Patient Medication Information: uses, side effects, how to take - Intanza
What the vaccine is used for:
INTANZA® is a vaccine that is used to help prevent influenza. Influenza (or flu) is an infection caused by the influenza virus.
This vaccine may be given to adults 18 years of age and over.
The majority of individuals who are vaccinated with INTANZA® will produce enough antibodies to help protect them against this disease. However, as with all vaccines, 100% protection cannot be guaranteed. What it does:
INTANZA® causes the body to produce its own natural protection against influenza virus. After you receive the vaccine, the body begins to make substances called antibodies. Antibodies help the body to fight disease. If a vaccinated person comes into contact with one of the germs that cause this disease, the body is usually ready to destroy it.
When it should not be used:
Do not give INTANZA® to anyone who has ever had
a severe allergic reaction to:
- egg or egg products
- chicken protein
- any component of INTANZA® or its container
What the medicinal ingredient is:
Each 0.1 mL dose of INTANZA® contains 9 µg or 15 µg of hemagglutinin antigens (HA) of split influenza virus*, inactivated, equivalent to the strains listed below:
- A/California/7/2009 (H1N1)pdm09-like strain
A(H3N2) strain antigenically like the cell-
propagated prototype strain A/Victoria/361/2011
- B/Massachusetts/2/2012-like strain
What the important non-medicinal ingredients are:
Manufacturing process residuals: neomycin, formaldehyde, ovalbumin and Triton X®100 may be present in trace amounts.
What dosage forms it comes in:
INTANZA® is supplied in a pre-filled syringe that is injected just under the surface of the skin. A single dose is 0.1 mL.
WARNINGS AND PRECAUTIONS
INTANZA® will only protect against the strains of flu virus contained in the vaccine or those that are closely related.
INTANZA® will not protect against any other strains of flu virus.
If you have any of the following conditions, talk to your doctor, nurse or pharmacist BEFORE you use INTANZA®:
- A high fever or serious illness. Wait until you are better to receive the vaccination.
- Allergy to any component of the vaccine or the container.
- Diseases of the immune system or are taking a medical treatment that affects the immune system. The vaccine may provide you with a lower level of protection than it does for people with healthy immune systems.
- An evolving disease of the nervous system. Your doctor will advise of a more appropriate time to receive the vaccination.
A history of Guillain-Barré syndrome (GBS)
within 6 weeks of a previous influenza vaccination.
Pregnant or breast-feeding women. It is important that you understand the risks and benefits of vaccination. INTANZA® should be given to a pregnant or nursing woman only if it is clearly needed. Tell the person giving you the injection if you are pregnant or breast-feeding.
INTERACTIONS WITH THIS VACCINE
No studies have been conducted on the administration of INTANZA® at the same time as other vaccines.
PROPER USE OF THIS VACCINE
Usual Dose
IMPORTANT: PLEASE READ Sanofi Pasteur Section 1.3.1 Clean Product Monograph 415/416 – INTANZA® Notifiable change – Revised Labelling
For persons 18 to 59 years of age – recommended single dose is 0.1 mL - 9 µg/strain.
For persons 60 years of age and over – recommended single dose is 0.1 mL – 15 µg/strain.
The vaccination should be given just under the skin (intradermally) near the shoulder (deltoid) region. Overdose
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
A vaccine, like any medicine, may cause side effects. The risk of INTANZA® causing serious harm is extremely small. The small risks associated with INTANZA® are much less than the risks associated with getting the disease against which it protects. The flu vaccine cannot cause influenza because it does not contain any live virus. As the vaccine is given just under the surface of the skin, the most common side effects are located where you received the injection and include redness, swelling, a lump, itching and soreness. You might also notice headache, muscle aches and tiredness. Usually, side effects are mild and may last one to three days.
Severe allergic reactions to the flu shots are very rare. A very rare but possible side effect of influenza vaccination is Guillain-Barré syndrome (GBS). This is an autoimmune disease that attacks the nervous system. GBS causes weakness and abnormal sensations. Most patients recover fully.
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well after receiving INTANZA®.
This is not a complete list of side effects. For any unexpected effects after taking INTANZA®, contact your doctor, nurse or pharmacist.
HOW TO STORE IT
Store the vaccine in a refrigerator at 2° to 8°C (35° to 46°F). Do not freeze. Throw the product away if it has been exposed to freezing.
Do not use after expiration date.
Keep out of reach of children.
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: 1-866-844-0018
By toll-free fax: 1-866-844-5931
Email: caefi@phac-aspc.gc.ca
Web: http://www.phac-aspc.gc.ca/im/vs-sv/index-eng.php
By regular mail:
The Public Health Agency of Canada
Vaccine Safety Section
A/L 6502A
130 Colonnade Road
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
This document plus the full product monograph, prepared for health professionals can be found at: www.sanofipasteur.ca
You may also contact the vaccine producer, Sanofi Pasteur Limited for more information. Telephone: 1-888-621-1146 (no charge) or 416-667-2779 (Toronto area).
Business Hours: 8 a.m. to 5 p.m. Eastern Time, Monday to Friday.