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AstraZeneca

Fendrix
hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)

Package leaflet: Information for the user


Fendrix suspension for injection

Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)


Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.


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 Pharmaceuticals SA/NV Tél/Tel: + 32 10 85 52 00

Lietuva

GlaxoSmithKline Biologicals SA Tel. +370 80000334


България

GlaxoSmithKline Biologicals SA

Тел. +359 80018205

Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals SA/NV Tél/Tel: + 32 10 85 52 00


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

cz.info@gsk.com

Magyarország

GlaxoSmithKline Biologicals SA Tel.: +36 80088309


Danmark

GlaxoSmithKline Pharma A/S

Tlf: + 45 36 35 91 00

dk-info@gsk.com

Malta

GlaxoSmithKline Biologicals SA

Tel: +356 80065004


Deutschland

GlaxoSmithKline GmbH & Co. KG

Tel: + 49 (0)89 360448701

produkt.info@gsk.com

Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081100


Eesti

GlaxoSmithKline Biologicals SA

Tel: +372 8002640

Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 00

Ελλάδα

GlaxoSmithKline Μονοπρόσωπη A.E.B.E. Tηλ: + 30 210 68 82 100

Österreich

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

at.info@gsk.com


España GlaxoSmithKline, S.A. Tel: + 34 900 202 700

es-ci@gsk.com

Polska

GSK Services Sp. z o.o.

Tel.: + 48 (22) 576 9000


France

Laboratoire GlaxoSmithKline

Tél: + 33 (0) 1 39 17 84 44

diam@gsk.com


Hrvatska

GlaxoSmithKline Biologicals SA

Tel.: +385 800787089

Portugal

Smith Kline & French Portuguesa - Produtos

Farmacêuticos, Lda. Tel: + 351 21 412 95 00

FI.PT@gsk.com


România

GlaxoSmithKline Biologicals SA

Tel: +40 800672524


Ireland

GlaxoSmithKline (Ireland) Ltd

Tel: + 353 (0)1 495 5000

Slovenija

GlaxoSmithKline Biologicals SA

Tel: +386 80688869


Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika GlaxoSmithKline Biologicals SA Tel: +421 800500589


Italia

GlaxoSmithKline S.p.A.

Tel: + 39 (0) 45 7741111

Suomi/Finland

GlaxoSmithKline Oy

Puh/Tel: + 358 (0)10 30 30 30


Κύπρος

GlaxoSmithKline Biologicals SA

Τηλ: +357 80070017

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

info.produkt@gsk.com


Latvija

GlaxoSmithKline Biologicals SA

Tel: +371 80205045

United Kingdom (Northern Ireland) GlaxoSmithKline Biologicals SA

Tel: +44(0)800 221441

customercontactuk@gsk.com


This leaflet was last revised in

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The following information is intended for healthcare professionals only:

Upon storage, a fine white deposit with a clear colourless supernatant can be observed. Before administration, the vaccine should be well shaken to obtain a slightly opaque, white

suspension.

The vaccine should be visually inspected both before and after re-suspension for any foreign particulate matter and/or change in physical appearance. The vaccine must not be used if any change in the appearance of the vaccine has taken place.


Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


Fendrix should not be given to subjects with hypersensitivity to the active substance or to any of the excipients.


Fendrix should not be given to subjects with hypersensitivity after previous administration of other hepatitis B vaccines.


Fendrix should not be given to subjects suffering from acute severe febrile illness. The presence of a minor infection such as a cold, is not a contraindication for immunisation.


Fendrix should be injected intramuscularly in the deltoid region.


Since intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, this route should be avoided.


Fendrixshouldundernocircumstancesbeadministeredintradermallyorintravenously.


As pre-haemodialysis and haemodialysis patients are particularly exposed to HBV and have a higher risk to become chronically infected, a precautionary attitude should be considered i.e. giving a booster dose in order to ensure a protective antibody level as defined by national recommendations and guidelines.


Appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.