IDflu
influenza vaccine (split virion, inactivated)
Influenza vaccine (split virion, inactivated)
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This vaccine has been prescribed for you only. Do not pass it on to others.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What IDflu is and what it is used for
What you need to know before you use IDflu
How to use IDflu
Possible side effects
How to store IDflu
Contents of the pack and other information
Medicinal product no longer authorised
IDflu is a vaccine.This vaccine is recommended to help to protect you against flu.
The vaccine may be administered to individuals of 60 years of age and over, especially in those who run an increased risk of associated complications.
When an injection of IDflu is given, the immune system (body's natural defences) will develop protection against flu infection.
IDflu 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.
If you are allergic to:
The active substances,
Any of the other ingredients of this vaccine (listed in section 6),
Any component that may be present in very small amounts such as eggs (ovalbumin, chicken proteins), 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.
Talk to your doctor, pharmacist or nurse before using IDflu.
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.
This vaccine 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.
IDflu is not recommended for use in children and adolescents below 18 years.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Other vaccines: IDflu 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.
This vaccine is intended for individuals 60 years of age and over. Therefore, this information is not applicable.
This vaccine has no or negligible influence on the ability to drive and use machines.
Medicinal product no longer authorised
Always use this vaccine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 0.1 ml for individuals 60 years of age and over. IDflu is administered to you by your doctor or nurse.
IDflu 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 vaccine, ask your doctor, pharmacist or nurse.
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Swollen face, tongue or pharynx
Difficulty to swallow
Hives and difficulties to breathe.
During clinical trials and after the vaccine came on the market, the following side effects were reported with the use of IDflu.
Very common reactions (may affect more than 1 in 10 people)
At the injection site: redness, hardness, swelling, itching and pain.
Headache and muscular pain.
Common reactions (may affect up to 1 in 10 people)
Bruising at the injection site.
Feeling generally unwell, fever (38.0°C or higher) and shivering.
Uncommon reactions (may affect up to 1 in 100 people)
Tiredness, joint pain and increased sweating.
Rare reactions (may affect up to 1 in 1000 people)
Tingling or numbness, inflammation of nerves, itching and rash.
Reactions of not known frequency (frequency cannot be estimated from the available data)
Allergic reactions including skin reactions that may spread throughout the body such as hives, severe allergic reactions (anaphylactic reactions), swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breathe (angioedema), failure of the circulatory system (shock) leading to medical emergency.
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 IDflu.
Temporary reduction in the number of blood particles called platelets which can result in bruising or bleeding, temporary swelling of the glands in the neck, armpit or groin.
Pain located on the nerve route, convulsions associated with fever, nervous system disorders including inflammation of the brain or spinal cord or Guillain-Barré syndrome which causes extreme weakness and paralysis.
Medicinal product no longer authorised
Vessel inflammation which may result in very rare cases in temporary kidney problems.
If you get any side effects, talk to your doctor, pharmacist 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.
Keep this vaccine out of the sight and reach of children.
Do not use this vaccine 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.
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.
The active substances are Influenza virus (inactivated split) of the following strains*:
A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)
.............................................................................................................................. 15 micrograms HA**
A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)
.............................................................................................................................. 15 micrograms HA**
B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) ..................... 15 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 2016/2017 season.
The other ingredients are: sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Medicinal product no longer authorised
The vaccine is a colourless and opalescent suspension.
IDflu 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: Sanofi Pasteur SA, 2, avenue Pont Pasteur, 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:
België/Belgique/Belgien Sanofi Belgium tel.: +32 2 710.54.00 | Lietuva Sanofi – Aventis Lietuva, UAB Tel.: +370 5 2730967 |
България Sanofi Bulgaria EOOD Teл.: +359 2 970 53 00 | Luxembourg/Luxemburg Sanofi Belgium tel.: +32 2 710.54.00 |
Medicinal product no longer authorised
Česká republika Sanofi Pasteur divize vakcín sanofi-aventis, s.r.o. Tel: +420 233 086 111 | Magyarország sanofi-aventis zrt Tel.: +36 1 505 0055 |
Danmark sanofi-aventis Denmark A/S Tel: +45 4516 7000 | Malta Cherubino Ltd Tel.: +356 21 343270 |
Deutschland Sanofi-Aventis Deutschland GmbH Tel.: 0800 54 54 010 Tel. aus dem Ausland: +49 69 305 21 130 | Nederland sanofi-aventis Netherlands B.V. Tel: +31 182 557 755 |
Eesti Sanofi-Aventis Estonia OÜ Tel.: +372 627 3488 | Norge Sanofi-aventis Norge AS Tel: + 47 67 10 71 00 |
Ελλάδα ΒΙΑΝΕΞ Α.Ε. Τηλ: +30.210.8009111 | Österreich Sanofi-Aventis GmbH Tel: +43 (1) 80185-0. |
España sanofi-aventis, S.A. Tel: +34 93 485 94 00 | Polska Sanofi Pasteur Sp. z o.o. Tel.: +48 22 280 05 00 |
France Sanofi Pasteur Europe Tél: 0800 42 43 46 Appel depuis l’étranger : +33 1 57 63 23 23 | Portugal Sanofi – Produtos Farmacêuticos, Lda. Tel: + 351 21 35 89 400 |
Hrvatska sanofi-aventis Croatia d.o.o Tel: + 385 1 6003 400 | România sanofi - aventis Romania SRL Tel.: +40(21) 317 31 36 |
Ireland sanofi-aventis Ireland T/A SANOFI Tel: + 353 (0) 1 4035 600 | Slovenija ALPE s.p. Tel.: +386 (0)1 432 62 38 |
Ísland Vistor Tel : +354 535 7000 | Slovenská republika sanofi-aventis Pharma Slovakia s.r.o. divízia vakcín Sanofi Pasteur Tel.: +421 2 33 100 100 |
Italia Sanofi S.p.A. Tel: 800536389 Tel dall'estero: +39 02 39394983 | Suomi/Finland Sanofi Oy Tel: +358 (0) 201 200 300 |
Κύπρος Γ. Α. Σταμάτης & Σια Λτδ. Τηλ.: +357 - 22 76 62 76 | Sverige Sanofi AB Tel: +46 8-634 50 00 |
Sanofi Aventis Latvia SIA Vakcīnu nodaļa Tel.: +371 67114978
Sanofi
Tel: +44 845 372 7101
Detailed information on this vaccine is available on the European Medicines Agency web site: .
---------------------------------------------------------------------------------------------------------------------------
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.
Medicinal product no longer authorised
The needle shielding system is designed to cover the micro-needle after use.
Medicinal product no longer authorised
Please read the instructions before use
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.
Insert the needle perpendicular to the skin, in the region of the deltoid, in a short, quick movement.
Medicinal product no longer authorised
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.
Remove the needle from the skin.
Orient the needle away from you and others.
Activated needle shield
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.
Injection is considered successful whether or not the presence of a wheal is observed.
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 IDflu