PENTAXIM (DTaP-IPV-Hib) is indicated for the joint prevention of diphtheria, tetanus, pertussis,
poliomyelitis, and invasive Haemophilus influenzae type b infections (meningitis, septicaemia, cellulitis,
arthritis, epiglottitis, etc.):
• in primary vaccination in infants from the age of 2 months,
• booster at 11 months of age.
This vaccine does not protect against infections caused by other types of Haemophilus influenzae, nor
against meningitis caused by other micro-organisms.

PENTAXIM should be administered according to current official recommendations.
Posology
Paediatric population
Primary vaccination: 2 injections two months apart, one at the age of 2 months, and one at the age of 4
months.
Booster: 1 injection at the age of 11 months.
Method of administration
Administer intramuscularly (IM).
Administration will preferably be in the anterolateral aspect of the thigh (middle third) in infants, and in the
deltoid region in children.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
After reconstitution, the suspension is cloudy and whitish.

The immunogenicity of PENTAXIM may be reduced by immunosuppressive therapy, or an
immunodeficiency state. It is then recommended to wait until the end of the treatment or the disease to
vaccinate. Nevertheless, vaccination of subjects with chronic immunosuppression, such as HIV infection,
is recommended even if the immune response may be limited.
In subjects who have had Guillain-Barré syndrome or brachial plexus neuropathy during previous
administration of a vaccine containing tetanus toxoid, the decision to vaccinate with a vaccine containing
tetanus toxoid should be based on careful evaluation of the potential benefits and risks of continuing this
vaccination. Vaccination is usually warranted in young children for whom the primary vaccination schedule
is not complete (i.e. less than three doses administered).
Do not inject intravascularly: ensure that the needle does not enter a blood vessel.
Do not inject intradermally.
As with any injectable vaccine, PENTAXIM should be administered with caution in case of
thrombocytopaenia or coagulation disorders, because intramuscular injection may cause bleeding in these
subjects.
Vaccination must be preceded by a search of the medical history (especially for previous vaccinations and
adverse events that may have occurred), and a physical examination.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the
needle injection. Procedures should be put in place to prevent any injury due to fainting and to manage
syncopal reactions.
If the occurrence of any of the following events is chronologically linked to the administration of the vaccine,
the decision to administer further doses of vaccine containing a pertussis component should be carefully
considered:
• Fever ≥ 40°C within 48 hours, with no other identifiable cause.
• Collapse or shock-like state with episode of hypotonia-hyporesponsiveness within 48 hours of
vaccination.
• Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours after vaccination.
• Seizures with or without fever, occurring within 3 days after vaccination.
A history of febrile convulsions unrelated to a previous vaccine injection does not in itself constitute a
contraindication to vaccination.
It is particularly important in this field to monitor the temperature within 48 hours of vaccination, and to give
regular antipyretic treatment for 48 hours.
A history of non-febrile seizures unrelated to a previous vaccine injection must be the subject of specialist
advice before any decision to vaccinate.
In the event of oedematous reactions of the lower limbs occurring following an injection of a vaccine
containing the Haemophilus influenzae type b valence, the administration of the two vaccines, diphtheriatetanus-
pertussis-poliomyelitis vaccine and the Haemophilus influenzae type b conjugate vaccine must be
carried out at two separate injection sites, and on different days.
As with any injectable vaccine, appropriate medical treatment should be immediately available, and
monitoring should be carried out for the rare event that an anaphylactic reaction occurs after vaccine
administration.
PENTAXIM does not protect against invasive diseases caused by serotypes other than Haemophilus
influenzae type b, nor against meningitis of other origins.
The potential risk of apnoea and the need for respiratory monitoring for 48–72 hours should be carefully
considered when administering the primary vaccination doses in very premature infants (born at ≤ 28 weeks
of pregnancy), and particularly for those with a history of respiratory immaturity. Due to the high benefit of
vaccination in these infants, administration should not be suspended or postponed.
Interference with laboratory tests: see section 4.5.
PENTAXIM contains phenylalanine, ethanol, and sodium
PENTAXIM contains 12.5 micrograms of phenylalanine per 0.5 ml dose. Phenylalanine may be dangerous
for people with phenylketonuria (PKU), a rare genetic condition where phenylalanine builds up and cannot
be eliminated properly.
PENTAXIM contains 2 mg of alcohol (ethanol) per 0.5 ml dose. The low quantity of alcohol in this medicinal
product is unlikely to cause a notable effect.
PENTAXIM contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially “sodium free”.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the
administered product should be clearly recorded.

This vaccine may be administered simultaneously, but at two separate sites, with the M-M-RVaxPro vaccine
or the HBVaxPro vaccine.
Interference with laboratory testing
Due to the urinary elimination of the Hib polysaccharide capsular antigen, a positive result may be observed
in a urine test for 1 to 2 weeks after vaccination. Other tests should be done to confirm Hib infection during
this time.

Not applicable.
PENTAXIM is intended for paediatric use only.

Not applicable.
PENTAXIM is intended for paediatric use only.

Adverse reactions are ranked in terms of frequency using the following convention:
Very common: ≥ 10%
Common: ≥ 1% and < 10%
Uncommon: ≥ 0.1% and < 1%
Rare: ≥ 0.01% and < 0.1%
Very rare: < 0.01%
Not known: cannot be estimated from the available data.
According to spontaneous reports, some adverse events have been reported very rarely following the use
of PENTAXIM. As events are reported voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. This is
why these undesirable events are ranked under the “Not known” frequency.
During clinical studies in children who received PENTAXIM as a primary vaccination series, the most
frequently reported reactions were local reactions at the injection site, abnormal crying, irritability, and fever.
These signs and symptoms usually appear within 48 hours of vaccination, and may last between 48 and
72 hours. They disappear spontaneously without specific treatment.
The frequency of reactions at the injection site tends to increase during the booster compared to the
frequency observed in the primary vaccination series.
Immune system disorders
Reactions of unknown frequency
• Immediate hypersensitivity reactions such as face oedema, angioedema, Quincke’s oedema,
anaphylactic reactions, and shock.
Metabolism and nutrition disorders
Very common reactions
• Loss of appetite.
Psychiatric disorders
Very common reactions
• Nervousness, irritability.
• Abnormal crying and screaming.
Common reactions
• Insomnia, sleep disorders.
Uncommon reactions
• Inconsolable and prolonged crying and screaming.
Nervous system disorders
Very common reactions
• Somnolence.
Reactions of unknown frequency
• Seizures with or without fever.
• Episodes of hypotonia-hyporesponsiveness.
Gastrointestinal disorders
Very common reactions
• Vomiting.
Common reactions
• Diarrhoea.
Skin and subcutaneous tissue disorders
Reactions of unknown frequency
• Skin rashes, erythema, urticaria.
General disorders and administration site conditions
Very common reactions
• Erythema at the injection site.
• Fever ≥ 38°C.
• Oedema at the injection site.
• Pain at the injection site.
Common reactions
• Induration at the injection site.
Uncommon reactions
• Fever ≥ 39°C.
• Redness and oedema ≥ 5 cm at the injection site.
Rare reactions
• Fever > 40°C
Oedematous reactions of one or both lower limbs may occur after vaccination with a vaccine containing the
Haemophilus influenzae type b conjugate valence. These reactions occur mainly after the primary
vaccination, in the first hours following vaccination, and disappear spontaneously and without sequelae
within 24 hours. These reactions may be accompanied by cyanosis, erythema, transient purpura, and
severe crying.
Reactions of unknown frequency
• Large reactions at the injection site (> 50 mm), including limb oedema, which may extend from the
injection site to either of the adjacent joints. These reactions appear 24 to 72 hours after vaccination,
and may be associated with symptoms such as erythema, warmth, tenderness, or pain at the injection
site. They disappear spontaneously in 3 to 5 days. The risk appears to be related to the number of
previous doses of vaccine containing the acellular pertussis component, with an increased risk after
the 4th and 5th dose.
Potential adverse reactions (i.e., which have not been reported directly with PENTAXIM, but with other
vaccines containing one or more of the antigenic constituents of PENTAXIM):
• Guillain-Barré syndrome and brachial plexus neuropathy after administration of a vaccine containing
tetanus toxoid.
Additional information concerning particular populations
Apnoea in very premature infants (born at ≤ 28 weeks pregnancy) (see section 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are
asked to report any suspected adverse reactions via the national reporting system.
To reports any side effect(s):
Saudi Arabia:
• The National Pharmacovigilance Centre (NPC):
- SFDA Call Center: 19999
- E-mail: npc.drug@sfda.gov.sa
- Website: https://ade.sfda.gov.sa/
Other GCC States:
- Please contact the relevant competent authority.
Sanofi Pharmacovigilance:
- KSA_Pharmacovigilance@sanofi.com
For any other medical inquiry:
- KSA.Medicalenquiry@sanofi.com

Not documented.

Pharmacotherapeutic group: Associated bacterial and viral vaccines, ATC code: J07CA06.
The diphtheria and tetanus toxins are detoxified by formaldehyde, and then purified.
The poliomyelitis vaccine is obtained by culture of polio virus types 1, 2, and 3 on Vero cells, purified, and
then inactivated by formaldehyde.
The acellular pertussis components (PT and FHA) are extracted from cultures of Bordetella pertussis, then
purified. The pertussis toxin (PT) is detoxified by glutaraldehyde, and corresponds to pertussis toxoid
(PTxd). The FHA is native. PTxd and FHA have been shown to play a major role in protection as regards
pertussis.
The capsular polysaccharide PRP (polyribosyl ribitol phosphate) is extracted from the culture of
Haemophilus influenzae type b, and conjugated to the protein tetanus (T) constituting the PRP-T conjugate
vaccine.
Capsular polysaccharide (polyribosyl ribitol phosphate: PRP) induces a serological anti-PRP response in
humans. However, as with all polysaccharide antigens, the immune response is thymus-independent,
characterised by low immunogenicity in infants, and by the absence of a booster effect before the age of
15 months. The covalent bond of the capsular polysaccharide of Haemophilus influenzae type b to a carrier
protein, tetanus protein, allows the conjugate vaccine to behave as a thymus-dependent antigen leading to
a specific anti-PRP serological response in the infant, and to achieve a booster effect.
Immune response after primary vaccination:
Immunogenicity studies performed in infants one month after primary vaccination showed that all infants
(100%) developed a protective antibody titre (> 0.01 IU/ml) against diphtheria and tetanus antigens.
For pertussis, one month after receiving the three primary doses, anti-PT and anti-FHA antibody titres
increased fourfold in 93%, and more than 88% of infants, respectively.
At least 99% of primary vaccinated children had protective titres of antibodies directed against poliomyelitis
virus types 1, 2, and 3 (≥ 5 reciprocal of dilution in seroneutralisation).
Finally, one month after the third dose of primary vaccination, at least 97.2% of vaccinated infants have an
anti-PRP antibody titre greater than 0.15 μg/ml.
Immune response after booster:
After the first booster dose (16–18 months), all the children developed protective antibody titres against
diphtheria (> 0.1 IU/ml) and tetanus (> 0.1 IU/ml), and against poliomyelitis viruses (≥ 5 reciprocal of dilution
in seroneutralisation).
The rate of seroconversion to pertussis antibodies (titres greater than 4 times the pre-vaccination titres) is
at least 98% for PT (EIA), and 99% for FHA (EIA).
An anti-PRP antibody titre of ≥1.0 μg/ml was obtained in all children.
A follow-up study of pertussis immunogenicity in children aged 5–6 years showed that the anti-PT and anti-
FHA antibody titres of children who received primary and booster vaccinations with combined acellular
vaccines were at least equivalent to those observed in children of the same age who had been vaccinated
with combined whole-cell pertussis vaccines.

Not applicable.

Non-clinical data reveal no special hazard for humans based on conventional studies of acute toxicity,
repeated dose toxicity and local tolerability.

Suspension for injection:
• Hanks’ Medium 199 without phenol red
• Glacial acetic acid and/or sodium hydroxide (for pH adjustment)
• Formaldehyde
• Phenoxyethanol
• Ethanol anhydrous
• Water for injections.
Hanks’ Medium 199 is a complex mixture of amino acids (including phenylalanine), mineral salts, vitamins
and other components (such as glucose), diluted in water for injections.
Powder:
• Sucrose
• Trometamol
• Concentrated hydrochloric acid for pH adjustment.
For the adsorbent, see section 2.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
products.

Store in a refrigerator (2°C – 8°C).
Do not freeze
For storage conditions after reconstitution of the medicinal product, see section 6.3. 

• Powder in vial (type I glass) fitted with a stopper (chlorobutyl) + 0.5 ml of suspension in pre-filled syringe
(type I glass) fitted with a plunger stopper (bromobutyl or chlorobutyl). Box of 1, 10 or 20.
• Powder in a vial (type I glass) fitted with a stopper (chlorobutyl) + 0.5 ml of suspension in a pre-filled
syringe (type I glass) fitted with a plunger stopper (bromobutyl or chlorobutyl), a tip-cap, without needle.
Box of 1 or 20.
• Powder in a vial (type I glass) fitted with a stopper (chlorobutyl) + 0.5 ml of suspension in a pre-filled
syringe (type I glass) fitted with a plunger stopper (bromobutyl or chlorobutyl), a tip-cap, with two
separate needles. Box of 1 or 10.
Not all pack sizes may be marketed.

For syringes without a needle attached, the needle should be fitted firmly onto the syringe by rotating it a
quarter turn.
Reconstitute the solution by injecting the combined diphtheria, tetanus, acellular pertussis, and poliomyelitis
vaccine suspension into the Haemophilus type b conjugate vaccine powder vial. Shake until the powder is
completely dissolved. The cloudy whitish appearance of the suspension after reconstitution is normal.
The vaccine should be administered immediately after reconstitution.
Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.