Infanrix Penta

Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 

1 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

 
1. NAME OF THE MEDICINAL PRODUCT 
 
Infanrix Penta, Suspension for injection  
Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), 
poliomyelitis (inactivated) (IPV) 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 40 IU 
Bordetella pertussis antigens 
 Pertussis toxoid1  25 micrograms 

Filamentous Haemagglutinin1  25 micrograms 
Pertactin1 8 micrograms 
Hepatitis B surface antigen2,3 10 micrograms 

Poliovirus (inactivated)  
 type 1 (Mahoney strain)4 40 D-antigen unit 

type 2 (MEF-1 strain) 4 8 D-antigen unit 
type 3 (Saukett strain) 4 32 D-antigen unit 

 
1adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 0.5 milligrams Al3+  
2produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 
3adsorbed on aluminium phosphate (AlPO4) 0.2 milligrams Al3+ 
4propagated in VERO cells 
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Suspension for injection  
Infanrix Penta is a turbid white suspension. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Infanrix Penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, 
pertussis, hepatitis B and poliomyelitis.  
 
 
4.2 Posology and method of administration 
 
Posology 
 
Primary vaccination: 
 
The primary vaccination schedule consists of three doses of 0.5 ml (such as 2, 3, 4 months; 3, 4, 5 
months; 2, 4, 6 months) or two doses (such as 3, 5 months). There should be an interval of at least 1 
month between doses.  
 

2 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

The Expanded Program on Immunisation schedule (at 6, 10, 14 weeks of age) may only be used if a 
dose of hepatitis B vaccine has been given at birth. 
 
Locally established immunoprophylactic measures against hepatitis B should be maintained. 
 
Where a dose of hepatitis B vaccine is given at birth, Infanrix Penta can be used as a replacement for 
supplementary doses of hepatitis B vaccine from the age of six weeks. If a second dose of hepatitis B 
vaccine is required before this age, monovalent hepatitis B vaccine should be used. 
 
Booster vaccination: 
 
After a vaccination with 2 doses (e.g. 3, 5 months) of Infanrix Penta a booster dose must be given at 
least 6 months after the last priming dose, preferably between 11 and 13 months of age. 
 
After vaccination with 3 doses (e.g. 2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) of Infanrix Penta a 
booster dose must be given at least 6 months after the last priming dose and preferably before 18 
months of age. 
 
Booster doses should be given in accordance with the official recommendations. 
 
Infanrix Penta can be considered for the booster if the composition is in accordance with the official 
recommendations. 
 
Paediatric population 
 
There is no relevant use of Infanrix Penta in children over 36 months. 
 
Method of administration 
 
Infanrix Penta is for deep intramuscular injection, preferably at alternating sites for subsequent 
injections. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substances or to any of the excipients or neomycin and polymyxin. 
 
Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B or polio 
vaccines. 
 
Infanrix Penta is contraindicated if the infant has experienced an encephalopathy of unknown 
aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine. 
In these circumstances pertussis vaccination should be discontinued and the vaccination should be 
continued with diphtheria-tetanus, hepatitis B and polio vaccines. 
 
As with other vaccines, administration of Infanrix Penta should be postponed in subjects suffering 
from acute severe febrile illness. The presence of a minor infection is not a contraindication. 
 
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 undesirable events) and a clinical examination. 
 
If any of the following events are known to have occurred in temporal relation to receipt of pertussis-
containing vaccine, the decision to give further doses of pertussis-containing vaccines should be 
carefully considered: 

• Temperature of ≥ 40.0 C within 48 hours, not due to another identifiable cause; 

3 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

• Collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of 
vaccination; 

• Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination; 
• Convulsions with or without fever, occurring within 3 days of vaccination. 

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 Infanrix Penta 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. 
 
As with all injectable vaccines, appropriate medical treatment and supervision should always be 
readily available in case of a rare anaphylactic event following the administration of the vaccine.  
 
Infanrix Penta should be administered with caution to subjects with thrombocytopenia or a bleeding 
disorder since bleeding may occur following an intramuscular administration to these subjects. 
 
Infanrix Penta should under no circumstances be administered intravascularly or intradermally. 
 
Infanrix Penta will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, 
Clostridium tetani, Bordetella pertussis, hepatitis B virus or poliovirus. However, it can be expected 
that hepatitis D will be prevented by immunisation as hepatitis D (caused by the delta agent) does not 
occur in the absence of hepatitis B infection. 
 
As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section 
5.1). 
 
A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome 
(SIDS) do not constitute a contraindication for the use of Infanrix Penta. Vaccinees with a history of 
febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days 
post vaccination. 
 
HIV infection is not considered as a contraindication. The expected immunological response may not 
be obtained after vaccination of immunosuppressed patients. 
 
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 the 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 
 
Clinical studies have demonstrated that Infanrix Penta can be administered simultaneously with 
Haemophilus influenzae type b vaccines. In these clinical studies, the injectable vaccines were given at 
different injection sites. 
 
There are no data with regard to the efficacy and safety of simultaneous administration of Infanrix 
Penta and Measles-Mumps-Rubella vaccine. 
 
As with other vaccines, it may be expected that in patients receiving immunosuppressive therapy an 
adequate response may not be achieved.   
 
4.6 Fertility, pregnancy and lactation 
 
As Infanrix Penta is not intended for use in adults, adequate human data on use during pregnancy or 
lactation and adequate animal reproduction studies are not available. 

4 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

 
4.7 Effects on ability to drive and use machines   
 
Not relevant. 
 
4.8 Undesirable effects 
 
• Clinical trials 
 
The safety profile presented below is based on data from more than 10,000 subjects. In virtually all 
instances, Infanrix Penta was administered at the same time as a Hib vaccine. 
 
As has been observed for DTPa and DTPa-containing combinations, an increase in local 
reactogenicity and fever was reported after booster vaccination with Infanrix Penta with respect to the 
primary course. 
 

- Tabulated summary of adverse reactions (clinical trials): 
 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
 
Frequencies per dose 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) 
 
Nervous system disorders: 
Uncommon: somnolence 
Very rare: convulsions (with or without fever) 
 
Respiratory, thoracic and mediastinal disorders
Uncommon: cough 
 
Gastrointestinal disorders: 
Common: diarrhoea, vomiting 
 
Skin and subcutaneous tissue disorders
Uncommon: dermatitis, rash 
Very rare: urticaria 
 
Metabolism and nutrition disorders 
Very common: appetite lost 
 
General disorders and administration site conditions: 
Very common: fever ≥ 38°C, local swelling at the injection site (≤ 50 mm), fatigue, pain, redness 
Common: fever >39.5°C, local swelling at the injection site (> 50 mm)*, injection site reactions, 
including induration  
Uncommon: diffuse swelling of the injected limb, sometimes involving the adjacent joint* 
 
Psychiatric disorders: 
Very common: crying abnormal, irritability, restlessness 
Uncommon: nervousness 
 

5 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

• Post-marketing surveillance 
 
Nervous system disorders: 
Collapse or shock-like state (hypotonic-hyporesponsiveness episode) 
 
Respiratory, thoracic and mediastinal disorders: 
Apnoea [see section 4.4 for apnoea in very premature infants (≤ 28 weeks of gestation)]  
 
General disorders and administration site conditions: 
Swelling of the entire injected limb* 
 
Immune system disorders 
Allergic reactions, including anaphylactic and anaphylactoid reactions  
 
• Experience with hepatitis B vaccine: 
 
In extremely rare cases, paralysis, neuropathy, Guillain-Barré syndrome, encephalopathy, encephalitis 
and meningitis have been reported.  The causal relationship to the vaccine has not been established. 
Thrombocytopenia has been reported with hepatitis B vaccine. 
 
* Children primed with acellular pertussis vaccines are more likely to experience swelling reactions 
after booster administration in comparison with children primed with whole cell vaccines.  These 
reactions resolve over an average of 4 days. 
 
4.9 Overdose 
 
No case of overdose has been reported. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code J07CA12 
 
Results obtained in the clinical studies for each of the components are summarised in the tables below:  
 
Percentage of subjects with antibody titres ≥ assay cut-off one month after primary vaccination 
with Infanrix Penta 

 
Antibody 
(cut-off) 

3-5 
months 
N= 168 

6-10-14  
weeks 

N= 362 

1.5-3.5-6 
months 
N= 55 

2-3-4 
months 
N= 326 

2-4-6 
months 

N= 1146) 

3-4-5 
months 
N= 884 

3-4.5-6 
months 
N=554 

Anti-diphtheria  
(0.1 IU/ml) † 

97.6 99.2 100 99.7 99.7 99.3 100 

Anti-tetanus 
(0.1 IU/ml) † 

99.4 100 100 100 100 99.4 100 

Anti-PT 
(5 EL.U/ml) 

100 99.7 100 100 99.7 99.4 100 

Anti-FHA  
(5 EL.U/ml) 

100 99.4 100 100 100 99.5 100 

Anti-PRN 
(5 EL.U/ml) 

100 100 100 100 99.8 99.5 100 

Anti-HBs 
(10 mIU/ml) † 

96.8 98.7* 100 98.4 99.4 98.2 99.6 

Anti-Polio type 1 
(1/8 dilution) † 

97.4 99.4 ND 99.6 99.7 99.5 100 

6 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

Anti-Polio type 2 
(1/8 dilution) † 

94.7 99.2 ND 97.1 99.6 99.5 100 

Anti-Polio type 3 
(1/8 dilution) † 

99.3 99.4 ND 99.6 99.9 99.5 100 

N = number of subjects 
ND = not determined 
* in a subgroup of infants not administered hepatitis B vaccine at birth, 80.2% of subjects had anti-
HBs titres ≥ 10 mIU/ml 
† cut-off accepted as indicative of protection 
 
Percentage of subjects with antibody titres ≥ assay cut-off one month after booster vaccination 
with Infanrix Penta 
Antibody 
(cut-off) 

Booster vaccination at 
11/12 months of age 

following a 3-5 month 
primary course 

N = 168 

Booster vaccination 
during the second 

year of life following a 
three dose primary 

course 
N = 350 

Anti-diphtheria 
(0.1 IU/ml) † 

100 100 

Anti-tetanus 
(0.1 IU/ml) † 

100 100 

Anti-PT 
(5 EL.U/ml) 

100 99.7 

Anti-FHA 
(5 EL.U/ml) 

100 99.7 

Anti-PRN 
(5 EL.U/ml) 

100 99.7 

Anti-HBs 
(10 mIU/ml) † 

100 98.8 

Anti-Polio type 1 
(1/8 dilution) † 

100 99.7 

Anti-Polio type 2 
(1/8 dilution) † 

100 100 

Anti-Polio type 3 
(1/8 dilution) † 

100 100 

N = number of subjects 
† cut-off accepted as indicative of protection 
 
As the immune response to pertussis antigens following Infanrix Penta administration is equivalent to 
that of Infanrix, the protective efficacy of the two vaccines is expected to be equivalent. 

 
The clinical protection of the pertussis component of Infanrix, against WHO-defined typical pertussis 
(≥ 21 days of paroxysmal cough) was demonstrated in: 
 
- a prospective blinded household contact study performed in Germany (3, 4, 5 months schedule). 

Based on data collected from secondary contacts in households where there was an index case 
with typical pertussis, the protective efficacy of the vaccine was 88.7%. 
 

- a NIH sponsored efficacy study performed in Italy (2, 4, 6 months schedule). The vaccine 
efficacy was found to be 84%. In a follow-up of the same cohort, the efficacy was confirmed up 
to 60 months after completion of primary vaccination without administration of a booster dose 
of pertussis. 

 
Results of long term follow-up in Sweden demonstrate that acellular pertussis vaccines are efficacious 
in infants when administered according to the 3 and 5 months primary vaccination schedule, with a 

7 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

booster dose administered at approximately 12 months. However, data indicate that protection against 
pertussis may be waning at 7-8 years of age with this 3-5-12 months schedule. This suggests that a 
second booster dose of pertussis vaccine is warranted in children aged 5-7 years who have previously 
been vaccinated following this particular schedule. 
 
Protective antibodies against hepatitis B have been shown to persist for at least 3.5 years in more than 
90% of children administered four doses of a combined vaccine containing the same HBs antigen as 
Infanrix Penta. Antibody levels were not different from what was observed in a parallel cohort 
administered 4 doses of monovalent hepatitis B vaccine. 
 
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 conventional studies of safety, specific 
toxicity, repeated dose toxicity and compatibility of ingredients. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium chloride (NaCl) 
Medium 199 containing principally amino acids, mineral salts, vitamins  
Water for injections 
 
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. 
 
Upon removal from the refrigerator, the vaccine is stable for 8 hours at 21°C. 
 
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 pre-filled syringe (type I glass) with plunger stoppers (butyl). 
 
Pack sizes of 1, 10, 20 and 50 with or without needles. 
 
Not all pack sizes may be marketed. 
 

8 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

6.6  Special precautions for disposal and other handling 
 
Upon storage, a white deposit and clear supernatant may be observed. This does not constitute a sign 
of deterioration. 
 
The syringe should be well shaken in order to obtain a homogeneous turbid white suspension. 
 
The DTPa-HBV-IPV suspension should be inspected visually for any foreign particulate matter and/or 
abnormal physical appearance. 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 NUMBERS 
 
EU/1/00/153/001 
EU/1/00/153/002 
EU/1/00/153/003 
EU/1/00/153/004 
EU/1/00/153/005 
EU/1/00/153/006 
EU/1/00/153/007 
EU/1/00/153/008 
EU/1/00/153/009 
EU/1/00/153/010 
 
 
9.  DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 23 October 2000 
Date of latest renewal: 23 October 2005 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 

9 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

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

 
B.  CONDITIONS OF THE MARKETING AUTHORISATION 
 

10 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

 
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 
 
Pharmacovigilance system 
The MAH must ensure that the system of pharmacovigilance, as described in version 3.06 
presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before 
and whilst the product is on the market. 
 
PSURs 
The holder of marketing authorisation will submit 2-yearly PSURs. 
 
 
The holder of the marketing authorisation must inform the European Commission about the marketing 
plans for the medicinal product authorised by this decision. 
 
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. 

11 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 

12 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 

13 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
1 PRE-FILLED SYRINGE WITHOUT NEEDLE 
10 PRE-FILLED SYRINGES WITHOUT NEEDLES 
20 PRE-FILLED SYRINGES WITHOUT NEEDLES 
50 PRE-FILLED SYRINGES WITHOUT NEEDLES 
1 PRE-FILLED SYRINGE WITH 1 NEEDLE 
10 PRE-FILLED SYRINGES WITH 10 NEEDLES 
20 PRE-FILLED SYRINGES WITH 20 NEEDLES 
50 PRE-FILLED SYRINGES WITH 50 NEEDLES 
1 PRE-FILLED SYRINGE WITH 2 NEEDLES 
10 PRE-FILLED SYRINGES WITH 20 NEEDLES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Infanrix Penta, Suspension for injection 
Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), 
poliomyelitis (inactivated) (IPV) vaccine (adsorbed) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 dose (0.5 ml): 
Diphtheria toxoid1  ≥ 30 IU 
Tetanus toxoid1  ≥ 40 IU 
Bordetella pertussis antigens  
(Pertussis toxoid1, Filamentous haemagglutinin1, Pertactin1) 25, 25, 8 micrograms 
Hepatitis B surface antigen2 10 micrograms 
Poliovirus (inactivated) type 1, 2, 3 40, 8, 32 DU 
 
1adsorbed on Al(OH)3 0.5 milligrams Al3+
2adsorbed on AlPO4 0.2 milligrams Al3+ 
 
 
3. LIST OF EXCIPIENTS 
 
Sodium chloride  
Medium 199 containing principally amino acids, mineral salts, vitamins 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection 
1 pre-filled syringe 
1 dose (0.5 ml) 
 
10 pre-filled syringes  
10 x 1 dose (0.5 ml) 
 
20 pre-filled syringes  
20 x 1 dose (0.5 ml) 
 
50 pre-filled syringes  

14 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

50 x 1 dose (0.5 ml) 
 
1 pre-filled syringe + 1 needle 
1 dose (0.5 ml) 
 
10 pre-filled syringes + 10 needles 
10 x 1 dose (0.5 ml) 
 
20 pre-filled syringes + 20 needles 
20 x 1 dose (0.5 ml) 
 
50 pre-filled syringes + 50 needles 
50 x 1 dose (0.5 ml) 
 
1 pre-filled syringe + 2 needles 
1 dose (0.5 ml) 
 
10 pre-filled syringes + 20 needles 
10 x 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 
 
 
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 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

15 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
B-1330 Rixensart, Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/00/153/001 - 1 pre-filled syringe without needle  
EU/1/00/153/002 - 10 pre-filled syringes without needles 
EU/1/00/153/003 - 20 pre-filled syringes without needles 
EU/1/00/153/004 - 50 pre-filled syringes without needles 
EU/1/00/153/005 - 1 pre-filled syringe with 1 needle 
EU/1/00/153/006 - 10 pre-filled syringes with 10 needles 
EU/1/00/153/007 - 20 pre-filled syringes with 20 needles 
EU/1/00/153/008 - 50 pre-filled syringes with 50 needles 
EU/1/00/153/009 - 1 pre-filled syringe with 2 needles 
EU/1/00/153/010 - 10 pre-filled syringes with 20 needles 
 
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 
 

16 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Infanrix Penta 
Suspension for injection 
DTPa-HBV-IPV 
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 
 

17 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 

18 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

 
Infanrix Penta, Suspension for injection 

Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), 
poliomyelitis (inactivated) (IPV) vaccine (adsorbed) 

 
Read all of this leaflet carefully before your child receives 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 Infanrix Penta is and what it is used for 
2. Before your child receives Infanrix Penta 
3. How Infanrix Penta is given 
4. Possible side effects 
5. How to store Infanrix Penta 
6. Further information 
 
 
1.   WHAT INFANRIX PENTA IS AND WHAT IT IS USED FOR 
 
Infanrix Penta is a vaccine used to protect your child again five diseases:  
• Diphtheria - a serious bacterial infection that mainly affects the airways and sometimes the skin. 

The airways become swollen causing serious breathing problems and sometimes suffocation. The 
bacteria also release a poison. This can cause nerve damage, heart problems, and even death. 

 
• Tetanus - tetanus bacteria enter the body through cuts, scratches or wounds in the skin. Wounds 

that are more likely to get tetanus infection are burns, fractures, deep wounds or wounds that have 
soil, dust, horse manure or wood splinters in them. The bacteria release a poison. This 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. 

 
• Whooping cough (Pertussis) - a highly infectious illness that affects the airways. It causes severe 

coughing that may lead to problems with breathing. The coughing often has a “whooping” sound. 
The cough may last for one to two months or longer. Whooping cough can also cause ear 
infections, chest infections (bronchitis) which may last a long time, lung infections (pneumonia), 
fits, brain damage and even death.   

 
• Hepatitis B - is caused by the hepatitis B virus. It makes the liver swollen. The virus is found in 

body fluids such as in the vagina, blood, semen, or spit (saliva) of infected people. 
 
• Polio - a viral infection. Polio is often only a mild illness. However, sometimes it can be very 

serious and cause permanent damage or even death. Polio can make the muscles unable to move 
(paralysis). This includes the muscles needed for breathing and walking. The arms or legs affected 
by the disease may be painfully twisted (deformed). 

 
How the vaccine works 
• Infanrix Penta helps your child’s body make its own protection (antibodies). This will protect your 

child against these diseases. 
• As with all vaccines, Infanrix Penta may not fully protect all children who are vaccinated. 
• The vaccine cannot cause the diseases that it protects your child from. 
 

19 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

 
2.   BEFORE YOUR CHILD RECEIVES INFANRIX PENTA 
 
Infanrix Penta should not be given if: 
 
• your child is allergic (hypersensitive) to  

- Infanrix Penta, or any ingredients in Infanrix Penta (listed in Section 6)  
- neomycin or polymyxin (antibiotics). 

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

• your child has had an allergic reaction to any vaccine against diphtheria, tetanus, whooping 
cough, hepatitis B or polio. 

• your child has had problems of the nervous system within 7 days after previous vaccination 
with a vaccine against whooping cough. 

• 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. 

 
Infanrix Penta should not be given if any of the above apply to your child. If you are not sure, talk to 
your doctor or pharmacist before your child is given Infanrix Penta. 
 
Take special care with Infanrix Penta 
 
Check with your doctor or pharmacist before your child is given this vaccine if: 
 
• after previously having Infanrix Penta or another vaccine against whooping cough, 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 
- fits with or without a high temperature within 3 days of vaccination 

• your child has an undiagnosed or progressive disease of the brain or epilepsy which is not 
controlled. After control of the disease the vaccine can be given. 

• your child has a bleeding problem or bruises easily 
• your child tends to have fits when they have a fever, or if there is a history of this in the family. 
If any of the above apply to your child (or you are not sure), talk to your doctor or pharmacist before 
your child is given Infanrix Penta. 
 
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 had any other vaccine. 
 
Important information about some of the ingredients of Infanrix Penta 
This vaccine contains neomycin and polymyxin (antibiotics). Please tell your doctor if your child has 
had an allergic reaction to these ingredients. 
 
 
3.  HOW INFANRIX PENTA IS GIVEN 
 
How much is given 
• Your child will have a total of two or three injections with at least 1 month between each injection.  
• You will be told by the doctor or nurse when your child should come back for their next injections. 
• If additional injections (boosters) are necessary, the doctor will tell you. 

 
How the vaccine is given 
• Infanrix Penta will be given as an injection into a muscle.   
• The vaccine should never be given into a blood vessel or into the skin. 

20 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

 
If your child misses a dose 
• If your child misses an injection which is due, it is important that you make another appointment. 
• Make sure your child finishes the complete vaccination course. If not, your child may not be 

fully protected against the diseases. 
 
 
4.   POSSIBLE SIDE EFFECTS 
 
Like all medicines, Infanrix Penta can cause side effects, although not everybody gets them. The 
following side effects may happen with this vaccine: 
 
Allergic reactions 
If your child has an allergic reaction, see your doctor straight away. The signs may include: 
• 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. 
These signs usually start very soon after the injection has been given. Talk to a doctor straight away if 
they happen after leaving the doctor’s surgery. 
 
See your doctor straight away if your child has any of the following serious side effects: 
• collapse 
• times when they lose consciousness or have a lack of awareness 
• fits – this may be when they have a fever 
These side effects have happened very rarely with other vaccines against whooping cough. They 
usually happen within 2 to 3 days after vaccination. 
 

Other side effects include: 
 
Very common (these may occur with more than 1 in 10 doses of the vaccine) 
• feeling tired 
• loss of appetite 
• high temperature of 38°C or higher 
• swelling, pain and redness where the injection was given 
• unusual crying 
• feeling irritable or restless. 
 
Common (these may occur in with up to 1 in 10 doses of the vaccine) 
• diarrhoea  
• being sick (vomiting) 
• high temperature of more than 39.5°C 
• swelling larger than 5 cm or hard lump where the injection was given. 
 
Uncommon (these may occur in up to 1 in 100 doses of the vaccine) 
• feeling sleepy 
• cough 
• itching (dermatitis), rash 
• large swelling at the injected limb 
• feeling nervous. 
 
Very rare (these may occur with up to 1 in 10,000 doses of the vaccine) 
• 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 
• temporarily stopping breathing (apnoea)  

21 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

• lumpy rash (hives) 
• swelling of the whole injected limb. 
 
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.  HHOW TO STORE INFANRIX PENTA 
 
• Keep out of the reach and sight of children. 
• Do not use Infanrix Penta 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. 
• 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 Infanrix Penta contains 
 
The active substances are: 

Diphtheria toxoid1 not less than 30 IU 
Tetanus toxoid1 not less than 40 IU 
Bordetella pertussis antigens 
 Pertussis toxoid1 25 micrograms 
 Filamentous Haemagglutinin1 25 micrograms 
 Pertactin1 8 micrograms 
Hepatitis B surface antigen2,3 10 micrograms 
Poliovirus (inactivated) 

type 1 (Mahoney strain) 4 40 D-antigen unit 
type 2 (MEF-1 strain) 4 8 D-antigen unit 
type 3 (Saukett strain) 4 32 D-antigen unit 

 
1adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 0.5 milligrams Al3+
2produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 
3adsorbed on aluminium phosphate (AlPO4) 0.2 milligrams Al3+ 
4propagated in VERO cells 

 
The other ingredients in Infanrix Penta are: sodium chloride (NaCl), medium 199 containing 
principally amino acids, mineral salts, vitamins and water for injections. 
 
What Infanrix Penta looks like and contents of the pack 
 
• Infanrix Penta is a white, slightly milky liquid presented in a pre-filled syringe (0.5 ml).  
• Infanrix Penta is available in packs of 1, 10, 20 and 50 with or 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 

22 



Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

 
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: + 420 222 001 111 
gsk.czmail@gsk.com 
 

Malta 
GlaxoSmithKline Malta 
Tel: + 356 21 238131 
 

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

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 

23 

mailto:dk-info@gsk.com


Me
dic

ina
l p

rod
uc

t n
o l

on
ge

r a
uth

ori
se

d

 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 
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 (EMA) web 
site: http://www.ema.europa.eu/. 
------------------------------------------------------------------------------------------------------------------------------- 
 
The following information is intended for medical or healthcare professionals only: 
 
Upon storage, a white deposit and clear supernatant can be observed. This does not constitute a sign of 
deterioration. 
 
The syringe should be well shaken in order to obtain a homogeneous turbid white suspension.  
 
The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV-IPV) 
suspension should be inspected visually for any foreign particulate matter and/or variation of physical 
aspect. In the event of either being observed, discard the container.  

24 

http://www.ema.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