What Tritanrix HepB contains
- The active substances contained in 1 dose (0.5 ml) are: Diphtheria toxoid 1? 30 IU Tetanus toxoid 1? 60 IU Bordetella pertussis (inactivated) 2? 4 IU Hepatitis B surface antigen 2,310 µg
123 adsorbed on aluminium hydroxide, hydrated 0.26 mg Al3 adsorbed on aluminium phosphate 0.37 mg Al3 produced in yeast cells Saccharomyces cerevisiae by recombinant DNA technology
- The other ingredients in Tritanrix HepB are: thiomersal, sodium chloride and water for injections.
What Tritanrix HepB looks like and contents of the pack
Suspension for injection, multidose.
Tritanrix HepB is a white, slightly milky liquid presented in a glass vial for 2 doses (1 ml) or in a glass vial for 10 doses (5 ml).
Tritanrix HepB is available in the following pack sizes:
For 2 doses: pack size of 1
For 10 doses: pack size of 1
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
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 infoglaxosmithkline.dk 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 United Kingdom GlaxoSmithKline UK
Tel 371 67312687 lv-epastsgsk.com 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
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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.
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.
When using a multidose vial, each dose should be taken with a sterile needle and syringe. As with other vaccines, a dose of vaccine should be withdrawn under strict aseptic conditions and precautions taken to avoid contamination of the contents.