Pentaxim Special Precautions

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 thrombocytopenia 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.
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 after 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, diphtheria-tetanus-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 Interactions.
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.
Effects on Ability to Drive and Use Machines: Not applicable.
PENTAXIM is intended for paediatric use only.