Flulaval 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
There are currently no FDA labeling changes available for this drug.
Uses
FLULAVAL® is indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. FLULAVAL 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
FLULAVAL, Influenza Vaccine, for intramuscular injection, is a trivalent, split-virion, inactivated influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens’ eggs. Each of the influenza viruses is produced and purified separately. The virus is inactivated with ultraviolet light treatment followed by formaldehyde treatment, purified by centrifugation, and disrupted with sodium deoxycholate.
FLULAVAL is a sterile, opalescent, translucent to off-white suspension in a phosphate-buffered saline solution that may sediment slightly. The sediment resuspends upon shaking to form a homogeneous suspension.
FLULAVAL 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/California/7/2009 NYMC X‑179A (H1N1), A/Texas/50/2012 NYMC X-223A (H3N2), and B/Massachusetts/2/2012 NYMC BX-51B.
The prefilled syringe is formulated without preservatives and does not contain thimerosal. Each 0.5-mL dose from the multi-dose vial contains 50 mcg thimerosal (<25 mcg mercury); thimerosal, a mercury derivative, is added as a preservative.
Each 0.5-mL dose of either presentation may also contain residual amounts of ovalbumin (≤0.3 mcg), formaldehyde (≤25 mcg), sodium deoxycholate (≤50 mcg), α-tocopheryl hydrogen succinate (≤240 mcg), and polysorbate 80 (≤665 mcg) from the manufacturing process. Antibiotics are not used in the manufacture of this vaccine.
The tip caps and plungers of the prefilled syringes are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex.
Sources
Flulaval 2013/2014 Manufacturers
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Id Biomedical Corporation Of Quebec
![Flulaval 2013/2014 (Influenza Virus Vaccine) Suspension Flulaval 2014/2015 (Influenza Virus Vaccine) Suspension [Id Biomedical Corporation Of Quebec]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Flulaval 2013/2014 | Id Biomedical Corporation Of Quebec
For intramuscular injection only.
2.1 Dosage and ScheduleThe dose and schedule for FLULAVAL are presented in Table 1.
Table 1. FLULAVAL: 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.
For the multi-dose vial, use a sterile needle and sterile syringe to withdraw the 0.5‑mL dose from the multi-dose vial and administer intramuscularly. A sterile syringe with a needle bore no larger than 23 gauge is recommended for administration. It is recommended that small syringes (0.5-mL or 1-mL) be used to minimize any product loss. Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial.
Between uses, return the multi-dose vial to the recommended storage conditions, between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen. Once entered, a multi-dose vial, and any residual contents, should be discarded after 28 days.
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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