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Fluzone (Influenza Virus Vaccine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Fluzone® is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. [See Dosage Forms and Strengths (3) .]

Fluzone High-Dose is an inactivated influenza virus vaccine indicated for active immunization of persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. [See Dosage Forms and Strengths (3) .]

This indication is based on the immune response elicited by Fluzone High-Dose; there have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with Fluzone High-Dose.

DOSAGE AND ADMINISTRATION

Dosage and Schedule

Basic dosing information for Fluzone and Fluzone High-Dose, and their respective age indications, are presented in Table 1 and Table 2.

Table 1: Fluzone
Vaccination Status and Age Dose/Route Schedule
Previously unvaccinated or incompletely vaccinated with an influenza vaccine (ie, no previous dose or vaccinated for the first time in the last influenza season and received only 1 dose)
  6 through 35 months 0.25 mL/Intramuscular 2 doses at least 1 month apart
  36 months through 8 years 0.5 mL/Intramuscular 2 doses at least 1 month apart
Previously vaccinated with an influenza vaccine (ie, received two doses last influenza season or one or more doses at any time before last season)
  6 through 35 months 0.25 mL/Intramuscular 1 dose
  36 months through 8 years 0.5 mL/Intramuscular 1 dose
Any vaccination status
  9 years and older 0.5 mL/Intramuscular 1 dose
Table 2: Fluzone High-Dose
Any vaccination status Dose/Route Schedule
  65 years and older 0.5 mL/Intramuscular 1 dose

Administration

Inspect Fluzone and Fluzone High-Dose syringes and vials visually for particulate matter and/or discoloration prior to administration. If either of these conditions exist, the vaccine should not be administered.

Shake the syringe or single-dose vial before administering the vaccine and shake the multi-dose vial each time before withdrawing a dose of vaccine.

The vaccine should not be injected into the gluteal region or into areas where there may be a major nerve trunk. For needle length, refer to the Advisory Committee on Immunization Practices (ACIP) recommendations. (1)

If Fluzone or Fluzone High-Dose are to be given at the same time as another injectable vaccine(s), the vaccine(s) should always be administered at separate injection sites.

Pediatrics

The preferred sites for intramuscular injections are the anterolateral aspect of the thigh in infants (6-12 months of age) or the deltoid muscle of the upper arm in children (12 months through 17 years of age).

Adults 18 years of age and older

Fluzone should be administered as a single intramuscular dose preferably in the deltoid muscle.

Adults 65 years of age and older

Fluzone High-Dose should be administered as a single intramuscular dose preferably in the deltoid muscle.

DOSAGE FORMS AND STRENGTHS

Sterile suspension for intramuscular injection is supplied in 5 presentations: 4 presentations of Fluzone (including 2 dosage strengths in pre-filled syringes) and 1 presentation of Fluzone High-Dose in a pre-filled syringe. Dosage strengths of the 3 different pre-filled syringes are distinguished by different colored plungers.

Fluzone

Sterile suspension for intramuscular injection supplied in 4 presentations:

1) Prefilled syringe, 0.25 mL, pediatric dose, for 6 through 35 months of age, distinguished by a pink syringe plunger rod.

2) Prefilled syringe, 0.5 mL, for 36 months of age and older, distinguished by a clear syringe plunger rod.

3) Single-dose vial, 0.5 mL, for 36 months of age and older.

4) Multi-dose vial, 5 mL, for 6 months of age and older, contains thimerosal as a preservative. [See Description .]

Each 0.25 mL dose of Fluzone contains influenza split virus antigens that are formulated to contain a total of 22.5 mcg of influenza virus hemagglutinin, 7.5 mcg each from the 3 influenza virus strains in the vaccine. Each 0.5 mL dose of Fluzone contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine. [See Description. ]

Fluzone High-Dose

Sterile suspension for intramuscular injection supplied in prefilled syringes, 0.5 mL, for adults 65 years of age and older, distinguished by a gray syringe plunger rod.

Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. [See Description. ]

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

The tip caps of the Fluzone and Fluzone High-Dose prefilled syringes may contain natural rubber latex. Vial presentations of Fluzone do not contain latex.

Fluzone

Prefilled syringe, without needle, 0.25 mL, package of 10 prefilled syringes per carton (may contain latex) – NDC 49281-010-25.

Prefilled syringe, without needle, 0.5 mL, package of 10 prefilled syringes per carton (may contain latex) – NDC 49281-010-50.

Single-dose vial, 0.5 mL, package of 10 vials per carton (contains no latex) – NDC 49281-010-10.

Multi-dose vial, 5 mL, one vial per carton (contains no latex). The vial contains ten 0.5 mL doses — NDC 49281-386-15.

Fluzone High-Dose

Prefilled syringe, without needle, 0.5 mL, package of 10 prefilled syringes per carton (may contain latex) – NDC 49281-387-65.

Storage and Handling

Store all Fluzone and Fluzone High-Dose presentations refrigerated at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Discard if vaccine has been frozen.

Between uses, return the multi-dose vial to the recommended storage conditions at 2° to 8°C (35° to 46°F).

Do not use after the expiration date shown on the label.

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