Fendrix

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Fendrix suspension for injection 
Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).  
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION  

 
1 dose (0.5 ml) contains:  
 
Hepatitis B surface antigen 1, 2, 3 20 micrograms 
 
1adjuvanted by AS04C containing: 

- 3-O-desacyl-4’- monophosphoryl lipid A (MPL) 2  50 micrograms 
 

2adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total)  
 
3produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology. 
 
For the full list of excipients, see section 6.1 
 
 
3. PHARMACEUTICAL FORM 
 
Suspension for injection. 
 
Turbid white suspension. Upon storage, a fine white deposit with a clear colourless supernatant can be 
observed. 
 
 
4.  CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Fendrix is indicated in adolescents and adults from the age of 15 years onwards for active 
immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with 
renal insufficiency (including pre-haemodialysis and haemodialysis patients). 
 
4.2 Posology and method of administration 
 
Posology 
 
Primary immunisation: 
 
The primary immunisation consists of 4 separate 0.5 ml doses administered at the following schedule: 
1 month, 2 months and 6 months from the date of the first dose.  
 
Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with 
Fendrix, and not with other commercially available HBV vaccine. 
 
Booster dose: 
 
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.  



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Fendrix can be used as a booster dose after a primary vaccination course with either Fendrix or any 
other commercial recombinant hepatitis B vaccine. 
 
Special posology recommendation for known or presumed exposure to HBV: 
 
Data on concomitant administration of Fendrix with specific hepatitis B immunoglobulin (HBIg) have 
not been generated. However, in circumstances where exposure to HBV has recently occurred (e.g. 
stick with contaminated needle) and where simultaneous administration of Fendrix and a standard 
dose of HBIg is necessary, these should be given at separate injection sites. 
 
Paediatric population 
 
The safety and efficacy of Fendrix in children aged less than 15 years have not been established. 
 
Method of administration 
 
Fendrix should be injected intramuscularly in the deltoid region. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  
 
Hypersensitivity after previous administration of other hepatitis B vaccines.  
 
The administration of Fendrix should be postponed in subjects suffering from acute severe febrile 
illness. The presence of a minor infection such as a cold, is not a contraindication for immunisation. 
 
4.4 Special warnings and precautions for use 
 
As with all injectable vaccines, appropriate medical treatment and supervision should always be 
readily available in case of rare anaphylactic reactions following the administration of the vaccine. 
 
Because of the long incubation period of hepatitis B, it is possible that subjects could have been 
infected before the time of immunisation. The vaccine may not prevent hepatitis B infection in such 
cases. 
 
The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and 
hepatitis E or other pathogens known to infect the liver. 
 
As with any vaccine, a protective immune response may not be elicited in all vaccinees.  
 
A number of factors have been observed to reduce the immune response to hepatitis B vaccines. These 
factors include older age, male gender, obesity, smoking, route of administration, and some chronic 
underlying diseases. Consideration should be given to serological testing of those subjects who may be 
at risk of not achieving seroprotection following a complete course of Fendrix. Additional doses may 
need to be considered for subjects who do not respond or have a sub-optimal response to a course of 
vaccinations. 
 
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. 
 
Patients with chronic liver disease or with HIV infection or hepatitis C carriers should not be 
precluded from vaccination against hepatitis B. The vaccine could be advised since HBV infection can 



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be severe in these patients: the Hepatitis B vaccination should thus be considered on a case-by-case 
basis by the physician.  
 
Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a 
psychogenic response to the needle injection. This can be accompanied by several neurological signs 
such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It 
is important that procedures are in place to avoid injury from faints. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No data on the concomitant administration of Fendrix and other vaccines or with specific hepatitis B 
immunoglobulin have been generated. If concomitant administration of specific hepatitis B 
immunoglobulin and Fendrix is required, these should be given at different injection sites. As no data 
are available for the concomitant administration of this particular vaccine with other vaccines, an 
interval of 2 to 3 weeks should be respected. 
 
It may be expected that in patients receiving immunosuppressive treatment or patients with 
immunodeficiency, an adequate immune response may not be elicited. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no data from the use of Fendrix in pregnant women. 
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, 
embryonal/foetal development, parturition or postnatal development. 
Vaccination during pregnancy should only be performed if the risk-benefit ratio at individual level 
outweighs possible risks for the foetus. 
 
Breast-feeding 
 
There are no data from use of Fendrix during lactation. In a reproductive toxicity study in animals 
which included post-natal follow-up until weaning (see section 5.3), no effect on the development of 
the pups was observed.  Vaccination should only be performed if the risk-benefit ratio at individual 
level outweighs possible risks for the infant. 
 
Fertility 
 
No fertility data are available. 
 
4.7 Effects on ability to drive and use machines 
 
Fendrix has moderate influence on the ability to drive and use machine.  
 
Some of the undesirable effects mentioned under section 4.8 may affect the ability to drive or use 
machines. 
 
4.8 Undesirable effects  
 
Summary of the safety profile 



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Clinical trials involving the administration of 2,476 doses of Fendrix to 82 pre-haemodialysis and 
haemodialysis patients and to 713 healthy subjects ≥ 15 years of age allowed to document the 
reactogenicity of the vaccine.  
 
Pre-haemodialysis and haemodialysis patients 
 
The reactogenicity profile of Fendrix in a total of 82 pre-haemodialysis and haemodialysis patients 
was generally comparable to that seen in healthy subjects.  
 
List of adverse reactions 
 
Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and 
considered as being related or possibly related to vaccination have been categorised by frequency. 
 
Frequencies are reported as: 
Very common: (≥1/10) 
Common: (≥1/100 to <1/10) 
Uncommon: (≥1/1,000 to <1/100) 
Rare:   (≥1/10,000 to <1/1,000) 
Very rare:  (<1/10,000) 
 
Clinical trial data 
 
Nervous system disorders: 
Very common: headache 
 
Gastrointestinal disorders: 
Common: gastrointestinal disorder 
 
General disorders and administration site conditions: 
Very common: fatigue, pain  
Common: fever, injection site swelling, redness  
 
Unsolicited symptoms considered to be at least possibly related to vaccination were uncommonly 
reported and consisted of rigors, other injection site reaction and maculo-papular rash. 
 
Healthy subjects 
 
The reactogenicity profile of Fendrix in healthy subjects was generally comparable to that seen in pre-
haemodialysis and haemodialysis patients.  
 
In a large double-blind randomised comparative study, healthy subjects were enrolled to receive a 
three dose primary course of Fendrix (N= 713) or a commercially available hepatitis B vaccine       
(N= 238) at 0, 1, 2 months. The most common adverse reactions reported were local reactions at the 
injection site.  
Vaccination with Fendrix induced more transient local symptoms as compared to the comparator 
vaccine, with pain at the injection site being the most frequently reported solicited local symptom. 
However, solicited general symptoms were observed with similar frequencies in both groups.  
 
Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and 
considered as being at least possibly related to vaccination have been categorised by frequency.  
 
Nervous system disorders: 
Common: headache 
 
Ear and labyrinth disorders: 



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Rare: vertigo 
 
Gastrointestinal disorders: 
Common: gastrointestinal disorder 
 
Muskuloskeletal and connective tissue disorders: 
Rare: tendinitis, back pain 
 
Infections and infestations: 
Rare: viral infection  
 
General disorders and administration site conditions: 
Very common: injection site swelling, fatigue, pain, redness 
Common: fever  
Uncommon: other injection site reaction 
Rare: rigors, hot flushes, thirst, asthenia 
 
Immune system disorders: 
Rare: allergy 
 
Psychiatric disorders: 
Rare: nervousness 
 
No increase in the incidence or severity of these adverse reactions was seen with subsequent doses of 
the primary vaccination schedule.  
 
No increase in the reactogenicity was observed after the booster vaccination with respect to the 
primary vaccination.  
 
• Experience with hepatitis B vaccine: 
 
Following widespread use of hepatitis B vaccines, in very rare cases, syncope, paralysis, neuropathy, 
neuritis (including Guillain-Barré syndrome, optic neuritis and multiple sclerosis), encephalitis, 
encephalopathy, meningitis and convulsions have been reported.  The causal relationship to the 
vaccine has not been established. 
 
Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness have 
also been reported very rarely with hepatitis B vaccines. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Limited data on overdose are available.  
 
 
5.  PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Vaccines, hepatitis vaccines, ATC code J07BC01. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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Fendrix induces specific humoral antibodies against HBsAg (anti-HBs antibodies).  An anti-HBs 
antibody titre ≥ 10 mIU/ml correlates with protection to HBV infection. 
 
It can be expected that hepatitis D will also be prevented by immunisation with Fendrix as hepatitis D 
(caused by the delta agent) does not occur in the absence of hepatitis B infection. 
 
Immunological data 
 
In pre-haemodialysis and haemodialysis patients: 
In a comparative clinical study in 165 pre-haemodialysis and haemodialysis patients (15 years and 
above), protective levels of specific humoral antibodies (anti-HBs titres ≥ 10 mIU/ml) were observed 
in 74.4% of Fendrix recipients (N = 82) one month after the third dose (i.e at month 3), as compared to 
52.4% of patients in the control group who received a double dose of a commercially available 
hepatitis B vaccine (N = 83) for this population. 

 
At month 3, Geometric Mean Titres (GMT) were 223.0 mIU/ml and 50.1 mIU/ml in the Fendrix and 
control groups respectively, with 41.0% and 15.9% of subjects with anti-HBs antibody titres ≥100 
mIU/ml respectively. 

 
After completion of a four dose primary course (i.e at month 7), 90.9% of Fendrix recipients were 
seroprotected (≥ 10 mIU/ml) against hepatitis B, in comparison with 84.4% in a control group who 
received the commercially available hepatitis B vaccine. 

 
At month 7, GMTs were 3559.2 mIU/ml and 933.0 mIU/ml in the Fendrix and control groups who 
received the commercially available hepatitis B vaccine respectively, with 83.1% and 67.5% of 
subjects with anti-HBs antibody titres ≥100 mIU/ml respectively. 
 
Antibody persistence 
 
In pre-haemodialysis and haemodialysis patients: 
Anti-HBs antibodies have been shown to persist for at least 36 months following a 0, 1, 2, 6 month 
primary course of Fendrix in pre-haemodialysis and haemodialysis patients. At month 36, 80.4% of 
these patients retained protective antibody levels (anti-HBs titres  ≥ 10mIU/ml), as compared to 51.3% 
of patients who received a commercially available hepatitis B vaccine. 
 
At month 36, GMTs were 154.1 mIU/ml and 111.9 mIU/ml in the Fendrix and control groups 
respectively, with 58.7% and 38.5% of subjects with anti-HBs antibody titres ≥100 mIU/ml 
respectively. 
 
5.2 Pharmacokinetic properties 
 
Pharmacokinetic properties of Fendrix or MPL alone has not been studied in humans. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional animal studies consisting 
of acute and repeated dose toxicity, cardiovascular and respiratory safety pharmacology and 
reproductive toxicity including pregnancy and peri and postnatal development of the pups till weaning 
(see section 4.6). 
 
 
6.  PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium chloride 
Water for injections  



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For adjuvants, see section 2. 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
3 years. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C – 8°C). 
 
Do not freeze. 
 
Store in the original package in order to protect from light. 
 
6.5 Nature and contents of container 
 
0.5 ml of suspension in pre-filled syringe (type I glass) with a plunger stopper (rubber butyl) with or 
without separate needle in a pack size of 1, or without needles in a pack size of 10. 
Not all pack sizes may be marketed. 
  
6.6 Special precautions for disposal and other handling 
 
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. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l'Institut 89 
B-1330 Rixensart, Belgium 
 
 
8.  MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/04/0299/001 
EU/1/04/0299/002 
EU/1/04/0299/003 
 
 
9.  DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 



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Date of first authorisation: 02 February 2005 
Date of latest renewal: 10 December 2009 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this product is available on the website of the European Medicines Agency  
http://www.ema.europa.eu 



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ANNEX II 
 
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 

SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR 
BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 



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A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 

MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer of the biological active substance 
 
GlaxoSmithKline Biologicals S.A. 
89, rue de l’Institut – 1330 Rixensart 
Belgium 
 
Name and address of the manufacturer responsible for batch release 
 
GlaxoSmithKline Biologicals S.A. 
89, rue de l’Institut – 1330 Rixensart 
Belgium 
 
 
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription 
 
• Official batch release 
 
In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken 
by a state laboratory or a laboratory designated for that purpose. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic Safety Update Reports 
 
The marketing authorisation holder shall submit periodic safety update reports for this product in 
accordance with the requirements set out in the list of Union reference dates (EURD list) provided for 
under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 
 
Not applicable.



 12  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 



 13  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 



 14  

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
1 PRE-FILLED SYRINGE WITH SEPARATE NEEDLE 
1 PRE-FILLED SYRINGE WITHOUT NEEDLE 
10 PRE-FILLED SYRINGES WITHOUT NEEDLES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Fendrix suspension for injection 
Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 dose (0.5 ml):  
Hepatitis B surface antigen1, 2, 3 20 micrograms 
 
1adjuvanted by AS04C containing: 

- 3-O-desacyl-4’- monophosphoryl lipid A (MPL) 2  50 micrograms 
 

2adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total)  
 
3produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium chloride 
Water for injections  
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection 
 
1 pre-filled syringe 
1 separate needle 
1 dose (0.5 ml) 
 
1 pre-filled syringe 
1 dose (0.5 ml) 
 
10 pre-filled syringes 
1 dose (0.5 ml) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Intramuscular use 
Shake well before use 
Read the package leaflet before use 
 
 



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6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Do not freeze 
Store in the original package in order to protect from light 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
B-1330 Rixensart, Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/04/0299/001 – pack of 1 with separate needle 
EU/1/04/0299/002 – pack of 1 without needle 
EU/1/04/0299/003 – pack of 10 without needles 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 



 16  

 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 



 17  

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
 
PREFILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Fendrix suspension for injection 
IM 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot  
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 dose (0.5 ml) 
 
 
6. OTHER 
 



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B. PACKAGE LEAFLET 
 



 19  

 
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. 
• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor or pharmacist. 
• This vaccine has been prescribed for you only. Do not pass it on to others. 
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet: 
1. What Fendrix is and what it is used for 
2. What you need to know before you receive Fendrix  
3. How Fendrix is given 
4. Possible side effects 
5. How to store Fendrix 
6. Contents of the pack and other information 
 
 
1. What Fendrix is and what it is used for 
 
Fendrix is a vaccine which prevents hepatitis B.  
It is used for patients with kidney problems: 
• patients having “haemo-dialysis”- where a “dialysis” machine removes waste products from the 

blood 
• patients who are going to have “haemo-dialysis” in the future. 
 
Fendrix is for adults and young people aged 15 years and above. 
 
What is hepatitis B? 
 
Hepatitis B is caused by a virus which makes the liver swollen.   
• Signs may not be seen for 6 weeks to 6 months after infection. 
• The main signs of the illness include mild signs of flu such as headache or fever, feeling very 

tired, dark urine, pale stools (faeces), yellow skin or eyes (jaundice). These or other signs may 
mean the person might need treatment in hospital. Most people fully recover from the illness. 

• Some people with hepatitis B do not look or feel ill - they do not have any signs of illness. 
• The virus is found in body fluids such as in the vagina, blood, semen, or saliva (spit). 
 
Carriers of hepatitis B 
 
• The hepatitis B virus stays in the body of some people all through their lives. 
• This means they can still infect other people and are known as virus “carriers”. 
• Carriers of the virus are likely to get serious liver problems, such as “cirrhosis” or liver cancer. 
 
How Fendrix works 
 
• Fendrix helps your body to produce its own protection against the virus (antibodies). These 

antibodies will protect you against the disease. 
• Fendrix contains two things called “MPL” (a non-toxic purified fat derivative from bacteria) and 

“aluminium phosphate”. These make the vaccine work quicker, better and last for longer. 
• As with all vaccines, a course of Fendrix cannot fully protect all people that are vaccinated. 



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• Fendrix may not protect you from being ill if you have already caught the hepatitis B virus. 
• Fendrix can only help to protect you against infection with the hepatitis B virus. It cannot protect 

you against other infections that can affect the liver - even though these infections might have 
signs similar to those caused by the hepatitis B virus. 

 
 
2.  What you need to know before you receive Fendrix 
 
Fendrix should not be given 
 
• if you are allergic to the active substance, or any of the other ingredients of this vaccine (listed 

in section 6). Signs of an allergic reaction may include itchy skin rash, shortness of breath and 
swelling of the face or tongue 

• if you have ever had an allergic reaction to any vaccine against hepatitis B 
• if you have a severe infection with a high temperature. The vaccine can be given after you have 

recovered. A minor infection such as a cold should not be a problem, but talk to your doctor 
first. 
 

Fendrix should not be given if any of the above apply to you. If you are not sure, talk to your doctor or 
pharmacist before having Fendrix. 
 
Warnings and precautions 
 
Talk to your doctor or pharmacist before you are given Fendrix: 
 
• if you have any known allergies 
• if you have had any health problems after having a vaccine in the past. 
 
Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore 
tell the doctor or nurse if you fainted with a previous injection. 
 
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before having 
Fendrix. 
 
Other medicines and Fendrix 
 
Tell your doctor if you are taking, have recently taken, might take any other medicines or have 
recently received any other vaccine. 
 
• You should have a gap of at least 2 to 3 weeks between having Fendrix and any other vaccine. 
• Fendrix may need to be given at the same time as an injection of hepatitis B “immuno-globulins”. 

Your doctor will make sure that the vaccines are injected into different parts of the body. 
 
Pregnancy, breast-feeding and fertility 
 
If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, 
ask your doctor for advice before you are given this vaccine. 
 
Driving and using machines 
 
You may feel tired or get a headache after receiving Fendrix. If this happens, take special care while 
driving or using any tools or machines. 
 
 
3. How Fendrix is given 
 
How the vaccine is given 



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The doctor or nurse will give Fendrix as an injection into your muscle. This is usually in your upper 
arm. 
 
How much is given 
• You will have a series of four injections. 
• The injections will be given within 6 months: 

- First injection   - on a date agreed with your doctor. 
- Second injection  - 1 month after the first injection. 
- Third injection   - 2 months after the first injection. 
- Fourth injection   - 6 months after the first injection. 

 
• The doctor or nurse will tell you when you should come back for the next injections. 
 
• Once you have had the first injection of Fendrix, the next injections need also to be Fendrix (not 

another sort of hepatitis B vaccine). 
 
Your doctor will tell you if you need any extra or “booster” injections in the future. Fendrix can also 
be used as a booster after a course of a different type of hepatitis B vaccine. 
 
If you miss a dose 
 
• If you miss an injection, talk to your doctor and arrange another visit. 
• Make sure you finish the complete course of four injections. If not, you may not be fully protected 

against the disease. 
 
 
4.  Possible side effects 
 
Like all medicines, this vaccine can cause side effects, although not everybody gets them. 
 
The following side effects may happen with this vaccine. Their frequency is defined using the 
conventions listed below: 
 
Very common (these may occur with more than 1 in 10 doses of the vaccine)  

• headache   
• feeling tired 
• pain or discomfort where the injection was given. 

 
Common (these may occur with up to 1 in 10 doses of the vaccine) 

• redness or swelling where the injection was given  
• fever  
• stomach and digestion problems. 

 
Uncommon (these may occur with up to 1 in 100 doses of the vaccine) 

• chills  
• red, raised skin rash  
• other reactions where the injection was given. 

 
Rare (these may occur with up to 1 in 1,000 doses of the vaccine) 

• allergy  
• hot flushes  
• feeling dizzy  
• feeling thirsty 
• feeling nervous  
• infection caused by a virus 
• back pain, swelling of your tendons. 



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Additionally, the following side effects have also been reported with other hepatitis B vaccines: 
 
Very rare (these may occur with up to 1 in 10,000 doses of the vaccine) 

• fits 
• fainting 
• problems with the nerves of your eye (optic neuritis) 
• multiple sclerosis 
• loss of feeling or problems moving some parts of your body 
• severe headache with a stiff neck 
• numbness or weakness of the arms and legs (neuropathy), inflammation of nerves 

(neuritis), weakness and paralysis in the extremities and often progressing to the chest and 
face (Guillain-Barré syndrome), swelling or infection of the brain (encephalitis, 
encephalopathy). 

• allergic reactions, including anaphylactoid reactions.  These may be local or widespread 
rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing 
or swallowing, a sudden drop in blood pressure and loss of consciousness.  Such reactions 
may occur before leaving the doctor’s surgery.  However, you should seek immediate 
treatment in any event.  

 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5.  How to store Fendrix 
 
• Keep this vaccine out of the sight and reach of children. 
 
• Do not use this vaccine after the expiry date which is stated on the carton. The expiry date refers 

to the last day of that month. 
 
• Store in a refrigerator (2°C - 8°C). 
• Store in the original package in order to protect from light. 
• Do not freeze.  Freezing destroys the vaccine. 
 
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how 

to throw away medicines you no longer use. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Fendrix contains 
 
• The active substance in 1 dose (0.5 ml) of Fendrix is:  
 
Hepatitis B surface antigen 1, 2, 3 20 micrograms 
 
1adjuvanted by AS04C containing: 

- 3-O-desacyl-4’- monophosphoryl lipid A (MPL) 2  50 micrograms 
 
2adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total)  
 
3produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology. 



 23  

 
• 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. 
 
België/Belgique/Belgien 
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Tél/Tel: + 32 10 85 52 00 
 

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel. +370 5 264 90 00 
info.lt@gsk.com 
 

България 
ГлаксоСмитКлайн ЕООД 
Тел. + 359 2 953 10 34 

Luxembourg/Luxemburg 
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
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 Kft. 
Tel.: + 36-1-2255300 

Danmark 
GlaxoSmithKline Pharma A/S 
Tlf: + 45 36 35 91 00 
dk-info@gsk.com 
 

Malta 
GlaxoSmithKline (Malta) Ltd 
Tel: + 356 21 238131 
 

Deutschland 
GlaxoSmithKline GmbH & Co. KG 
Tel: + 49 (0)89 360448701 
produkt.info@gsk.com 
 

Nederland 
GlaxoSmithKline BV 
Tel: + 31 (0)30 69 38 100 
nlinfo@gsk.com 
 

Eesti 
GlaxoSmithKline Eesti OÜ  
Tel: +372 667 6900 
estonia@gsk.com 
 

Norge 
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
firmapost@gsk.no 
 
 

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

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



 24  

 at.info@gsk.com 
 
España 
GlaxoSmithKline, S.A. 
Tel: + 34 902 202 700 
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 d.o.o. 
Tel.: + 385 (0)1 6051999 
 

Portugal 
Smith Kline & French Portuguesa - Produtos 
Farmacêuticos, Lda. 
Tel: + 351 21 412 95 00 
FI.PT@gsk.com 
 
România 
GlaxoSmithKline (GSK) SRL 
Tel: +40 (0)21 3028 208 
 

Ireland 
GlaxoSmithKline (Ireland) Ltd 
Tel: + 353 (0)1 495 5000 
 

Slovenija 
GlaxoSmithKline d.o.o. 
Tel: + 386 (0) 1 280 25 00 
medical.x.si@gsk.com 
 

Ísland 
Vistor hf.  
Sími: +354 535 7000 

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 
gskcyprus@gsk.com 
 

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)800 221 441 
customercontactuk@gsk.com 
 

  
 
This leaflet was last revised in  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu 
---------------------------------------------------------------------------------------------------------------------- 
 
The following information is intended for healthcare professionals only: 
 
Upon storage, a fine white deposit with a clear colourless supernatant can be observed.  
 

mailto:gskcyprus@gsk.com


 25  

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.   
 
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. 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

	A. LABELLING
	B. PACKAGE LEAFLET

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    /NLD (Gebruik deze instellingen om Adobe PDF-documenten te maken die zijn geoptimaliseerd voor prepress-afdrukken van hoge kwaliteit. De gemaakte PDF-documenten kunnen worden geopend met Acrobat en Adobe Reader 5.0 en hoger.)
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    /ENU (Use these settings to create Adobe PDF documents best suited for high-quality prepress printing.  Created PDF documents can be opened with Acrobat and Adobe Reader 5.0 and later.)
  >>
  /Namespace [
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    (Common)
    (1.0)
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  /OtherNamespaces [
    <<
      /AsReaderSpreads false
      /CropImagesToFrames true
      /ErrorControl /WarnAndContinue
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      ]
      /OmitPlacedBitmaps false
      /OmitPlacedEPS false
      /OmitPlacedPDF false
      /SimulateOverprint /Legacy
    >>
    <<
      /AddBleedMarks false
      /AddColorBars false
      /AddCropMarks false
      /AddPageInfo false
      /AddRegMarks false
      /ConvertColors /ConvertToCMYK
      /DestinationProfileName ()
      /DestinationProfileSelector /DocumentCMYK
      /Downsample16BitImages true
      /FlattenerPreset <<
        /PresetSelector /MediumResolution
      >>
      /FormElements false
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    >>
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>> setdistillerparams
<<
  /HWResolution [2400 2400]
  /PageSize [612.000 792.000]
>> setpagedevice