaccine strain 21 days after the final vaccination. Pre-specified non-inferiority criteria required that the upper bound of the 2-sided 95% CI of the GMT ratio (Comparator/AFLURIA) did not exceed 1.5 and the upper bound of the 2-sided 95% CI of the seroconversion rate difference (Comparator minus AFLURIA) did not exceed 10.0% for each strain. As shown in Table 7, non-inferiority of AFLURIA to the comparator vaccine was demonstrated in the per protocol population for influenza A subtypes A(H1N1) and A(H3N2), but not for influenza type B. For influenza type B, non-inferiority was demonstrated for HI GMTs, but not for seroconversion rates. Note that the study was powered to assess the pre-specified non-inferiority criteria based on 1400 evaluable subjects. Analysis of the 761 subjects aged 5 through 17 years reduced the power of the study and widened the confidence intervals. In the pre-specified analysis, AFLURIA was not inferior to the comparator vaccine for all three virus strains. Post-hoc analyses of immunogenicity by gender did not demonstrate significant differences between males and females. The study was not sufficiently diverse to assess differences between races or ethnicities.
| Post-vaccination GMT | GMT Ratio * | Seroconversion % † | Difference | Met both pre-defined non-inferiority criteria? ‡ | |||
|---|---|---|---|---|---|---|---|
| Strain | Comparator N=381 | AFLURIA N=380 | Comparator over AFLURIA (95% CI) | Comparator N=381 | AFLURIA N=380 | Comparator minus AFLURIA (95% CI) | |
| Abbreviations: CI, confidence interval; GMT, geometric mean titer. | |||||||
| A(H1N1) | 526.2 | 507.4 | 1.03 (0.88, 1.21) | 62.7 | 62.6 | 0.1 (-6.8, 7.0) | Yes |
| A(H3N2) | 1060.0 | 961.3 | 1.07 (0.94, 1.23) | 72.2 | 69.7 | 2.4 (-4.0, 8.9) | Yes |
| B | 123.3 | 110.1 | 1.10 (0.94, 1.29) | 75.1 | 70.0 | 5.1 (-1.3, 11.4) | No |
* GMT ratios are adjusted for baseline HI titers
† 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.
‡ Note that the study was powered to assess the pre-specified non-inferiority criteria based on 1400 evaluable subjects.
Two randomized, controlled clinical studies of AFLURIA evaluated the immune responses by measuring HI antibody titers to each virus strain in the vaccine in adults as compared to placebo (adults 18 through 64 years) or another U.S.-licensed trivalent influenza vaccine (adults ≥ 65 years). In these studies, post-vaccination immunogenicity was evaluated on sera obtained 21 days after administration of a single dose of AFLURIA.
Study 4 was a randomized, double-blinded, placebo-controlled, multi-center study in healthy subjects ages 18 through 64 years. A total of 1,357 subjects were vaccinated (1,089 subjects with AFLURIA and 268 with a placebo). Subjects who received AFLURIA were vaccinated using either the preservative-free or thimerosal-containing presentation. The evaluable population consisted of 1,341 subjects (1,077 in the AFLURIA group and 264 in the placebo group). The mean age of the entire evaluable population receiving AFLURIA was 38 years. 62.5% of subjects were female, 81.3% were White, 12.1% were Black, and 6.2% were Asian.
Serum HI antibody responses to AFLURIA met the pre-specified co-primary endpoint criteria for all three virus strains (Table 8). Similar responses were observed between genders. The study was not sufficiently diverse to assess immunogenicity by race or ethnicity.
| Strain Variable | AFLURIA N=1077 value (95% CI) | Placebo N=264 value (95% CI) |
|---|---|---|
| A(H1N1) | ||
| HI Titer ≥ 1:40 * | 97.8% (96.7, 98.6) | 74.6% (68.9, 79.8) |
| Seroconversion Rate (%) † | 48.7% (45.6, 51.7) | 2.3% (0.8, 4.9) |
| A(H3N2) | ||
| HI Titer ≥ 1:40 * | 99.9% (99.5, 100.0) | 72.0% (66.1, 77.3) |
| Seroconversion Rate (%) † | 71.5% (68.7, 74.2) | 0.0% (N/A) |
| B | ||
| HI Titer ≥ 1:40 * | 94.2% (92.7, 95.6) | 47.0% (40.8, 53.2) |
| Seroconversion Rate (%) † | 69.7% (66.9, 72.5) | 0.4% (< 0.1, 2.1) |
* 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 > 70% for the study population.
† 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 > 40% for the study population.
Study 6 was a randomized, observer-blind, comparator-controlled study that enrolled 1,268 subjects 65 years of age and older (Table 9). This study compared the immune response following administration of AFLURIA to that following a US-licensed trivalent inactivated influenza vaccine (manufactured by Sanofi Pasteur Inc.). Subjects were randomized in a 1:1 ratio to receive a single vaccination of AFLURIA (enrolled subjects: 631; evaluable subjects: 605) or the comparator vaccine (enrolled subjects: 637; evaluable subjects: 610). Immunogenicity assessments were performed prior to vaccination and at 21 days after vaccination. Most of the subjects in the per-protocol immunogenicity population were female (56.7%) and White (97.4%). 2.0% were Black and less than 1.0% were of other races or ethnicities.
The co-primary endpoints were HI GMT ratios (adjusted for baseline HI titers) and the difference in seroconversion rates for each vaccine strain 21 days after vaccination. Pre-specified non-inferiority criteria required that the upper bound of the 2-sided 95% CI of the GMT ratio (Comparator/AFLURIA) did not exceed 1.5 and the upper bound of the 2-sided 95% CI of the seroconversion rate difference (Comparator minus AFLURIA) did not exceed 10.0% for each strain. As shown in Table 9, non-inferiority of AFLURIA to the comparator vaccine was demonstrated in the per protocol population for influenza A subtypes A(H1N1) and A(H3N2), but not for influenza type B. For the B strain, non-inferiority was demonstrated for HI GMTs, but not for seroconversion rates. Post-hoc analyses of immunogenicity by gender did not demonstrate significant differences between males and females. The study was not sufficiently diverse to assess differences between races or ethnicities.
| Post-vaccination GMT | GMT Ratio * | Seroconversion % † | Difference | Met both pre-defined non-inferiority criteria? | |||
|---|---|---|---|---|---|---|---|
| Strain | Comparator N=610 | AFLURIA N=605 | Comparator over AFLURIA (95% CI) | Comparator N=610 | AFLURIA N=605 | Comparator minus AFLURIA (95% CI) | |
| Abbreviations: CI, confidence interval; GMT, geometric mean titer. | |||||||
| A(H1N1) | 59.2 | 59.4 | 1.04 (0.92, 1.18) | 43.0 | 38.8 | 4.1 (-1.4, 9.6) | Yes |
| A(H3N2) | 337.7 | 376.8 | 0.95 (0.83, 1.08) | 68.7 | 69.4 | -0.7 (-5.9, 4.5) | Yes |
| B | 33.4 | 30.4 | 1.12 (1.01, 1.25) | 34.4 | 29.3 | 5.2 (-0.1, 10.4) | No |
Study 7 was a randomized, comparator-controlled non-inferiority study that enrolled 1,250 subjects 18 through 64 years of age. This study compared the immune response following administration of AFLURIA when delivered IM using either the PharmaJet Stratis Needle-Free Injection System or needle and syringe. Immunogenicity assessments were performed prior to vaccination and at 28 days after vaccination in the immunogenicity population (1130 subjects, 562 PharmaJet Stratis Needle-Free Injection System group, 568 needle and syringe group). The co-primary endpoints were HI GMT ratios for each vaccine strain and the absolute difference in seroconversion rates for each vaccine strain 28 days after vaccination. As shown in Table 10, non-inferiority of administration of AFLURIA by the PharmaJet Stratis Needle-Free Injection System compared to administration of AFLURIA by needle and syringe was demonstrated in the immunogenicity population for all strains. Post-hoc analyses of immunogenicity by age showed that younger subjects (18 through 49 years) elicited higher immunological responses than older subjects (50 through 64 years). Post-hoc analyses of immunogenicity according to gender and body mass index did not reveal significant influences of these variables on immune responses. The study population was not sufficiently diverse to assess immunogenicity by race or ethnicity.
| Baseline GMT | Post-vaccination GMT | GMT Ratio * | Seroconversion % † | Difference | Met both pre-defined non-inferiority criteria? ‡ | ||||
|---|---|---|---|---|---|---|---|---|---|
| Strain | Needle and Syringe N=568 | PharmaJet Stratis Needle-Free Injection System N=562 | Needle and Syringe N=568 | PharmaJet Stratis Needle-Free Injection System N=562 | Needle and Syringe over PharmaJet Stratis Needle-Free Injection System (95% CI) | Needle and Syringe N=568 | PharmaJet Stratis Needle-Free Injection System N=562 | Needle and Syringe minus PharmaJet Stratis Needle-Free Injection System (95% CI) | |
| Abbreviations: CI, confidence interval; GMT, geometric mean titer | |||||||||
| A(H1N1) | 79.5 | 83.7 | 280.6 | 282.9 | 0.99 (0.88, 1.12) | 38.4 | 37.5 | 0.8 (-4.8, 6.5) | Yes |
| A(H3N2) | 75.4 | 68.1 | 265.9 | 247.3 | 1.08 (0.96, 1.21) | 45.1 | 43.8 | 1.3 (-4.5, 7.1) | Yes |
| B | 12.6 | 13.5 | 39.7 | 42.5 | 0.94 (0.83, 1.06) | 35.2 | 34.9 | 0.3 (-5.2, 5.9) | Yes |
* GMT ratio is defined as post-vaccination GMT for Needle and Syringe/PharmaJet Stratis Needle-Free Injection System
† 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.
‡ Non-inferiority (NI) criteria for the GMT ratio: upper bound of 2-sided 95% CI on the ratio of Needle and Syringe/PharmaJet Stratis Needle-Free Injection System. GMT should not exceed 1.5. NI criteria for the seroconversion rate (SCR) difference: upper bound of 2-sided 95% CI on the difference between SCR Needle and Syringe – SCR PharmaJet Stratis Needle-Free Injection System should not exceed 10%.
Each product presentation includes a package insert and the following components:
| Presentation | Carton NDC Number | Components |
|---|---|---|
| Pre-Filled Syringe | 33332-015-01 |
|
| Multi-Dose Vial | 33332-115-10 |
|
www.cdc.gov/vaccines).Manufactured by:
bioCSL Pty Ltd.
Parkville, Victoria, 3052, Australia
US License No. 2002
Distributed by:
bioCSL Inc. 1020 First Avenue, King of Prussia, PA 19406, USA
AFLURIA is a registered trademark of CSL Limited used under license. bioCSL Pty Ltd. and bioCSL Inc. are subsidiaries of CSL Limited.
PharmaJet® and STRATIS® are registered trademarks of PharmaJet.
Influenza Vaccine
afluria® 5 mL Multi-dose Vial
2015 – 2016 Formula
FOR INTRAMUSCULAR
INJECTION
Rx only
NDC 33332–115–10
Influenza Vaccine
afluria®
2015 – 2016 Formula
For use in persons 5 years
and older
5 mL Multi-dose Vial
Rx only
bioCSL™
NDC 33332–015–02
Influenza Vaccine
afluria
®
0.5 mL
For 5 years and older
2015 – 2016 Formula
bioCSL Pty Ltd., Parkville, Australia
US Lic. No. 2002
Rx only
bioCSL™
26462A (46)
NDC 33332–015–01
Influenza Vaccine
afluria
®
2015 – 2016 Formula
For use in persons 5 years and older
Rx only
10 Pre-Filled Syringes
each containing a single 0.5 mL dose
Store between 2 – 8°C (36 – 46°F).
Refrigerate. Do not freeze.
Protect from light. SHAKE WELL.
bioCSL™
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 33332-115-10 | ML - Milliliter | 33332-115 | 59d2765f-c34a-4837-a55b-be4e68606d54 | 1 | 2015-09-10 |
| 33332-115-11 | ML - Milliliter | 33332-115 | 2c66977e-99f9-4d55-883e-3ec60032dbfa | 1 | 2015-09-10 |
| 33332-015-01 | ML - Milliliter | 33332-015 | 4088f24f-73fc-4f48-b860-c1273bb32a45 | 1 | 2015-09-10 |
| 33332-015-02 | ML - Milliliter | 33332-015 | b1edc422-0599-45ec-874a-7792a5c2ad7b | 1 | 2015-09-10 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) | ACTIVE INGREDIENT | BH0R06YXFZ | 5 | |
| INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 IVR-175 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) | ACTIVE INGREDIENT | 5087BPO79O | 5 | |
| INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (PROPIOLACTONE INACTIVATED) | ACTIVE INGREDIENT | KFX1673OOP | 5 | |
| INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) | ACTIVE MOIETY | MHG4XW7BIG | 5 | |
| INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 IVR-175 (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) | ACTIVE MOIETY | 9A68J3T9TE | 5 | |
| INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) | ACTIVE MOIETY | 8UK4958MZX | 5 | |
| CALCIUM CHLORIDE | INACTIVE INGREDIENT | M4I0D6VV5M | 5 | |
| POTASSIUM CHLORIDE | INACTIVE INGREDIENT | 660YQ98I10 | 5 | |
| POTASSIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 4J9FJ0HL51 | 5 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 5 | |
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | 22ADO53M6F | 5 | |
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | INACTIVE INGREDIENT | 5QWK665956 | 5 | |
| THIMEROSAL | INACTIVE INGREDIENT | 2225PI3MOV | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 33332-115 | 33332-115-11, 33332-115-10 |
| 33332-015 | 33332-015-02, 33332-015-01 |
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 125254 | Afluria, Afluria Quadrivalent | Influenza Vaccine | 351(a) | Disc | 2026-09-01 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | INJECTION, SUSPENSION / SOFT TISSUE | 3 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS | 0.86 %w/v | ||
| POTASSIUM PHOSPHATE, MONOBASIC | MONOBASIC POTASSIUM PHOSPHATE | 4J9FJ0HL51 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 110 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / PARENTERAL | 584 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRALESIONAL | 0.9 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRAMUSCULAR | 26 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | INJECTION / SUBCUTANEOUS | 0.3 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 0.86 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / SUBCUTANEOUS | 90 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRAVESICAL | 351 mg | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | FILM / BUCCAL | 0.35 mg | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 139.2 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 360 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / TOPICAL | 0.32 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LOTION / TOPICAL | 0.3 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, COATED / ORAL | 54.7 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / SUBMUCOSAL | 16 %w/v | ||
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 1.6 mg | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1751 mg | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | INJECTION, SUSPENSION / INTRALESIONAL | 3 mg | ||
| POTASSIUM PHOSPHATE, MONOBASIC | MONOBASIC POTASSIUM PHOSPHATE | 4J9FJ0HL51 | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / PERINEURAL | 648 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | SOLUTION / OPHTHALMIC | 2 mg | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | TROCHE / ORAL | 28 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SPRAY, METERED / NASAL | 36 mg | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | OINTMENT / TOPICAL | 1 mg | ||
| POTASSIUM PHOSPHATE, MONOBASIC | MONOBASIC POTASSIUM PHOSPHATE | 4J9FJ0HL51 | SOLUTION / AURICULAR (OTIC) | 0.2 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRAVITREAL | 6 mg | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | TABLET / ORAL | 96 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, CHEWABLE / ORAL | 20 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / INTRATYMPANIC | 2 mg | ||
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 660YQ98I10 | SOLUTION / INTRAOCULAR | 38 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, DELAYED RELEASE / ORAL | 97 mg | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | SOLUTION / OPHTHALMIC | 1.21 %w/v | ||
| THIMEROSAL | THIMEROSAL | 2225PI3MOV | LOTION / TOPICAL | NA | ||
| THIMEROSAL | THIMEROSAL | 2225PI3MOV | DROPS / NASAL | 0.01 mg/1ml | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | INJECTION, SUSPENSION / INTRAMUSCULAR | 36 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | GEL / TOPICAL | 0.02 %w/w | ||
| POTASSIUM PHOSPHATE, MONOBASIC | MONOBASIC POTASSIUM PHOSPHATE | 4J9FJ0HL51 | INJECTION / INTRAVENOUS | 68 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / OPHTHALMIC | 13 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | ELIXIR / ORAL | 1 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INHALANT / RESPIRATORY (INHALATION) | 3 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAVENOUS | 90 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / EPIDURAL | 3535 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / INTRAMUSCULAR | 9 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GEL / TOPICAL | 0.18 %w/w | ||
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 660YQ98I10 | SOLUTION / IRRIGATION | 0.04 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GEL / OPHTHALMIC | 0.9 %w/v | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | SUSPENSION / ORAL | 66 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRA-ARTERIAL | 278 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | SOLUTION/ DROPS / OPHTHALMIC | 1.15 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION/ DROPS / TOPICAL | 0.23 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACAVITARY | 0.82 %w/v | ||
| POTASSIUM PHOSPHATE, MONOBASIC | MONOBASIC POTASSIUM PHOSPHATE | 4J9FJ0HL51 | SOLUTION / ORAL | 287 mg | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | CAPSULE, DELAYED RELEASE / ORAL | 43 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRACAUDAL | 210 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / OPHTHALMIC | 55 mg | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | INJECTION, EMULSION / INTRAVENOUS | 0.28 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL | 1.35 mg | ||
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 139.2 mg |
Adverse event summaries are temporarily unavailable. Other product information remains available.