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 ?????.15 micrograms HA**
A/Perth/16/2009 (H3N2) ? like strain used NYMC X-187 derived from A/Victoria/210/2009
????????????????????????????????.15 micrograms HA**
B/Brisbane/60/2008 ????????????????????????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 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 Needle 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