Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: SANOFI PASTEUR, 14 Espace Henry Vallée, 69007 Lyon, France
The immunogenicity of PENTAXIM may be reduced by immunosuppressive treatment or immunodeficiency. It is then recommended to wait until the end of the treatment or disease before vaccinating. Nevertheless, vaccination of subjects with chronic immunodeficiency such as HIV infection is recommended even if the immune response may be limited.
If Guillain-Barré syndrome or brachial neuritis has occurred in subjects following receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks of vaccination. Vaccination is usually justified for infants whose primary immunization schedules are incomplete (i.e. fewer than three doses administered).
Do not inject via the intravascular route: make sure the needle does not penetrate a blood vessel. Do not inject via the intradermal route.
As with all injectable vaccines, PENTAXIM must be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Vaccination must be preceded by medical history screening (especially with regard to vaccination history and any 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 vaccine, the decision to give further doses of pertussis-containing vaccine should be carefully considered:
A history of febrile convulsions not related to a previous vaccine injection is not a contraindication to vaccination. In this respect, it is particularly important to monitor the temperature in the 48 hours following vaccination and to give antipyretic treatment regularly for 48 hours.
A history of afebrile convulsions not related to a previous vaccine injection should be assessed by a specialist before deciding to vaccinate.
In the event of oedematous reactions occurring in the lower limbs after injection of a Haemophilus influenzae type b-containing vaccine, the two vaccines, diphtheria-tetanus-pertussis-poliomyelitis vaccine and the Haemophilus influenzae type b conjugate vaccine should be administered in two separate injection sites and on two different days.
As with all injectable vaccines, appropriate medical treatment must be readily available and close supervision provided should a rare anaphylactic reaction occur following administration of the vaccine.
PENTAXIM does not protect against invasive diseases caused by serotypes other than Haemophilus influenzae type b, nor against meningitis from other origins.
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.
Interference with laboratory tests: see Section 4.5.
Pentaxim contains 12.5 micrograms phenylalanine in each 0.5 ml dose. Phenylalanine may be harmful for individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Pentaxim contains 2 mg of alcohol (ethanol) in each 0.5 ml dose. The small amount of alcohol in this medicine will not have any noticeable effects.
Pentaxim contains less than 1 mmol sodium per dose, that is to say essentially “sodium-free”.
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 can be administered simultaneously with the M-M-RVAXPRO vaccine or with the HBVAXPRO vaccine, but in two separate sites.
Since the Hib capsular polysaccharide antigen is excreted in the urine, a positive urine test can be observed within 1 to 2 weeks following vaccination. Other tests should be performed in order to confirm Hib infection during this period.
Not applicable.
PENTAXIM is intended for paediatric use only.
Not applicable.
PENTAXIM is intended for paediatric use only.
The adverse events are ranked under headings 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.
Based on spontaneous reports, certain undesirable events were very rarely reported following the use of PENTAXIM. Because 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.
In clinical studies in children who received PENTAXIM as a primary series, the most frequently reported reactions are local injection-site reactions, abnormal crying, irritability and fever.
These signs and symptoms usually occur within 48 hours following the vaccination and may continue for 48-72 hours. They resolve spontaneously without specific treatment.
The frequency of injection-site reactions tends to increase at booster vaccination compared with the frequency observed for primary series.
Reactions with a Not Known frequency:
Very common reactions:
Very common reactions:
Common reactions:
Uncommon reactions:
Very common reactions:
Reactions with a Not Known frequency:
Very common reactions:
Common reactions:
Reactions with a Not Known frequency:
Very common reactions:
Common reactions:
Uncommon reactions:
Rare reactions:
Oedematous reactions on one or on both lower limbs may occur after vaccination with a Haemophilus influenzae type b conjugate-containing vaccine. These reactions generally occur after primary series, within hours of the vaccination, and resolve without sequelae within 24 hours. These reactions may be accompanied with cyanosis, erythema, transient purpura and severe crying.
Reactions with a Not Known frequency:
Apnoea in very premature infants (born ≤28 weeks of gestation) (see Section 4.4).
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: Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Tel.: +357 22608607, Fax: +357 22608669, Website: www.moh.gov.cy/phs
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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