INTANZA 9 microgram/strain suspension for injectionInfluenza vaccine (split virion, inactivated)

INTANZAis a vaccine. This vaccine is recommended to help to protect you against flu. The vaccine may be administered to adults up to 59 years of age, especially in those who run an increased risk of associated complications.

When an injection of INTANZA is given, the immune system (body's natural defences) will develop protection against flu infection.
INTANZA will help to protect you against the three strains of virus contained in the vaccine, or other strains closely related to them. Full effect of the vaccine is generally achieved 2-3 weeks after the vaccination.

Do not use INTANZA

• If you are allergic (hypersensitive) to:
• The active substances,
• Any of the other ingredients of INTANZA listed in section 6 of this leaflet in the section "FURTHER INFORMATION",
• Residues of eggs such as ovalbumin, to chicken proteins, to neomycin, formaldehyde and octoxinol 9.
• If you have an illness with fever or acute infection, the vaccination shall be postponed until after you have recovered.

Take special care with INTANZA

• You should tell your doctor before vaccination if you have a poor immune response (immunosuppression) due to disease or medicines, because the vaccine may not work very well in this case.
• INTANZA should under no circumstances be administered into a vein (intravascularly).

• If, for any reason, you have a blood test within a few days following an influenza vaccination, please tell your doctor. Tests for HIV-1, hepatitis C virus and HTLV-1 may be affected.

Using other medicines

• Other vaccines: INTANZA can be given at the same time as other vaccines by using separate limbs. It should be noted that the side effects may be intensified.
• Tell your doctor if you have been treated with medicines that may reduce your immune response such as corticosteroids (for example cortisone), medicines against cancer (chemotherapy), radiotherapy or other medicines affecting the immune system. In this case, the vaccine may not work very well.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Pregnancy
Tell your doctor or pharmacist if you are pregnant or think you may be pregnant.
Your doctor or pharmacist will be able to decide if you should receive INTANZA.

Breast - feeding
The vaccine INTANZA may be used during breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicines.

Driving and using machines

INTANZA has no or negligible influence on the ability to drive and use machines.

INTANZA is administered to you by your doctor or nurse.

Adults from 18 to 59 of age receive one 0.1 ml dose.

Use in children and adolescents

INTANZA is not recommended for use in children and adolescents below 18 years.

INTANZA is given as an injection into the upper layer of the skin (preferably the muscle of the upper arm).

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

Like all medicines, INTANZA can cause side effects, although not everybody gets them. During clinical trials, the following side effects were reported with the use of INTANZA:

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)
Not known (frequency cannot be estimated from the available data).

Very common

• At the injection site: redness, swelling, hardness, itching and pain.
• Feeling generally unwell, headache and muscular pain.

Common

• Bruising at the injection site
• Shivering and fever (38.0°C or higher).

Uncommon

• Tiredness, swelling of the glands in the neck, armpit or groin, tingling or numbness, joint pain, itching and rash.

Rare

• Increased sweating.

Most of side effects listed above disappeared without treatment within 1 to 3 days after onset. In some cases, redness at the injection site lasted up to 7 days.

The following side effects have been reported with other vaccines given to prevent flu. These side effects may occur with INTANZA:

• Temporary reduction in the number of blood particles called platelets which can result in bruising or bleeding
• Allergic reactions which can lead in rare cases:
• to a failure of the circulatory system (shock) leading to medical emergency
• to swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breathe (angioedema)
• Pain located on the nerve route, convulsions associated with fever, nervous system disorders including inflammation of the brain or spinal cord, inflammation of nerves, or Guillain-Barré syndrome which causes extreme weakness and paralysis
• Vessel inflammation which may result in very rare cases in temporary kidney problems
• Skin reactions that may spread throughout the body including hives.

You should see your doctor immediately if you experience symptoms of angioedema, such as:

• Swollen face, tongue or pharynx
• Difficulty to swallow
• Hives and difficulties to breathe.

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

Keep out of the reach and sight of children.

Do not use INTANZA after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the syringe in the outer carton 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 INTANZA contains

The active substances are Influenza virus (inactivated, split) of the following strains*:

A/California/7/2009 (H1N1) ? derived strain used NYMC X-179A ?????9 micrograms HA**

A/Perth/16/2009 (H3N2) ? like strain used NYMC X-187 derived from A/Victoria/210/2009?

??????????????????????????????..?..9 micrograms HA**

B/Brisbane/60/2008??????????????????.?????.. 9 micrograms HA**

Per 0.1 ml dose

propagated in fertilised hens eggs from healthy chicken flocks haemagglutinin

This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2010/2011 season.

The other ingredients are: sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.

What INTANZA looks like and contents of the pack

The vaccine is a colourless and opalescent suspension.

INTANZA is a suspension for injection in a pre-filled syringe of 0.1 ml with a Micro-Injection System in packs of 1, 10 or 20.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon, France.

Manufacturer:
sanofi pasteur - Parc Industriel d?Incarville- 27100 Val-de-Reuil- France
sanofi pasteur, Campus Mérieux ? 1541, avenue Marcel Mérieux ? 69280 Marcy l?Etoile - France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Sanofi Pasteur MSD TélTel 32 2 726.9584 LuxembourgLuxemburg Sanofi Pasteur MSD Tél 32 2 726.9584 Sanofi Pasteur representative Office Te. 359 2 980 08 33 Magyarország sanofi-aventis zrt Tel. 36 1 505 2723

Malta Cherubino Ltd Tel. 356 21 343270 eská republika Sanofi Pasteur Odd. vakcín Sanofi-aventis, s.r.o. Tel 420 233 086 111 Danmark Sanofi Pasteur MSD Tlf 45 23 32 69 29 Nederland Sanofi Pasteur MSD Tel 31.23.567.96.00 Deutschland Sanofi Pasteur MSD GmbH Tel 49 6224.594.0 Norge Sanofi Pasteur MSD Tlf 47.67.50.50.20 Eesti Sanofi-Aventis Estonia OÜ Tel. 372 627 3488 Österreich Sanofi Pasteur MSD GmbH Tel 43.1.866.70.22.202 .. 30.210.8009111 Polska Sanofi Pasteur Sp. z o.o. Tel. 48 22 280 05 00 España Sanofi Pasteur MSD S.A. Tel 34.91.371.78.00 Portugal Sanofi Pasteur MSD, SA Tel 351 21 470 4550 France Sanofi Pasteur MSD SNC Tél 33.4.37.28.40.00 România Sanofi - Aventis Romania SRL Tel. 4021 317 31 36 Ireland Sanofi Pasteur MSD Ltd Tel 353 1 468 5600 Slovenija ALPE s.p. Tel. 386 01 432 62 38 Ísland Sanofi Pasteur MSD Sími 32.2.726.95.84 Slovenská republika sanofi-aventis Pharma Slovakia s.r.o. divízia vakcín Sanofi Pasteur Tel. 421 2 33 100 100 Italia Sanofi Pasteur MSD Spa Tel 39 06.664.09.211 SuomiFinland Sanofi Pasteur MSD PuhTel 358.9.565.88.30 . . . . 357 - 22 76 62 76 Sverige Sanofi Pasteur MSD Tel 46.8.564.888.60 Latvija Sanofi Aventis Latvia SIA Vakcnu nodaa Tel. 371 67114978 United Kingdom Sanofi Pasteur MSD Ltd Tel 44.1.628.785.291 Lietuva Sanofi Aventis Lietuva, UAB Tel. 370 5 2730967

This leaflet was last approved in {MM/YYYY}.

• As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of anaphylactic event following the administration of the vaccine.
• The vaccine should be allowed to reach room temperature before use.
• The vaccine should not be used if foreign particles are present in the suspension.
• It is not necessary to shake the vaccine before use.
• The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro-needle (1.5 mm) and a needle shielding system. The needle shielding system is designed to cover the microneedle after use.

Micro-Injection System

Micro-needle Finger pads Plunger Window Nedele shield Needle cap Vaccine Flange

INSTRUCTIONS FOR USE

Please read the instruction before use

1 REMOVE NEEDLE CAP 2 HOLD MICRO-INJECTION SYSTEM BETWEEN THUMB MIDDLE FINGER Remove the needle cap from the Micro-Injection System. Hold the system by placing the thumb and middle finger only on the finger pads the index finger remains free. Do not purge air through the needle. Do not place fingers on the windows.

4 INJECT USING THE INDEX FINGER 3 INSERT NEEDLE RAPIDLY PERPENDICULAR TO THE SKIN Insert the needle perpendicular to the skin, in the region of the deltoid, in a short, quick movement. Once the micro-needle has been inserted, maintain a light pressure on the surface of the skin and inject using the index finger to push on the plunger. The vein test is unnecessary.

5/ ACTIVATE NEEDLE SHIELD BY PUSHING FIRMLY ON PLUNGER

Remove the needle from the skin. Orient the needle away from you and others. With the same hand, push very firmly with the thumb on the plunger to activate the needle shield. You hear a click and a shield comes out to cover the needle. Immediately dispose of the system in the nearest sharps collector. Click Injection is considered successful whether or not the presence of a wheal is observed. Activated needle shield In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not required.

See also section 3. HOW TO USE INTANZA