What FluMist Quadrivalent is used for and how to use it
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FluMist Quadrivalent - Consumer Medicine Information

Manufacture: AstraZeneca
Country: Canada
Condition: Influenza Prophylaxis
Class: Viral vaccines
Form: Aerosol, Nasal suppositories
Ingredients: Influenza vaccine (live, attenuated), gelatin hydrolysate (porcine Type A), sucrose, arginine, gentamicin

FLUMIST QUADRIVALENT

INFLUENZA VACCINE (LIVE, ATTENUATED)

About this Medication

What the medication is used for

FLUMIST QUADRIVALENT is a vaccine used to prevent the flu in people between 2 to 59 years of age.

What it does

FLUMIST QUADRIVALENT is a vaccine against the flu. The vaccine is made from strains of the flu that are expected to come within the next year in North America.

When it should not be used

Do not take FLUMIST QUADRIVALENT if you have had an allergic reaction to any of the ingredients contained in FLUMIST QUADRIVALENT, especially to eggs, to egg proteins, gentamicin (a trace residual), gelatin, or arginine.

Do not take FLUMIST QUADRIVALENT if you have had an allergic reaction to previous flu vaccination.

What the medicinal ingredient is

Influenza vaccine (live, attenuated)

What the nonmedicinal ingredients are

Gelatin hydrolysate (porcine Type A), sucrose, arginine and gentamicin.

FLUMIST QUADRIVALENT contains no preservatives (e.g. no thimerosal). The intranasal sprayer contains no latex.

For a full listing of non-medicinal ingredients see Part 1 of the Product Monograph.

What dosage form it comes in

FLUMIST QUADRIVALENT is a spray for nasal administration. Each 0.2 mL dose contains 106.5-7.5 FFU (fluorescent focus units) of live attenuated influenza virus reassortants of each of the four virus strains for the specific season. The four strains used for the 2015-2016 season are: A/California/7/2009 (H1N1)pdm09-like virus (A/Bolivia/559/2013), A/Switzerland/9715293/2013 (H3N2)-like virus, B/Phuket/3073/2013 (Yamagata lineage)-like virus, and B/Brisbane/60/2008 (Victoria lineage)-like virus.

Warnings and Precautions

BEFORE you use FLUMIST QUADRIVALENT, talk to your doctor or pharmacist if you or your child (ren):

  • are under the age of 18 years receiving aspirin or medicines containing aspirin;
  • have severe asthma or active wheezing;
  • have had Guillain-Barré syndrome with a previous flu shot;
  • are immunosuppressed due to disease or drug treatment, or associate with people who are immunosuppressed;
  • are pregnant or intend to become pregnant or are nursing.

Interactions with this Medication

Drugs that may interact with FLUMIST QUADRIVALENT include:

  • if 2 to 17 years old: aspirin or medicines containing aspirin;
  • prescription medicines used to treat flu.

Proper Use of this Medication

FLUMIST QUADRIVALENT is given by health care professionals.

FLUMIST QUADRIVALENT is needle-free. FLUMIST QUADRIVALENT must only be used as a nasal spray. FLUMIST QUADRIVALENT must not be injected.

FLUMIST QUADRIVALENT is a gentle mist and will be given as a spray in each nostril. You can breathe normally while FLUMIST QUADRIVALENT is being given. There is no need to actively inhale or sniff.

Administration

FLUMIST QUADRIVALENT is administered by quickly spraying approximately one-half of the contents into each nostril. Please refer to the diagram below for simple step-by-step administration instructions. Once FLUMIST QUADRIVALENT has been administered, the sprayer should be disposed of according to the standard procedures for medical waste (e.g., sharps container or biohazard container).





Usual Dose

One 0.2 mL dose of FLUMIST QUADRIVALENT per year; about one-half of the contents will be sprayed into each nostril.

Children (2-8 years) who have not previously been vaccinated with the flu shot should receive a second dose 4 weeks after the first dose.

Overdose

There is no relevant information available on overdose with FLUMIST QUADRIVALENT vaccine.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Side Effects and what to do about them

Like all medicines, FLUMIST QUADRIVALENT can cause side effects, although not everybody gets them. Ask your doctor, nurse or pharmacist if you want more information about possible side effects from FLUMIST QUADRIVALENT.

Very common (occurs in more than 1 in 10 people):

  • Children: runny or stuffy nose, reduced appetite, weakness, headache, and fever.
  • Adults: runny or stuffy nose, headache, sore throat, weakness and cough.

Common (occurs in less than 1 in 10 people):

  • Children: muscle aches.
  • Adults: chills

Uncommon (occurs in less than 1 in 100 people):

  • rash
  • nose bleed

Rare (occurs in less than 1 in 1,000 people):

  • allergic reactions.

Very rare (occurs in less than 1 in 10,000 people):

  • Guillain-Barré syndrome.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

This is not a complete list of side effects. For any unexpected effects while taking FLUMIST QUADRIVALENT, contact your doctor or pharmacist.

How to Store it

FLUMIST QUADRIVALENT must be stored in a refrigerator (2°C – 8°C) upon receipt and until use. DO NOT FREEZE.

Use FLUMIST QUADRIVALENT as indicated by the expiry date on the sprayer label.

Reporting Suspected Side Effects

To monitor vaccine safety, the Public Health Agency of Canada collects case reports on adverse events following immunization.

For health care professionals:

If a patient experiences an adverse event following immunization, please complete the appropriate Adverse Events following Immunization (AEFI) Form and send it to your local Health Unit in your province/territory.

For the General Public:

Should you experience an adverse event following immunization, please ask your doctor, nurse, or pharmacist to complete the Adverse Events following Immunization (AEFI) Form.

If you have any questions or have difficulties contacting your local health unit, please contact Vaccine Safety Section at Public Health Agency of Canada.

By toll-free telephone: 866-844-0018

By toll-free fax: 866-844-5931

Email: caefi@phac-aspc.gc.ca

Web: http://www.phac-aspc.gc.ca/im/vs-sv/index-eng.php


Mail:

The Public Health Agency of Canada

Vaccine Safety Section

130 Colonnade Road

A/L 6502A

Ottawa, ON K1A 0K9


NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying the Public Health Agency of Canada. The Public Health Agency of Canada does not provide medical advice.

More Information

NOTE: This INFORMATION FOR THE CONSUMER leaflet provides you with the most current information at the time of printing.

For the most current information, the Consumer Information Leaflet plus the full Product Monograph, prepared for health professionals can be found at:

www.astrazeneca.ca,

or by contacting the sponsor, AstraZeneca Canada Inc. at:

Customer Inquiries – 1 (800) 668-6000,

Renseignements – 1 (800) 461-3787.