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The product code(s) for this leaflet is: PLGB 47991/0013.
Adjuvanted Zoonotic Influenza Vaccine_H5N8
Adjuvanted Zoonotic Influenza Vaccine
(Surface Antigen, Inactivated) Seqirus suspension for injection in pre‐filled syringe
Zoonotic influenza vaccine (H5N8) (surface antigen, inactivated, adjuvanted)
1. What Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 is and what it is used for
2. What you need to know before you receive Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8
3. How Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 suspension for injection in pre‐filled syringe is given
4. Possible side effects
5. How to store Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8
6. Contents of the pack and other information
Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 is a vaccine for use in individuals 6 months of age and older, intended to be given in the context of outbreaks of zoonotic influenza (coming from birds) to prevent flu caused by H5 subtype influenza A viruses.
Zoonotic influenza viruses occasionally infect humans, and can cause disease ranging from mild upper respiratory infection (fever and cough) to rapid progression to severe pneumonia, acute respiratory distress syndrome, shock and even death. Human infections are primarily caused by contact with infected animals, but do not spread easily between people.
Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 is intended also to be given when there is anticipation of a possible pandemic due to the same or a similar strain.
When a person is given the vaccine, the immune system (the body’s natural defence system) will produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu.
if you have previously had a sudden life-threatening allergic reaction to any ingredient of Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 (listed in section 6) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics), hydrocortisone or cetyltrimethylammonium bromide (CTAB). Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Talk to your doctor or nurse before having this vaccine
Fainting can occur following, or even before, any needle injection. Therefore tell the doctor or nurse if you fainted with a previous injection.
Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 may not fully protect everyone who is vaccinated, especially elderly subjects and those with weakened immune systems, such as HIV patients, or those with underlying long term medical problems, such as diabetes, lung disease or heart problems. Tell your doctor if you have a weak immune system or an underlying long term medical problem.
In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.
Tell your doctor or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 can be given at the same time as non-adjuvanted seasonal influenza vaccines. There is no information on administration of Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 with non-influenza vaccines. If administration of Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 with other vaccines can not be avoided, the vaccines should be injected into separate limbs. In such cases, you should be aware that the side effects may be more intense.
Vaccination is currently not recommended in children less than 6 months of age.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before receiving this vaccine. Your doctor needs to assess the benefits and potential risks of giving you the vaccine.
Some effects mentioned under section 4. “Possible side effects” may affect the ability to drive or use machines.
Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per 0.5 ml dose, i.e. essentially sodium- and potassium-free.
Your doctor or nurse will administer the vaccine in accordance with official recommendations.
A dose (0.5 ml) of the vaccine will be injected into the upper arm (deltoid muscle) or upper thigh, depending on the muscle mass. The vaccine should never be given into a vein.
Two doses of 0.5 ml will be given with an interval of at least 3 weeks.
There is limited experience in elderly over 70 years of age.
If you have any further questions on the use of this medicinal product, ask your doctor or nurse.
Like all medicines, Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 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 side effect – you may need urgent medical attention or hospitalisation:
The side effects listed below have occurred with a vaccine similar to Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 in clinical studies in adults:
Very common (affects more than 1 user in 10):
Common (affects 1 to 10 users in 100):
Uncommon (affects 1 to 10 users in 1000)
These side effects are usually mild and disappear within 3 days without treatment. If they persist, CONSULT YOUR DOCTOR.
The side effects listed below have occurred with a vaccine similar to Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 in clinical studies in children:
6 months to less than 3 years of age
Very common (affects more than 1 user in 10):
Common (affects 1 to 10 users in 100):
3 years to less than 18 years of age
Very common (affects more than 1 user in 10):
* Reported as common in the 9 to <18 year old population
Common (affects 1 to 10 users in 100):
Undesirable effects in patients with underlying long term medical problems such as diabetes, lung disease or heart problems and weakened immune systems (immunocompromised) such as HIV patients
Very common (affects more than 1 user in 10): Nausea, aching joints, diarrhoea and loss of appetite Common (affects 1 to 10 users in 100): Vomiting
Other rare side effects observed after routine use:
The additional side effects listed below have occurred in the days or weeks after vaccination with another vaccine similar vaccine. These side effects may occur with Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8.
In addition, side effects listed below have occurred in the days or weeks after vaccination with adjuvanted and not-adjuvanted vaccines given routinely every year to prevent seasonal flu. These side effects may occur with Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8.
If you get any side effects, talk to your doctor 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.
Keep this vaccine out of the sight and reach of children.
Do not use Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 after the expiry date which is stated on the carton and the label. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Store in the original package in order to protect from light.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Adjuvanted Zoonotic Influenza Vaccine Seqirus H5N8 is a suspension for injection in a pre-filled syringe.
The suspension is a milky-white liquid.
It is provided in a ready-to-use pre-filled syringe, containing a single dose of 0.5 ml for injection.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in 10/2024