"The U.S. Food and Drug Administration announced today that it has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the six manufacturers licensed to produce and distribute influenza vaccine for the United "...
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].
FLUVIRIN® is not indicated for children less than 4 years of age because there is evidence of diminished immune response in this age group.
DOSAGE AND ADMINISTRATION
Preparation For Administration
Shake 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]. If either of these conditions exists, the vaccine should not be administered.
Between uses, return the multidose vial to the recommended storage conditions between 2° and 8°C (36° and 46°F). 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.
Recommended Dose And Schedule
The dose and schedule for Fluvirin is presented in Table 1.
TABLE 1 : Fluvirin Dose and 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||-|
|a 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.
“-” indicates information is not applicable
In 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.
Dosage Forms And Strengths
FLUVIRIN®, a sterile suspension for intramuscular injection, is supplied in two presentations:
- 0.5 mL single-dose prefilled syringe
- 5.0 mL multi-dose vial containing 10 doses (each dose is 0.5 mL)
FLUVIRIN® product presentations are listed in Table 9 below:
TABLE 9 : Fluvirin Product Presentations
|Presentation||Carton NDC Number||Components|
|Pre-filled syringe||66521-117-02||0.5 mL single dose pre-filled syringe, package of 10 syringes per carton (may contain latex)
|Multi-dose vial||66521-117-10||5.0 mL multi-dose vial, individually packaged in a carton (contains no latex) [NDC 66521-117-11]|
Storage And Handling
Store FLUVIRIN® refrigerated between 2° and 8°C (36° and 46°F).
Do not freeze. Discard if the vaccine has been frozen.
Store in the original package to protect from light.
Do not use after the expiration date.
Between uses, return the multidose vial to the recommended storage conditions.
Manufactured by: Novartis Vaccines and Diagnostics Limited, Speke, Liverpool, UK. An affiliate of: Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue, Cambridge, MA 02139 USA. Revised: April 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/11/2015
Additional Fluvirin Information
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