Fluarix 2013/2014
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
FLUARIX® is indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine [see Description (11)]. FLUARIX is approved for use in persons 3 years of age and older.
History
There is currently no drug history available for this drug.
Other Information
FLUARIX, Influenza Vaccine, for intramuscular injection, is a sterile colorless and slightly opalescent suspension. FLUARIX is a vaccine prepared from influenza viruses propagated in embryonated chicken eggs. Each of the influenza viruses is produced and purified separately. After harvesting the virus-containing fluids, each influenza virus is concentrated and purified by zonal centrifugation using a linear sucrose density gradient solution containing detergent to disrupt the viruses. Following dilution, the vaccine is further purified by diafiltration. Each influenza virus solution is inactivated by the consecutive effects of sodium deoxycholate and formaldehyde leading to the production of a “split virus.” Each split inactivated virus is then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The vaccine is formulated from the 3 split inactivated virus solutions.
FLUARIX has been standardized according to USPHS requirements for the 2014‑2015 influenza season and is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5‑mL dose, in the recommended ratio of 15 mcg HA of each of the following 3 strains: A/Christchurch/16/2010 NIB‑74XP (H1N1) (an A/California/7/2009‑like virus), A/Texas/50/2012 NYMC X-223A (H3N2), and B/Massachusetts/2/2012 NYMC BX‑51B.
FLUARIX is formulated without preservatives. FLUARIX does not contain thimerosal. Each 0.5-mL dose also contains octoxynol-10 (TRITON® X-100) ≤0.085 mg, α-tocopheryl hydrogen succinate ≤0.1 mg, and polysorbate 80 (Tween 80) ≤0.415 mg. Each dose may also contain residual amounts of hydrocortisone ≤0.0016 mcg, gentamicin sulfate ≤0.15 mcg, ovalbumin ≤0.05 mcg, formaldehyde ≤5 mcg, and sodium deoxycholate ≤50 mcg from the manufacturing process.
The tip caps and plungers of the prefilled syringes of FLUARIX are not made with natural rubber latex.
Sources
Fluarix 2013/2014 Manufacturers
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Glaxosmithkline Biologicals Sa
![Fluarix 2013/2014 (Influenza Virus Vaccine) Suspension Fluarix 2014/2015 (Influenza Virus Vaccine) Suspension [Glaxosmithkline Biologicals Sa]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Fluarix 2013/2014 | Glaxosmithkline Biologicals Sa
For intramuscular injection only.
2.1 Dosage and ScheduleThe dose and schedule for FLUARIX are presented in Table 1.
Table 1. FLUARIX: DosingAge
Vaccination Status
Dose and Schedule
3 through 8 years of age
Not previously vaccinated with influenza vaccine
Two doses (0.5‑mL each) at least 4 weeks apart
Vaccinated with influenza vaccine in a previous season
One or two dosesa (0.5‑mL each)
9 years of age and older
Not applicable
One 0.5‑mL dose
a One dose or two doses (0.5‑ mL each) depending on vaccination history as per the annual Advisory Committee on Immunization Practices (ACIP) recommendation on prevention and control of influenza with vaccines. If two doses, administer each 0.5‑ mL dose at least 4 weeks apart.
2.2 Administration InstructionsShake well before administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.
Attach a sterile needle to the prefilled syringe and administer intramuscularly.
The preferred site for intramuscular injection is the deltoid muscle of the upper arm. Do not inject in the gluteal area or areas where there may be a major nerve trunk.
Do not administer this product intravenously, intradermally, or subcutaneously.
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