Patient leaflet - Foclivia
1. What Foclivia is and what it is used for
Foclivia is a vaccine intended to be given to prevent influenza (flu) in an officially declared pandemic.
Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades. It spreads rapidly around the world. The signs of pandemic flu are similar to those of ordinary flu but may be more serious.
It is for use in adults (from 18 to 60 years old) and elderly (over 60 years) to prevent flu caused by the H5N1 type of the virus.
When a person is given the vaccine, the body’s natural defence system (immune system) produces its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu.
As with all vaccines, Foclivia may not fully protect all persons who are vaccinated.
2. What you need to know before you receive Foclivia
Foclivia should not be given if you:
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– have experienced serious allergic reaction (i.e. life-threatening) to any of the constituents of Foclivia, – are allergic (hypersensitive) to influenza vaccines or any of the ingredients of Foclivia, – are allergic to eggs, chicken protein, ovalbumin,
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– are allergic to kanamycin sulphate and neomycin sulphate (antibiotics), formaldehyde, cetyltrimethylammonium bromide (CTAB).
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– Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
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– However, in a pandemic situation, you may still be given the vaccine. This is as long as medical treatment is available straight away, in case you have an allergic reaction.
Warnings and precautions
Talk to your doctor or nurse before having this vaccine:
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– if you feel feverish,
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– if you have any illness or infection,
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– if you are having immunosuppressive therapy, e.g. corticosteroid treatment or chemotherapy for cancer, or if you have any condition which makes you prone to infections (immunodeficiency conditions).
Please inform your doctor or nurse if you have a bleeding problem or bruise easily.
The doctor should inform you about the posibility to experience convulsion, in particular if you have had previous history of epilepsy.
Fainting can occur following, or even before, any needle injection. Therefore, tell the doctor or nurse if you fainted with a previous injection.
Foclivia 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.
Other medicines and Foclivia
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. Foclivia can be given at the same time as non-adjuvanted seasonal influenza vaccines. There is no information on administration of Foclivia with non-influenza vaccines. If administration of Foclivia with other vaccines cannot 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.
Pregnancy and breast-feeding
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 taking this vaccine. Your doctor needs to assess the benefits and potential risks of giving you the vaccine.
Driving and using machines
Some side effects listed in Section 4. “Possible side effects” may affect your ability to drive or use tools or machines.
Foclivia contains sodium and potassium
Foclivia contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose. It is essentially sodium- and potassium-free.
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3. How Foclivia is given
Your doctor or nurse administers 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.
A second dose of vaccine should be given after an interval of at least 3 weeks.
4. Possible side effects
Like all medicines, Foclivia can cause side effects, although not everybody gets them.
Allergic reactions may occur following vaccination, in rare cases leading to shock. Doctors are aware of this possibility and have emergency treatment available for use in such cases.
The side effects listed below have occurred with Foclivia in clinical studies in adults, including the elderly:
Very common (affects more than 1 user in 10) :
- Pain at the site of injection
- Hardening of the skin at the injection site
- Injection site redness
- Injection site swelling
- Aching muscles
- Headache
- Fatigue
- Generally feeling unwell
- Shivering
Common (affects 1 to 10 users in 100) :
- Brusing of the skin at the injection site
- Aching joints
- Fever and nausea
- Sweating
Rare (affects 1 to 10 users in 10,000):
- Anaphylaxis (severe allergic reactions)
These side effects usually disappear within 1–2 days without treatment. If they persist, CONSULT
YOUR DOCTOR.
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
Nausea, aching joints, diarrhoea and loss of appetite were reported very commonly in this population. In addition, vomiting was commonly reported.
Side effects from clinical study in children (6 months to 17 years of age)
General side effects reported very commonly in the 6 months to 35 months of age group were injection site redness, muscle ache, irritability and unusual crying. Very commonly reported reactions in the 36 months to 17 years of age group were pain, headache and fatigue.
Other rare side effects observed after routine use
The side effects listed below have occurred in the days or weeks after vaccination with another vaccine called Focetria H1N1v similar to Foclivia. These side effects may occur with Foclivia.
- Generalised skin reactions including
- Itching
- Urticaria (hives)
- Rash or swelling of the skin and mucous membranes
- Disorders of the gut such as
- Nausea
- Vomiting
Abdominal pain Diarrhoea
- Headache, dizziness, drowsiness, fainting.
- Neurological disorders such as
- Severe stabbing or throbbing pain along one or more nerves
- Tingling
- Fits
- Neuritis (inflammation of nerves)
- Swollen lymph nodes, palpitations (irregular or forceful heart beat), tachycardia (faster than normal heart beat), weakness, pain in the extremities, cough and asthenia (unusual weakness).
- Allergic reactions possibly with shortness of breath, wheezing, swelling of the throat, or leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock. Doctors are aware of this possibility and have emergency treatment available for use in such cases.
- Angioedema (abnormal swelling of the skin, usually around the eyes, lips, tongue, hands or feet, due to an allergic reaction).
Data in children and adolescents suggest a slight decrease in side effects after the second dose of the vaccine, with no increase in rates of fever.
In addition, the side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent seasonal flu. These side effects may occur with Foclivia.
- Low blood platelet count which can result in bleeding or bruising.
- Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems).
- Erythema multiforme (type of allergic skin reaction that occurs in response to medications, infections, or illness).
- Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), and a type of paralysis known as Guillain-Barré Syndrome.
- Swelling, pain and redness at the injection site extending to more than 10 cm and lasting more than one week (Injection site cellulitis-like reaction).
- Extensive swelling of injected limb lasting more than one week.
Reporting of side effects
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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Foclivia
Keep this vaccine out of the sight and reach of children.
Do not use Foclivia after the expiry date which is stated on the carton and the label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze. Discard if the vaccine has been frozen. Store in the original package in order to protect from light.
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 to protect the environment.
6. Contents of the pack and other information
What Foclivia contains
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- Active substance :
The active ingredients of the vaccine are purified viral proteins (called haemagglutinin and neuraminidase). They are isolated from the surface of influenza virus particles, which are grown in fertilised hen’s eggs from healthy chicken flocks and inactivated with formaldehyde. These viral proteins are prepared from the strain of influenza virus that complies with the World Health Organisation recommendations and EU decision in an officially declared Pandemic situation.
One dose (0.5 ml) of the vaccine contains at least 7.5 micrograms of haemagglutinin from the following recommended influenza virus strain:
A/Vietnam/1194/2004 (H5N1)
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- Adjuvant :
The vaccine contains an ‘adjuvant’ (a compound containing squalene) to stimulate a better response. The adjuvant includes also polysorbate 80 and sorbitan trioleate in a citrate buffer (sodium citrate, citric acid).
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- Other ingredients :
What Foclivia looks like and contents of the pack
Foclivia is a milky-white liquid.
It is provided in a ready-to-use syringe, containing a single dose (0.5 ml) for injection, in box of 1 or 10, with or without needle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Seqirus S.r.l.
Via del Pozzo 3/A, S. Martino
53035 Monteriggioni (SI)
Italy
Manufacturer
Seqirus Netherlands B.V.
Paasheuvelweg 28
1105BJ Amsterdam
Netherlands
This leaflet was last revised in {MM/YYYY}.
Foclivia has been authorised under “Exceptional Circumstances”.
This means that for scientific reasons, it has not been possible to obtain complete information on this medicinal product. The European Medicines Agency (EMA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Detailed information on this medicine is available on the European Medicines Agency web site: .
The following information is intended for healthcare professionals only:
Instructions for administration of the vaccine:
The vaccine should under no circumstances be administered intravascularly or intradermally. There are no data with Foclivia using the subcutaneous route of administration.
When using a pre-filled syringe without a needle supplied with a Luer Lock system, remove the tip cap by unscrewing it in a counter-clockwise direction. Once the tip cap is removed, attach a needle to the syringe by screwing it on in a clockwise direction until it locks. Once the needle is locked in place, remove the needle protector and administer the vaccine.
Ready-to-use syringe, containing a single dose of 0.5 ml for injection.
Gently shake before use. After shaking, the normal appearance of Foclivia is a milky-white suspension.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.