Afssaps recalls the modes of administration of Uvestol

Afssaps recalls the modes of administration of Uvestol

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Following the administration of Uvestol, new cases of malaise have been reported in newborns. The French Agency for the safety of health products, Afssaps, recalls the need to respect the methods of administration of this drug indicated in the prevention and treatment of vitamin D deficiency. (News from 22/03 / 11)

Enhanced pharmacovigilance

  • Uvestol is a medicine whose prescription is widespread in the prevention of vitamin D deficiency in infants and children up to 5 years.
  • Already in 2006, cases of vagal discomfort (apnea of ​​the infant) had been demonstrated during the administration of Uvestol.
  • The hypothesis of a "false route" mechanism linked to too fast administration of the product seemed to be most likely.
  • New cases of recent discomfort have led Afssaps to scrupulously strengthen Uvestol's recommendations for administration.

Limit the dangers

  • For premature infants and in case of gastroesophageal reflux, Afssaps recalls that Uvestol must always be diluted in a little water or milk and administered in a pacifier.
  • When the product can be used pure, it is imperative to use the syringe supplied with the vial for oral administration
  • In all cases, Afssaps recalls that the child must be in a semi-sitting position (head slightly bent, resting on the arm).
  • The product should be administered slowly to give the infant time to swallow it naturally.

Frédérique Odasso