Aflunov - patient leaflet, side effects, dosage

Patient leaflet - Aflunov

B. PACKAGE LEAFLET

Package leaflet: information for the user

AFLUNOV suspension for injection in pre-filled syringe Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)

Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or nurse.
– If you get any side effects, talk to your doctor or nurse. This includes any possible side effects

not listed in this leaflet. See section 4.

What is in this leaflet

1. What AFLUNOV is and what it is used for
2. What you need to know before you receive AFLUNOV
3. How AFLUNOV is given
4. Possible side effects
5. How to store AFLUNOV
6. Contents of the pack and other information

1. What AFLUNOV is and what it is used for

AFLUNOV is a vaccine for use in adults from 18 onwards, intended to be given in the context of outbreaks of zoonotic influenza viruses (coming from birds) with pandemic potential to prevent flu caused by H5N1 viruses similar to the vaccine strain reported in section 6.

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.

AFLUNOV 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.

As with all vaccines, AFLUNOV may not fully protect all persons who are vaccinated.

2. What you need to know before you receive AFLUNOV

You should not receive AFLUNOV:

if you have previously had a sudden life-threatening allergic reaction to any ingredient of

AFLUNOV (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) or cetyltrimethylammonium bromide (CTAB). Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. However, in a pandemic situation, it may be appropriate for you to be vaccinated with AFLUNOV provided that appropriate medical treatment is immediately available in case of an allergic reaction.

Warnings and precautions

Talk to your doctor or nurse before having this vaccine

if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to egg and chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB) (see section 6. Further information);
if you have a severe infection with a high temperature (over 38°C). If this applies to you then your vaccination will usually be postponed until you are feeling better. A minor infection such as a cold should not be a problem, but your doctor or nurse should advise whether you could still be vaccinated with AFLUNOV;
if you are having a blood test to look for evidence of infection with certain viruses. In the first few weeks after vaccination with AFLUNOV the results of these tests may not be correct. Tell the doctor requesting these tests that you have recently been given AFLUNOV.
in the presence of immune deficiencies AFLUNOV may be administered but a protective immune response may not be elicited.

Please inform your doctor or nurse if you have a bleeding problem or bruise easily.

Fainting can occur following, or even before, any needle injection. Therefore tell the doctor or nurse if you fainted with a previous injection.

AFLUNOV 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 AFLUNOV

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.

Data obtained in adults showed that AFLUNOV can be given at the same time as non-adjuvanted seasonal influenza vaccines. There is no information on administration of AFLUNOV with noninfluenza vaccines. If administration of AFLUNOV 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.

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 receiving this vaccine. Your doctor needs to assess the benefits and potential risks of giving you the vaccine.

Driving and using machines

Some effects mentioned under section 4. “Possible side effects” may affect the ability to drive or use machines.

AFLUNOV contains sodium and potassium.

AFLUNOV 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.

3. How AFLUNOV is given

Your doctor or nurse will administer the vaccine in accordance with official recommendations.

The vaccine will be injected into the muscles of the upper arm (deltoid muscle). The vaccine should never be given into a vein.

Adults from 18 onwards :

One dose of 0.5 ml will be given. A second dose of 0.5 ml should be given after an interval of

at least 3 weeks.

There is limited experience in elderly over 70 years of age.

Use in children

Children from 6 months to 17 years of age

There is limited experience in children between 6 months and 17 years of age. Vaccination is currently not recommended in this age group.

Children aged less than 6 months of age

Vaccination is currently not recommended in this age group.

If you have any further questions on the use of this medicinal product, ask your doctor or nurse.

4. Possible side effects

Like all medicines, AFLUNOV 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 AFLUNOV 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.

Common (affects 1 to 10 users in 100) :

Brusing of the skin at the injection site
Aching joints
Fever and nausea
Generally feeling unwell
Shivering
Sweating

Uncommon (affects 1 to 10 users in 1.000) :

Flu like symptoms
Urticaria (hives).

Rare (affects 1 to 10 users in 10.000) :

Convulsions
Eye swelling
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 AFLUNOV. These side effects may occur with AFLUNOV.

Generalised skin reactions including
Itching
Urticaria (hives)
Rash or swelling of the skin and mucous membranes
Angioedema (abnormal swelling of the skin, usually around the eyes, lips, tongue, hands

or feet, due to an allergic reaction).

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.

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 AFLUNOV.

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 AFLUNOV

Keep this vaccine out of the sight and reach of children.

Do not use AFLUNOV 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.

6. Contents of the pack and other information

What AFLUNOV contains

Active Substance :

Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:

A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms** per 0.5 ml dose

* propagated in fertilised hens’ eggs from healthy chicken flocks ** expressed in microgram haemagglutinin.

What AFLUNOV looks like and contents of the pack

AFLUNOV 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 and Manufacturer

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}

Detailed information on this medicine is available on the European Medicines Agency web site:.