Tritanrix HepB

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Tritanrix HepB, suspension for injection 
Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed) 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
1 dose (0.5 ml) contains: 
 
Diphtheria toxoid1 not less than 30 IU 
Tetanus toxoid1 not less than 60 IU 
Bordetella pertussis (inactivated)2 not less than 4 IU 
Hepatitis B surface antigen 2,3 10 micrograms 
 
1 Adsorbed on aluminium hydroxide, hydrated 0.26 milligrams Al3+ 
2 Adsorbed on aluminium phosphate 0.37 milligrams Al3+ 
3 Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Suspension for injection. 
Turbid white suspension. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Tritanrix HepB is indicated for active immunisation against diphtheria, tetanus, pertussis and hepatitis B 
(HBV) in infants from 6 weeks onwards (see section 4.2). 
 
4.2 Posology and method of administration 
 
Posology 
 
The recommended dose is 0.5 ml. 
 
Primary vaccination: 
 
The primary vaccination schedule consists of three doses within the first six months of life.  Where HBV 
vaccine is not given at birth, the combined vaccine can be administered beginning as early as 8 weeks of age.  
Where there is a high endemicity of HBV, the practice to administer HBV vaccine at birth should be 
continued. In these circumstances, vaccination with the combined vaccine should start at 6 weeks of age. 
 
Three vaccine doses must be administered at intervals of at least 4 weeks. 
 
When Tritanrix HepB is given according to the 6-10-14 weeks schedule, it is recommended to 
administer a dose of HBV vaccine at birth to improve protection. 
 
In the case of children born of known HBV carrier mothers the immunoprophylactic measures for hepatitis B 
should not be modified. This may require separate vaccination with HBV and DTPw vaccines and also 
include the administration of HBIg at birth.  



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Booster vaccination: 
 
A booster dose with Tritanrix HepB will give rise to increased reactogenicity as would be expected for a 
booster during the second year of life. In consequence, boostering should follow local recommendations.   
 
The administration of a booster dose with trivalent DTP vaccine is recommended before the end of the 
second year of life. For long-term protection against HBV, a booster dose of HBV vaccine could also be 
administered after the first year of life. However, the need for this dose is currently not established. 
 
Method of administration 
 
Tritanrix HepB is for deep intramuscular injection, preferably in the anterolateral thigh. 
 
It is recommended that in patients with thrombocytopenia or bleeding disorders the vaccine be administered 
subcutaneously (see section 4.4). 
 
4.3 Contraindications 
 
Hypersensitivity to the active substances or to any of the excipients. 
 
Hypersensitivity after previous administration of diphtheria, tetanus, pertussis or hepatitis B vaccines. 
 
The administration of Tritanrix HepB should be postponed in subjects suffering from acute severe febrile 
illness. 
 
Tritanrix HepB is contraindicated if the child has experienced an encephalopathy of unknown aetiology, 
occurring within 7 days following previous vaccination with pertussis containing vaccine.  In these 
circumstances the vaccination course should be continued with DT and HBV vaccines. 
 
4.4 Special warnings and precautions for use 
 
Vaccination should be preceded by a review of the medical history (especially with regard to previous 
vaccination and possible occurrence of adverse reactions) and a clinical examination. 
 
As with all injectable vaccines, appropriate medical treatment should always be readily available in case of 
anaphylactic reactions following the administration of the vaccine. For this reason, the vaccinee should 
remain under medical supervision for 30 minutes after vaccination. 
 
If any of the following events occur in temporal relation to receipt of Tritanrix HepB, the decision to give 
subsequent doses of vaccine containing the pertussis component should be carefully considered. 

Temperature of ≥ 40.0 C within 48 hours, not due to another identifiable cause. 
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours. 
Persistent crying lasting ≥ 3 hours, occurring within 48 hours. 
Convulsions with or without fever, occurring within 3 days. 

There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh 
possible risks.  
 
As for any vaccination, the risk-benefit of immunising with Tritanrix HepB or deferring this vaccination 
should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe 
neurological disorder. 
A history of febrile convulsions, a family history of convulsions, a family history of SIDS (Sudden Infant 
Death Syndrome) and a family history of an adverse reaction following Tritanrix HepB vaccination do not 
constitute contra-indications. 
 



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HIV infection is not considered as a contra-indication for diphtheria, tetanus, pertussis and HBV vaccination. 
The expected immunological response may not be obtained after vaccination of immunosuppressed patients, 
e.g. patients on immunosuppressive therapy. 
 
Tritanrix HepB should be administered with caution to subjects with thrombocytopenia or a bleeding 
disorder since bleeding may occur following an intramuscular administration to these subjects. 
 
TRITANRIX HepB SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED 
INTRAVENOUSLY. 
 
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when 
administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and 
particularly for those with a previous history of respiratory immaturity. 
 
As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
It is current practice in paediatric vaccination to co-administer different vaccines during the same session 
with injectable vaccines being administered at separate injection sites. 
 
Tritanrix HepB can be administered simultaneously at separate sites or in any temporal relationship with 
other paediatric vaccines if this fits conveniently in the immunisation scheme. 
 
In clinical studies, Tritanrix HepB has been administered simultaneously with oral polio vaccine (OPV) and 
Haemophilus influenzae type b (Hib) vaccine. In these studies the immune response to the oral polio vaccine 
has not been investigated, however, previous experience with simultaneous administration of DTP, OPV and 
HBV vaccines has not shown any interference. In some clinical studies, Tritanrix HepB was used to 
reconstitute the lyophilised Hib vaccine (Hiberix); no interference in the immune response to any of the 
antigens was observed as compared to the responses observed following administration of the vaccines at 
separate sites (see section 6.2). 
 
In patients receiving immunosuppressive therapy or patients with immunodeficiency, an adequate response 
may not be achieved. 
 
4.6 Pregnancy and lactation 
 
As Tritanrix HepB is not intended for use in adults, information on the safety of the vaccine when used 
during pregnancy or lactation is not available. 
 
4.7 Effects on ability to drive and use machines 
 
Not relevant. 
 
4.8 Undesirable effects 
 
• Clinical trials: 
 

In clinical studies, the most commonly reported adverse events were reactions at the injection site, 
including redness, swelling and pain. 
 
General reactions that may occur in temporal association with Tritanrix HepB vaccination are listed 
below. 
 
Frequencies are defined as follows: 
Very common (≥1/10) 
Common (≥1/100 to <1/10) 



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Uncommon (≥1/1,000 to <1/100) 
Rare (≥1/10,000 to <1/1,000) 
Very rare (<1/10,000) 
Not known (cannot be estimated from the available data) 
 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 

 
Nervous system disorders: 
very common: drowsiness 
 
Respiratory, thoracic and mediastinal disorders: 
common: bronchitis  
uncommon: respiratory disorder 
 
Gastro-intestinal disorders: 
very common: feeding problems 
common: gastro-intestinal symptoms such as vomiting and diarrhoea 
 
Infections and infestations: 
common: otitis media, pharyngitis 
uncommon: pneumonia 
 
General disorders and administration site conditions: 
very common: fever, swelling, pain and redness 
 
Immune system disorders: 
very rare: allergic reactions including anaphylactic and anaphylactoid reactions and serum sickness 
like disease 
 
Psychiatric disorders: 
very common: unusual crying, irritability 
 



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In a prospective comparative study, which compared the administration of the combined DTPw-HBV 
vaccine with the simultaneous separate administration of DTPw and HBV vaccine, higher incidences of pain, 
redness, swelling and fever were reported in the group receiving the combined vaccine. The incidences are 
presented below: 
 
 Group 1 Group 2 
 DTPw-HBV 

(combined) 
 DTPw HBV 

(separate) 
N° of symptom checklists 
 

175 
 

177 177 

Local symptoms (%)    
 
Pain Total 

 
32.0 

 
15.3 

 
2.8 

 Severe* 0.0 0.0 0.0 
Redness Total 38.9 27.1 5.1 
 > 2cm 9.1 3.4 0.6 
Swelling Total 30.9 21.5 4.5 
 > 2cm 10.9 3.4 0.6 

 
 
General Symptoms (%) 
 

   

Fever > 38°C 53.1 35.0 
Fever > 39.5° C 1.1 0.0 

 
* reported by the parents as adversely affecting the child’s daily activities  
 
For both vaccination groups, the majority of the reactions were short lasting. 
 
• Post marketing surveillance: 
 

Nervous system disorders: 
Collapse or shock-like state (hypotonic-hyporesponsive episode)  
 
Respiratory, thoracic and mediastinal disorders: 
Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4) 

 
• Experience with hepatitis B vaccine: 
 

Blood and lymphatic system disorders: 
Thrombocytopenia 
 
Nervous system disorders: 
Convulsions 

 
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it 
is possible that sensitisation reactions may occur (see section 4.3) 
 
4.9 Overdose 
 
No case of overdose has been reported. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 



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Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code J07CA05. 
 
Tritanrix HepB contains diphtheria (D), tetanus (T) toxoids, inactivated pertussis bacteria (Pw) and the 
purified major surface antigen of the hepatitis B virus (HBV), adsorbed on aluminium salts. 
 
The D and T toxoids are prepared from the toxins of cultures of Corynebacterium diphtheriae and 
Clostridium tetani by formalin inactivation using established technology.  The Pw component is obtained by 
heat inactivation of phase I culture of Bordetella pertussis bacteria. 
 
The surface antigen of the HBV (HBsAg) is produced by culture of genetically-engineered yeast cells 
(Saccharomyces cerevisiae) which carry the gene coding for the major surface antigen of the HBV.  This 
HBsAg expressed in yeast cells is purified by several physico-chemical steps.  The HBsAg assembles 
spontaneously, in the absence of chemical treatment, into spherical particles of 20 nm in average diameter 
containing non-glycosylated HBsAg polypeptide and a lipid matrix consisting mainly of phospholipids.  
Extensive tests have demonstrated that these particles display the characteristic properties of the natural 
HBsAg. 
 
Four different schedules have been studied (6-10-14 weeks, 2-4-6 months; 3-4-5 months and 3-4½-6 months) 
according to routine vaccination practices in different countries with three doses administered within the first 
six months of life. 
 
For each component of the vaccine, the following immune responses have been documented one month after 
completion of the primary vaccination schedule. 
 
Percentage of subjects with antibody titres ≥ assay cut-off one month after primary vaccination with 
Tritanrix HepB: 
 

6-10-14 weeks 2-4-6 months; 3-4-5 months 
and 3-4½-6 months 

Antibody 
(cut-off) 

% % 

Anti-diphtheria  
(0.1 IU/ml) † 

93.1 99.7 

Anti-tetanus  
(0.1 IU/ml) † 

100 100 

Anti-B. Pertussis 
(vaccine response) †† 

97.2 97.7 

Anti-HBs  
(10 mIU/ml) † 

97.7* 99.2 

* in a subgroup of infants not administered hepatitis B vaccine at birth, 89.9% of subjects had anti-HBs titres 
≥ 10 mIU/ml 
† cut-off accepted as indicative of protection 
†† vaccine response: % of subjects considered to have responded to the Bordetella pertussis antigen 
 
5.2 Pharmacokinetic properties 
 
Evaluation of pharmacokinetic properties is not required for vaccines. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on general safety studies. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 



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6.1 List of excipients 
 
Thiomersal 
Sodium chloride 
Water for injections 
 
For adjuvants, see section 2. 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products except those mentioned in section 
6.6. 
 
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 a vial (type I glass) with a plunger stopper (rubber butyl) – pack size of 1. 
 
6.6 Special precautions for disposal and other handling 
 
Tritanrix HepB can be mixed with the lyophilised Hib vaccine (Hiberix). 
 
Upon storage, a white deposit and clear supernatant can be observed. 
 
The vaccine should be well shaken in order to obtain a homogeneous turbid white suspension and visually 
inspected for any foreign particulate matter and/or variation of physical aspect prior to administration. In the 
event of either being observed, discard the vaccine. 
 
Any unused product of 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/1/96/014/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 19 July 1996. 



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Date of latest renewal: 19 July 2006. 
 
 
10. DATE OF REVISION OF THE TEXT 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Tritanrix HepB, suspension for injection, multidose 
Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed) 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
1 dose (0.5 ml) contains: 
 
Diphtheria toxoid1 not less than 30 IU 
Tetanus toxoid1 not less than 60 IU 
Bordetella pertussis (inactivated)2 not less than 4 IU 
Hepatitis B surface antigen2,3 10 micrograms 
 
1 Adsorbed on aluminium hydroxide, hydrated 0.26 milligrams Al3+ 
2 Adsorbed on aluminium phosphate 0.37 milligrams Al3+ 
3 Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 
 
This is a multidose container. See section 6.5 for the number of doses per vial. 
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Suspension for injection. 
Turbid white suspension. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Tritanrix HepB is indicated for active immunisation against diphtheria, tetanus, pertussis and hepatitis 
B (HBV) in infants from 6 weeks onwards (see section 4.2). 
 
4.2 Posology and method of administration 
 
Posology 
 
The recommended dose is 0.5 ml. 
 
Primary vaccination: 
 
The primary vaccination schedule consists of three doses within the first six months of life.  Where HBV 
vaccine is not given at birth, the combined vaccine can be administered beginning as early as 8 weeks of 
age.  Where there is a high endemicity of HBV, the practice to administer HBV vaccine at birth should 
be continued.  In these circumstances, vaccination with the combined vaccine should start at 6 weeks of 
age. 
 
Three vaccine doses must be administered at intervals of at least 4 weeks. 
 
When Tritanrix HepB is given according to the 6-10-14 weeks schedule, it is recommended to 
administer a dose of HBV vaccine at birth to improve protection. 
 



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In the case of children born of known HBV carrier mothers the immunoprophylactic measures for 
hepatitis B should not be modified.  This may require separate vaccination with HBV and DTPw 
vaccines and also include the administration of HBIg at birth.  
 
Booster vaccination: 
 
A booster dose with Tritanrix HepB will give rise to increased reactogenicity as would be expected for a 
booster during the second year of life. In consequence, boostering should follow local recommendations.  
 
The administration of a booster dose with trivalent DTP vaccine is recommended before the end of the 
second year of life. For long-term protection against HBV, a booster dose of HBV vaccine could also be 
administered after the first year of life. However, the need for this dose is currently not established. 
 
Method of administration 
 
Tritanrix HepB is for deep intramuscular injection, preferably in the anterolateral thigh. 
 
It is recommended that in patients with thrombocytopenia or bleeding disorders the vaccine be administered 
subcutaneously (see section 4.4.). 
 
4.3 Contraindications 
 
Hypersensitivity to the active substances or to any of the excipients. 
 
Hypersensitivity after previous administration of diphtheria, tetanus, pertussis or hepatitis B vaccines. 
 
The administration of Tritanrix HepB should be postponed in subjects suffering from acute severe 
febrile illness. 
 
Tritanrix HepB is contraindicated if the child has experienced an encephalopathy of unknown aetiology, 
occurring within 7 days following previous vaccination with pertussis containing vaccine.  In these 
circumstances the vaccination course should be continued with DT and HBV vaccines. 
 
4.4 Special warnings and precautions for use 
 
Vaccination should be preceded by a review of the medical history (especially with regard to previous 
vaccination and possible occurrence of adverse reactions) and a clinical examination. 
 
As with all injectable vaccines, appropriate medical treatment should always be readily available in case 
of anaphylactic reactions following the administration of the vaccine.  For this reason, the vaccinee 
should remain under medical supervision for 30 minutes after vaccination. 
 
If any of the following events occur in temporal relation to receipt of Tritanrix HepB, the decision to give 
subsequent doses of vaccine containing the pertussis component should be carefully considered. 

Temperature of ≥ 40.0 C within 48 hours, not due to another identifiable cause. 
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours. 
Persistent crying lasting ≥ 3 hours, occurring within 48 hours. 
Convulsions with or without fever, occurring within 3 days. 

There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh 
possible risks.  
 
As for any vaccination, the risk-benefit of immunising with Tritanrix HepB or deferring this vaccination 
should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe 
neurological disorder. 
 



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A history of febrile convulsions, a family history of convulsions, a family history of SIDS (Sudden Infant 
Death Syndrome) and a family history of an adverse reaction following Tritanrix HepB vaccination do 
not constitute contra-indications. 
 
HIV infection is not considered as a contra-indication for diphtheria, tetanus, pertussis and HBV vaccination. 
The expected immunological response may not be obtained after vaccination of immunosuppressed patients, 
e.g. patients on immunosuppressive therapy. 
 
Tritanrix HepB should be administered with caution to subjects with thrombocytopenia or a bleeding 
disorder since bleeding may occur following an intramuscular administration to these subjects. 
 
TRITANRIX HepB SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED 
INTRAVENOUSLY. 
 
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when 
administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and 
particularly for those with a previous history of respiratory immaturity. 
 
As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or 
delayed. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
It is current practice in paediatric vaccination to co-administer different vaccines during the same 
session with injectable vaccines being administered at separate injection sites. 
 
Tritanrix HepB can be administered simultaneously at separate sites or in any temporal relationship with 
other paediatric vaccines if this fits conveniently in the immunisation scheme. 
 
In clinical studies, Tritanrix HepB has been administered simultaneously with oral polio vaccine (OPV) 
and Haemophilus influenzae type b (Hib) vaccine. In these studies the immune response to the oral polio 
vaccine has not been investigated, however, previous experience with simultaneous administration of 
DTP, OPV and HBV vaccines has not shown any interference.  In some clinical studies, Tritanrix HepB 
was used to reconstitute the lyophilised Hib vaccine (Hiberix); no interference in the immune response 
to any of the antigens was observed as compared to the responses observed following administration of 
the vaccines at separate sites. (see section 6.2.). 
 
In patients receiving immunosuppressive therapy or patients with immunodeficiency, an adequate 
response may not be achieved. 
 
4.6 Pregnancy and lactation 
 
As Tritanrix HepB is not intended for use in adults, information on the safety of the vaccine when used 
during pregnancy or lactation is not available. 
 
4.7 Effects on ability to drive and use machines 
 
Not relevant. 
 
4.8 Undesirable effects 
 
• Clinical trials: 
 

In clinical studies, the most commonly reported adverse events were reactions at the injection site, 
including redness, swelling and pain. 
 



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General reactions that may occur in temporal association with Tritanrix HepB vaccination  are listed 
below. 

 
 Frequencies are defined as follows: 

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) 
Not known (cannot be estimated from the available data) 
 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
 
Nervous system disorders: 
very common: drowsiness 
 
Respiratory, thoracic and mediastinal disorders: 
common: bronchitis  
uncommon: respiratory disorder 
 
Gastro-intestinal disorders: 
very common: feeding problems 
common: gastro-intestinal symptoms such as vomiting and diarrhoea 
 
Infections and infestations: 
common: otitis media, pharyngitis 
uncommon: pneumonia 
 
General disorders and administration site conditions: 
very common: fever, swelling, pain and redness 
 
Immune system disorders: 
very rare: allergic reactions including anaphylactic and anaphylactoid reactions and serum sickness 
like disease 
 
Psychiatric disorders: 
very common: unusual crying, irritability 
 



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In a prospective comparative study, which compared the administration of the combined DTPw-HBV 
vaccine with the simultaneous separate administration of DTPw and HBV vaccine, higher incidences of pain, 
redness, swelling and fever were reported in the group receiving the combined vaccine. The incidences are 
presented below: 
 
 Group 1 Group 2 
 DTPw-HBV 

(combined) 
 DTPw HBV 

(separate) 
N° of symptom checklists 
 

175 
 

177 177 

Local symptoms (%)    
 
Pain Total 

 
32.0 

 
15.3 

 
2.8 

 Severe* 0.0 0.0 0.0 
Redness Total 38.9 27.1 5.1 
 > 2cm 9.1 3.4 0.6 
Swelling Total 30.9 21.5 4.5 
 > 2cm 10.9 3.4 0.6 

 
 
General Symptoms (%) 
 

   

Fever > 38°C 53.1 35.0 
Fever > 39.5° C 1.1 0.0 

 
* reported by the parents as adversely affecting the child’s daily activities  
 
For both vaccination groups, the majority of the reactions were short lasting. 
 
• Post marketing surveillance: 
 

Nervous system disorders: 
Collapse or shock-like state (hypotonic-hyporesponsive episode). 
 
Respiratory, thoracic and mediastinal disorders: 
Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4) 

 
• Experience with hepatitis B vaccine: 
 

Blood and lymphatic system disorders: 
Thrombocytopenia 
 
Nervous system disorders: 
Convulsions 

 
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it 
is possible that sensitisation reactions may occur (see section 4.3) 
 
4.9 Overdose 
 
No case of overdose has been reported. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 



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Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code J07CA05. 
 
Tritanrix HepB contains diphtheria (D), tetanus (T) toxoids, inactivated pertussis bacteria (Pw) and 
the purified major surface antigen of the hepatitis B virus (HBV), adsorbed on aluminium salts. 
 
The D and T toxoids are prepared from the toxins of cultures of Corynebacterium diphtheriae and 
Clostridium tetani by formalin inactivation using established technology.  The Pw component is 
obtained by heat inactivation of phase I culture of Bordetella pertussis bacteria. 
 
The surface antigen of the HBV (HBsAg) is produced by culture of genetically-engineered yeast cells 
(Saccharomyces cerevisiae) which carry the gene coding for the major surface antigen of the HBV.  
This HBsAg expressed in yeast cells is purified by several physico-chemical steps.  The HBsAg 
assembles spontaneously, in the absence of chemical treatment, into spherical particles of 20 nm in 
average diameter containing non-glycosylated HBsAg polypeptide and a lipid matrix consisting 
mainly of phospholipids.  Extensive tests have demonstrated that these particles display the 
characteristic properties of the natural HBsAg. 
 
Four different schedules have been studied (6-10-14 weeks, 2-4-6 months; 3-4-5 months and 3-4½-6 months) 
according to routine vaccination practices in different countries with three doses administered within the first 
six months of life. 
 
For each component of the vaccine, the following immune responses have been documented one 
month after completion of the primary vaccination schedule. 
 
Percentage of subjects with antibody titres ≥ assay cut-off one month after primary vaccination with 
Tritanrix HepB: 
 

6-10-14 weeks 2-4-6 months; 3-4-5 months 
and 3-4½-6 months 

Antibody 
(cut-off) 

% % 

Anti-diphtheria  
(0.1 IU/ml) † 

93.1 99.7 

Anti-tetanus  
(0.1 IU/ml) † 

100 100 

Anti-B. Pertussis 
(vaccine response) †† 

97.2 97.7 

Anti-HBs  
(10 mIU/ml) † 

97.7* 99.2 

* in a subgroup of infants not administered hepatitis B vaccine at birth, 89.9% of subjects had anti-HBs titres 
≥ 10 mIU/ml 
† cut-off accepted as indicative of protection 
†† vaccine response: % of subjects considered to have responded to the Bordetella pertussis antigen 
 
5.2 Pharmacokinetic properties 
 
Evaluation of pharmacokinetic properties is not required for vaccines. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on general safety studies. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 



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6.1 List of excipients 
 
Thiomersal 
Sodium chloride 
Water for injections 
 
For adjuvants, see section 2. 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products except those mentioned in section 
6.6. 
 
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 
 
1 ml of suspension in a vial (type I glass) for 2 doses with a plunger stopper (rubber butyl) – pack size of 
1. 
 
5 ml of suspension in a vial (type I glass) for 10 doses with a plunger stopper (rubber butyl) – pack size of 
1. 
 
Not all pack-sizes may be marketed 
 
6.6 Special precautions for disposal and other handling 
 
Tritanrix HepB can be mixed with the lyophilised Hib vaccine (Hiberix). 
 
Upon storage, a white deposit and clear supernatant can be observed. 
 
The vaccine should be well shaken in order to obtain a homogeneous turbid white suspension and visually 
inspected for any foreign particulate matter and/or variation of physical aspect prior to administration.  In 
the event of either being observed, discard the vaccine. 
 
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. 
 
Any unused product of 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 



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8. MARKETING AUTHORISATION NUMBER 
 
EU/1/96/014/002 
EU/1/96/014/003 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 19 July 1996. 
Date of latest renewal: 19 July 2006. 
 
 
10. DATE OF REVISION OF THE TEXT 
 



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ANNEX II 
 

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND 
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH 
RELEASE 

 
B. CONDITIONS OF THE MARKETING AUTHORISATION 
 



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A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND 

MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH 
RELEASE  

 
Name and address of the manufacturers of the biological active substances 
 
GlaxoSmithKline  Biologicals s.a. 
Rue de l’Institut 89, 
1330 Rixensart 
Belgium 
 
Novartis Vaccines and Diagnostics GmbH & Co. KG 
Emil-von-Behring-Str. 76, 
D-35041 Marburg 
Germany 
 
Name and address of the manufacturer responsible for batch release 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89, 
1330 Rixensart 
Belgium 
 
 
B. CONDITIONS OF THE MARKETING AUTHORISATION 
 
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE 

MARKETING AUTHORISATION HOLDER 
 
Medicinal product subject to medical prescription. 
 
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE 

OF THE MEDICINAL PRODUCT 
 
Not applicable. 
 
• OTHER CONDITIONS 
 
PSUR: The Marketing Authorisation Holder will continue to submit Periodic Safety Update Reports on a 2 
years basis. 
 
Official batch release: in accordance with Article 114 of Directive 2001/83/EC as amended, the official batch 
release will be undertaken by a state laboratory or a laboratory designated for that purpose. 
 



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ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 



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A. LABELLING 
 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING   
MONODOSE VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tritanrix HepB – Suspension for injection 
Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 dose (0.5 ml): 
Diphtheria toxoid1 ≥ 30 IU 
Tetanus toxoid1 ≥ 60 IU 
Bordetella pertussis (inactivated)2 ≥ 4 IU 
Hepatitis B surface antigen2,3 10 µg 
 
1 adsorbed on aluminium hydroxide, hydrated 0.26 mg Al3+ 
2 adsorbed on aluminium phosphate 0.37 mg Al3+ 
3 produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 
 
 
3. LIST OF EXCIPIENTS 
 
Thiomersal 
Sodium chloride 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection 
 
1 vial 
1 dose (0.5 ml) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use 
intramuscular use 
Shake before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT  OF 

THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 



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8. EXPIRY DATE 
 
EXP: MM/YYYY 
 
 
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 

 
Dispose of in accordance with local regulations 
 
 
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/1/96/014/001 
 
 
13. BATCH NUMBER 
 
LOT: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
MONODOSE VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Tritanrix HepB – Suspension for injection 
DTPw-HBV vaccine 
I.M. 
 
 
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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PARTICULARS TO APPEAR ON THE OUTER PACKAGING   
MULTIDOSE VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tritanrix HepB – Suspension for injection 
Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 dose (0.5 ml): 
Diphtheria toxoid1 ≥ 30 IU 
Tetanus toxoid1 ≥ 60 IU 
Bordetella pertussis (inactivated)2 ≥ 4 IU 
Hepatitis B surface antigen2,3 10 µg 
 
1 adsorbed on aluminium hydroxide, hydrated 0.26 mg Al3+ 
2 adsorbed on aluminium phosphate 0.37 mg Al3+ 
3 produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 
 
 
3. LIST OF EXCIPIENTS 
 
Thiomersal 
Sodium chloride 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection 
1 vial 
2 doses (1 ml) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use 
intramuscular use 
Shake before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT  OF 

THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 



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EXP: MM/YYYY 
 
 
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 

 
Dispose of in accordance with local regulations 
 
 
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/1/96/014/003 
 
 
13. BATCH NUMBER 
 
LOT: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
MULTIDOSE VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Tritanrix HepB – Suspension for injection 
DTPw-HBV vaccine 
I.M. 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP:  
 
 
4. BATCH NUMBER 
 
LOT:  
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
2 doses (1 ml) 
 
 
6. OTHER 
 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING   
MULTIDOSE VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tritanrix HepB – Suspension for injection 
Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 dose (0.5 ml): 
Diphtheria toxoid1 ≥ 30 IU 
Tetanus toxoid1 ≥ 60 IU 
Bordetella pertussis (inactivated)2 ≥ 4 IU 
Hepatitis B surface antigen2,3 10 µg 
 
1 adsorbed on aluminium hydroxide, hydrated 0.26 mg Al3+ 
2 adsorbed on aluminium phosphate 0.37 mg Al3+ 
3 produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 
 
 
3. LIST OF EXCIPIENTS 
 
Thiomersal 
Sodium chloride 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection 
1 vial 
10 doses (5 ml) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use 
intramuscular use 
Shake before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT  OF 

THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 



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EXP: MM/YYYY 
 
 
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 

 
Dispose of in accordance with local regulations 
 
 
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/1/96/014/002 
 
 
13. BATCH NUMBER 
 
LOT: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS  
MULTIDOSE VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Tritanrix HepB – Suspension for injection 
DTPw-HBV vaccine 
I.M. 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP:  
 
 
4. BATCH NUMBER 
 
LOT:  
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
10 doses (5 ml) 
 
 
6. OTHER 
 



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B. PACKAGE LEAFLET 
 



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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. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or your pharmacist. 
- This vaccine has been prescribed for your child. Do not pass it on to others. 
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please 

tell your doctor or pharmacist. 
 
In this leaflet: 
1. What Tritanrix HepB is and what it is used for 
2. Before your child receives Tritanrix HepB 
3. How Tritanrix HepB is given 
4. Possible side effects 
5. How to store Tritanrix HepB 
6. Further information 
 
 
1.   WHAT TRITANRIX HepB IS AND WHAT IT IS USED FOR 
 
Tritanrix HepB is a vaccine used in children to prevent four diseases: diphtheria, tetanus (lockjaw), pertussis 
(whooping cough) and hepatitis B. The vaccine works by causing the body to produce its own protection 
(antibodies) against these diseases. 
 
• Diphtheria: Diphtheria mainly affects the airways and sometimes the skin.  Generally the airways 

become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation.  The bacteria 
also release a toxin (poison), which can cause nerve damage, heart problems, and even death. 

 
• Tetanus (Lockjaw): Tetanus bacteria enter the body through cuts, scratches or wounds in the skin.  

Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated 
with soil, dust, horse manure/dung or wood splinters.  The bacteria release a toxin (poison), which can 
cause muscle stiffness, painful muscle spasms, fits and even death.  The muscle spasms can be strong 
enough to cause bone fractures of the spine. 

 
• Pertussis (Whooping cough): Pertussis is a highly infectious illness.  The disease affects the airways 

causing severe spells of coughing that may interfere with normal breathing.  The coughing is often 
accompanied by a “whooping” sound, hence the common name “whooping cough”.  The cough may last 
for 1-2 months or longer.  Pertussis can also cause ear infections, bronchitis which may last a long time, 
pneumonia, fits, brain damage and even death.   

 
• Hepatitis B: Hepatitis B is caused by the hepatitis B virus.  It causes the liver to become inflamed and 

swollen .  The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of 
infected people. 

 
Vaccination is the best way to protect against these diseases. None of the components in the vaccine are 
infectious.  
 
 
2.  BEFORE YOUR CHILD RECEIVES TRITANRIX HepB 
 
Tritanrix HepB should not be given: 
 



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• if your child has previously had any allergic reaction to Tritanrix HepB, or any ingredient contained in 
this vaccine.  The active substances and other ingredients in Tritanrix HepB are listed at the end of the 
leaflet.  Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of 
the face or tongue. 

• if your child has previously had an allergic reaction to any vaccine against diphtheria, tetanus, 
pertussis (whooping cough) or hepatitis B diseases. 

• if your child experienced problems of the nervous system within 7 days after previous vaccination 
with a vaccine against pertussis (whooping cough) disease. 

• if your child has a severe infection with a high temperature (over 38°C).  A minor infection such as a 
cold should not be a problem, but talk to your doctor first. 

 
Take special care with Tritanrix HepB: 
 
• if your child has experienced any health problems after previous administration of a vaccine. 
• if after previously having Tritanrix HepB or another vaccine against pertussis (whooping cough) 

disease, your child had any problems, especially:  
♦ A high temperature (over 40°C) within 48 hours of vaccination 
♦ A collapse or shock-like state within 48 hours of vaccination 
♦ Persistent crying lasting 3 hours or more within 48 hours of vaccination 
♦ Seizures/fits with or without a high temperature within 3 days of vaccination 

• if your child is suffering from an undiagnosed or progressive disease of the brain or uncontrolled 
epilepsy. After control of the disease the vaccine should be administered 

• if your child has a bleeding problem or bruises easily 
• if your child has a tendency to seizures/fits due to a fever, or if there is a history in the family of this 
 
Using other medicines or vaccines 
Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines 
obtained without a prescription or has recently received any other vaccine. 
 
Important information about some of the ingredients of Tritanrix HepB 
This medicinal product contains thiomersal as a preservative and it is possible that your child may 
experience an allergic reaction. Tell your doctor if your child has any known allergies. 
 
 
3. HOW TRITANRIX HepB IS GIVEN 
 
Your child will receive a total of three injections with an interval of at least one month between each one. 
Each injection is given on a separate visit. You will be informed by the doctor or nurse when you should 
come back for subsequent injections. 
 
If additional injections are necessary, the doctor will tell you. 
 
If your child misses a scheduled injection, talk to your doctor and arrange another visit. 
 
Make sure your child finishes the complete vaccination course of three injections.  If not, your child may not 
be fully protected against the diseases. 
 
The doctor will give Tritanrix HepB as an injection into the thigh muscle. Your child will remain under 
medical supervision for 30 minutes after each injection. 
 
The vaccine should never be given into a vein. 
 
 
4.  POSSIBLE SIDE EFFECTS 
 
Like all medicines, Tritanrix HepB can cause side effects, although not everybody gets them. 



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Side effects that occurred during clinical trials with Tritanrix HepB were as follows: 
 
♦ Very common (side effects which may occur in more than 1 per 10 doses of vaccine):  

• pain or discomfort at the injection site 
• redness or swelling at the injection site 
• fever (more than 38°C) 
• drowsiness, irritability, unusual crying 
• feeding problems 

 
♦ Common (side effects which may occur in less than 1 per 10 but more than 1 per 100 doses of 

vaccine):  
• infection of the middle ear 
• bronchitis 
• sore throat and discomfort when swallowing 
• gastrointestinal symptoms such as vomiting and diarrhoea 
 

♦ Uncommon (side effects which may occur in less than 1 per 100 but more than 1 per 1,000 doses of 
vaccine):  
• pneumonia (serious lung infection) 
• respiratory disorder 

 
♦ Very rare (side effects which may occur in less than 10,000 doses of vaccine):  

• allergic reactions, including anaphylactic and 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.  

• serum sickness like disease (a hypersensitivity reaction to the administration of a foreign serum 
with symptoms like fever, swelling, skin rash, enlargement of the lymph nodes) 

 
After the marketing of Tritanrix HepB, the following additional side effects have been reported on a few 
occasions: 
 

• collapse or periods of unconsciousness or lack of awareness have been reported within 2 to 3 days 
after vaccination 

• in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal 
between breaths may occur for 2-3 days after vaccination 

 
Tritanrix HepB contains a hepatitis B component, to provide protection against disease caused by hepatitis B 
virus.  The following undesirable events have occurred very rarely following the administration of hepatitis 
B containing vaccines: 
♦ seizures or fits 
♦ bleeding or bruising more easily than normal 
 
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your 
doctor or pharmacist. 
 
 
5.  HOW TO STORE TRITANRIX HepB 
 
Keep out of the reach and sight of children. 
 
Do not use Tritanrix HepB after the expiry date which is stated on the carton. The expiry date refers to the 
last day of that month. 
 



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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. 
 
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 
dispose of medicines no longer required.  These measures will help to protect the environment. 
 
 
6. FURTHER INFORMATION 
 
What Tritanrix HepB contains 
 
- The active substances contained in 1 dose (0.5 ml) are:  
 Diphtheria toxoid1 ≥ 30 IU 
 Tetanus toxoid1 ≥ 60 IU 
 Bordetella pertussis (inactivated)2 ≥ 4 IU 
 Hepatitis B surface antigen2,3 10 µg 
 
 1 adsorbed on aluminium hydroxide, hydrated 0.26 mg Al3+ 
 2 adsorbed on aluminium phosphate 0.37 mg Al3+ 
 3 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. 
 
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 
 



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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 
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 

 



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Tel: +370 5 264 90 00 
info.lt@gsk.com 
 
This leaflet was last approved in  
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: 
http://www.emea.europa.eu/. 
 
--------------------------------------------------------------------------------------------------------------------- 
 
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.  
 

http://www.emea.europa.eu/


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PACKAGE LEAFLET: INFORMATION FOR THE USER 

 
Tritanrix HepB suspension for injection, multidose 

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. 
- Keep this leaflet . You may need to read it again. 
- If you have any further questions, ask your doctor or your pharmacist. 
- This vaccine has been prescribed for your child. Do not pass it on to others. 
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please 

tell your doctor or pharmacist. 
 
In this leaflet: 
1. What Tritanrix HepB is and what it is used for 
2. Before your child receives Tritanrix HepB 
3. How Tritanrix HepB is given 
4. Possible side effects 
5. How to store Tritanrix HepB 
6. Further information 
 
 
1.   WHAT TRITANRIX HepB IS AND WHAT IT IS USED FOR 
 
Tritanrix HepB is a vaccine used in children to prevent four diseases: diphtheria, tetanus (lockjaw), pertussis 
(whooping cough) and hepatitis B. The vaccine works by causing the body to produce its own protection 
(antibodies) against these diseases. 
 
• Diphtheria: Diphtheria mainly affects the airways and sometimes the skin.  Generally the airways 

become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation.  The bacteria 
also release a toxin (poison), which can cause nerve damage, heart problems, and even death. 

 
• Tetanus (Lockjaw): Tetanus bacteria enter the body through cuts, scratches or wounds in the skin.  

Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated 
with soil, dust, horse manure/dung or wood splinters.  The bacteria release a toxin (poison), which can 
cause muscle stiffness, painful muscle spasms, fits and even death.  The muscle spasms can be strong 
enough to cause bone fractures of the spine. 

 
• Pertussis (Whooping cough): Pertussis is a highly infectious illness.  The disease affects the airways 

causing severe spells of coughing that may interfere with normal breathing.  The coughing is often 
accompanied by a “whooping” sound, hence the common name “whooping cough”.  The cough may last 
for 1-2 months or longer.  Pertussis can also cause ear infections, bronchitis which may last a long time, 
pneumonia, fits, brain damage and even death.   

 
• Hepatitis B: Hepatitis B is caused by the hepatitis B virus.  It causes the liver to become inflamed and 

swollen.  The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of 
infected people. 

 
Vaccination is the best way to protect against these diseases. None of the components in the vaccine are 
infectious.  
 
 
2.  BEFORE YOUR CHILD RECEIVES TRITANRIX HepB 
 
Tritanrix HepB should not be given: 
 



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• if your child has previously had any allergic reaction to Tritanrix HepB, or any ingredient contained in 
this vaccine.  The active substances and other ingredients in Tritanrix HepB are listed at the end of the 
leaflet.  Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of 
the face or tongue. 

• if your child has previously had an allergic reaction to any vaccine against diphtheria, tetanus, 
pertussis (whooping cough) or hepatitis B diseases. 

• if your child experienced problems of the nervous system within 7 days after previous vaccination 
with a vaccine against pertussis (whooping cough) disease. 

• if your child has a severe infection with a high temperature (over 38°C).  A minor infection such as a 
cold should not be a problem, but talk to your doctor first. 

 
Take special care with Tritanrix HepB: 
 
• if your child has experienced any health problems after previous administration of a vaccine.  
• if after previously having Tritanrix HepB or another vaccine against pertussis (whooping cough) 

disease, your child had any problems, especially:  
♦ A high temperature (over 40°C) within 48 hours of vaccination 
♦ A collapse or shock-like state within 48 hours of vaccination 
♦ Persistent crying lasting 3 hours or more within 48 hours of vaccination 
♦ Seizures/fits with or without a high temperature within 3 days of vaccination 

• if your child is suffering from an undiagnosed or progressive disease of the brain or uncontrolled 
epilepsy. After control of the disease the vaccine should be administered 

• if your child has a bleeding problem or bruises easily 
• if your child has a tendency to seizures/fits due to a fever, or if there is a history in the family of this 
 
Using other medicines or vaccines 
Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines 
obtained without a prescription or has recently received any other vaccine. 
 
Important information about some of the ingredients of Tritanrix HepB 
This medicinal product contains thiomersal as a preservative and it is possible that your child may 
experience an allergic reaction. Tell your doctor if your child has any known allergies. 
 
 
3. HOW TRITANRIX HepB IS GIVEN 
 
Your child will receive a total of three injections with an interval of at least one month between each one. 
Each injection is given on a separate visit. You will be informed by the doctor or nurse when you should 
come back for subsequent injections. 
 
If additional injections are necessary, the doctor will tell you. 
 
If your child misses a scheduled injection, talk to your doctor and arrange another visit. 
 
Make sure your child finishes the complete vaccination course of three injections.  If not, your child may not 
be fully protected against the diseases. 
 
The doctor will give Tritanrix HepB as an injection into the thigh muscle. Your child will remain under 
medical supervision for 30 minutes after each injection. 
 
The vaccine should never be given into a vein. 
 
 
4.  POSSIBLE SIDE EFFECTS 
 
Like all medicines, Tritanrix HepB can cause side effects, although not everybody gets them. 



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Side effects that occurred during clinical trials with Tritanrix HepB were as follows: 
 
♦ Very common (side effects which may occur in more than 1 per 10 doses of vaccine):  

• pain or discomfort at the injection site 
• redness or swelling at the injection site 
• fever (more than 38°C) 
• drowsiness, irritability, unusual crying 
• feeding problems 

 
♦ Common (side effects which may occur in less than 1 per 10 but more than 1 per 100 doses of 

vaccine):  
• infection of the middle ear 
• bronchitis 
• sore throat and discomfort when swallowing 
• gastrointestinal symptoms such as vomiting and diarrhoea 
 

♦ Uncommon (side effects which may occur in less than 1 per 100 but more than 1 per 1,000 doses of 
vaccine):  
• pneumonia (serious lung infection) 
• respiratory disorder 

 
♦ Very rare (side effects which may occur in less than 10,000 doses of vaccine):  

• allergic reactions, including anaphylactic and 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.  

• serum sickness like disease (a hypersensitivity reaction to the administration of a foreign serum 
with symptoms like fever, swelling, skin rash, enlargement of the lymph nodes) 

 
After the marketing of Tritanrix HepB, the following additional side effects have been reported on a few 
occasions: 
 

• collapse or periods of unconsciousness or lack of awareness have been reported within 2 to 3 days 
after vaccination 

• in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal 
between breaths may occur for 2-3 days after vaccination 

 
Tritanrix HepB contains a hepatitis B component, to provide protection against disease caused by hepatitis B 
virus. The following undesirable events have occurred very rarely following the administration of hepatitis B 
containing vaccines: 
♦ seizures or fits 
♦ bleeding or bruising more easily than normal 
 
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your 
doctor or pharmacist. 
 
 
5.  HOW TO STORE TRITANRIX HepB 
 
Keep out of the reach and sight of children. 
 
Do not use Tritanrix HepB after the expiry date which is stated on the carton. The expiry date refers to the 
last day of that month. 
 



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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. 
 
Medicines should not be disposed of via wastewater or household waste.  Ask your pharmacist how to 
dispose of medicines no longer required. These measures will help to protect the environment. 
 
 
6. FURTHER INFORMATION 
 
What Tritanrix HepB contains 
 
- The active substances contained in 1 dose (0.5 ml) are:  
 Diphtheria toxoid1 ≥ 30 IU 
 Tetanus toxoid1 ≥ 60 IU 
 Bordetella pertussis (inactivated)2 ≥ 4 IU 
 Hepatitis B surface antigen2,3 10 µg 
 
 1 adsorbed on aluminium hydroxide, hydrated 0.26 mg Al3+ 
 2 adsorbed on aluminium phosphate 0.37 mg Al3+ 
 3 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: 
 
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 
 
 



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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 
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 

United Kingdom 
GlaxoSmithKline UK 



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Tel: + 371 67312687 
lv-epasts@gsk.com 
 

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  
 
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: 
http://www.emea.europa.eu/. 
 
--------------------------------------------------------------------------------------------------------------------- 
 
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. 

http://www.emea.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE 
	B. CONDITIONS OF THE MARKETING AUTHORISATION

	A. LABELLING
	B. PACKAGE LEAFLET