ISOPEDIA, electrolytes and glucose

PAEDIATRIC INTENSIVE CARE - New medicinal product
Opinions on drugs - Posted on Jul 07 2017

Reason for request

Inclusion

No clinical benefit demonstrated in the therapeutic strategy of its different indications

 

  • ISOPEDIA, solution for infusion, has Marketing Authorisation in newborns and children up to 14 years of age, in the following cases:

 - Perioperative plasma-isotonic fluid and electrolyte replacement with partial coverage of carbohydrate requirements,

 - Short-term intravascular fluid replacement,

 - Treatment of isotonic dehydration,

 - Use as carrier solution for compatible electrolyte concentrates and medicinal products.

  • This ready-to-use injectable solution has a composition suitable for paediatric use.
  • Its isotonic nature and its composition could help to prevent the occurrence of serious and irreversible neurological complications due to perioperative dilutional hyponatraemia in children.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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