Medical Provider Single Use Ez Flu Shot Kit
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Questions & Answers
Side Effects & Adverse Reactions
Warnings
For external use only. Flammable, keep away from fire or flame.
Do not use with electrocautery procedures, or in/near eyes.
Stop use if irritation or redness develops.
If irritating condition persists for more than 72 hours, consult a physician.
Keep out of reach of children. If swallowed, seek medical attention and/or contact a Poison Control Center immediately.
Do not use with electrocautery procedures, or in/near eyes.
Stop use if irritation or redness develops.
If irritating condition persists for more than 72 hours, consult a physician.
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
FLUVIRIN® is an inactivated influenza virus vaccine indicated for immunization of persons 4 years of age and older against influenza virus disease caused by influenza virus subtypes A and type B contained in the vaccine. [see DOSAGE FORMS AND STRENGTHS (3)]
FLUVIRIN® is not indicated for children less than 4 years of age because there is evidence of diminished immune response in this age group.
Use
For preparation of the skin prior to injection
History
There is currently no drug history available for this drug.
Other Information
FLUVIRIN® is a trivalent, sub-unit (purified surface antigen) influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens' eggs inoculated with a specific type of influenza virus suspension containing neomycin and polymyxin. Each of the influenza virus strains is harvested and clarified separately by centrifugation and filtration prior to inactivation with betapropiolactone. The inactivated virus is concentrated and purified by zonal centrifugation. The surface antigens, hemagglutinin and neuraminidase, are obtained from the influenza virus particle by further centrifugation in the presence of nonylphenol ethoxylate, a process which removes most of the internal proteins. The nonylphenol ethoxylate is removed from the surface antigen preparation.
FLUVIRIN® is a homogenized, sterile, slightly opalescent suspension in a phosphate buffered saline. FLUVIRIN® has been standardized according to USPHS requirements for the 2012-2013 influenza season and is formulated to contain 45 mcg hemagglutinin (HA) per 0.5-mL dose in the recommended ratio of 15 mcg HA of each of the following 3 viruses:
A/Christchurch/16/2010, NIB-74 (H1N1) (an A/California/7/2009-like virus); A/Victoria/361/2011, IVR-165 (H3N2); and B/ Hubei-Wujiagang/158/2009, NYMC BX-39 (a B/Wisconsin/1/2010-like virus).
The 0.5-mL prefilled syringe presentation is formulated without preservative. However, thimerosal, a mercury derivative used during manufacturing, is removed by subsequent purification steps to a trace amount (≤ 1 mcg mercury per 0.5-mL dose).
The 5-mL multidose vial formulation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5-mL dose from the multidose vial contains 25 mcg mercury.
Each dose from the multidose vial or from the prefilled syringe may also contain residual amounts of egg proteins (≤ 1 mcg ovalbumin), polymyxin (≤ 3.75 mcg), neomycin (≤ 2.5 mcg), betapropiolactone (not more than 0.5 mcg) and nonylphenol ethoxylate (not more than 0.015% w/v).
The tip caps of the FLUVIRIN® prefilled syringes may contain natural rubber latex. The multidose vial stopper and the syringe stopper/plunger do not contain latex.
Sources
Medical Provider Single Use Ez Flu Shot Kit Manufacturers
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Medchem Manufacturing Inc. Dba Enovachem
![Medical Provider Single Use Ez Flu Shot Kit (Influenza A Virus A/christchurch/16/2010 Nib-74 (H1n1) Antigen (Propiolactone Inactivated), Influenza A Virus A/victoria/361/2011 Ivr-165 (H3n2) Antigen (Propiolactone Inactivated), Influenza B Virus B/hubei-wujiagang/158/2009 Bx-39 Antigen (Propiolactone Inactivated) And Isopropyl Alcohol) Kit [Medchem Manufacturing Inc. Dba Enovachem]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Medical Provider Single Use Ez Flu Shot Kit | Medchem Manufacturing Inc. Dba Enovachem
2.1 Preparation for AdministrationShake the syringe vigorously before administering the vaccine and shake the multidose vial preparation each time before withdrawing a dose of vaccine.
Inspect FLUVIRIN® syringes and multidose vials visually for particulate matter and/or discoloration prior to administration [see DESCRIPTION (11)]. If either of these conditions exists, the vaccine should not be administered.
Between uses, return the multidose vial to the recommended storage conditions between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen.
A separate sterile syringe and needle must be used for each injection to prevent transmission of infectious agents from one person to another. Needles should be disposed of properly and not recapped.
It is recommended that small syringes (0.5 mL or 1 mL) should be used to minimize any product loss.
For intramuscular use only.
2.2 Recommended Dose and ScheduleThe dose and schedule for Fluvirin is presented in Table 1.
TABLE 1 Fluvirin Dose and Schedulea 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines.
Age Dose Schedule 4 years through 8 years One or two doses a, 0.5 mL each If 2 doses, administer at least 1 month apart 9 years and older One dose, 0.5 mL -
"-" indicates information is not applicableIn children, the needle size may range from 7/8 to 1¼ inches, depending on the size of the child's deltoid muscle, and should be of sufficient length to penetrate the muscle tissue. The anterolateral thigh can be used, but the needle should be longer, usually 1 inch.
In adults, a needle of ≥1 inch is preferred because needles <1 inch might be of insufficient length to penetrate muscle tissue in certain adults. The preferred site for intramuscular injection is the deltoid muscle of the upper arm. The vaccine should not be injected in the gluteal region or areas where there may be a major nerve trunk.
Directions
Prepare site by wiping vigorously
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