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AstraZeneca

Tritanrix HepB
diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)

PACKAGE LEAFLET: INFORMATION FOR THE USER


Tritanrix HepB suspension for injection

Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)


Read all of this leaflet carefully before your child starts receiving this vaccine.


What Tritanrix HepB looks like and contents of the pack


Medicinal product no longer authorised

Suspension for injection.


Tritanrix HepB is a white, slightly milky liquid presented in a glass vial for 1 dose (0.5 ml). Tritanrix HepB is available in pack of 1.

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:


België/Belgique/Belgien GlaxoSmithKline s.a./n.v. Tél/Tel: + 32 2 656 21 11

Luxembourg/Luxemburg GlaxoSmithKline s.a./n.v. Tél/Tel: + 32 2 656 21 11


България ГлаксоСмитКлайн ЕООД ул. Димитър Манов бл.10 София 1408

Тел. + 359 2 953 10 34

Magyarország GlaxoSmithKline Kft. Tel.: + 36-1-2255300


Česká republika GlaxoSmithKline s.r.o. Tel: + 420 2 22 00 11 11

gsk.czmail@gsk.com

Malta GlaxoSmithKline Malta Tel: + 356 21 238131

Danmark

GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00

info@glaxosmithkline.dk

Nederland GlaxoSmithKline BV Tel: + 31 (0)30 69 38 100

nlinfo@gsk.com


Deutschland

GlaxoSmithKline GmbH & Co. KG Tel: + 49 (0)89 360448701

produkt.info@gsk.com

Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 00

firmapost@gsk.no


Eesti

GlaxoSmithKline Eesti OÜ Tel: +372 667 6900

estonia@gsk.com

Österreich

GlaxoSmithKline Pharma GmbH. Tel: + 43 1 970 75-0

at.info@gsk.com


Ελλάδα

GlaxoSmithKline A.E.B.E Tηλ: + 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-ci@gsk.com

Portugal

Smith Kline & French Portuguesa, Produtos Farmacêuticos, Lda.

Tel: + 351 21 412 95 00

FI.PT@gsk.com


France

Medicinal product no longer authorised

Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44

diam@gsk.com

România

GlaxoSmithKline (GSK) SRL Tel: +40 (0)21 3028 208


Ireland

GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 4955000

Slovenija GlaxoSmithKline d.o.o. Tel: + 386 (0) 1 280 25 00

medical.x.si@gsk.com


Ísland GlaxoSmithKline ehf. Sími: +354-530 3700

Slovenská republika GlaxoSmithKline Slovakia s.r.o. Tel: + 421 (0)2 48 26 11 11

recepcia.sk@gsk.com


Italia

GlaxoSmithKline S.p.A. Tel:+ 39 04 59 21 81 11

Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 10 30 30 30

Finland.tuoteinfo@gsk.com


Κύπρος

GlaxoSmithKline (Cyprus) Ltd

Τηλ: + 357 22 39 70 00

Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00

info.produkt@gsk.com


Latvija

GlaxoSmithKline Latvia SIA Tel: + 371 67312687

lv-epasts@gsk.com

United Kingdom GlaxoSmithKline UK Tel: + 44 (0)808 100 9997

customercontactuk@gsk.com


Lietuva

GlaxoSmithKline Lietuva UAB

Tel: +370 5 264 90 00

info.lt@gsk.com


This leaflet was last approved in

https://www.emea.europa.eu/.


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The following information is intended for medical or healthcare professionals only: Tritanrix HepB can be mixed with the lyophilised Hib vaccine (Hiberix).

Upon storage, a white deposit and clear supernatant can be observed. This does not constitute a sign of deterioration.


Medicinal product no longer authorised

The vaccine should be well shaken in order to obtain a homogeneous turbid white suspension and be inspected visually for any foreign particulate matter and/or variation of physical aspect. In the event of either being observed, discard the container.