What Fendrix contains
- The active substance in 1 dose (0.5 ml) of Fendrix is:
Hepatitis B surface antigen 1, 2, 320 micrograms
1adjuvanted by AS04C containing - 3-O-desacyl-4- monophosphoryl lipid A MPL 250 micrograms
2adsorbed on aluminium phosphate 0.5 milligrams Al3 in total
3produced in yeast cells Saccharomyces cerevisiae by recombinant DNA technology.
- The other ingredients in Fendrix are: sodium chloride, water for injections.
What Fendrix looks like and contents of the pack
- Suspension for injection in a prefilled syringe.
- Fendrix is a white, milky suspension presented in a glass prefilled syringe (0.5 ml).
- Fendrix is available in packs of 1 (with or without a separate needle) and in a pack size of 10 without needles.
- 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 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
Polska
GlaxoSmithKline A.E.B.E. T 30 210 68 82 100 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
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
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 vaccine 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.
Fendrix should under no circumstances be administered intradermally or intravenously.
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.