Active ingredient
- influenza vaccine (surface antigen, inactivated)
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 47991/0003.
Flucelvax Tetra
Package leaflet: Information for the user
Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
▼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 Flucelvax Tetra is and what it is used for
2. What you need to know before you receive Flucelvax Tetra
3. How Flucelvax Tetra is given
4. Possible side effects
5. How to store Flucelvax Tetra
6. Contents of the pack and other information
1. What Flucelvax Tetra is and what it is used for
Flucelvax Tetra is a vaccine against flu (influenza). Flucelvax Tetra is prepared in cell cultures, and, therefore, is egg-free.
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.
Flucelvax Tetra is used to prevent flu in adults and children from 2 years of age.
The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2021/2022 season.
2. What you need to know before you receive Flucelvax Tetra
You should not receive Flucelvax Tetra:
If you are allergic to:
Warnings and precautions
Talk to your doctor, pharmacist or nurse before receiving Flucelvax Tetra.
BEFORE receiving the vaccine
As with all vaccines, Flucelvax Tetra may not fully protect all persons who are vaccinated.
Other medicines and Flucelvax Tetra
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.
Flucelvax Tetra may be given at the same time as other vaccines.
Pregnancy and breast-feeding
Pregnancy:
Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. Influenza vaccinations can be used at any stage of pregnancy.
Breast-feeding:
Use of Flucelvax Tetra during breast-feeding has not been studied. Flucelvax Tetra may be used during breast-feeding.
Driving and using machines
Flucelvax Tetra has no or negligible effect on your ability to drive and use machines.
Flucelvax Tetra contains sodium chloride and potassium chloride
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 Flucelvax Tetra is given
Flucelvax Tetra is given to you by your doctor or nurse as an injection into the muscle at the top of the upper arm (deltoid muscle).
Adults and children from 2 years of age:
One dose of 0.5 ml
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported during clinical trials and during general use:
Very serious side effects
Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect – you may need urgent medical attention or hospitalisation:
Serious side effects
Tell your doctor immediately if you experience any of the following side effects – you may need medical attention:
Mild side effects
Very common (may affect more than 1 in 10 people):
Hardening or swelling at the site of the injection, headache, muscle pain, and tiredness were common in the elderly.
Bruising at the site of the injection was common in adults, eldery and children 9 to < 18 years.
Headache was common in the elderly.
Loss of appetite was common in adults, eldery and children 9 to < 18 years.
Common (may affect up to 1 in 10 people):
Vomiting was uncommon in the elderly.
Fever was uncommon in adults and the elderly.
Not known (cannot be estimated from the available data):
Reporting of side effects
If you get any side effects, talk to your healthcare professional. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 Flucelvax Tetra
Keep this vaccine out of the sight and reach of children.
Store in a refrigerator (2 °C to 8 °C). Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Do not use this vaccine 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 Flucelvax Tetra contains
This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2021/2022 season.
What Flucelvax Tetra looks like and contents of the pack
Flucelvax Tetra is a suspension for injection in a pre-filled syringe (ready to use syringe).
Flucelvax Tetra is a clear to slightly opalescent suspension.
A single syringe contains 0.5 ml of suspension for injection.
Flucelvax Tetra is available in packs containing 1 pre-filled syringe with or without needle 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 07/2021
Other sources of information
The Point, 29 Market Street, Maidenhead, SL6 8AA, UK
+44 (0)1628 641 500
+44 (0) 1748 828816
08457 451 500