What Rotarix contains
- The active substances are:
Human rotavirus RIX4414 strain live, attenuated not less than 106.0 CCID50
*Produced on Vero cells
- The other ingredients in Rotarix are: sucrose, Di-sodium Adipate, Dulbecco?s Modified Eagle Medium (DMEM), sterile water
What Rotarix looks like and contents of the packOral
Rotarix is supplied as clear and colourless liquid in a single dose squeezable tube (1.5 ml).
Rotarix is available in a pack of 1, 10 or 50.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Biologicals s.a.Rue de l?Institut 89
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
Malta GlaxoSmithKline Malta Ltd Tel 356 21 238131 eská republika GlaxoSmithKline s.r.o. Tel 420 2 22 00 11 11 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 Smith Kline French Portuguesa, 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
GlaxoSmithKline Lietuva UAB
Tel: +370 5 264 90 00
This leaflet was last approved in
The vaccine is presented as a clear, colourless liquid, free of visible particles, for oral
The vaccine is ready to use (no reconstitution or dilution is required).
The vaccine is to be administered orally without mixing with any other vaccines or solutions.
The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed, discard the vaccine.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Instructions for administration of the vaccine:
1. Pull off the cap from the top of the tube.
2. Turn the cap upside-down and replace the cap vertically over the tip seal as shown in the diagram.
3. Twist the cap to remove the tip seal (do not snap it off) leaving a hole through which the vaccine can be expelled.
4. Ensure that the tip seal has been properly removed. A hole should be clearly visible at the tip of the tube and the tip seal should be inside the top of the tube cap. In the event that the tip seal is accidentally pushed into the tube, discard the vaccine. This is just a precaution, since it is unlikely that the tip seal could be expelled from the tube while administering the vaccine.
5. This vaccine is for oral administration only. The child should be seated in a reclining position. Administer orally (i.e. into the child?s mouth,towards the inner cheek) the entire content of the tube by gently squeezing the tube several times. (A residual drop may remain in the tip of the tube).
Tube Cap Tip seal Tube 1. Pull off the cap from the top of the tube. 2. Turn the cap upside-down and replace the cap vertically over the tip seal as shown in the diagram. Tube tip Tip seal 3. Twist the cap to remove the tip seal do 4. Ensure that the tip seal has been 5. This vaccine is for oral administration not snap it off leaving a hole through properly removed. A hole should be clearly only. The child should be seated in a which the vaccine can be expelled. visible at the tip of the tube and reclining position. Administer orally i.e. the tip seal should be inside the top into the childs mouth, towards the inner of the tube cap. cheek the entire content of the tube by In the event that the tip seal is accidentally gently squeezing the tube several times. pushed into the tube, discard the vaccine. A residual drop may remain in the tip of This is just a precaution, since it is unlikely the tube. that the tip seal could be expelled from the tube while administering the vaccine.
Discard the empty tube and cap in approved biological waste containers according to local regulations.
GROUNDS FOR ONE ADDITIONAL RENEWAL
GROUNDS FOR ONE ADDITIONAL RENEWAL
Based upon the data that have become available since the granting of the Marketing Authorisation, the CHMP considers that the benefit-risk balance of Rotarix remains positive, but considers that its safety profile is to be closely monitored for the following reasons :
Final data from post-authorisation safety studies are still awaited and the CHMP considers that the Rotarix safety profile remains to be closely monitored. Given the remaining questions regarding the risk of intussusception (IS) following administration of Rotarix, the regulatory authorities should be kept updated of the results of the ongoing post-authorisation safety studies to further study IS, as well as analyses of spontaneously reported IS cases. The CHMP considers that more safety experience needs to be gained about IS and recommended that the MAH should continue to submit yearly PSURs. Therefore, based on the safety profile of Rotarix, which requires the submission of yearly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.