What Cervarix contains
- The active substances are:
Human PapillomavirusHuman Papillomavirus1 type 16 L1 protein2,3,41 type 18 L1 protein2,3,420 micrograms 20 micrograms
1Human Papillomavirus HPV
2adjuvanted by AS04 containing 3-O-desacyl-4- monophosphoryl lipid A MPL350 micrograms
3adsorbed on aluminium hydroxide, hydrated AlOH33 0.5 milligrams Al in total
4L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from the insect Trichoplusia ni.
- The other ingredients are sodium chloride (NaCl), sodium dihydrogen phosphate dihydrate (NaH 2PO 4.2 H 2O) and water for injections.
What Cervarix looks like and contents of the pack
Suspension for injection.
Cervarix is a turbid white suspension.
Cervarix is available in vials for 1 dose (0.5 ml) in packs of 1, 10 and 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 medicinal product, 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
Malta GlaxoSmithKline Malta Tel 356 21 238131 eská republika 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 02 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
Cervarix should be administered as soon as possible after being removed from the
refrigerator. However, stability data generated indicate that Cervarix presented in
monodose containers remains stable and can be administered in case it has been stored outside the refrigerator up to three days at temperatures between 8°C and 25°C or up to one day at temperatures between 25°C and 37°C.
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 well shaken before use.
Any unused product or waste material should be disposed of in accordance with local requirements.