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Pentaxim

Pentaxim Special Precautions

haemophilus influenzae type b conjugate vaccine

Manufacturer:

Sanofi Pasteur

Distributor:

Zuellig
Full Prescribing Info
Special Precautions
Talk to a doctor before using PENTAXIM.
If child has blood disorders such as a low number of platelets (thrombocytopenia) or clotting disorders due to the risk of bleeding, which may occur during intramuscular administration.
If child has ever had seizures with fever, not related to a previous vaccine injection; it is particularly important in this case to monitor the temperature within 48 hours of vaccination and to give regular treatment to reduce the fever, for 48 hours.
If child has had any of the following events after receiving a vaccine (the decision to give further doses of vaccine containing a pertussis valence should then be carefully evaluated): Fever greater than or equal to 40°C within 48 hours, without any other identifiable cause, Collapse or state suggesting a state of shock with episode of hypotonia-hyporesponsiveness (decrease in tone) within 48 hours of vaccination, Persistent, inconsolable crying for 3 hours or more, occurring within 48 hours after vaccination, Convulsions with or without fever, occurring within 3 days after vaccination.
If child has or has had any medical problems or allergies, in particular an allergic reaction following an injection of PENTAXIM.
If child has had Guillain-Barré syndrome (abnormal sensitivity, paralysis) or brachial plexus neuropathy (paralysis, widespread pain in the arm and shoulder) after injection of a vaccine containing tetanus toxoid (tetanus vaccine), the decision to re-administer a vaccine containing tetanus toxoid in this case will be evaluated by the doctor.
If child has experienced swelling (oedematous reactions) of the lower limbs following an injection of a vaccine containing the Haemophilus influenzae type b valence: the administration of the diphtheria-tetanus-pertussis-poliomyelitis vaccine and the Haemophilus influenzae type b conjugate vaccine must then be carried out at two separate injection sites and on different days.
If child has weakened immune defenses or is undergoing treatment with corticosteroids, cytotoxic medicines, radiotherapy or other treatments that may weaken his immune system: then the immune response may be diminished. It is then recommended to wait until the end of the treatment or the disease to vaccinate. Nevertheless, vaccination is recommended in subjects with chronic immunosuppression, such as HIV infection, even if the immune response may be limited.
PENTAXIM does not protect against invasive diseases caused by serotypes other than Haemophilus influenzae type b, nor against meningitis of other origins.
Fainting can occur following, or even before, any needle injection. Also, tell the doctor or nurse if the child has fainted from a previous injection.
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 small amount of alcohol in this medicine will not have any noticeable effect.
PENTAXIM contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially 'sodium-free'.
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 1 to 2 weeks after vaccination. Other tests should be done to confirm Hib infection during this time.
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