Medical Provider Single Use Ez Flu Shot Flucelvax 2014-2015 Kit
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Questions & Answers
Side Effects & Adverse Reactions
For external use only
Flammable - keep away from fire or flame
with electrocautery procedures
- get into eyes
- apply over large areas of the body
- in case of deep or puncture wounds, animal bites or serious burns consult a doctor
- condition persists or gets worse or lasts for more than 72 hours
- do not use longer than 1 week unless directed by a doctor
If swallowed, get medical help or contact a Poison Control Center right away.
with electrocautery procedures
Stop use and ask a doctor if- condition persists or gets worse or lasts for more than 72 hours
- do not use longer than 1 week unless directed by a doctor
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
FLUCELVAX® is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine
FLUCELVAX is approved for use in persons 18 years of age and older.
For first aid to decrease germs in
- minor cuts
- scrapes
- burns
For preparation of the skin prior to injection
History
There is currently no drug history available for this drug.
Other Information
FLUCELVAX (Influenza Vaccine), a vaccine for intramuscular injection, is a “subunit” influenza vaccine prepared from virus propagated in Madin Darby Canine Kidney (MDCK) cells, a continuous cell line. These cells were adapted to grow freely in suspension in culture medium. The virus is inactivated with ß-propiolactone, disrupted by the detergent cetyltrimethylammonium bromide and purified through several process steps. Each of the 3 virus strains is produced and purified separately then pooled to formulate the trivalent vaccine.
FLUCELVAX is a sterile, slightly opalescent suspension in phosphate buffered saline. FLUCELVAX is standardized according to United States Public Health Service requirements for the 2014-2015 influenza season and is formulated to contain a total of 45 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA of each of the following three influenza strains: A/Brisbane/10/2010 (H1N1) (an A/California/7/2009 -like virus); A/Texas/50/2012, NYMC X-223A (H3N2); and B/Massachusetts/2/2012. Each dose of FLUCELVAX may contain residual amounts of MDCK cell protein (≤8.4 mcg), protein other than HA (≤ 120 mcg), MDCK cell DNA (≤ 10 ng), polysorbate 80 (≤ 1125 mcg), cetyltrimethlyammonium bromide (≤ 13.5 mcg), and β-propiolactone (<0.5 mcg), which are used in the manufacturing process.
FLUCELVAX contains no preservative or antibiotics.
The tip caps of the pre-filled syringes may contain natural rubber latex.
Sources
Medical Provider Single Use Ez Flu Shot Flucelvax 2014-2015 Kit Manufacturers
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Asclemed Usa, Inc.
![Medical Provider Single Use Ez Flu Shot Flucelvax 2014-2015 Kit (Influenza A Virus A/brisbane/10/2010 (H1n1) Antigen (Mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/texas/50/2012 X-223a (H3n2) Antigen (Mdck Cell Derived, Propiolactone Inactivated), And Influenza B Virus B/massachusetts/2/2012 Antigen (Mdck Cell Derived, Propiolactone Inactivated) And Isopropyl Alcohol) Kit [Asclemed Usa, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Medical Provider Single Use Ez Flu Shot Flucelvax 2014-2015 Kit | Asclemed Usa, Inc.
For intramuscular injection only.
2.1 Dosage and ScheduleAdminister FLUCELVAX as a single 0.5 mL intramuscular injection preferably in the region of the deltoid muscle of the upper arm. Do not inject the vaccine in the gluteal region or areas where there may be a major nerve trunk.
2.2 AdministrationShake the syringe vigorously before administering. FLUCELVAX should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. [see Description (11)] If either condition exists, do not administer the vaccine. Do not use the vaccine if the contents have been frozen.
Attach a sterile needle to the pre-filled syringe and administer intramuscularly.
apply to skin as needed discard after single use
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