Fluarix Quadrivalent 2013/2014
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Questions & Answers
Side Effects & Adverse Reactions
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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® QUADRIVALENT is indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine [see Description (11)]. FLUARIX QUADRIVALENT 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 QUADRIVALENT, Influenza Vaccine, for intramuscular injection, is a sterile colorless and slightly opalescent suspension. FLUARIX QUADRIVALENT is 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. Each vaccine is formulated from the split inactivated virus solutions.
FLUARIX QUADRIVALENT has been standardized according to USPHS requirements for the 2015‑2016 influenza season and is formulated to contain 60 micrograms (mcg) hemagglutinin (HA) per 0.5‑mL dose, in the recommended ratio of 15 mcg HA of each of the following 4 influenza virus strains: A/Christchurch/16/2010 NIB‑74XP (H1N1) (an A/California/7/2009‑like virus), A/Switzerland/9715293/2013 NIB-88 (H3N2), B/Phuket/3073/2013, and B/Brisbane/60/2008./
FLUARIX QUADRIVALENT is formulated without preservatives. FLUARIX QUADRIVALENT does not contain thimerosal. Each 0.5‑mL dose also contains octoxynol-10 (TRITON® X-100) ≤0.115 mg, α-tocopheryl hydrogen succinate ≤0.135 mg, and polysorbate 80 (Tween 80) ≤0.550 mg. Each dose may also contain residual amounts of hydrocortisone ≤0.0016 mcg, gentamicin sulfate ≤0.15 mcg, ovalbumin ≤0.050 mcg, formaldehyde ≤5 mcg, and sodium deoxycholate ≤65 mcg from the manufacturing process.
The tip caps and plungers of the prefilled syringes of FLUARIX QUADRIVALENT are not made with natural rubber latex.
Sources
Fluarix Quadrivalent 2013/2014 Manufacturers
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Glaxosmithkline Biologicals Sa
![Fluarix Quadrivalent 2013/2014 (Influenza Virus Vaccine) Suspension Fluarix Quadrivalent 2014/2015 (Influenza Virus Vaccine) Suspension [Glaxosmithkline Biologicals Sa]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Fluarix Quadrivalent 2013/2014 | Roxane Laboratories, Inc
The recommended adult initial dosage of Megestrol Acetate Oral Suspension USP is 800 mg/day (20 mL/day). Shake container well before using.
In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective.
A plastic dosage cup with 5 mL, 10 mL, 15 mL and 20 mL markings is provided for convenience.
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