AFLUNOV suspension for injection in pre-filled syringe.Prepandemic Influenza vaccine (H5N1) (surface antigen,inactivated, adjuvanted)

AFLUNOV is a vaccine for use in adults (from 18 to 60 years old). and elderly (over 60 years old). It is intended to be given before or during the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus.

Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly around the world. The symptoms of pandemic flu are similar to those of an ordinary flu but may be more severe.

When a person is given the vaccine, the immune system (the body?s natural defense 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.

You should not receive AFLUNOV:

• if you have previously had a sudden life-threatening allergic reaction to any ingredient of AFLUNOV (these are listed at the end of the leaflet) 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 have the vaccine provided that appropriate medical treatment is immediately available in case of an allergic reaction.

If you are not sure, talk to your doctor or nurse before having this vaccine.

Take special care with AFLUNOV:

• 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.

In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.

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

Taking other medicines

Please tell your doctor or nurse if you are taking or have recently taken 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, with injections made into separate limbs. In such cases, you should be aware that the side effects may be more intense.

Pregnancy and breast-feeding

Limited data was obtained from women who became pregnant with AFLUNOV during the course of clinical trials.
Your doctor needs to assess the benefits and potential risks of giving you the vaccine if you are pregnant or breast-feeding. Tell your doctor if you are pregnant, think you may be pregnant, plan to become pregnant. You should discuss with your doctor whether you should receive AFLUNOV. Tell your doctor if you are breast-feeding and follow his advice.

Driving and using machines

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

Important information about some of the ingredients of AFLUNOV

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

Adults and elderly (18 years of age and above):
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
There is limited experience in children between 6 months and 17 years of age.

Visually inspect the suspension prior to administration. In case of any particles and/or abnormal appearance, the vaccine should be discarded.

The vaccine should be allowed to reach room temperature before use. Gently shake before use.

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

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.

In the clinical trials with the vaccine, most side effects were mild in nature and short term. The side-effects are generally similar to those related to the seasonal flu vaccine.

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)

The side effects listed below have occurred with AFLUNOV in clinical studies in adults, including the elderly:

Very common:
Pain, hardening of the skin at the injection site, injection site redness, injection site swelling, pain at the site of injection, aching muscles, headache, sweating, fatigue.

Common:
Brusing of the skin at the injection site, fever and nausea, generally feeling unwell and shivering.

Uncommon:
Flu like symptoms.

Rare:
Convulsions, eye swelling and anaphylaxis.

These side effects usually disappear within 1-2 days without treatment. If they persist, CONSULT YOUR DOCTOR.

Side effects from clinical study in children (6 months to 17 years of age)
A clinical study was conducted with the same vaccine in children. 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 Focetria H1N1v vaccine.

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 and diarrhoea.
Headache, dizziness, drowsiness, fainting.
Neurological disorders such as severe stabbing or throbbing pain along one or more nerves, tingling, fits, and neuritis (inflammation of nerves).
Swollen lymph nodes, palpitations, weakness, pain in the extremities and cough.
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 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), and exudative 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.

If any of these side effects occur, please tell your doctor or nurse immediately.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Keep out of the reach and sight 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What AFLUNOV contains

• Active Substance: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14) 7.5 micrograms** per 0.5 ml dose * propagated in eggs ** expressed in microgram haemagglutinin.
• Adjuvant MF59C.1: The vaccine contains per 0.5 ml 9.75 mg squalene, 1.175 mg polysorbate 80 and 1.175 mg sorbitan trioleate.
• Other Ingredients: The other ingredients are: sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid and water for injections.

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

Novartis Vaccines and Diagnostics S.r.l.
Via Fiorentina, 1
Siena, Italy.

Manufacturer

Novartis Vaccines and Diagnostics S.r.l.
Loc. Bellaria - 53018 Rosia
Sovicille (SI), Italy.

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