Flucelvax
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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
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.
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 2015-2016 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 (wild type) (an A/California/7/2009 (H1N1)pdm09-like virus); A/South Australia/55/2014 (wild type) (an A/Switzerland/9715293/2013 (H3N2)-like virus); B/Utah/9/2014 (a B/Phuket/3073/2013-like virus).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
Flucelvax Manufacturers
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Novartis Vaccines And Diagnostics, Inc.
![Flucelvax (Influenza A Virus A/brisbane/10/2010 (H1n1) Antigen (Mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/south Australia/55/2014 (H3n2) Antigen (Mdck Cell Derived, Propiolactone Inactivated) And Influenza B Virus B/utah/9/2014 Antigen (Mdck Cell Derived, Propiolactone Inactivated)) Injection, Suspension [Novartis Vaccines And Diagnostics, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Flucelvax | Novartis Vaccines And Diagnostics, 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.
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Novartis Vaccines And Diagnostics Gmbh
Flucelvax | Novartis Vaccines And Diagnostics Gmbh
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. [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.
-
Novartis Vaccines And Diagnostics, Inc.
Flucelvax | Novartis Vaccines And Diagnostics, 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.
![Flucelvax (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)) Injection, Suspension [Novartis Vaccines And Diagnostics Gmbh]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=030dfb30-589d-4335-85fe-d609644088e0&name=flu0p-0001-01.jpg)
![Flucelvax (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)) Injection, Suspension [Novartis Vaccines And Diagnostics, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cb063bf0-4aaf-4733-a950-9ab5229ea137&name=flu0y-0000-01.jpg)
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