* Clinical significance has not been established.

Patients 6 months through 35 months

1 or 2 doses^a, 4 weeks apart^b 0.25 mL^c or 0.5 mL^d

Injection steps

1. Do not administer by intravascular injection. Administer the vaccine intramuscularly.
2. FLUZONE^® Trivalent should not be administered into the buttocks. The preferred site is into the deltoid muscle in adults and children >1 year of age. The preferred site for infants and children <1 year of age is the anterolateral aspect of the mid-thigh.
3. Shake vial or prefilled syringe well before administering each dose.
4. Aseptic technique must be used. Use a separate sterile needle and syringe (or sterile prefilled syringe) for each individual patient and for each entry into a multi-dose vial. Needles should not be recapped and should be disposed of according to biohazard waste
guidelines.
5. Give the patient a permanent personal immunization record. In addition, it is essential that the physician or nurse record the
immunization history in the permanent medical record of each patient. This permanent office record should contain the name of the
vaccine, date given, dose, manufacturer and lot number.

The strain composition of the influenza virus vaccines is subject to annual changes. Respective clinical studies, including at least 50 adults 18–60 years of age and at least 50 older adults aged 60 years or older, are conducted to assess the safety and immunogenicity of FLUZONE^®.  For the purpose of the cumulative analysis, five years of annual clinical safety data are presented below. In this data set, a total of 601 vaccinees received an intramuscular injection of FLUZONE^®.

CONTRAINDICATIONS:

Should not be administered to anyone with with a history of severe allergic reaction to egg protein or any component of the vaccine or after previous administration of the vaccine or a vaccine containing the same components or constituents. 

CLINICAL USE:

Pediatrics (6 months – 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of FLUZONE^® in pediatric patients have been established. Therefore, Health Canada has authorized an indication for pediatric use.
Safety and efficacy of FLUZONE^® administration in children less than 6 months of age have not been established.
Geriatrics: Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness.

RELEVANT WARNINGS & PRECAUTIONS:

• Do not administer by intravascular injection. Do not administer into the buttocks.
• As with any vaccine, immunization with FLUZONE^® Trivalent may not protect 100% of individuals.
• Vaccination should be postponed in case of a moderate or severe acute disease with or without fever: however in case of mild disease with low-grade fever, vaccine could be administered 
• FLUZONE^® Trivalent should not be administered to persons with bleeding disorders such as hemophilia or thrombocytopenia, or in persons on anticoagulant therapy, unless the potential benefits outweigh the risk of administration. If the decision is made to administer any product by intramuscular injection to such persons, it should be given with caution, with steps taken to avoid hematoma formation risk following injection.
• Immunocompromised persons may not achieve the expected immune response.
• Immunization should be delayed in a patient with an active neurologic disorder but should be considered when the disease process has been stabilized.
• Guillain-Barré syndrome (GBS) has been reported after influenza vaccination. However, it is not known whether influenza vaccination specifically might increase the risk for recurrence of GBS. Therefore, NACI and the US Advisory Committee on Immunization Practices (ACIP) state it is prudent to avoid vaccinating persons who are not at high risk for severe influenza complications and who are known to have experienced GBS within 6 weeks after a previous influenza vaccination.
• Syncope can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent falling and injury and to manage syncope. 

• Animal reproductive studies have not been conducted with FLUZONE^®. It is also not known whether FLUZONE^® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Data on the use of this vaccine in pregnant women are limited. FLUZONE^® should be given to pregnant women only if clearly needed and following an assessment of the risks and benefits. However, there is no evidence to suggest a risk to the fetus or the pregnancy from maternal immunization with FLUZONE^®. NACI states that influenza vaccination is recommended for pregnant women

• There are no available data on the presence of FLUZONE^® Trivalent in human milk, effects on milk production or the effects on the breastfed infant. No conclusions can be drawn regarding whether or not FLUZONE^® Trivalent is safe for use during breastfeeding. FLUZONE^® Trivalent should be used during breastfeeding only if the potential benefits to the mother outweigh the potential risks including those to the breastfed child. NACI states that influenza vaccination is considered safe for breastfeeding women. 

FOR MORE INFORMATION: 

Consult the Product Monograph for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The product monograph is also available through our medical department.

Call us at 1-800-265-7927.