What Synflorix contains
- The active substances are:
One 0.5 ml dose contains Pneumococcal polysaccharide serotype 11,2Pneumococcal polysaccharide serotype 41,2Pneumococcal polysaccharide serotype 51,2Pneumococcal polysaccharide serotype 6B1,2Pneumococcal polysaccharide serotype 7F1,2Pneumococcal polysaccharide serotype 9V1,2Pneumococcal polysaccharide serotype 141,2Pneumococcal polysaccharide serotype 18C1,31,4Pneumococcal polysaccharide serotype 19FPneumococcal polysaccharide serotype 23F1,21 microgram 3 micrograms 1 microgram 1 microgram 1 microgram 1 microgram 1 microgram 3 micrograms 3 micrograms 1 microgram
1 adsorbed on aluminium phosphate 0.5 milligram Al32 conjugated to protein D derived from non-typeable Haemophilus influenzae carrier protein 9-16 micrograms 3 conjugated to tetanus toxoid carrier protein 5-10 micrograms 4 conjugated to diphtheria toxoid carrier protein 3-6 micrograms
- The other ingredients are: sodium chloride and water for injections
What Synflorix looks like and contents of the pack
- Suspension for injection
- Synflorix is a turbid white suspension.
- Synflorix is available in vials in packs of 1, 10 or 100
- Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Biologicals s.a.Rue de l?Institut 89
B-1330 Rixensart
Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien GlaxoSmithKline s.a.n.v. TélTel 32 2 656 21 11 LuxembourgLuxemburg GlaxoSmithKline s.a.n.v. TélTel 32 2 656 21 11
Magyarország GlaxoSmithKline Kft. Tel. 36-1-2255300 . .10 1408 . 359 2 953 10 34
eská republika Malta
GlaxoSmithKline Malta Tel 356 21 238131 GlaxoSmithKline s.r.o. Tel 420 2 22 00 11 11 gsk.czmailgsk.com
Danmark GlaxoSmithKline Pharma AS Tlf 45 36 35 91 00 dk-infogsk.com Nederland GlaxoSmithKline BV Tel 31 030 69 38 100 nlinfogsk.com
Deutschland GlaxoSmithKline GmbH Co. KG Tel 49 089 360448701 produkt.infogsk.com Norge GlaxoSmithKline AS Tlf 47 22 70 20 00 firmapostgsk.no
Eesti GlaxoSmithKline Eesti OÜ Tel 372 667 6900 estoniagsk.com Österreich GlaxoSmithKline Pharma GmbH. Tel 43 1 970 75-0 at.infogsk.com
GlaxoSmithKline A.E.B.E T 30 210 68 82 100 Polska GSK Commercial Sp. z o.o. Tel. 48 22 576 9000
España GlaxoSmithKline, S.A. Tel 34 902 202 700 es-cigsk.com Portugal GlaxoSmithKline, Produtos Farmacêuticos, Lda. Tel 351 21 412 95 00 FI.PTgsk.com
România GlaxoSmithKline GSK SRL Tel 40 021 3028 208 France Laboratoire GlaxoSmithKline Tél 33 0 1 39 17 84 44 diamgsk.com
Ireland GlaxoSmithKline Ireland Ltd Tel 353 01 4955000 Slovenija GlaxoSmithKline d.o.o. Tel 386 0 1 280 25 00 medical.x.sigsk.com
Ísland GlaxoSmithKline ehf. Sími 354-530 3700 Slovenská republika GlaxoSmithKline Slovakia s.r.o. Tel 421 0 2 48 26 11 11 recepcia.skgsk.com
Italia GlaxoSmithKline S.p.A. Tel 39 04 59 21 81 11 SuomiFinland GlaxoSmithKline Oy PuhTel 358 10 30 30 30 Finland.tuoteinfogsk.com
GlaxoSmithKline Cyprus Ltd 357 22 39 70 00 Sverige GlaxoSmithKline AB Tel 46 08 638 93 00 info.produktgsk.com
Latvija GlaxoSmithKline Latvia SIA Tel 371 67312687 lv-epastsgsk.com United Kingdom GlaxoSmithKline UK Tel 44 0808 100 9997 customercontactukgsk.com
Lietuva
GlaxoSmithKline Lietuva UAB
Tel. +370 5 264 90 00
info.lt@gsk.com
This leaflet was last approved in
------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
A fine white deposit with a clear colourless supernatant may be observed upon storage of the vial. This does not constitute a sign of deterioration.
The content of the vial should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to administration. In the event of either being observed, discard the vaccine.
The vaccine should be allowed to reach room temperature before use.
The vaccine should be well shaken before use.
The vaccine is for intramuscular use only. Do not administer intravascularly.
If Synflorix is co-administered with other vaccines, different injection sites should be used.
Synflorix should not be mixed with other vaccines. If a vaccine dose is withdrawn into a syringe for injection, the needle used for withdrawal must be replaced by a needle suitable for intramuscular injection.
Any unused product or waste material should be disposed of in accordance with local requirements.