SUMMARY CMI
Fluad® Quad
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor, nurse or pharmacist.
1. Why am I being given Fluad® Quad?
Fluad® Quad contains the active ingredient influenza virus haemagglutinin. Fluad® Quad is a vaccine used to help prevent certain types of influenza or “flu”. It is for use in people aged 65 years and older only.
For more information, see Section 1. Why am I being given Fluad® Quad? in the full CMI.
2. What should I know before being given Fluad® Quad?
Tell your doctor, nurse or pharmacist if you have ever had an allergic reaction to any influenza vaccine or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions or take any other medicines.
For more information, see Section 2. What should I know before being given Fluad® Quad? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Fluad® Quad and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How is Fluad® Quad given?
Fluad® Quad is given as an injection usually, into your upper arm muscle by a doctor, nurse or pharmacist.
Fluad® Quad is given once every year, one injection of 0.5 mL.
More instructions can be found in Section 4. How is Fluad® Quad given? in the full CMI.
5. What should I know about being given Fluad® Quad?
| Things you should do | Call your doctor straight away if you do not feel well after having Fluad® Quad. Keep an updated record of your vaccinations. Keep any follow-up appointments with your doctor or clinic. |
For more information, see Section 5. What should I know about being given Fluad® Quad? in the full CMI.
6. Are there any side effects?
Common side effects may include local reaction around the injection site, fatigue and headache. Mostly these are mild and usually disappear within 3 days without treatment. Serious side effects are rare.
Sudden signs of allergy may be a serious side effect. If you experience this, tell your doctor immediately. Typical symptoms include rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
FULL CMI
Fluad® Quad
Active ingredient(s): influenza virus haemagglutinin
Consumer Medicine Information (CMI)
This leaflet provides important information about using Fluad® Quad. You should also speak to your doctor, nurse or pharmacist if you would like further information or if you have any concerns or questions about using Fluad® Quad.
Where to find information in this leaflet:
1. Why am I being given Fluad® Quad?
2. What should I know before being given Fluad® Quad?
3. What if I am taking other medicines?
4. How is Fluad® Quad given?
5. What should I know about being given Fluad® Quad?
6. Are there any side effects?
7. Product details
1. Why am I being given Fluad® Quad?
Fluad® Quad contains the active ingredient influenza virus haemagglutinin.
Fluad® Quad is an adjuvanted vaccine used to help prevent certain types of influenza or “flu”. It is for use in people aged 65 years and older only.
Influenza is a sudden respiratory infection caused by the ‘flu’ virus. It is very contagious. It is usually spread from one person to another by small droplets from coughs and sneezes. The virus enters the nose or throat and may spread to the lungs. Influenza infection can lead to serious illness.
Vaccination with Fluad® Quad helps prevent infection with influenza and to control the spread of the disease. Influenza strains can change every year therefore previous influenza vaccinations are unlikely to give you protection against the current strains most common this year. You will therefore need to receive a vaccine against flu every year to lower the chance of catching the ‘flu’, especially if you are at risk. Influenza vaccination is particularly recommended for people aged 65 years and older.
Fluad® Quad works by causing your body to produce its own protection against the four types of influenza virus from which it is made. It does this by making substances called antibodies in the blood that fight the influenza virus. Your body usually takes 2-3 weeks after vaccination to develop protection against influenza. Most people will produce enough antibodies against the influenza virus. However, as with all vaccines, 100% protection cannot be guaranteed.
An influenza vaccine will only protect you against the types of influenza virus used to make it. It will not protect you from other types of influenza virus or from infections with other agents causing flu-like symptoms (such as the common cold).
The virus in Fluad® Quad has been killed therefore the vaccine cannot ‘give’ you the flu.
2. What should I know before being given Fluad® Quad?
Warnings
Do not use Fluad® Quad if:
- You are under 65 years old. Fluad® Quad is for use in persons 65 years and older only.
- You are severely allergic to any of the ingredients listed at the end of this leaflet or any previous influenza vaccine. Symptoms of a severe allergic reaction may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body or skin rash, itching or hives.
- Always check the ingredients to make sure you can use this medicine.
Tell your doctor if you:
have reacted to previous vaccination with any of the following:
- severe allergic reaction (anaphylaxis),
- difficulty breathing,
- swelling of the throat,
- fainting or collapse,
- fits or convulsions,
- have an infection or high temperature (greater than 40°C)
- severe skin reaction at the injection site, including severe bruising.
have or have had any other medical conditions, especially the following:
- Guillain-Barré Syndrome (an illness affecting nerves resulting in weakness of muscles),
- lowered immunity due to diseases such as some blood disorders, malaria, kidney disease requiring dialysis, HIV/AIDS or cancer
- lowered immunity due to treatment with medicines such as corticosteroids, cyclosporin or other medicines used to treat cancer (including radiation therapy)
- take any medicines for any other condition
have allergy to
- any other medicines,
- eggs, or egg proteins
- or any other substances, such as latex, food, preservative or dyes.
Your doctor, nurse or pharmacist will decide if you can receive Fluad® Quad. A minor illness such as a cold should not be a problem but talk to your doctor about this if being vaccinated.
After vaccination, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Fluad® Quad is indicated for people aged 65 years and older only.
3. What if I am taking other medicines?
Tell your doctor, nurse or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with Fluad® Quad and affect how it works. These include medicines which lower the immune system, such as corticosteroids, cyclosporin or other medicines used to treat cancer (including radiation therapy).
Your doctor, nurse or pharmacist will consider whether adjustment of your medication is necessary.
Tell your doctor, nurse or pharmacist if you have had any vaccines in the last 4 weeks. Fluad® Quad can be given at the same time as other vaccines.
Check with your doctor, nurse or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Fluad® Quad.
4. How is Fluad® Quad given?
How much is given
Fluad® Quad is given as a single 0.5 mL dose.
When Fluad® Quad is given
Fluad® Quad is usually given before the start of the influenza season or when recommended by your doctor, nurse or pharmacist.
Vaccination for influenza should be repeated every year as new types of influenza virus can appear each year.
How is Fluad® Quad given
It is given as an injection, usually into your upper arm muscle by a doctor, nurse or pharmacist.
5. What should I know about being given Fluad® Quad?
Things you should do
Call your doctor, nurse or pharmacist straight away if you do not feel well after having Fluad® Quad.
Keep an updated record of your vaccinations.
Keep any follow-up appointments with your doctor or clinic.
Driving or using machines
Do not drive or use machines if you are feeling unwell after vaccination. Wait until any effects of the vaccine have worn off before you drive or use machines.
Looking after your medicine
Fluad® Quad is usually stored in the doctor's surgery or clinic, or at the pharmacy. However, if you need to store Fluad® Quad:
- Keep it where young children cannot reach it.
- Keep Fluad® Quad in the original pack until it is time for it to be given.
- Keep it in the refrigerator, between 2°C and 8°C. Do not freeze Fluad® Quad. Protect from light. Discard if the vaccine has been frozen. Freezing destroys the vaccine.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal. A doctor, nurse or pharmacist will dispose of any unused vaccine.
Do not use Fluad® Quad after the expiry date.
6. Are there any side effects?
All vaccines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor, nurse or pharmacist if you have any further questions about side effects.
Less serious side effects
| Less serious side effects | What to do |
| Speak to your doctor if you have any of these less serious side effects and they worry you. Mostly these are mild and usually disappear within 3 days without treatment. |
Serious side effects
| Serious side effects | What to do |
| Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. All of these serious side effects are rare. |
Tell your doctor, nurse or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this vaccine.
7. Product details
Fluad® Quad is only available with a doctor's prescription.
What Fluad® Quad contains
| Active ingredient (main ingredient) | Influenza virus haemagglutinin Each 0.5 mL contains 15 micrograms from each of the following types of influenza virus:
|
| Other ingredients (inactive ingredients) | Adjuvant: MF59C.1: containing squalene (of fish origin), polysorbate 80, sorbitan trioleate, sodium citrate dihydrate, citric acid monohydrate, water for injections. Other: sodium chloride, potassium chloride, monobasic potassium phosphate, dibasic sodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, water for injections. May also contain traces of kanamycin sulfate, neomycin sulfate, egg proteins (ovalbumin), formaldehyde, cetrimonium bromide, sucrose, and hydrocortisone as residues of the manufacturing process. |
Tell your doctor if you have an allergy to any of the above ingredients. Your doctor will decide if you can receive Fluad® Quad.
Fluad® Quad does not contain lactose, gluten, tartrazine, any azo dyes, or preservative.
What Fluad® Quad looks like
Fluad® Quad is a milky-white liquid, in glass pre-filled syringe with or without a needle for single use only (AUST R 316323 and AUST R 313724).
Who distributes Fluad® Quad
Seqirus Pty Ltd
ABN 26 160 735 035
63 Poplar Road
Parkville, Victoria 3052
AUSTRALIA
This leaflet was prepared in October 2023.
Fluad® Quad is a trademark of Seqirus UK Limited or its affiliates.
Published by MIMS December 2023
Unsolicited adverse events (AEs) were collected for 21 days after vaccination. The frequency of unsolicited AEs was similar between the different vaccination groups, Fluad Quad (15.3%), Fluad (11.3%) and aTIV-2 (15.3%). Influenza-like-illness (2.0%), injection site bruising (1.1%) and cough (1.0%) were reported in ≥ 1% of subjects who received Fluad Quad.
Immunogenicity based on CBER (Center for Biologics Evaluation and Research) criteria as measured by the percentage of subjects achieving seroconversion for HI antibodies and percentage of subjects achieving an HI antibody titre ≥ 1:40 at 21 days post-vaccination was assessed as a second co-primary endpoint. Success criteria was met if the lower limit of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody met or exceeded 30% and the lower limit of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titre ≥ 1:40 met and exceeded 60%.
Fluad Quad contains no antimicrobial preservative.