Patient Leaflet Updated 20-Jun-2023 | Seqirus UK Limited
Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1
Package leaflet: Information for the user
Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe
Influenza vaccine, Adjuvanted with MF59C.1
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you receive this medicine because it contains important information for you.
What is in this leaflet
1. What Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1 is and what it is used for
2. What you need to know before you receive Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1
3. How Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1 is given
4. Possible side effects
5. How to store Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1
6. Contents of the pack and other information
1. What Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1 is and what it is used for
Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1 is a vaccine against flu (influenza).
When a person is given the vaccine, the immune system (the body’s natural defence system) will produce its own protection against the influenza virus. None of the ingredients in the vaccine can cause flu.
Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1 is used to prevent flu in elderly adults of 65 years of age and older.
The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2023/2024 season.
2. What you need to know before you receive Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1
You should not receive Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1
Warnings and precautions
Talk to your doctor, pharmacist or nurse before receiving Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1
BEFORE receiving the vaccine
As with all vaccines, Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1 may not fully protect all persons who are vaccinated.
Children
Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1 is not recommended for use in children.
Other medicines and Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1
Tell your doctor or nurse if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription or if you have recently received any other vaccine.
Pregnancy and breast-feeding
This vaccine is for use in elderly adults 65 years and older. It is not to be used in women who are, or may be, pregnant or breast-feeding.
Driving and using machines
Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1 has no or negligible influence on the ability to drive and use machines.
Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1 contains potassium and sodium
This vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free’.
This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium free’.
3. How Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1 is given
Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1 is given by your doctor or nurse as an injection into the muscle at the top of the upper arm (deltoid muscle).
Adults of 65 years of age and older:
One dose of 0.5 ml
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following serious side effect – you may need urgent medical attention or hospitalisation:
The following side effects have been reported during clinical trials in adults 65 years of age and older.
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Most side effects were mild or moderate and went away within 3 days of appearing.
Next to the above side effects, the following side effects occurred occasionally during general use of Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1 or a similar vaccine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2 °C to 8 °C). Do not freeze. Discard if the vaccine has been frozen.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1 contains
per 0.5 ml dose
A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022 IVR-238) 15 micrograms HA**
A/Darwin/9/2021 (H3N2)-like strain (A/Darwin/6/2021 IVR-227) 15 micrograms HA**
B/Austria/1359417/2021-like strain (B/Austria/1359417/2021 BVR-26) 15 micrograms HA**
B/Phuket/3073/2013-like strain (B/Phuket/3073/2013 BVR-1B) 15 micrograms HA**
*propagated in fertilised hens’ eggs from healthy chicken flocks and adjuvanted with MF59C.1
**haemagglutinin
This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU recommendation for the 2023/2024 season.
What Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1 looks like and contents of the pack
Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1 is a suspension for injection in a pre-filled (ready to use) syringe. Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1 is a milky-white suspension. A single syringe contains 0.5 ml of suspension for injection. Adjuvanted Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe Influenza vaccine, Adjuvanted with MF59C.1 is available in packs containing 1 or 10 pre-filled syringes with or without needles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in 06/2023.
The Point, 29 Market Street, Maidenhead, SL6 8AA, UK
+44 (0)1628 641 500
http://www.seqirus.com
+44 (0) 1748 828816
08457 451 500